cyrilzakka/clinical-trials huggingface dataset:
Study With Lu AF20513 in Patients With Mild Alzheimer's Disease (AD) or Mild Cognitive Impairment (MCI) Due to AD

The purpose of this study is to study the effect of monthly dosing with a single dose of Lu AF20513, with and without booster vaccine, on antibody response.

Cohort 1 encompasses 8 patients enrolled prior to the Protocol Amendment (PA) 1, dose regimen 1.

Cohort 2 includes patients enrolled under the PA and will consist of 20 patients, randomly assigned to two arms:

* dose regimen 2: 10 patients who will receive one administration of booster vaccine 4 weeks prior to the first IMP administration
* dose regimen 3: 10 patients who will not receive a booster vaccine

After the PA1, the study consists of the following periods:

* Screening Period - up to 12 weeks
* Priming period: 28 weeks, monthly dosing with Lu AF20513
* Maintenance Period - 56 weeks, quarterly dosing with Lu AF20513
* Follow-up Period - 4 weeks

Eligibility Criteria:
Inclusion Criteria:

* The patient has a diagnosis of AD or Mild Cognitive Impairment (MCI) due to AD.
* The patient has evidence of an abnormal amyloid and tau status, consistent with AD, by means of a positive CSF test at screening
* The patient is aged ≥50 and ≤85 years. If a woman, the patient must be post-menopausal.

Exclusion Criteria:

* The patient has participated in a clinical study where he/she has received passive or active anti-Aβ immunotherapy or other active immunisation for the treatment of AD.
* The patient has, in the investigator's opinion, evidence and/or history (clinically or on MRI) of any clinically significant neurodegenerative disease, serious neurological disorder, other intracranial or systemic diseases or conditions resulting in a definite or probable diagnosis of Major or Mild Neuro-Cognitive disorder other than AD, per DSM-5® criteria.

Other in- and exclusion criteria may apply
Zanubrutinib Combined With Rituximab and Chemotherapy for Newly-Diagnosed PCNSLBCL Patients Intolerant to HSCT

This single-center, open, single-arm study aim to evaluate the efficacy and tolerability of a therapy introducing zanubrutinib on the basis of rituximab and methotrexate (MTX) \[or temozolomide (TMZ), if intolerant to MTX\] in treating patients newly diagnosed with primary CNS large B-cell lymphoma and intolerant to HSCT.

Participants will receive zanubrutinib in addition to first-line therapy consisting of rituximab and either MTX or TMZ. After treatment of 6 cycles with the new regimen, the patients achieving CR or PR would go on to receive zanubrutinib maintenance of 1 year (if tolerable).

Eligibility Criteria:
Inclusion Criteria:

* 18 to 80 years old;
* Histopathologically confirmed CD20 positive primary large B-cell lymphoma of the central nervous system (CNS) or primary vitreoretinal lymphoma according to the 5th edition of the World Health Organization (WHO) Classification of Haematolymphoid Tumours \[primary large B-cell lymphoma of the CNS previously named as primary diffuse large B-cell lymphoma (DLBCL) of the CNS in the revised 4th edition\];
* Life expectancy of \> 3 months (in the opinion of the investigator);
* Creatinine Clearance Rate (CCR) ≥ 50 mL/min or estimated Glomerular Filtration Rate (eGFR) ≥ 60 mL/(min·1.73 m\^2);
* International Normalized Ratio (INR) ≤ 1.5 and activated Partial Thromboplastin Time (aPTT) ≤ 1.5 times the upper limit of normal;
* Left Ventricular Ejection Fraction (LVEF) ≥ 50%;
* Agreeing to provide written informed consent prior to any special examination or procedure for the research on their own or legal representative.

Exclusion Criteria:

* Pregnant or lactating women;
* Known Hepatitis B Virus (HBV) and/or Hepatitis C Virus (HCV) infection (HBV infection refers to HBV-DNA \> detectable limit);
* With acquired or congenital immunodeficiency;
* With congestive heart failure in 6 months before enrollment, New York Heart Association (NYHA) heart function class III or IV, or LVEF \< 50%;
* Known to be allergic to the test drug ingredients;
* Diagnosed with or being treated for malignancy other than lymphoma;
* With severe infection;
* Substance abuse, medical, psychological, or social conditions that may interfere with the subjects' participation in the study or evaluation of the study results;
* Deemed unsuitable for the group.
Evaluation of the Pharmacokinetic Interaction Between Candesartan and Felodipine After Ingestion of a Specific Meal

The purpose of this study is to evaluate the pharmacokinetic interaction of test formulations of candesartan and felodipine in a combination package comparing with the fasting intake of commercial formulations of both Atacand ® and Splendil®


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* BMI \> or = 19 and \< or = 28 (Dietary Guidelines Advisory Committee, 2005)

Exclusion Criteria:

* Not healthy
* Chronic drug intake
Effect of Anesthesia Technique on Outcome After Hip Fracture Surgery in Elderly Adult Patients

Despite many previous studies, whether anesthetic technique will significantly affect overall patient outcome, morbidity and mortality in elderly hip fracture patients is controversial. Due to old age, poor patient condition and emergent clinical settings, patients undergoing surgical procedures for hip fracture management are often subject to poor postoperative outcome and high mortality rates. While many studies have reported that regional anesthesia leads to improved postoperative outcome after hip fracture surgery, others have concluded otherwise. Moreover, because the majority of these previous studies are retrospective cohorts or systemic reviews, there is a need for randomized clinical trials to provide high quality evidence. This study aims to compare patient outcome between three different anesthetic techniques in elderly patients undergoing surgery for hip fracture management by evaluating proinflammatory cytokines, chemistry lab testing and clinical outcome between general anesthesia with either desflurane or propofol-based TIVA and spinal anesthesia with bupivacaine.


Eligibility Criteria:
Inclusion Criteria:

1. Patients older than 65 years scheduled for elective or emergency hip fracture surgery.

Exclusion Criteria:

1. Patient refusal
2. Inflammation or wound at puncture site, increased intracranial pressure, bleeding diathesis
3. Allergies to propofol or its ingredients, soybeans or peanuts
4. Patients with altered mental status
5. Illiterate patients or foreigners
Efficacy of Additional Osteotomies to Correct Hallux Valgus

Deviation of the big toe in valgus at the level of the first metatarsophalangeal joint is called Hallux Valgus. In case of significant pain especially due to a conflict with the shoes, surgery could be indicated. Angle between the first metatarsal (M1) and the first phalangeal (P1) is named Hallux Valgus Angle (HVA). Angle between M1 and the second metatarsal (M2) is named InterMetatarsal Angle (IMA). Angle between M1 distal articular surface and M1 shaft axis in a frontal plane is named Distal Metatarsal Articular Angle (DMAA).

Insufficient surgical correction is a risk factor of recurrence (HVA\>20° after surgery). According to Okuda et al in a 67 patients group treated by proximal osteotomies correction, postoperative risk factors of recurrence at 33 month of follow-up are : HVA\>40° before the surgery and HVA\>15° with an IMA\>10° 10 weeks (3-24) after the surgery.

Currently, one of the most common used procedure is a translated (laterally) distal chevron associated with a release of the metatarso-sesamoid suspensory ligament and a Akin procedure on P1. Nevertheless this procedure does not correct deformation in all plans. HVA and IMA are corrected but DMAA and M1 pronation angle are not.

Surgeons can add three different osteotomies in this type of chevron. In the dorsal saw cut a varisation wedge osteotomy is possible , in the plantar saw cut a supination wedge osteotomy is possible, and both are possible. No studies have tried to assess these three possibilities.

The investigators hypothesize that the addition of a varisation and/or a supination wedge osteotomies in a distal chevron decrease risk factors of recurrence at six months of follow-up


Eligibility Criteria:
Inclusion Criteria:

* Patient older than 18 years.
* Informed consent

Exclusion Criteria:

* Associated lesser metatarsals surgery.
* Associated surgery on midfoot, hindfoot or ankle.
* Neurologic diseases (Charcot Marie Tooth disease, poliomyelitis, compartment syndrome sequelae)
* Clinical or X-ray degenerative signs (Hallux rigidus) or irreducible deformations (MTP1 arthrodesis indications).
* Patient who declined the study.
A Randomized Trial: Changing Behavior in Post-Angioplasty Patients

The long-term objective of this study is to determine whether a positive affect and self-affirmation condition added to an empirically demonstrated approach for motivating behavior change is more effective than a standard approach in reducing risk factor behavior among a high-risk group of patients with coronary artery disease. Thus, the goal of the project is to refine and improve strategies for long-term maintenance of physical activity among patients post-angioplasty or stent.

Among coronary artery disease patients who have just had either angioplasty or stents, the objective of this randomized trial is to evaluate whether a novel behavioral intervention that employs induced positive affect and self-affirmation is more effective than an intervention without positive affect in increasing the maintenance of newly initiated physical activity post-procedure.

Secondary objectives:

* To determine whether more patients who receive the positive affect and self-affirmation intervention initiate more multiple behavior changes (e.g., changes in more health behaviors directed to their risk-factor profile) than those in the control group at one year.
* To determine whether the positive affect and self-affirmation intervention increases physical activity among patients who have depressive symptoms.
* To determine whether patients who are successful in increasing physical activity are more successful at changing other health behaviors.

Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing coronary artery catheterization who are found to have at least single vessel stenosis and who have had revascularization with angioplasty or coronary artery stenting will be eligible for enrollment.
* Patients must be able to provide informed consent within the one week after the procedure.

Exclusion Criteria:

* Patients who are unable to walk several blocks regardless of the reason will be excluded from all the trials (e.g., arthritis, stroke, claudication).
* Enrollment in other trials designed to modify post-procedure behaviors.
* Patients who refuse to participate will be excluded.
* If at any time prior to enrollment in the study, the patient's cardiologist determines that the patient should not participate in this study, the patient will not be enrolled in the trial.
Adjunctive Use Of A Novel Hyaluronic Acid/Chlorhexidine Gel In The Non Surgical Treatment Of Periodontitis

General Objective :

To evaluate the outcome of non surgical periodontal therapy with local drug delivery adjunct to scaling and root planning

Specific Objective :

To determine the effect of intra-pocket application of hyaluronic acid /chlorohexidine gel in non surgical periodontal treatment on clinical periodontal parameters and microbiological level .


Eligibility Criteria:
Inclusion Criteria:

* Age : 20-60 years old
* At least 20 remaining teeth
* Periodontitis stage III and IV ,Grade A, B and C

Exclusion Criteria:

* Patients taking specific medications: antibiotic , anticoagulants or anti-inflammatory
* Previous periodontal therapy in the past 3-6 months.
* Immunocompromised patients
* Systemically diseased patients: Diabetes ,osteoporosis etc
* History of allergies or hypersensitivity reactions to chlorohexidine or Hyaluronic acid
* Pregnant or lactating women.
* Heavy Smokers (more than 20/day)
Effectiveness Evaluation of the Digital Workflow for Single-implant Immediate Loading

Immediately implantation and immediate prosthesis could preserve the alveolar contour and gingival shape. The visiting time is quiet long. Pre-made prosthesis is a way to shorten the visiting time. But the implant has to be placed precisely. Novel digital workflow integrating dynamic navigation or static surgical guide to process one-visit single -implant immediate loading is possible. The study is to compare the x-guide dynamic navigation system or static guide system which one could assist the surgery more accuracy and place the prosthesis more smoothly.


Eligibility Criteria:
Inclusion Criteria:

* 20 to 80 years old
* Miss two functional opposing teeth in one quadrant or the same jaw
* The situation of oral tissue satisfies the condition of implant immediate loading.

Exclusion Criteria:

* catastrophic illness,
* diabetes,
* cardiovascular diseases,
* osteoporosis,
* head and neck cancer,
* disabled
* pregnant.
Effect of EGF With Silver Sulfadiazine Cream Compared With Silver Zinc Sulfadiazine Cream for Treatment of Burn Wound

Partial thickness burn wounds are most likely to heal within 2-3 weeks mainly by mechanism of epithelialization. However, it depends on the depth of the wounds and patient condition. Infection is one of the most common complications causing delay in wound healing which might affect to quality of patient's life. Generally, the standard treatment of partial thickness burn wound is topical 1% silver sulfadiazine cream. Previous studies had been reported the broad spectrum antimicrobial activity of silver sulfadiazine cream but it did not demonstrate the accelerating effect of wound healing. Therefore, the combination of substance which can promote wound healing to topical silver sulfadiazine cream might benefit for partial thickness burn wound treatment.

The objective of this study was to compare the results of partial thickness burn wound treatment at burn unit, Siriraj hospital with topical cream containing 1% silver sulfadiazine plus 6% epidermal growth factor (EGF) and 1% silver zinc sulfadiazine. The demographic data (age, sex, %body surface area burn), time of wound closure, pain and itching, dose and type of pain and itching medication, adverse effect of topical medication, some laboratory results and cost of expenses.

This is the prospective, double blinded, randomize-controlled study. The sample sizes were partial thickness burn wound patients who were treated at burn unit, Siriraj hospital. Patients were allocated into 2 groups receiving treatment with either topical silver sulfadiazine plus EGF or silver zinc sulfadiazine. All parameter data were analyzed with repeated measure ANOVA and independent t-test.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18-60 years.
* Partial thickness burn wound more than 20%TBSA.
* No underlying diseases that interfere wound healing such as chronic kidney disease, diabetes mellitus, liver disease, immunocompromised deficiency.
* In case of reproductive age woman, they have to control the birth rate at least 4 weeks before study.
* Patients who are willing to participate in the trial and to sign the informed consent form.

Exclusion Criteria:

* Immunocompromised defects
* Known allergy or hypersensitivity reaction to epidermal growth factor, silver sulfadiazine or other substances in formulation.
* Pregnancy or lactation
Repair of Multiple Finger Defects Using the Dorsal Homodigital Island Flaps

Multiple finger defects are common in hand trauma and result in functional disability. These injuries are often complex and severe, and thus reconstructive alternatives are limited. In this study, we use the dorsal homodigital island flaps, based on the dorsal branch of the digital artery, for reconstruction of multiple finger defects. At the final follow-up, we would evaluate the efficacy of this technique.

At final follow-up, sensation of the flap and the donor site would be assessed using static two-point discrimination and Semmes-Weinstein monofilament testing. The range of motion of the proximal interphalangeal joint and the distal interphalangeal joint of the injured finger is measured by a goniometer. The cold intolerance of the injured finger is measured using the self-administered Cold Intolerance Severity Score questionnaire that is rated into mild, moderate, severe, and extreme. The pain of the injured finger and the donor site is given subjectively by the patient using the visual analogue scale, which ranges from 0 to 10 cm and groupes into mild (0-3 cm), moderate (4-6 cm) and severe (7-10 cm).

Eligibility Criteria:
Inclusion Criteria:

1. a patient who had separate soft tissue defects in different fingers in same hand;
2. the defect ≥ 1.5 cm and ≤ 3.5 cm in length;
3. local tissue near the defect is uninjured; and
4. a patient between 15 and 60 years of age.

Exclusion Criteria:

1. concomitant injuries to local tissue around the defect that precluded its use as donor site;
2. a defect \< 1.5 cm and ≥ 3.5 cm in length;
3. a finger degloving injury;
4. the defect of the thumb.
Adjuvant Chemotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

The purpose of this study is to compare concurrent chemoradiotherapy plus adjuvant chemotherapy with concurrent chemoradiotherapy in patients with locoregionally advanced NPC, in order to evaluate the value of adjuvant chemotherapy in nasopharyngeal carcinoma (NPC) patients.

Patients presented with non-keratinizing NPC and stage T3-4N1M0/TxN2-3M0 are randomly assigned to receive concurrent chemoradiotherapy plus adjuvant chemotherapy (investigational arm)or concurrent chemoradiotherapy (control arm). Patients in both arms receive radical radiotherapy and cisplatin (40mg/m2 on day 1) weekly during radiotherapy. Patients in the investigational arm receive cisplatin (80mg/m2 on day 1) and fluorouracil (800mg/m2 on Day 1 to 5) every four weeks for three cycles after completion of radiotherapy. Patients are stratified according to the treatment centers. The primary end point was failure-free survival (FFS). Secondary end points included overall survival (OS), distant failure-free survival (D-FFS), locoregional failure-free survival (LR-FFS), the initial response rates after treatments, toxic effects and treatment compliance. All efficacy analyses were conducted in the intention-to-treat population; the safety population included only patients who received their randomly assigned treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with newly histologically confirmed non-keratinizing carcinoma (according to World Health Organization (WHO) histologically type)
2. Tumor staged as N2-3or T3-4N1 (according to 6th American Joint Committee on Cancer staging system)
3. No evidence of distant metastasis (M0)
4. Performance status: KPS ≥70
5. With normal liver function test (Alanine Aminotransferase、Aspartate Aminotransferase ≤2.5×upper limit of normal)
6. Renal: creatinine clearance ≥60ml/min
7. Adequate marrow: leucocyte count ≥4000/μL, hemoglobin ≥80g/L and platelet count ≥100000/μL
8. Written informed consent

Exclusion Criteria:

1. WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.
2. Age ≥70 or \<18
3. With a history of renal disease
4. Prior malignancy
5. Previous chemotherapy or radiotherapy
6. Patient is pregnant or lactating
7. Unstable cardiac disease requiring treatment.
8. Emotion disturbance
Deep Neural Network Approaches for Closed-Loop Deep Brain Stimulation

In this research study the researchers want to learn more about brain activity related to speech perception and production in patients with Parkinson's Disease who are undergoing deep brain stimulation (DBS).

Deep brain stimulation (DBS) is the gold-standard treatment for patients with medication resistant motor complications of Parkinson's disease (PD) and provides the only opportunity to record and stimulate in the human basal ganglia. Most recently, the concurrent use of research electrocorticography (ECoG) during DBS surgery, including pioneering work from Pittsburgh, has further enabled basic neuroscience investigation of human cortical-subcortical network dynamics. The discovery that aberrant synchronization of rhythmic neuronal activity recorded in PD patients is suppressed by DBS has advanced the concept that measures associated with pathological activity may be used as biomarkers to control the delivery of DBS therapy. Pilot studies of aDBS in PD have reported promising clinical results from triggering DBS stimulation when the signal recorded from the DBS electrode showed a high level of oscillatory power in the beta frequency range (13 - 35 Hz). That approach, however, has important limitations. Most importantly, beta power recorded from the DBS lead is suppressed by movement including PD tremor, its detection is highly dependent on lead location and the recording montage needed to record during stimulation is incompatible with directional current steering, a recent innovation employing segmented stimulation contacts. The inherent complexity of the increased parameter space through DBS innovations also overwhelms standard programming techniques. Finally, use of additional biomarker signals (e.g., recorded from cortex) is likely to improve the ability to adaptively control DBS for disorders marked by complex multidimensional symptomatologies such as PD. The current proposal will establish methods for overcoming these limitations by developing techniques for multi-feature classification from ECoG recordings, using advanced machine learning algorithms.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects scheduled for DBS implantation, as determined by the clinical multidisciplinary movement disorders board with definitive diagnosis of Parkinson's disease
2. Subjects able to provide informed consent and comply with task instructions.
3. Subjects 18-85 years old

Exclusion Criteria:

1. Non-English-speaking subjects
An Efficacy and Safety Study of XP19986 in Subjects With Symptomatic GERD

To evaluate efficacy and safety of treatment with XP19986 Sustained Release (SR) Tablet compared to placebo in subjects with symptomatic GERD


Eligibility Criteria:
Inclusion Criteria:

* History and documentation of GERD diagnosed by a gastroenterologist, with symptoms (heartburn and/or regurgitation) on ≥ 3 days during the week prior to screening and prior to randomization

Exclusion Criteria:

* Current or historical endoscopic evidence of erosive esophagitis LA Classification Grade B, C, or D
Muscle Energy Technique on Sacroiliac Dysfunction

Sacroiliac pain is a huge problem in women during pregnancy and postpartum period. Muscle energy technique has potential effect in decreasing the pain and disability

A sample of forty women diagnosed with postpartum sacroiliac dysfunction, their ages ranged from 20 to 40 years and their BMI was ranged from 25-30 kg / m2 participated in this study, they were selected and divided randomly into 2 equal groups (A\&B). Group (A) (Control group): consisted of 20 patients, they received muscle energy technique for 12 sessions, 3 sessions / week. Group (B) (Study group): consisted of 20 patients, they received alternative heat and ice for another 20 minutes /session (10 minutes for each). All patients in both group were evaluated at the beginning of the study and after 12 sessions through measuring pain intensity using visual analog scale and disability using oswestry disability index (ODI)

Eligibility Criteria:
Inclusion Criteria:

* Their ages ranged from 20 to 40 years .
* Their BMI was ranged from 25-30 kg / m2

Exclusion Criteria:

* hip fracture,
* SIJ infection.
* scoliosis
Effect of Mental Stress on Platelet Function in Healthy Subject

Psychological stress is an independent cardiovascular risk factor. Activation of platelets plays an important role in atherosclerosis development and it could one of the mechanisms linking psychological stress and cardiovascular diseases


Eligibility Criteria:
Inclusion criteria:

* Healthy subjects
* No smokers
* Written informed consent

Exclusion criteria:

* Smoking
* Alcohol- or Drug Abuse
* Pregnancy
* Use of benzodiazepins, Aspirin or NSAIDs in the last week before inclusion
* Participation to another study within the last month