cyrilzakka/clinical-trials huggingface dataset:
Catechin Gargling for Influenza Infection

The purpose of this study is to clarify the preventive effects of catechin gargling on the influenza infection.

In-vitro experimental studies have revealed that tea catechin extracts induce preventive effects on influenza infection. However, few studies have been conducted on the effects of tea gargling on influenza infection, and the clinical evidence is unclear. Also there have been no studies reported on the gargling effects with tea catechin extracts on the prevention of influenza infection.

Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers
* aged 20 to 65 years old
* obtained written informed concent before participation
* inoculated with influenza vaccine before entering the study

Exclusion Criteria:

* other gargling except water during the study
* possessing tea allergy
The Efficacy of the Alma Hybrid System for a New Approach of Facial Skin Treatment

The study is aimed to evaluate the efficacy of the Alma Hybrid system for a new approach of facial skin treatment, using both ablative and non-ablative wavelengths.

The study will include 20 subjects with mild-moderate photodamaged skin, that will undergo 2 facial skin treatments. Follow up visit to evaluate the efficacy of the treatments will take place 1 and 3 months after the last treatment.


Eligibility Criteria:
Main Inclusion Criteria:

1. Male or Female, 35 to 60 years of age, at the time of enrollment
2. Fitzpatrick skin type I-IV
3. Mild-moderate photo damages and wrinkles, with Fitzpatrick-Goldman Wrinkle and Elastosis Score of 3-6

Main Exclusion Criteria:

1. Pregnant, intending to become pregnant during the course of study, less than 3 months postpartum or less than 6 weeks after completion of breastfeeding
2. Heavy smoker (\>1 pack of cigarettes a day)
3. Unable or unlikely to refrain from tanning, including the use of tanning booths, during the course of the study
4. Previous rejuvenation treatments on the same area, such as chemical peel, dermabrasion, non-ablative or ablative resurfacing procedure, or face-lift with laser or other devices, up to 3 months prior to the enrollment
5. Prior use of collagen, fat injections, or other methods of skin augmentation within the past 12 months.
6. Prior use of Botox in the treatment area within 5 months
7. Infection, dermatitis, rash, or other skin abnormality in the target area
8. History of any disease or condition that could impair wound healing
9. History of keloid formation, hypertrophic scarring, or abnormal/delayed wound healing
Evaluation Study of New Compounds with Potential Use in Schizophrenia

Different compounds that might modify the glucose regulation in the central nervous system will be evaluated in healthy volunteers. Several examinations will be performed in order to get a detailed plan how these substances might work.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* Informed consent given by the subject
* Both, female and male subjects may participate
* Age between 18 and 65 years
* Negative drug-screening at the time of screening
* In female participants in fertile age, reliable contraception, which means contraception's pearl-index is equal or smaller than 1.
* Non-Smoker
* Body Mass Index between 18 and 40.

Exclusion Criteria:

* Lack of accountability
* Any current psychiatric disorder through the Structured Clinical Interview for DSM-IV (SCID) at the time of screening
* Any known psychiatric or neurological illness in the participant's history.
* Known family history concerning psychiatric disorders
* Relevant use of cannabis (which is defined on the present state of knowledge as at the most five times lifetime-consumption and no consumption for at least one year)
* Pregnancy or lactation phase in female at the time of screening
* Severe physical (internal) or neurological illness, especially cardiovascular, renal, advanced respiratory, haematological or endocrinological failures or infectious diseases (acute hepatitis A, B or C or HIV) assessed at the time of the screening by the subject's history, clinical examination and laboratory testing, at the discretion of the investigator
* Consumption of any illegal drugs (except cannabis in history, see above)
Educational Materials Development for Physical Activity in CAncer

In cancer setting, physical exercise has emerged as an important factor to control cancer-related symptoms and improve patients' quality of life. In addition, the correlation between physical activity and survival is recently consolidating. Nevertheless, several previous studies have shown that the majority of cancer patients are insufficiently active. Written information, for example a guidebook, may be a good oppurtunity, to improve lifestyle. Developing and testing an exercise guidebook, based on Theory of Planned Behavior and specifically designed for cancer patients, may be an effective tool to deliver information and increase physical activity level in this population.


Eligibility Criteria:
Inclusion Criteria:

* signed informed consent;
* confirmed cancer diagnosis.

Exclusion Criteria:

- sufficient physical activity level.
Olfactory Decision-making and Deprived Sleep

This research study will use magnetic resonance imaging (MRI) and olfactory stimuli to better understand the connection between sleep deprivation, brain activity, and olfaction in humans.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old
* Fluent English speakers

Exclusion Criteria:

* History of neurological conditions (e.g., epilepsy, dementia, multiple sclerosis, brain tumors, etc.)
* History of psychiatric conditions (e.g., general anxiety disorder, depression, schizophrenia, obsessive-compulsive disorder, post-traumatic stress disorder, attention deficit hyperactivity disorder, alcoholism, etc.)
* Significant medical illnesses (e.g., cancer, meningitis, chronic obstructive pulmonary disease, cardiovascular disease, etc.)
* Cerebrovascular risk factors (e.g., hypertension, diabetes, elevated cholesterol, etc.)
* Use of psychoactive medications (e.g., barbiturates, benzodiazepines, chloral hydrate, haloperidol, lithium, carbamazepine, phenytoin, citalopram, escitalopram, fluoxetine, diazepam, etc.)
* Smell or taste dysfunction
* History of severe allergies requiring hospitalization for treatment
* History of severe asthma requiring hospitalization for treatment
* Habitual smoking
* History of eating disorders (e.g., anorexia nervosa, bulimia nervosa, binge-eating disorder, etc.)
* Dieting or fasting
* History of sleep disorders (e.g., obstructive sleep apnea, narcolepsy, insomnia, etc.) Magnetic implants (e.g., shunts or stents, aneurysm clips, surgical clips, cochlear implants, metal bone/joint pins, plates and screws, eyelid spring or wires, etc.)
* Electronic implants (e.g., implanted cardiac defibrillator, cardiac pacemaker, deep brain/spinal cord or nerve stimulator, internal electrodes/wires, medication infusion devices, etc.)
* History of metal working without proper eye protection, or injury with metal shrapnel or metal slivers
* Left-handedness
* Claustrophobia
Patellar Resurfacing Versus Patellar Retention in Total Knee Arthroplasty - A Randomized Clinical Trial

Background:

Despite the excellent results of total knee replacement, also known as total knee arthroplasty (TKA) there is persistent controversy over whether or not to replace the surface of the kneecap. Anterior knee pain, which occurs with variable and unpredictable frequency, continues to be a problem in a subset of TKA patients. Some clinicians replace the surface of all kneecaps during TKA to avoid repeat surgery, which occurs in approximately 10% of cases. However, others cite the complications attributed to replacing the surface of kneecap as reasons to avoid this procedure.

This study prospectively randomized patients receiving TKA into two groups, those receiving replacement of the kneecap surface and those left without replacement of the kneecap surface to determine clinical outcomes and revisions over the first 5-10 postoperative years.

Objectives:

The primary objective of this work was to compare pain, stiffness and function between groups at five years postoperatively. Secondarily, we compared pain, stiffness and function at one and 10 years postoperatively. Finally, we examined the number of reoperations following TKR over 10 years in the 2 groups of subjects. The investigators hypothesized that there would be no difference between the two groups of subjects in the measured outcomes.

Methods:

Patients receiving TKA were prospectively enrolled before surgery and randomized intraoperatively to either receive a replacement of the kneecap surface or have no kneecap intervention. The Smith and Nephew Profix TKA system was implanted in all cases; the post-operative regimen was standardized. Subjects were assessed pre-operatively and at 1 and 5 years postoperatively for pain, function, and stiffness using a disease-specific (Western Ontario and MacMaster Osteoarthritis Index \[WOMAC\]) and generic health status (Short Form 36 \[SF-36\]) questionnaire. At the end of the five year follow-up, the study was extended to a 10-year followup and the same outcomes were assessed. The revision rate was also compared between the two groups at the end of the 10-year follow-up.


Eligibility Criteria:
Inclusion Criteria:

* scheduled for primary TKA to treat non-inflammatory arthritis
* age 40- 75 years of age

Exclusion Criteria:

* history of knee sepsis
* previous patellectomy
* previous high tibial osteotomy
* knee flexion contracture of \>20 degrees
* varus or valgus deformity of \> 20 degrees
* \< 90 degrees of knee flexion
* tibial or femoral bone deficiency requiring augmentation
The Effectiveness of Arthroscopic Cartilage Regeneration Facilitating Procedure for Patients With Knee Osteoarthritis

The aim of this study is to discuss the effect of gait pattern in patients receiving arthroscopic cartilage regeneration facilitating procedure (ACRFP) for treatment of osteoarthritis of knees.

Pain during gait is the most common and problematic symptom in individuals with osteoarthritis (OA) of knee joints. Limited range of motion, reduced walking speed, and a shortened stride length are also occasionally observed. These changes may be secondary or compensatory phenomena adopted by individuals to lessen the load on the OA-affected knees.

It is generally agreed that medial plica can produce symptoms in the knee joint, and can be successfully treated by arthroscopic resection when it becomes inflamed, thickened, and fibrotic. In 2006, Lyu and Hsu reported that medial plica had strong correlation with medial compartment osteoarthritis of knees. In their further studies disclosing the kinematic relationship of the medial plica with the medial femoral condyle found that medial plica might cause some degree of abrasion on the surface of medial femoral condyle during knee motion. The repeated injuries elicited by this abrasion phenomenon might trigger some inflammatory process to gradually damage the cartilage of knee.

Based on these findings, Lyu developed a concept of arthroscopic cartilage regeneration facilitating procedure (ACRFP) by arthroscopic resection of the medial plica, in addition to both medial and lateral capsular release, for the treatment of osteoarthritis of the knee joint. The clinical outcome of this procedure by eradication of the abrasion phenomenon caused by the tight, fibrotic, and hypertrophied medial plica, with decompression of the patellofemoral joint, the pain in most patients could be reduced, and the degenerative process in the medial compartment of some patients might be decelerated or arrested.

During the ACRFP, additional procedures such as synovectomy, abrasiochondroplasty, or partial menisectomy may also be carried out when necessary. It has been found that the elimination of the existing detrimental factors may provide a preferable environment for regeneration of the damaged cartilage.

Although the results of ACRFP for treatment of osteoarthritis of knee has been supported by several researches as being an effective method, it still lacks investigations on the gait pattern after such procedure. Therefore, the aim of this study is to discuss the effectiveness of the ACRFP for the patients with osteoarthritis of knee joints, specifically focused on their gait pattern.

Eligibility Criteria:
Inclusion Criteria:

* Patients between the ages 20 and 85 who will receive ACRFP for treatment of osteoarthritis in the knee joints

Exclusion Criteria:

* Patients with walking disability
Lateral Wedge Insole With Subtalar Strapping for Knee Osteoarthritis

This is a clinical study to evaluate the efficacy of a lateral wedge insole with subtalar strapping in knee osteoarthritis treatment.

The objective of this study is to evaluate the efficacy of a lateral wedge insole with subtalar strapping in knee osteoarthritis treatment. Fifty-eight patients with knee osteoarthritis were randomized to use either a lateral wedge or a neutral insole. VAS, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Lequesne questionnaires were applied at baseline, and weeks two, eight, and 24.

Eligibility Criteria:
Inclusion Criteria:

* Meet the American College of Rheumatology criteria for knee Osteoarthritis
* Varus malalignment of the knee
* Absence of previous fracture on the index knee
* Absence of previous surgery on the index knee
* Absence of Rheumatoid Arthritis
* No Intra-articular injection on the index knee in the past 6 months
* Receiving usual care for Osteoarthritis for at least 6 months
* Be able to understand and agree with the informed consent

Exclusion Criteria:

* Undergo surgery during the study
* Undergo Intra-articular injection during the study
* Develop articular infection of the index joint during the study
Canadian Hemophilia Prophylaxis Study

Primary prophylaxis given less frequently initially, with the infusion frequency increased if needed (Escalating Dose Prophylaxis), is likely to be less expensive and associated with fewer complications than standard prophylaxis while reducing disability to a greater degree than intermittent therapy.

There are 2 specific study objectives. The first is to estimate the incidence of target joint bleeding in patients with severe hemophilia A treated (for primary prophylaxis) with Escalating Dose Prophylactic factor replacement. The second objective is to obtain accurate estimates of the direct and indirect costs associated with this protocol for use in a cost-effectiveness model (comparing Escalating Dose with standard prophylaxis and with intermittent therapy).

Eligibility Criteria:
Inclusion Criteria:

* Severe hemophilia A (factor level less than 2%).
* Age greater than 1 year and less than or equal to 2.5 years.
* Normal joints using the World Federation of Hemophilia orthopedic scale.
* Normal radiographs of joints in which bleeding has occurred using the World Federation of Hemophilia radiographic scale.
* Platelet count of \> 150,000.
* Informed consent to participate.

Exclusion Criteria:

* Three or more clinically determined bleeds into any single elbow, knee or ankle.
* Presence or past history of a circulating inhibitor (level ≥ 0.5 Bethesda Units).
* Family judged to be non-compliant by the local hemophilia clinic director.
* Competing risk (symptomatic HIV infection, juvenile rheumatoid arthritis, metabolic bone disease, or other diseases known to cause or mimic arthritis.)
Emergency Department CT Scanning for Appendicitis

The purpose of this study is to compare IV contrast only vs. IV and oral contrast Computed Tomography (CT) for the diagnosis of acute appendicitis in adult patients in our emergency department. A secondary purpose will be to design a specific CT for appendicitis protocol at our institution at the conclusion of this study.


Eligibility Criteria:
Inclusion Criteria:

* 18 years and older who present to the York Hospital Emergency Department with signs and symptoms suggestive of acute appendicitis, but in whom the diagnosis remains unclear as determined by an attending emergency physician or consulting surgeon and in which a CT scan is needed to further assist in the diagnosis

Exclusion Criteria:

* pregnant patients
* patients with known IV dye or oral contrast allergy
* patients in whom acute appendicitis is not the primary diagnosis
* patients with renal insufficiency that may have significant adverse effect from IV dye
Evaluation of Time Interval Between Ovulation Trigger With Triptorelin Acetate and Oocyte Retrieval

The aim of this study is to determine what is the best time interval between GnRH agonist (triptorelin acetate) ovulation induction allowing for the higher number of mature oocytes (MII) collected in IVF cycles.

Human chorionic gonadotrophin (hCG) has been the gold standard for ovulation induction for several decades. When GnRH antagonist protocols were introduced, it became possible to trigger final oocyte maturation and ovulation with a single bolus of a GnRH agonist (GnRHa) as an alternative to hCG. The use of GnRHa to trigger final oocyte maturation has potential advantages: the simultaneous induction of a FSH surge, higher numbers of mature oocytes retrieved as compared to hCG and the total elimination of ovarian hyperstimulation syndrome.

From the earliest reports of GnRHa for ovulation triggering, it has been presumed that the timing of the ovum pick-up (OPU) after GnRHa administration should be the same as after hCG triggering (34-36 h). However, differences exist regarding the duration and profile of the GnRHa induced surge of gonadotrophins when compared with that of hCG. Even more, differences in the intra-follicular mechanisms involved in ovulation have been described after GnRHa and hCG trigger.

No previous randomized controlled trials have been reported to evaluate the optimal interval of time between ovulation induction by GnRHa and oocyte collection.

The present study compares the ovarian response and the IVF outcomes after induction by triptorelin 0.2 mg at four different time intervals:

Group 1: OPU 24 hours after GnRHa administration. Group 2: OPU 30 hours after GnRHa administration. Group 3: OPU 40 hours after GnRHa administration. Group 4: control group: OPU 36 hours after GnRHa administration.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent prior to carry out any procedure associated with the clinical trial.
* Women between 18 and 37 years of age at the time of randomization (both ages included).

Basal serum levels of FSH \<10 mIU /ml.

* Serum AMH \> 5 to \<45 pmol / l.
* Antral follicle count \> 6 and \< 24.
* Vaginal ultrasound documenting correct visualization of both ovaries and the absence of significant ovarian pathology.
* Short stimulation protocol with GnRH antagonist and conventional dose for ovarian stimulation with 225-300 UI of rhFSH.
* Number of follicles ≥ 16 mm \> 5 on the ovulation induction day.

Exclusion Criteria:

* Presence of severe endometriosis (Grade III-IV).
* Absence of one ovary due to previous surgery.
* Presence of significant uterine pathology (submucous myomas, endometrial polyp, malformations..)
* Diagnosis of polycystic ovary syndrome (defined according to the Rotterdam criteria).
* History of previous poor response to conventional ovarian stimulation protocols (\< 3 MII oocytes or canceled cycle)
* Severe male factor ( TMS\< 1 million).
* Participation in another RCT within the past one year.
Observational Study of Sifrol® in Patients With Primary Restless Legs Syndrome (RLS)

The objectives of this Post Marketing Surveillance (PMS) are:

* Evaluation of the treatment effect of pramipexole on Restless Legs Syndrome (RLS) severity as measured by International Restless Legs Syndrome Scale (IRLS) and Clinical Global Impression Improvement scale (CGI- I)
* Evaluation of the time to reaching maintenance dose of pramipexole
* Evaluation of work productivity impairment associated with RLS based on the Work Productivity and Activity Impairment Questionnaire (WPAI) questionnaire


Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from primary RLS who are eligible for Pramipexol (PPX) treatment could be included into the study
* Patients not pre-treated with any dopaminergic agent (de novo patients) or patients pre-treated with dopaminergic medication
* Male of female patients of any age

Exclusion Criteria:

* The treating physicians are asked to consider the regulations described in the Summary of Product Characteristics (SmPC) for the treatment with pramipexole
Immune Profiling After HDR in Local Relapsed Prostate Cancer

Immunotherapy is currently revolutionizing the field in oncology. However, prostate cancer until now fails to respond to classical IO, like PD-1 and CTLA-4 inhibitors. Radiotherapy (RT) delivered to the primary tumor impacts both tumor cells and surrounding stromal cells. Radiation damage to cancer cells exposes tumor-specific antigens leading to increased visibility to the immune system by improved priming and activation of cytotoxic T cells. RT-induced modulation of the tumor microenvironment may also facilitate the recruitment and infiltration of immune cells by increasing the expression or T-cell attracting chemokines and by increasing T-cell docking molecules on the endothelial cells like VCAM-1. The main-hypothesis is that HDR-brachytherapy will turn an immunologically "cold" (no T-cell infiltrations) prostate cancer into an immunologically "hot" (CD4 and CD8-cell infiltrations) tumor, creating leverage points for different forms of IO.

Prospective analysis of biopsies from 10 patients with local recurrence in the prostate selected for salvage HDR brachytherapy in MAASTRO Clinic, Maastricht. HDR treatment is standard in Maastro Clinic for local relapses of prostate cancer after previously irradiation (internal or external).

Biopsies will be taken at 4 different time points (before and after the 1st fraction; before the 2nd and 3rd fraction of the salvage treatment).

Several immunotyping (expression of PD-(L)-1, CXCL12, IL-23 receptor, etc.) and HLA class I expression will be performed on the biopsies. In addition, HLA genotypes will be determined on DNA isolated from pheripheral blood.

The plasma and the biopsies will be stored for eventually additional research.

Eligibility Criteria:
Inclusion Criteria:

* Local relapse of prostate cancer, who is candidate for a salvage HDR treatment:
* Biochemical relapse (PSA increase)
* Local relapse on imaging: PSMA scan, mp-MRI
* Pathology proven relapse

  * Willing and able to comply with the study prescriptions.
  * 18 years or older
  * Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations.

Exclusion Criteria:

* Not eligible for proposed (HDR brachytherapy) treatment:

  * Life expectancy \< 10 years
  * Distant Metastasis
  * Recently TURP with big urethral defect
  * Not able to stop anticoagulants
  * Flow \< 10 ml/sec • No compliance to study procedure