cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Subcutaneous Immunotherapy in Birch Pollen Allergic Patients

To compare versus placebo the efficacy and safety of recombinant Bet v1, natural purified Bet v1 and birch pollen licenced extract used for subcutaneous immunotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-50 with seasonal rhinoconjunctivitis for at least 2 years, and/or mild asthma range 1 and 2 GINA.
* Positive history of birch pollen allergy (clinical history, positive skin prick test, birch specific IgE, presence of birch pollen)
* Compliant patients
* Written consent.

Exclusion Criteria:

* Perennial rhinoconjunctivitis and/or asthma due to cosensitization with: animal danders, mites, alternaria cladosporium
* Uncontrolled seasonal asthma : severe asthma permanent or not range 3 and 4 of GINA.
* Patients treated with beta-blockers or under continuous oral corticosteroids.
* Pregnant women
Endoscopic Surgery for Gastrointestinal Disorders: A Multicenter Registry Study

Currently, there is limited multi-center data on endoscopic surgery outcomes in western populations.

Evaluation of these measurement would help the investigators compare them to conventional treatment modalities within current tertiary facilities; and consequently help the investigators identify appropriate treatment techniques and improve clinical management of patients at Rutgers RWJMS.

The purpose of this retrospective registry study is to assess long term data on efficacy, safety and clinical outcome of Endoscopic Surgery within the gastrointestinal tract.

Our tertiary-care institution performs clinically-indicated various Endoscopic Surgery procedures gastrointestinal indications in more than 800-1000 patients annually.

The study investigators would collect data on a large sample size of subjects undergoing various endoscopic resection procedures such as POEM (Peroral Endoscopic Myotomy), EMR (Endoscopic Mucosal Resection), ESD (Endoscopic submucosal dissection), STER (Submucosal tunneling endoscopic resection), NOTES (Natural Orifice Translumenal Endoscopic Surgery), TIF (Transoral Incisionless Fundoplication), Endoscopic Fistula Closure, Endoscopic Suturing, Capsule Endoscopy and EFTR (Endoscopic full-thickness resection). Clinical metrics will be collected including procedure times, length of follow-up, specific tumor characteristics, resection method, pathology results, procedural complications, additional therapy required, and disease-free survival time.

Various endoscopic surgical procedures are less invasive than traditional surgery, have fewer side effects and provide better efficacy. Moreover, they can be available to patients who are ineligible for surgery or who have refused more aggressive surgical intervention.

They improve quality of life and extend survival duration.

Endoscopic surgery procedures can be an appropriate approach in many gastrointestinal disorders including early neoplasms, challenging adenomas or sub-epithelial lesions that requires the resection of the superficial layers, mucosa and submucosa, or full thickness resection of the tract wall.

Currently, there is limited multi-center data on endoscopic surgery outcomes in western populations.

Evaluation of these measurement would help the investigators compare them to conventional treatment modalities within current tertiary facilities; and consequently help the investigators identify appropriate treatment techniques and improve clinical management of patients at Rutgers RWJMS.

The purpose of this retrospective registry study is to assess long term data on efficacy, safety and clinical outcome of Endoscopic Surgery within the gastrointestinal tract.

Eligibility Criteria:
Inclusion Criteria:

* Subjects undergoing Endoscopic Surgery

Exclusion Criteria:

* Subjects not undergoing Endoscopic Surgery
The School SPIT Study - Elementary Schools in Low COVID-19 Incidence Regions

This study will conduct an evaluation of a program that is being implemented SickKids / Toronto Public health that provides take-home saliva testing kits in schools. Operationally, there is a planned randomization so that all schools have an equitable chance to receive the intervention at various time periods during the planned operational roll-out, which will require a staggered implementation consistent with the stepped-wedge study design. This study will leverage this chance implementation to do a robust evaluation of the public health intervention. Schools that are not being rolled out to week one, will begin in the "control phase" (testing at an assessment center, primary care or acute care facility) and transition to the program "intervention phase" (take home saliva kits available at schools) at a randomly assigned time (wedge) over a 6-week period with all schools receiving the program by the end of the study. The investigators will evaluate the impact of the program on SARS-CoV-2 case identification in schools.

This is a prospective evaluation of a program that is being implemented using a stepped-wedge, cluster randomized design.

Eligible elementary public schools Toronto Region in low SARS-CoV-2 incidence regions (quintiles 1,2 or 3) will be randomized. The study will occur over a 7-week period with a minimum of one-week of baseline data (control phase - testing at an assessment center, primary care or acute care center) and then schools will start the program in a stepwise manner (20 crossovers per week) with take-home saliva being available to all 120 schools by the end of the study period. The primary objective of the study is to assess whether the availability of take home saliva kits at schools for symptomatic testing leads to increased diagnosis of SARS-CoV-2 cases in the school.

Eligibility Criteria:
Elementary schools will be included in the evaluation if they are:

* Considered an elementary school by the school board
* Open for in-person learning during the study period
* They have at least 200 students
* Offer at least 4 grades

Exclusion Criteria:

Schools that are middle schools only, that are not open for in-person learning, have fewer than 200 students or are not a complete elementary school (i.e.schools offering independent courses, prep schools with 1-2 grades, elementary schools with \< 4 grades) will be excluded.
Drug Interaction Study of an OCP (Norethindrone (ND) Acetate and Ethinyl Estradiol (EE))With a Combination of Daclatasvir (DCV) Asunaprevir (ASV) and BMS-791325

The purpose of this study is to assess the effect of DCV/ASV/BMS-791325 fixed dose combination (FDC) + 75mg BMS-791325 on the Pharmacokinetics (PK) of the oral contraceptive agent.

IND Number: 79,599 and 101,943

Other: Phase 1 Clinical Pharmacology drug interaction study in healthy female subjects

Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Healthy females within age of 18-40 years
* Must be a Women of Childbearing potential
* Must be on a stable regimen of oral contraceptive therapy for at least 3 consecutive months prior to study start

Exclusion Criteria:

* Subjects must not have any significant acute or chronic medical illnesses or conditions precluding safe use of oral contraceptives
* Prior exposure to DCV, ASV or BMS-791325 within 30 days of dosing on study day 1
* Smoking within 6 months of study start
Functionality Assessments in Patients (Adults and Children) Following Treatment With Debrase Compared to Standard of Care

Once the victim survived the acute phase, the outcome of wound healing, the scarring, became a major medical issue with complications that may lead to cosmetic and functional sequelae. Scar tissue is clinically distinguished from normal skin by an aberrant color, rough surface texture, increased thickness (hypertrophy), contraction, firmness and sometimes, decrease function.

Thus, functional and cosmetic outcomes became at least important as wound closure in assessing wound healing products

This is a multi-center, assessor-blinded study aiming to evaluate the long term functionality in adults and children who have participated in study MW2004-11-02 (previous phase 3 study).

We had previously shown that by using the MVSS scale which includes objective assessment of the physical characteristics of size, shape, volume, color, texture, and pliability as well as structural, mechanical and physiologic characteristics, lower (favorable) scores in Debrase vs. SOC group were observed in sub-groups of highly functional body parts of the hands and feet. This study will include specific functionality evaluation using the "Lower Extremity Functional Scale" test for burns in the lower extremities and the "QuickDASH" outcome measure for burns in the upper extremities as well as range of motion measurements of the joints (knee, ankle, shoulder, elbow and wrist, as relevant).

Eligibility Criteria:
Inclusion Criteria:

* Adults and children who had participated and completed study MW2004-11-02. Patients must be able to sign and dated written informed consent prior to study entry (by Patient or by a guardian, when applicable).

Exclusion Criteria:

* None
Clinical Trial to Evaluate the Efficacy and Safety of Naftopidil in Male Patients With Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia

This study is designed to evaluate the efficacy and safety of Naftopidil in Korean male patients with with lower urinary tract symptoms associated with benign prostatic hyperplasia.

The investigators hypothesized that Naftopidil which came onto marcket in Japan would effect in improvement of voiding and storage difficulty.

Design:

Placebo-controlled, Randomized, Double-blind, Double-dummy, Parallel group, Fixed dose design


Eligibility Criteria:
Inclusion Criteria:

* Male patients aged 4 years or more diagnosed with BPH

Exclusion Criteria:

* subjects with uncontrolled blood pressure
* subjects with hepatic or renal dysfunction
* subjects with prostate cancer
* Had treatments for BPH using other alpha receptor antagonists within 2 weeks
Clinical Characteristics and Outcome of Patients With Community Acquired Pneumonia

the goal of this observational study is to evaluate the clinical characteristic and outcomes of patients with community-acquired pneumonia admitted to Sohag University Hospital.

the researcher will take medical history and clinical examination and investigations of participants .

the participants will visit the clinic after one month to be reevaluated again .

Community acquired pneumonia is acute infection of the pulmonary parenchyma that occurs in the community in a patient who has not been hospitalized within 14 days prior to onset of symptoms or hospitalized less than 2 days prior to the onset of symptoms the aim of the study typically focuses on examining the various factors that influence the presentation, management, and outcomes of individuals diagnosed with pneumonia that is acquired outside of a hospital or healthcare setting.

Type of the study: observational study

Outcomes of interest include:

I. Mortality (in hospital and 30 days). II. The need for further mechanical ventilation or ICU admission. III. Duration of hospital stay.

Eligibility Criteria:
Inclusion Criteria:

* The study will include patients ≥18 years old with community acquired pneumonia

Exclusion Criteria:

1. Patients already was diagnosed as active malignancy before admission
2. Patient on chemotherapy
3. HIV patients
4. Indication of mechanical ventilation on admission
MRgFUS in the Treatment of Osteoarthritic Knee Pain

A double-blind placebo-controlled randomized clinical trial to evaluate the efficacy of magnetic resonance-guided focused ultrasound surgery (MRgFUS) in the treatment of pain caused by knee osteoarthritis (OA)

Osteoarthritis (OA) is a common, disabling, and costly disease, and the knee is one of the most affected joints. The predominant symptom is pain. Effective and lasting non-invasive treatment approaches are missing. MR-guided focused ultrasound surgery (MRgFUS) is a new minimally invasive technique which may represent a valid solution providing several advantages. The primary aim of this work will be to assess the efficacy of MRgFUS in the treatment of pain caused by knee OA in 80 patients candidate for arthroplasty in a prospective, randomized, double-blinded, placebo-controlled clinical trial. Different parameters related to pain, quality of life, function, and imaging will be collected and analyzed in a 12-month follow-up. The secondary aims will be focused on a) the evaluation of the effects on the joint organ and changes of biological features in response to MRgFUS, and b) the impact of selective ablation of nociceptors on OA pain, based on the analysis of resected joint tissues.

Eligibility Criteria:
Inclusion Criteria:

* Male and female aged 50-80 years
* Activity-related joint pain
* Patients who have not responded to previous treatments and patients candidate for surgery
* Kellgren-Lawrence score 2-4 on X-rays
* Patients able to give their informed consent

Exclusion Criteria:

* Prior surgery in the past 12 months or previous local treatment in the past 3 months
* Changes in medications used during the previous 2 months
* Corticosteroid use for more than 3 months within the preceding year
* Rheumatologic and neurological disorders
* Fibromyalgia
* Trauma, fracture or osteomyelitis of the investigated joints within the preceding year
* Pregnancy
* Patients with large scars potentially included in the ultrasound beam path
* General contraindications to MRI and/or to anaesthesiological procedures
* Presence of internal hardware or device potentially affecting MR thermometry
* Patients involved in other clinical studies
Stereotactic Pelvic Brachytherapy With HDR Boost for Dose Escalation in High Tier Intermediate and High Risk Prostate ca

HDR brachytherapy in conjunction with pelvic SABR in high tier intermediate and high risk prostate cancer patients can provide a safe and effective means of radiotherapy dose escalation.

Utilizing multiparametric MRI to focally boost the dominant intraprostatic lesion during HDR brachytherapy is safe and feasible.

HDR brachytherapy:

Under general anesthetic, prostate will be implanted transperineally using up to 18 catheters. Three gold seed fudicials will also be implanted transperineally at base, midgland and apex forSABR treatment. Prostate will be contoured as Clinical Target Volume (CTV) on the transrectal ultrasound (TRUS) based ONCENTRA planning system. Rectum and urethra will be contoured as organs at risk. 15Gy will be prescribed to CTV as the MPD (minimal Peripheral Dose).

Treatment Delivery-SABR There will be a 2 week interval between HDR and SABR component to allow for normal tissue recovery and radiotherapy planning time. Daily image guidance will be performed using the implanted fiducials to calculate patient shifts to ensure proper positioning. Post-treatment images will be taken to estimate intrafraction motion.

Androgen Deprivation Therapy Twelve to 18 months of luteinizing-hormone releasing hormone agonists (LHRHa) will be used. Anti-androgen and neoadjuvant LHRHa can be used according to physician discretion

Follow-Up and Toxicity Assessment Time zero will be the start of radiotherapy. Baseline rectal and urinary function will be recorded using common toxicity criteria adverse effect (CTCAE v3.0) and Expanded prostate Cancer Index Composite (EPIC). CTCAE v3.0 and EPIC assessments will be done at weeks 3, 5 and 12 weeks. Bloodwork (PSA and testosterone), quality of life (EPIC) and late GI and GU toxicity evaluation (using the RTOG/EORTC Late Radiation Morbidity Scheme) will be performed every 6 months for the first 5 years.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent obtained
* Men \>18 years
* Histologically confirmed prostate adenocarcinoma (centrally reviewed)
* High tier intermediate risk defined as :

Clinical stage T1-T2c AND PSA 10-20ng/ml AND {PSA\>10ng/ml AND (T2b-2c Or Gleason 7)} OR Gleason 4+3

-High-risk prostate cancer, defined as at least one of: Clinical stage T3, OR Gl 8-10, OR PSA \> 20 ng/mL

Inclusion Criteria:

* Prior pelvic radiotherapy
* Anticoagulation medication (if unsafe to discontinue for gold seed insertion)
* Diagnosis of bleeding diathesis
* Large prostate (\>50cm3) on imaging
* No evidence of castrate resistance (defined as PSA \< 3 ng/ml while testosterone is \< 0.7 nmol/l. Patients could have been on combined androgen blockade but are excluded if this was started due to PSA progression.
* Definitive regional or distant metastatic disease on staging investigations.
Effect of Apple and Apple Pomace on Inflammation and Cholesterol Metabolism in Healthy Overweight

The investigators will assess the protective and antiinflammatory effects of processed fruit and fruit fibre in overweight subjects with signs of metabolic syndrome. A single-blinded parallel study is conducted to investigate the protective effects of fruit fibre on colonic epithelium. Relevant signalling pathways related to cholesterol metabolism, vascular inflammation, oxidative defence, apoptosis and sterol metabolism will be targeted. Volunteers are randomly assigned one of three groups. They are instructed to follow a polyphenol and pectin restricted diet for six weeks. The last four weeks in this six week period, the restricted diet is supplemented with whole apples (550g/day), apple pomace (22g/day) or nothing. Blood, urine, faecal samples and colon biopsies are collected before and after the four weeks intervention period.


Eligibility Criteria:
Inclusion Criteria:

* Healthy
* BMI over 30
* No daily medication
* Not strenuous exercise \> 10hours/week
* No blood donation 3 months before or during the study

Exclusion Criteria:

* Smoking
* Simultaneous participation in other research projects
* Use of any dietary supplements
Saraiki Translation, Validity & Reliability of the Activities Specific Balance Confidence (ABC) Scale Questionnaire

There is a need for a culturally adapted screening tool to aid health care professionals or clinicians screen for the presence of fall and balance issues associated with injuries in saraiki population. Furthermore, while culturally adapting the scale is necessary, it is important that changes do not alter the original intent, which requires it to be broad, comprehensible and applicable to the entire population. As saraiki language is the most-used language in the South Punjab, translating and adapting the ABC scale to the saraiki population while accounting for its sociocultural characteristics is an important task. So, I decided to conduct a tool translation and validation study. This study will help the clinicians to assess their patient's confidence and balance easily through the saraiki version of ABC scale in saraiki population and hence will help in timely management of the balance.

The ABC scale is a 16-item questionnaire with 11-point subscales that assess the level of confidence in performing a specific task without losing balance or becoming unsteady. Each item score ranges from 0% (no confidence) to 100% (total confidence).

As cross-border and cross-cultural studies continue to increase, there is a greater need for linguistic validation of tools across a variety of societies. Until now, no translation or adaptation of the ABC scale has been made for the population with different languages in Pakistan. In order to use questionnaires in areas with different languages and cultures, translation into new languages of ABC scale, for identifying fall and balance issues is required.

Eligibility Criteria:
Inclusion Criteria:

* Able to read saraiki language.
* Healthy older population
* People with controlled Diabetes mellitus
* People with controlled hypertension
* Older adults with BBS score 45-56.

Exclusion Criteria:

* Unstable medical condition.
* Cognitive issues like not able to concentrate, can't perform the task attentively.
* Any physical disability like not able to walk and patient with vestibular disorders.
GLUtEus Maximus Fascia Plasty Flap for Pilonidal Sinus

Surgical treatment is still gold standard for pilonidal sinus disease. Several surgical techniques have been proposed to treat this disease in the last two decades. A new method - midline excision of pilonidal sinus and wound closure using gluteus maximus fascia plasty flap (GMFF) - was proposed recently as a new method of treatment that results in low reccurence rate and good cosmetic results.

The aim of this study is to compare a new method (GMFF) with a traditional method (midline excision and primary closure) in terms of recurrence rate, complications and patient satisfaction with results.

Pilonidal sinus disease (PSD) is a rather rare benign condition (about 26 cases per 100,000 population) that affects primarily young adults. Because of purulent nature it is treated with surgery only.

Traditional surgical techniques encompass midline excision of the purulent cyst and either leaving the wound "lay open" for secondary closure or midline primary closure. The latter method has a major drawback of high recurrence rate and very long healing and patient disability periods. Therefore alternative techniques to close the wound after pilonidal sinus excision were proposed. In some a muscular-cutaneous flaps are created and the wound is closed in a Z- or Y- or other shape manner. The recurrence rate of these techniques is significantly lower than with a traditional midline closure, but healing time and final cosmetic results are far from ideal in patient view.

Recently a new method of wound closure was developed independently by a few groups that includes bilateral mobilisation of gluteus maximus muscles fascia and midline closure of the wound. Preliminary results demonstrated that this method leads to lower recurrence rate and better cosmetic results because the natal cleft is saved.

Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent
2. Chronic primary or recurrent pilonidal sinus at the remission stage.
3. Presence or absence of secondary orifices.
4. Planned surgical treatment with excision of pilonidal sinus.
5. Location of secondary orifices less than 2 cm from the natal cleft.
6. The distance between bilateral symmetrical secondary orifices less than 2 cm.
7. American Society Anesthesiologists (ASA) score 1 to 3

Non-inclusion Criteria:

1. Acute pilonidal sinus abscess.
2. The secondary openings (orifice) position more than 2 cm from the midline.
3. ASA 4-5.
4. Predictable impossibility of following the protocol.
5. Pregnancy

Exclusion criteria:

1 The patients lost for the further observation. 2. The patient's refusal to continue participate in the investigation.