cyrilzakka/clinical-trials huggingface dataset:
Opioid-Free Orthopaedic Surgery

To compare the safety and effectiveness of two pain control pathways following routine orthopaedic surgical procedures (single level or two-level ACDF/ACDA, 1st CMC arthroplasty, Hallux Valgus/Rigidus corrections, diagnostic knee arthroscopies, total hip arthroplasty, and total shoulder arthroplasty / reverse total shoulder arthroplasty). The control group will undergo surgery with an opioid-based pain protocol and the intervention group will undergo surgery with a multimodal, opioid-free protocol.

Patients will have data collected with respect to pain scores, overall comfort level, overall satisfaction with the surgical experience and recovery, constipation, falls, and overall satisfaction with pain control, in addition to procedure-specific outcome scores and patient-specific metrics.


Eligibility Criteria:
Inclusion Criteria

1. Patient is scheduled to undergo one of the following procedures:

* Primary single-level or two-level ACDF or ACDA for degenerative disease
* Primary 1st CMC arthroplasty
* Primary Hallux Valgus or Hallux Rigidus correction
* Diagnostic knee arthroscopy +/- meniscal debridement
* Elective primary total shoulder or reverse total shoulder arthroplasty
* Primary total hip arthroplasty

Exclusion Criteria

1. Revision surgery for one of the study-specific procedures
2. Chronic opioid therapy - per investigator discretion
3. Significant liver disease - (NOTE: Patients with a history of liver disease will have a hepatic panel drawn to be reviewed by the study investigator to asses if the values are within acceptable limits for inclusion in the study)
4. Fracture or soft tissue injury
5. Sickle cell disease
6. Workers compensation
7. Alcohol dependence
8. Contra-indication to regional anesthesia
9. History of gastrointestinal (GI) bleeding or peptic ulcer
10. History of bleeding problems
11. Patients taking anticoagulants, not including aspirin (only applies to Randomized portion of study. These patients can still participate in Observational Control Group)
12. Renal insufficiency - Creatinine clearance less than 30 mL/min (only applies to patients having surgery requiring NSAIDs treatment)
13. Outpatient THA or TSA/RTSA
14. Hammertoe in isolation (Hallux Valgus/Rigidus exclusion only)
15. Concomitant meniscal repair or microfracture (Knee Arthroscopy exclusion only)
16. Ineligible for spinal anesthesia (THA exclusion only)
17. Previous ipsilateral hip surgery, not including hip scope (THA exclusion only)
18. Allergy to non-steroidal anti-inflammatory medications (NSAIDs)
Safety and Tolerability of ToleroMune Grass in Grass Allergic Subjects With Rhinoconjunctivitis

Grass pollen allergens are universally recognised as a major cause of allergic diseases in humans and animals, including asthma, allergic rhinitis, conjunctivitis and dermatitis. Worldwide, at least 40% of allergic patients are sensitized to grass pollen allergens and between 50-90% of hayfever or seasonal allergy sufferers are allergic to grass pollen.

ToleroMune Grass is a novel, synthetic, allergen-derived peptide desensitising vaccine, currently being developed for the treatment of grass allergy.

The purpose of the present study is to evaluate the safety and tolerability of multiple ascending doses of ToleroMune Grass in subjects allergic to grass.

This study is designed as a randomised, double-blind, placebo-controlled study to evaluate the safety and tolerability of escalating multiple doses of ToleroMune Grass in subjects with a documented history of allergic rhinoconjunctivitis on exposure to grass. The efficacy of ToleroMune HDM will also be explored LPSR, EPSR, CPT and levels of grass specific IgE.

The study will consist of 3 study periods. In Period 1, Screening will be performed up to a maximum of 6 weeks before randomisation.

Period 2 (Treatment Period) will consist of 4 visits (Visits 3A-3D) four weeks apart. The first cohort will receive the lowest dose and successive dose groups will increasing doses of ToleroMune Grass, provided the first administration of the previous dose was safe and well tolerated.

In Period 3, 2 Post-treatment Challenge visits will take place, the first will be 2 weeks after the last administration in the Treatment Period and the second will be 17 weeks after the first administration. Follow-up will be conducted 3-10 days after the second PTC.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged 18-65 years
* Minimum 2 year history of rhinoconjunctivitis on exposure to grass
* Positive skin prick test to whole grass allergen
* LPSR to whole grass allergen 8-10 hours after intradermal injection of greater than 35mm diameter response
* Positive CPT to whole grass allergen with a score ≥4

Exclusion Criteria:

* Subjects with a history of asthma
* Subjects with an FEV1 \<80% of predicted
* Subjects with a rye grass specific IgE \>100 kU/L
* Subjects with an acute phase skin response to whole grass allergen with a mean wheal diameter \> 50 mm
* Subjects who score \>1 for redness of conjunctiva or who have any watering or itchiness in the eye before administration of the CPT
* Treatment with beta-blockers, alpha-adrenoreceptor blockers, tranquillisers or psychoactive drugs
* History of any significant disease or disorder (e.g. cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment)
Barrett's Esophagus - 315 - 3 Way Cross Over

This study evaluates PGE2 production, COX-2 enzyme activity and PCNA expression in Barrett's metaplastic tissue. All patients will have a baseline endoscopy with multiple biopsies. The patients will then be receive four dosing regimens (esomeprazole, esomeprazole and aspirin, esomeprazole and rofecoxib, or rofecoxib alone) consecutively each for a 10 day dosing period, whilst undergoing further follow up endoscopies and multiple biopsies.


Eligibility Criteria:
Inclusion Criteria:

* A biopsy-proven diagnosis of Barrett's esophagus segment length greater than 2cm with no dysplasia or adenocarcinoma.
* Clinically normal laboratory results and physical findings at screening.

Exclusion Criteria:

* A history of esophageal, gastric or duodenal surgery, including antireflux surgery or endoscopic antireflux procedures, except for simple closure of an ulcer.
* Evidence of the following diseases or conditions:
* Barrett's esophagus less than or greater than 2cm that is positive for high grade dysplasia or adenocarcinoma
* Signs and symptoms of gastric outlet obstruction
* Active peptic ulcer disease
* severe liver disease
* Pancreatitis
* Malabsorption
* Active inflammatory bowel disease
* Severe pulmonary, cardiovascular or renal disease
* Impaired renal function or abnormal urine sediment on repeated examinations
* esophageal stricture or active, severe esophagitis.
Rollover Study for Participants Previously Enrolled in Clinical Trials of Povorcitinib

Rollover study for participants from predetermined, Incyte-sponsored parent clinical trials of povorcitinib.


Eligibility Criteria:
Inclusion Criteria:

* Ability to comprehend and willingness to sign a written ICF for the study.
* Completed the treatment period of a predetermined, Incyte-sponsored, povorcitinib parent study without safety or tolerability concerns, per investigator's assessment.
* Received clinical benefit from treatment with study drug during the parent study, as determined by the investigator.
* Demonstrated compliance, as assessed by the investigator, with the parent Protocol requirements.
* Willingness to avoid pregnancy or fathering children as defined in the protocol.
* Willingness and ability to comply with the study Protocol and procedures.

Exclusion Criteria:

* Had been permanently discontinued from study treatment during the parent study.
* Had temporary study drug interruption due to safety and/or efficacy reasons at or after the final visit of the parent study.
* Received at least 1 dose of either of the following therapies within the 28 days prior to starting treatment in this rollover study:

  * Biologic immunomodulator (examples include but are not limited to adalimumab, bimekizumab, dupilumab, infliximab, nemolizumab, secukinumab).
  * Live, attenuated vaccine.
* Plans for administration of a live, attenuated vaccine during this study or within 8 weeks after the last dose of study drug.
* Women who are pregnant (or who are considering pregnancy) or breastfeeding.
* Known hypersensitivity or severe reaction to povorcitinib or excipients of povorcitinib and/or other products in the same class.
* Currently enrolled in any other clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study.
* Any condition that would, in the investigator's and/or sponsor's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.

Other protocol-defined Inclusion/Exclusion Criteria may apply.
Transcutaneous Vagus Nerve Stimulation (taVNS) Dosage Study 1

The purpose of this research study is to investigate the effects of different forms of a gentle form of electrical stimulation applied to the ear, known as transcutaneous auricular vagus nerve stimulation (taVNS). The research team is interested in how the different forms affect comfort and tolerability, as well as how well it works.


Eligibility Criteria:
Inclusion Criteria:

1. between the ages of 18-80 years
2. English speaking (must be able to consent and complete the interviews in English)

Exclusion Criteria:

1. chronic pain (average intensity \&gt;2/10 on 0-10 scale, for longer than 3 months)
2. acute pain of intensity greater than 3/10
3. chronic inflammatory conditions that are poorly controlled (e.g., diabetes, autoimmune disease)
4. any unstable medical condition or medical contraindication to moderate physical exertion (e.g., unstable angina or cardiac arrythmia)
5. pregnancy
6. currently taking Buprenorphine or recently stopped taking (within 1 month)
7. presence of cognitive impairment or language barrier that impairs full autonomy in the consent process or in the ability to participate in detailed interviews
8. implants in the head or neck, cochlear implants, or pacemaker
9. head or neck metastasis or recent ear trauma
10. history of epilepsy
11. history of autonomic nervous system dysfunction (e.g., postural orthostatic tachycardia syndrome).
VIAging Deceleration Trial Using Metformin, Dasatinib, Rapamycin and Nutritional Supplements

This study aims to assess the safety and efficacy of study drugs and supplements on clinical (structural and functional) signs of aging and to explore/identify other possible biological measures of aging.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects 65 years of age or older
2. Received full dose of COVID-19 vaccine
3. Fasting Glucose: \> 60 - \< 125 mg/dl;
4. HbA1C: \</= 6.4
5. Vitamin D: \> 30 ng/mL
6. Homocysteine \< 14 mol/L
7. B12 levels \>232 pg/mL
8. Ferritin: \> 30 ng/mL
9. Cystatin C: \> 0.62 mg/L
10. eGFR \> 45 mL/min/1.73 m2
11. BMI \> 18 kg/m2 \< 35 kg/m²
12. Stable body weight (+/-10 lbs.) over last 6 months
13. Be willing to travel to the study facility as required for this study
14. Be willing to avoid taking antacids 2 hours prior and 2 hours after taking dasatinib
15. Be willing to discontinue proton pump inhibitors
16. Be willing to discontinue St. John's Wort
17. Be willing to discontinue medication/supplements, if applicable, for a washout period and while participating on this study.
18. If taking metformin for anti-aging, willing to washout for 2 months prior to initiating protocol intervention.
19. Be willing to take the investigational product(s) according to schedule and keep a diary for compliance monitoring.
20. Has not participated in another clinical trial within last 30 days
21. If applicable, five years or more post cancer treatment and disease free (define as tumor free or 5 years of clean PET/CT scans).
22. Able to provide signed written informed consent prior to any study specific procedures being performed.

Exclusion Criteria:

1. Inability to provide written informed consent.
2. ECOG score \>/= 2
3. More than 1 alcoholic drinks consumed per day.
4. Anemic (defined as hemoglobin (Hb) levels \< 12.0 g/dL in women and \< 13.0 g/dL in men)
5. Thrombocytopenia (defined as platelet count \< 100 × 10\^9/L
6. Neutropenia (defined as \< 1.0-1.5 × 10\^9 neutrophils/L (mild))
7. Any allergy to any medications or supplements used on this trial.
8. Shellfish or iodine allergy (note: glucosamine sulfate supplement contains shellfish (shrimp, crab)
9. Clinically significant vital signs (e.g. uncontrolled hypertension \>/= 180/100) or lab abnormalities (defined as platelet count \< 100 × 10\^9/L; absolute granulocyte count \< 1,000/mm3; ALT (SGOT) \> 2.0 times the upper limit of normal range; total bilirubin \> 2.5 times the upper limit of normal range) at baseline
10. HIV and/or Hepatitis infection
11. Immunosuppressed due to any condition (e.g. transplant).
12. Taking concurrent medications that may interfere with the drugs or supplements used on this study.
13. Any concurrent uncontrolled medical condition or psychiatric illness which could place the patient at unacceptable risk of study treatment.
14. Other concerns that in the PI's judgment will be a potential safety issue for the subject or that precludes the ability to provide informed consent or complete the study.
Single-incision Versus Retropubic Mid-Urethral Sling (Solyx) for SUI During Minimally Invasive Sacrocolpopexy

SASS (Single-incision Versus Retropubic Mid-Urethral Sling (Solyx) for SUI During Minimally Invasive Sacrocolpopexy) will be a multicenter, prospective, randomized, single-blind non-inferiority trial.

SASS aims to compare the efficacy of a single-incision (SIS) versus a retropubic mid-urethral sling (RP) placed at the time of minimally invasive sacrocolpopexy in women with pelvic organ prolapse and objectively confirmed stress urinary incontinence (SUI).

Eligibility Criteria:
Inclusion Criteria:

* At least 21 years of age
* Vaginal bulge symptoms as indicated by an affirmative response of \>1 to question 3 of the PFDI-SF20
* POP ≥ stage II according to the pelvic organ prolapse quantification (POP-Q) system45, with evidence of apical descent
* Women being considered for minimally invasive sacrocolpopexy (with or without concomitant hysterectomy)
* Objective SUI: positive standardized cough stress test on clinical examination or on urodynamic study with reduced prolapse
* Understanding and acceptance of the need to return for all scheduled follow-up visits and willing to complete study questionnaires
* Able to give informed consent

Exclusion Criteria:

* Prior surgery for stress urinary incontinence including mid-urethral sling; Burch/MMK; fascial pubovaginal sling (autologous, xenograft or allograft); and urethral bulking injection
* Any serious disease, or chronic condition, that could interfere with the study compliance
* Unwilling to have a synthetic sling
* Untreated and unresolved urinary tract infection
* Poorly-controlled diabetes mellitus (HgbA1c \> 9 within 3 months of surgery date)
* Neurogenic bladder/ pre-operative self-catheterization
* Elevated post-void residual/PVR (\>150 ml) that does not resolve with prolapse reduction testing (pessary, prolapse reduced uroflow or micturition study)
* Prior pelvic radiation
* Inflammatory bowel disease
* Current genitourinary fistula or urethral diverticulum
* Planned concomitant bowel related surgery including sphincteroplasty and perineal rectal prolapse surgery, rectovaginal fistula repair, hemorrhoidectomy
* Pregnant or Planning to Conceive
* Incarcerated
A Study of Genetic and Environmental Factors and Their Effect on Response to Treatment With Lucentis (Ranibizumab) for Wet AMD

The purpose of this study is to understand whether genes or certain factors in the environment determine how eyes will respond to Lucentis (ranibizumab) treatment. For example, whether having variants within specific genes means that a patient is likely to get better vision from treatment than another patient with different genes.

Age-related macular degeneration (AMD) is the leading cause of blindness in the developed world. The advanced stages of the disease are characterized by the development of geographic atrophy or choroidal neovascularization, both of which result in significant loss of vision. Development of intravitreal anti-VEGF agents such as ranibizumab has significantly improved outcomes for the neovascular for of the disease. However, it is not possible to predict which individuals will respond to the treatment.

The objective of this study is to establish the association between genetic factors and treatment response to intravitreal Lucentis. This will be accomplished by SNP-genotyping participants for AMD-susceptibility and candidate angiogenesis-pathway genes, collecting environmental risk factor variables and evaluating clinical outcomes. The aim of this pharmacogenetics study will be to identify patients at the outset of their treatment that require more intensive therapy.

Eligibility Criteria:
Inclusion Criteria:

* All AMD-related CNV lesion types will be included.
* Age \>50 years
* The study eye must never have received treatment for neovascular AMD
* Visual acuity in treatment eye must be between 20/30 and 20/320 (ETDRS).

Exclusion Criteria:

* Age \<50 years;
* Previous therapy in either eye for AMD or other retinal disease which may be used in the treatment of AMD;
* Choroidal neovascularization not from AMD;
* Concomitant non-AMD related maculopathy in study eye;
* Active treatment for neovascular AMD in fellow eye;
* Acuity loss or central field loss from non-AMD cause;
* Pigment epithelial detachment without evidence of CNV;
* Individuals in whom Lucentis is contraindicated;
* Participation in another clinical trial in last three months
* Pregnancy (positive pregnancy test) or lactation
* Premenopausal women not using adequate contraception
* Prior enrollment in the study
* Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
Glucocorticoid-induced Tumour Necrosis Factor Receptor Related Protein (GITR) in Rheumatoid Arthritis

This study aimed to measure serum and synovial fluid (SF) levels of GITR in patients with recent onset RA before and after initiation of therapy

1. Technical design:

   Study design: a longitudinal observational cohort study.

   This study will be carried out on two groups:
   * Group (I): fifty early onset rheumatoid arthritis (RA) patients fulfilled the 2010 American college of rheumatology (ACR) - European league against rheumatism (EULAR) classification criteria for RA \[11\].
   * Group (II): Twenty healthy individuals of matching age and sex as control group.

   Both groups will be recruited from the in-patients and out-patients' clinic of the Rheumatology, Rehabilitation\& Physical Medicine Department, Benha University Hospital.

   All patients will be evaluated at baseline at 6 months follow up using:

   (A) Clinical evaluation 1. Complete history taking. 2. Thorough clinical examination. 3. Disease activity using DAS28 \[12\]

   (B) Laboratory assessment:

   All patients will be subjected to the following measurements:
   1. Erythrocyte sedimentation rate (ESR).
   2. C reactive protein (CRP).
   3. Rheumatoid factor (RF)
   4. Anti-cyclic citrullinated peptide (Anti- CCP).
   5. glucocorticoid-induced tumour necrosis factor receptor related protein (GITR)

   (D) Musculoskeletal ultrasound assessment: Ultrasound examinations will be performed for patients and control groups using a Logiq e equipped with a broadband 8- to 13-MHz linear transducer
2. Statistical analysis The collected data will be tabulated and analyzed using suitable statistical computer version.

Eligibility Criteria:
Inclusion Criteria:

* fulfill 2010 criteria for classification of rheumatoid arthritis recentely diagnosed

Exclusion Criteria:

* infection malignancy receiving treatment
Tinnitus Treatment Using a Smartphone Application

People with tinnitus will use a smartpphone app in which they are instructed to reject maladaptive thoughts by throwing them away from themselves (upwards) and embrace supportive thoughts by pulling them towards themselves (downwards). The Tinnitus Handicap Inventory will be used to measure the effect of the application.


Eligibility Criteria:
Inclusion Criteria:

* Tinnitus lasting more than 3 months

Exclusion Criteria:

* Brain space occupying lesion
Kinesio Taping and Physiotherapeutic Exercises for Children With DCD

Aim: To investigate the effectiveness of a novel elastic taping-augmented functional movement power training (KT-FMPT) program in improving leg muscular performance, body balance, motor proficiency and functional independence in children with developmental coordination disorder (DCD).

Methodology: In this clinical trial, twenty children with DCD (aged 6-12) will be randomly assigned to either a KT-FMPT group or a placebo control group. Children in the KT-FMPT and control groups will receive elastic taping-augmented FMPT and general jogging exercise with non-elastic taping, respectively, for 12 weeks (2 hours/week). Major outcome measures: body balance and leg muscle activity will be measured via muscle sensors along with a force platform. Secondary outcome measures: leg muscle strength, motor proficiency and functional independence will be assessed by a digital dynamometer, the Movement Assessment Battery for Children-2 and Pediatric Evaluation of Disability Inventory, respectively (before- and after-intervention measurements).

Significance: The KT-FMPT group is predicted to display much better muscular and motor performances than the control group. This novel training program can be readily adopted in clinical, school, or home settings to improve functional independence in children with DCD, an outcome with positive socioeconomic implications. Moreover, study findings will inspire future research work in children with other childhood-onset disabilities.


Eligibility Criteria:
Inclusion Criteria:

* 6- to 12-years-old
* classified as DCD according to the Diagnostic and Statistical Manual of Mental Disorders V
* score \< 5th percentile on the Movement Assessment Battery for Children, 2nd edition (MABC-2)
* total score \< 46 on the DCD questionnaire (2007)
* attending a mainstream primary school with intelligence level within the normal range
* no KT or FMPT experience

Exclusion Criteria:

* any known congenital, cognitive, psychiatric, neurological, sensorimotor, musculoskeletal or cardiopulmonary disorder that may affect test performance
* receiving active rehabilitation treatment
* demonstrating excessive disruptive behaviour
* unable to follow instructions