cyrilzakka/clinical-trials huggingface dataset:
Influence of Caffeinated and Non-caffeinated Pre-workout Supplements on Resistance Exercise Performance

This study is a randomized, double-blind, placebo-controlled crossover trial examining the effects of caffeinated and non-caffeinated pre-workout supplements on resistance exercise performance. Resistance-trained adults will be randomly assigned to complete three study conditions (caffeinated pre-workout, non-caffeinated pre-workout, and placebo) in one of the six possible condition orders. During each condition, participants will report to the laboratory for ingestion of the assigned beverage and subsequent muscular performance testing. Major performance outcomes will be force production variables from a mechanized squat device and maximal strength and muscular endurance on the bench press and leg press exercises.


Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18 and 40;
* Body mass between 50 - 100 kg (110-220 lb)
* Generally healthy (defined as an absence of any disease or medical condition which could potentially be negatively affected by consumption of the commercially available dietary supplements or performance of exercise, including but not limited to musculoskeletal or cardiovascular diseases).
* Resistance-trained, defined as completing 2+ resistance training sessions per week for at least three months prior to screening.
* Participants must have reported regular training of the lower body through a multi-joint exercise such as the squat or leg press at least once weekly during the three-month period prior to screening.
* Participants must have reported regular training of the bench press or chest press variation at least once weekly during the three-month period prior to screening.
* Female participants will be required to bench press ≥ 0.5 x body mass and leg press ≥ 1.75 x body mass during initial 1RM assessments to be eligible for this study.
* Male participants will be required to bench press ≥ 1.0 x body mass and leg press ≥ 3.0 x body mass to be eligible.
* Regular caffeine consumption (due to the presence of caffeine in the commercially available dietary supplement). This will be defined as an average self-reported daily intake of 250+ mg of caffeine, which is equivalent to approximately 2.5 cups of coffee.

Exclusion Criteria:

* Failing to meet any of the aforementioned inclusion criteria.
* Pregnant or breastfeeding (for female participants)
* Taking prescription medication which could reasonably make participation unsafe for the participant or influence study outcomes
* An inability to complete resistance exercise due to injury or medical condition
* Self-reported caffeine sensitivity, as indicated by unwanted side effects when caffeine is consumed.
* Allergy to any of the ingredients in the test beverages or standardized breakfast.
* Current use of anabolic steroids
* Presence of a pacemaker or other implanted electrical device.
* Unwillingness to wear the provided surgical mask during all testing procedures.
HEALEY ALS Platform Trial - Regimen F ABBV-CLS-7262

The HEALEY ALS Platform Trial is a perpetual multi-center, multi-regimen clinical trial evaluating the safety and efficacy of investigational products for the treatment of ALS.

Regimen F will evaluate the safety and efficacy of a single study drug, ABBV-CLS-7262, in participants with ALS.

The HEALEY ALS Platform Trial is a perpetual multi-center, multi-regimen clinical trial evaluating the safety and efficacy of investigational products for the treatment of ALS. This trial is designed as a perpetual platform trial. This means that there is a single Master Protocol dictating the conduct of the trial. The HEALEY ALS Platform Trial Master Protocol is registered as NCT04297683. Once a participant enrolls into the Master Protocol and meets all eligibility criteria, the participant will be eligible to be randomized into any currently enrolling regimen. All participants will have an equal chance of being randomized to any currently enrolling regimen.

If a participant is randomized to Regimen F ABBV-CLS-7262, the participant will complete a screening visit to assess additional Regimen F eligibility criteria.

Once Regimen F eligibility criteria are confirmed, participants will complete a baseline assessment and be randomized in a 3:1 ratio to either active ABBV-CLS-7262 or matching placebo.

Regimen F will enroll by invitation, as participants may not choose to enroll in Regimen F. Participants must first enroll into the Master Protocol and be eligible to participate in the Master Protocol before being able to be randomly assigned to Regimen F.

For a list of enrolling sites, please see the HEALEY ALS Platform Trial Master Protocol under NCT04297683.

Eligibility Criteria:
Inclusion Criteria:

* No additional inclusion criteria beyond the inclusion criteria specified in the Master Protocol (NCT NCT04297683).

Exclusion Criteria:

* The following exclusion criteria are in addition to the exclusion criteria specified in the Master Protocol (NCT NCT04297683).

  1. Based on the metabolism of the compound, the concomitant use of certain inhibitors and inducers of cytochrome P450 enzymes.
  2. Any clinically significant ECG abnormalities.
  3. Clinically significant clinical laboratory abnormalities.
Prospective Study of the Outcomes of the Surgical Treatment of Deeply Infiltrating Endometriosis

The aim of this study is to examine the incidence of deeply infiltrating endometriotic lesions among surgically treated endometriosis patients, and examine the impact of endometriosis, and its surgical treatment, on severity of pain symptoms, quality of life, and sexual functioning.

Patients scheduled for operation on suspected endometriosis in two study hospitals specialized in the surgical treatment of endometriosis between January 2005 - December 2007 (Päijät-Häme Central Hospital) and January 2008 - December 2008 (Helsinki University Hospital) were enrolled to the study. The diagnosis of endometriosis was histologically verified for all patients. Background data was collected from patients' age, body mass index, previous deliveries, previous endometriosis surgery, and current hormonal treatment for endometriosis.

From the beginning of January 2006 patients also completed preoperative questionnaires considering visual analogue scales (VAS) for pain symptoms (dysmenorrhea, deep dyspareunia, pain with urination and defecation, chronic pelvic pain, pain with ovulation), functional bowel and urinary symptoms, and 15D Quality of Life questionnaire, McCoy sexual functioning questionnaire, EHP-5 Short Form Endometriosis Profile questionnaire. Same questionnaires will also be completed six months, one year, two years, four years, and six years after the endometriosis operation. Follow-up questionnaires also contain questions concerning complications related to surgery, endometriosis recurrence, pregnancies, and infertility treatments.

Eligibility Criteria:
Inclusion Criteria:

* Finnish speaking patients scheduled for operation on suspected endometriosis

Exclusion Criteria:

* Non-Finnish speaking patients
* Previous hysterectomy.
* Previous bilateral salpingo-oophorectomy
* Any cancer
* Chronic inflammatory bowel or bladder disease
* Diabetes treated with insulin
* Rheumatoid arthritis.
Switching to Faricimab in Neovascular Age-related Macular Degeneration Resistant to Both Aflibercept and Ranibizumab

The goal of this retrospective single-center chart review is to establish the response rate, efficacy and safety of a single dose of intravitreal faricimab injection in real-world patients with aflibercept- and ranibizumab-resistant neovascular age-related macular degeneration.


Eligibility Criteria:
Inclusion criteria

* Presence of neovascular age-related macular degeneration (AMD) in the study eye
* Previous treatment with minimum 6 consecutive, monthly aflibercept (Eylea®) injections in the study eye without optimal treatment response, defined as persisting intraretinal fluid or subretinal fluid or both on optical coherence tomography scans
* Subsequently, a sequential switch to ranibizumab (Lucentis®), with minimum 1 injection, also without optimal response
* Finally, a sequential treatment switch from ranibizumab to faricimab.

Exclusion criteria

* Neovascular conditions other than AMD (e.g., choroidal neovascularisation due to other causes) or co-existence of other retinal disease in the study eye
* Significant optical media opacities that would result in poor imaging quality on OCT scans in the study eye
* Intraocular surgery in the study eye 3 months before or within 1 month after the treatment switch
Regimens Comparison for Breast Cancers of Positive Lymph Nodes

To compare the efficacy and safety of EC-T and ET regimen as adjuvant treatment of breast cancer patients with positive lymph nodes

EC-T regimen: epirubicin 90mg/m2 day1, CTX 600mg/m2, day 1, 21 days per cycle \*4cycle. followed by paclitaxel 175mg/m2,d1,21days per cycle, 4 cycle.

ET regimen: epirubicin 75mg/m2 day1,paclitaxel 175mg/m2,d2,21days per cycle, 6 cycle

Eligibility Criteria:
Inclusion Criteria:

* patients with breast cancer after breast cancer surgery with positive lymph nodes age 18-70 years old

Exclusion Criteria:

* with other malignance disease
Assessing E-Cigarettes for Tobacco Harm Reduction in the Context of Lung Cancer Screening

This study investigates the feasibility, acceptability, and short-term effects of providing 4 weeks of complimentary electronic cigarettes (ECs) to 30 individuals who did not quit after smoking cessation treatment provided in the context of lung cancer screening and do not plan to quit smoking. This open-label single-arm pilot clinical trial will test the impact of EC provision on: 1) study feasibility, 2) EC acceptability, 3) tobacco use behavior (e.g., cigarettes per day, EC use), and 4) biomarkers (e.g., carbon monoxide, cotinine, and anabasine). Participants will be asked to switch from combustible cigarettes to the NJOY ACE 5% nicotine electronic cigarette (EC) for 4 weeks. They will be followed an additional 4 weeks after EC provision ends (to 8 weeks).

The first study hypothesis is that more than 40% of eligible smokers who are offered participation in the trial will enroll, and that 75% of enrollees will complete the trial. The second study hypothesis is that participants will report fewer cigarettes smoked per day at the end of 4 weeks of EC provision, relative to their baseline values.


Eligibility Criteria:
Inclusion Criteria:

* Participants who completed the Screen Assist study (NCT03611881) and self-reported smoking cigarettes at the end of the study were asked to complete a survey to ascertain their potential interest in participating in a research study to test the effects of switching from combustible cigarettes (CC) to electronic cigarettes (EC). Individuals who expressed interest in switching to EC on that survey were screened for eligibility for this pilot study
* Smoked ≥5 cigarettes/day in past month
* Smoking status at study entry confirmed by breath carbon monoxide (CO) ≥ 6ppm
* Willing to try switching from CC to EC for 4 weeks
* Owns a mobile telephone
* English speaking
* Willing to travel to the Massachusetts General Hospital campus for 3 in-person visits.

Exclusion Criteria:

* Plans to quit smoking and has set a quit date in the next 30 days
* Used smoking cessation treatment in the past 30 days
* Used EC on \>2 days in the past 30 days
* Hospitalized for acute coronary syndrome, unstable angina, congestive heart failure, stroke, pneumonia or chronic pulmonary disease/asthma exacerbation in the past 1 month
* Not willing to abstain from smoking marijuana in the 24h before each study visit
The Role of Occupational Therapy for Improving Medication Management for Persons With AMD, DR and Glaucoma

The goal of this clinical trial is to learn if education about additional task lighting, enhanced contrast, enlarged print instructions, smart apps and organizational strategies will improve medication management skills. The main questions it aims to answer are:

Does additional task lighting, enhanced contrast, enlarged print instructions, smart apps and organizational strategies improve medication management skills, reduce errors and improve functional use of remaining vision for this task?

Participants will:

Oftentimes, the client is unaware of these strategies which may improve occupational performance during a valued activity. Clients with AMD, DR or Glaucoma who choose to receive the one hour OT service will be provided with 1:1 education regarding the devices and strategies that may improve their ability to perform medication management skills.

Many clients with low vision are unaware of OT, or the services OT can provide to assist with low vision needs. Clients with AMD, DR or Glaucoma who choose to receive the one hour OT service will be provided with 1:1 education regarding the devices and strategies that may improve their ability to perform medication management skills. Clients will complete the MediCog and the Revised-Self-Report Assessment of Functional Visual Performance (R-SRAFVP) assessment tools with the assistance of the OT. These tools will inform the therapist to areas of client needs and allow for focus on intervention to support these challenges. Follow up in OT 4 weeks post intervention will allow therapist to reassess the effectiveness of interventions provided via a phone or in-person interview as well as provide the assessments again. Second set of data from these assessments will be compared to initial findings obtained.

Eligibility Criteria:
Inclusion Criteria:

* Clients with AMD, DR or Glaucoma
* Clients who choose to participate will allow their deidentified data to be evaluated for outcomes.

Exclusion Criteria:

* Clients with other age related eye diseases other than AMD, DR or Glaucoma.
* Clients who do not wish to participate in this study.
Using Cannabis to Treat Restless Legs Syndrome

Restless Legs Syndrome (RLS) is a disorder that causes painful and uncomfortable sensations in the legs, and its symptoms have a significant impact on sleep and quality of life. Cannabis has been used by some RLS patients as a treatment due to its painkilling and drowsiness effects, however there has never been a clinical research trial investigating cannabis in patients with RLS. A controlled trial is needed to establish how safe and feasible cannabis is as a treatment for RLS. The investigators plan to randomize 30 participants with moderate-to-severe RLS to receive either cannabis or placebo for 8 weeks. The investigators will measure patients sleep quality and quality of life at baseline and 8-week follow-up. The investigators will also monitor patients for any adverse reactions to the study drug.


Eligibility Criteria:
Inclusion Criteria:

* ≥25 years of age
* diagnosis of RLS based on the International RLS Study Group criteria
* refractory RLS symptoms despite use of dopaminergic and/or alpha-2-delta ligand therapy
* onset of RLS at least 6 months before screening

Exclusion Criteria:

* sleep disordered breathing, or sleep disordered breathing that is not adequately controlled on therapy (apnea-hypopnea index of \>15)
* cannabis use within 4 weeks of study enrollment
* known allergy to cannabis, cannabinoids or palm/coconut oil
* Currently pregnant or breast-feeding (a negative urine pregnancy test must be obtained for women of childbearing potential during pretreatment evaluation)
* Active substance abuse
* Ischemic heart disease with unstable angina or recent acute coronary syndrome in the last 3 months, uncontrolled arrhythmias, poorly controlled hypertension
* Serious liver disease
* History of schizophrenia or any other psychotic disorder
Application of a Dental-dedicated MRI in the Diagnosis of Temporomandibular Joint Disorders, Tissue Alterations Related to Third Molars, Periapical and Periodontal Inflammatory Diseases, and Implant Treatment Planning

The aim of the present study is to show that the use of 0.55T MRI combined with a "dental" coil produces images of sufficient diagnostic value to assess areas of interest in dentistry, and to compare MR images to traditional, dental-oriented radiographic images for diagnostic purposes.


Eligibility Criteria:
Inclusion Criteria (one of the following):

* referred for CBCT imaging of at least one tooth for endodontic reasons
* referred for intra-oral and/or panoramic imaging covering at least one molar tooth for periodontal reasons
* referred for CBCT imaging of the TMJ (bilaterally)
* referred for panoramic imaging of the third molar (retained/semi-retained, uni- or bilateral), prior to treatment planning
* referred for CBCT imaging prior to implant treatment

Exclusion Criteria:

* younger than 18 years
* unable to give consent
* pregnant
* pronounced claustrophobia
* pacemakers or implanted defibrillators
* metal shrapnel injuries of the eyes or MRI incompatible metallic inclusions or implants large tatoos
* non-removable piercings
Early Insulin Treatment in Patients With Latent Autoimmune Diabetes

Among adult patients diagnosed with type 2 diabetes, about 6% have autoantibodies directed against the insulin producing beta cells in the pancreas. These patients have a progressive beta cell destruction and most of them will be insulin dependent within 3-5 yrs. Patients with this latent autoimmune diabetes in adults (LADA) have a considerable remaining beta cell mass at diagnosis, and are suitable for evaluating new therapies for autoimmune diabetes Animal studies in diabetes prone mice have demonstrated potential positive effects of early insulin treatment, with a lower incidence of diabetes or a delay before diagnosis. The aim of this study was to investigate the effect of early insulin treatment of LADA patients, in respect to residual beta-cell function and metabolic control, compared to a group who were conventionally treated with diet and/or oral hypoglycaemic agents (OHA) and insulin not before it was clinically needed.

All adult newly diagnosed diabetic patients in the certain areas are screened for pancreatic antibodies. Patients clinically classified as Type 2, not insulin requiring at diagnosis and positive for at least one autoantibody are eligible for inclusion. After randomisation to insulin treatment or diet and/or OHA, the patients are followed up with fasting C-peptide every third month. A glucagon test is performed, and stimulated C-peptide and HbA1c, + clinical data and body weight are recorded at baseline and after 12, 24 and 36 months. The final outcome of the study is C-peptide, and change in C-peptide compared to baseline level, and HbA1c, after 36 months.

Eligibility Criteria:
Inclusion Criteria:

* \>18 yrs
* Positive for pancreatic autoantibodies

Exclusion Criteria:

* \<18 yrs
* Significant concomitant diseases
* Not able to follow protocol
Neoadjuvant Apalutamide (ARN509) and Radical Prostatectomy in Treatment of Intermediate to High Risk Prostate Cancer

This is an investigator-initiated phase II single arm trial, combining neoadjuvant apalutamide (ARN509) with radical prostatectomy, in the treatment of D'Amico intermediate to high risk organ-confined prostate cancer. Apalutamide has shown efficacy in castrate resistant prostate cancer in phase II studies and are now in phase III trials combined with radiation in organ confined disease.

The primary study objectives include assessment of (i) oncological efficacy as determined by tumour downstaging and achievement of nadir PSA The secondary study objectives include(i) determination of adverse effects related to apalutamide and surgical complication rates (ii) human prostate tissue effect of apalutamide

The study will recruit thirty eligible participants who will receive 12 weeks of oral apalutamide 240mg daily. This will be followed by standard-of-care radical prostatectomy. The total trial duration is 26 weeks.

This is a phase II single arm study looking at the efficacy of 12 weeks of neoadjuvant apalutamide (ARN 509), combined with standard-of-care radical prostatectomy, for D'Amico intermediate to high risk prostate cancer patients. The phases of the study will include: screening, treatment and follow-up phases.

Safety will be monitored throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* histologically diagnosed primary adenocarcinoma of the prostate gland
* non-metastatic D'Amico intermediate to high risk patients undergoing radical prostatectomy as primary definitive therapy
* no known hypersensitivity to the study drug
* able to swallow study drug as whole tablets

Exclusion Criteria:

* presence of small cell, neuroendocrine or ductal differentiation at needle biopsy
* individuals with prior pelvic irradiation therapy for any form of pelvic malignancy
* patients with psychiatric conditions requiring anti-psychotic therapy, or preventing the provision of informed consent
* renal impairment with serum creatinine more than twice the upper limit of normal
* Other prior malignancy less than or equal to 5 years prior to recruitment
* ECOG performance status 2 or poorer
Evaluation of Efficacy and Hypothalamus-pituitary-adrenal Axis Suppression Due to Corticosteroids Intrabursal Injection

The purpose of this study is to compare the efficacy and effects on the hypothalamus-pituitary-adrenal axis of a single intrabursal injection of two different types of corticosteroids (methylprednisolone and triamcinolone) in patients with calcific shoulder tendinopathy.

Rotator cuff calcific tendonitis is a common disease, mainly affecting women aged 30 to 50 years old. It is associated to severe pain and impotence. US-guided percutaneous treatment is considered the gold standard treatment with the aim to destroy and wash out shoulder's calcification, responsible for inflammation, pain and functional limitation. Corticosteroids are injected in the subacromial-subdeltoid bursa at the end of the procedure to facilitate the prompt pain relief and functional recovery. Although corticosteroids represent the most powerful drugs to reduce inflammation and pain, their use is associated to important side effects, mainly the suppression of the hypothalamus-pituitary-axis (HPA). At the same time, no standardized protocols exist regarding the best type and dose of corticosteroid to be injected in association to the above mentioned treatment, nor data evaluating the exact duration of HPA suppression following a single intrabursal injection of corticosteroids.

40 patients affected by rotator cuff calcific tendonitis will be enrolled in the study and randomly assigned to two groups: one group (20 patients) will be treated with a single intrabursal injection of 40 mg of methylprednisolone; the other group (20 patients) will be treated with a single intrabursal injection of 40 mg of triamcinolone.

All patients will be tested at time 0 (morning before treatment) and at 1, 7, 15, 30 and 45 days after the injection, using clinical, laboratory and US parameters in order to compare the efficacy and safety of the two drugs.

Eligibility Criteria:
Inclusion Criteria:

* painful rotator cuff calcific tendonitis demonstrated by ultrasounds

Exclusion Criteria:

* pregnancy
* use of corticosteroids in the previous 2 months
* systemic chronic inflammatory or allergic diseases
* allergy to methylprednisolone or triamcinolone
* diabetes
* glaucoma
* coagulopathies or current treatment with antiaggregants or anticoagulants
* septic arthritis or infections
* calcific enthesopathy