cyrilzakka/clinical-trials huggingface dataset:
A Dose-Escalation Study to Evaluate Safety, Tolerability and Pharmacokinetics of Multiple Doses of Q203 in Normal Healthy Male and Female Volunteers

This is randomized, double-blind, placebo-controlled, multiple ascending dose study of Q203 in healthy volunteers conducted at one study center in the United States

Six (6) cohorts of 8 subjects (6 active and 2 placebo) are planned for evaluation. In each cohort, subjects will receive multiple oral doses of Q203 or placebo for 14 days QD with a standard meal. Subjects will participate in only one cohort.

Safety (i.e., physical examinations, vital signs, ECGs, clinical laboratory tests, and adverse events \[AEs\]) will be assessed throughout the study; serial blood and urine samples will be collected for these assessments. Blood samples will also be collected for the PK assessment of Q203.

Escalation to the next dose level (i.e., initiation of the next cohort) will not take place until the Principal Investigator (PI), medical monitor, and representatives of the Sponsor have reviewed all available safety and tolerability from the previous cohorts and agree to the initiation of the next cohort.

Eligibility Criteria:
Inclusion Criteria:

1. Understands the study procedures in the informed consent form (ICF), and be willing and able to comply with the protocol.
2. Healthy adult male and/or female (non-childbearing potential only), 19 to 55 years of age, inclusive, at screening.

Exclusion Criteria:

1. Subject is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.
2. History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI.
3. History of any illness that, in the opinion of the PI, might confound the results of the study or poses an additional risk to the subject by their participation in the study.
Rotator Cuff Pathway

Rotator cuff surgery is mostly performed on an outpatient basis, and many patients still experience moderate to severe pain after surgery, despite the use of regional anesthesia and opioids. The specific aim is to determine whether a comprehensive pathway that includes a well-defined regional technique and multimodal analgesia will reduce the worst pain with movement 0-48 hours after block placement compared to the current standard practice. This is a 'before and after' study. We plan to have 70 patients studied prior to initiation of a pathway, and 70 patients studied after initiation of a pathway. Both groups will receive identical postoperative follow-up.

Previous study in shoulder arthroplasty patients demonstrated low pain scores and minimal intravenous opioid use when utilizing a clinical pathway that included peripheral nerve block and preemptive non-opioid analgesia (Goon et al. 2014). These surgeries were done as inpatient and patients had availability of intravenous opioids. Assessment of the current approach to managing rotator cuff repairs demonstrated an average worst pain score after surgery of 7.0, SD 2.1 (Kahn) which is often categorized as "severe" pain. Given that most rotator cuff repairs are done as outpatients, it is important to develop a clinical pathway that mitigates the worst pain experienced after surgery. With outpatient surgery, there are obvious limitations regarding availability of rescue pain medications. Therefore, the pathway needs to emphasize patient education and strategies to reduce the pain as peripheral nerve block subsides. Given these issues, we believe there is an advantage to prolonging the analgesia from the nerve block (Rosenfeld et al. 2016, Yadeau et al. 2016, Kahn) and educating patients regarding the importance of preemptive analgesia and when to take opioid medications. This study will evaluate whether the clinical pathway might mitigate the worst pain after surgery that occurs with the current standard practice.

Eligibility Criteria:
Inclusion Criteria:

* Ambulatory rotator cuff patients with participating surgeons.

Includes the following concomitant procedures:

* Arthroscopic SLAP (Superior Labrum Anterior and Posterior) repair
* Arthroscopic Stabilization
* Arthroscopic AC (Acromioclavicular) resection
* Arthroscopic SAD (Sub-Acromial Decompression)
* Arthroscopic or mini open biceps tenodesis
* Age 18-80

Exclusion Criteria:

* chronic pain history (defined as use of opioids \> 3 months or current gabapentinoids for pain)
* open surgery (but sub pectoralis mini open biceps tenodesis is not excluded)
* revision surgery
* kidney disease (GFR \< 60 ml/min/1.73 m2 for 3 months or more)
* liver disease (transaminitis, cirrhosis, hepatitis, hypoalbuminemia, coagulopathy)
* planned avoidance of regional anesthesia
* any contraindication to or patient refusal of any component in the pathway
* Non-English speakers
Efficacy of "Tailored Physical Activity" in Health Care Workers

The purpose of this study is to test the effect of "Tailored Physical Activity" on the number of sick-days.

The hypothesis is that "Tailored Physical Activity" is superior in efficacy on sick-days.

Health care workers have high prevalence of musculoskeletal pain. Pain in the back and neck and other musculoskeletal disorders are the leading cause for long-term sick leave.

This study test the effect of "Tailored Physical Activity" on self-reported days on sick leave and parameters regarding pain, function and quality of life respectively on the body function and participation level of health care workers which have experienced musculoskeletal pain related to the back or upper body.

A minimum of 44 health care workers in DK-Sønderborg Municipality will be randomized for "Tailored Physical Activity" or a reference group.

Primary endpoint is 3 months and 12 months follow-up.

Eligibility Criteria:
Inclusion Criteria:

Health care workers in municipality of Sønderborg that have experienced musculoskeletal pain related to the spine or upper body.

Exclusion Criteria:

Medically safety.
A Phase II Controlled Trial of Velafermin for Prevention of Oral Mucositis

CG53135-05 (velafermin), a recombinant human fibroblast growth factor-20 (rhFGF-20) protein, is under investigation for the prevention of oral mucositis. Oral mucositis is a commonly occurring side effect of high-dose chemotherapy in patients undergoing autologous hematopoietic stem cell transplant. The objective of this Phase II trial is to confirm the safety and efficacy of CG53135-05 (velafermin) when administered as a single dose to patients at risk for developing oral mucositis.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Patients with multiple myeloma or lymphoma receiving myeloablative CT with or without TBI that require autologous stem cell support. The CT regimens are limited to high dose melphalan (200 mg/m2) as a single agent, BEAM, or TBI with cyclophosphamide or VP-16.
* Adequate organ function that meets institutional requirements for autologous stem cell transplant. A minimum CD34+ cell dose of 2X106 /kg based on ideal body weight (IBW) has been or will be infused.
* ECOG Performance Score of 2 or less
* Signed Informed Consent Form (ICF)

Exclusion Criteria:

* Premenopausal female patients who are pregnant, lactating or are likely to become pregnant
* Patients diagnosed with active sero-positive acquired immunodeficiency syndrome (AIDS) or Hepatitis B/ C
* Patients with known hypersensitivity to recombinant protein therapeutics
* Patients who have taken velafermin (CG53135-05) previously
* Patients who have taken palifermin in the past 90 days
* Patients who have taken other investigational drugs in the past 30 days
* Patients who have untreated symptomatic dental infection
* Patients with a history of sensitivity or allergy to E. coli-derived products
* Patients with WHO Grade 3 or 4 OM at the time of randomization
* Patients who are sensitive or allergic to G-CSF, Fluconazole or acyclovir or equivalent
* Patients with altered mental status precluding understanding of the informed consent process and/or completion of the necessary assessments
* Patients with baseline creatinine level greater than or equal to 3 or any patient with renal insufficiency requiring dialysis.
Cytochrome P450's Pharmacogenomics in Chronic Pain Patients

The use of titrated drugs is at the base of a successful antalgic treatment in order to provide both an adequate relief and a satisfactory tolerability profile. These molecules, though, have a varying degree of efficacy in different subjects due to medical and genetic reasons. The latter are mainly represented by cytochrome (CYP) P450, in particular CYP2D6's polymorphisms are responsible for the diversified metabolism of analgesics used in chronic pain treatments.

Four main types of enzymatic metabolism make up the population, each one defined by a different CYP2D6 allele: extensive metabolizers, ultra-rapid metabolizers, intermediate metabolizers and poor metabolizers.

Moreover, regarding polytherapies, the analgesics' metabolism could be influenced by coadministration of other drugs, thus determining an inhibition or induction of the metabolic enzymes - known as phenocopying - and potentially also a change in the metabolic phenotype itself. The final outcome is the inconstancy of effectiveness and of the risk of developing side effects.

The primary objective of this study is to define a genetic pattern for the gene CYP2D6 by assessing the incidence of poor or ultrarapid metabolizers in a population of chronic pain patients. This will also allow to observe phenocopying in the same population.

Hence 100 patients diagnosed with chronic pain will be enrolled. The genetic pattern of the gene CYP2D6 of such patients will be examined by taking mouth samples. At the same time parametric tests for paired data to survey the correlations between phenotypical patterns and pharmacological therapies will be conducted.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of chronic pain

Exclusion Criteria:

-
Comparison of Biofilm Characteristics Between an in Situ Biofilm Model of Supragingival Plaque and Natural Teeth

The purpose of this study is to determine in situ the bacterial viability, thickness and bacterial diversity of a biofilm formed on different substrates in comparison to a naturally tooth-formed oral biofilm. In addition, it will be evaluated whether the restraint of oral hygiene measures may influence the development of the PL-Biofilm.

* To calculate an a priori sample size, the following statistical criteria were established: an effect size of 0.35, an alpha error of 0.05 and a statistical power of 87%. Assuming these criteria and using the repeated measures ANOVA test, a sample size of 15 subjects was required.
* Bacterial viability and thickness will be analyse by Confocal Laser Scanning Microscope and Live/Dead BackLight staining solution.
* Bacterial diversity will be analyse by Pyrosequencing the 16S DNAr gene.

Eligibility Criteria:
Inclusion Criteria:

* systemically healthy
* good oral health status

Exclusion Criteria:

* smoker or former smoker,
* presence of dental prostheses or orthodontic devices,
* antibiotic treatment or routine use of oral antiseptics in the previous 3 months,
* presence of any systemic disease that could alter the production or composition of saliva
Virtual Reality as a Self-Efficacy Intervention

The goal is to explore the use of Virtual Reality (VR) as an intervention to increase self-efficacy in a healthcare setting. The investigators would like to determine if an educational VR intervention in the course of healthcare could increase pediatric patient self-efficacy compared to standard of care (i.e no VR).

While virtual reality has gained momentum as a therapeutic supplement to distract from pain perception and to reduce anxiety, it has received less attention as an intervention to promote more holistic psychological self-efficacy in the course of in-patient care. Child and adolescent self-reported measures of self-efficacy have also been looked over in favor of parent or practitioner measures of a child's self-efficacy.

To evaluate the effectiveness of virtual reality on child and adolescent self-efficacy while undergoing hospital care, the investigators will determine the effect of virtual reality to 1) increase pediatric patient self-efficacy compared to standard of care using educational virtual reality, 2) establish a comprehensive profile of short-term psychological well-being in school-aged children and adolescents following admission to a hospital. Participants will serve as their own control to either receive intervention on the first day or second day of the in-patient care and no intervention will be given on the other day.

Eligibility Criteria:
Inclusion Criteria:

* Patients' age range from 5 to 25 at LPCH/SHC facilities

Exclusion Criteria:

* Participants who do not consent
* Have a history of seizure disorder
* Currently have nausea
* Have motion sickness
* Are clinically unstable
* Currently using corrective glasses (not compatible with VR headset)
* Currently pregnant
Study to Evaluate the Efficacy and Safety of CTP-543 in Adults With Moderate to Severe Alopecia Areata (THRIVE-AA1)

This study evaluates the safety and effectiveness of an investigational study drug (called CTP-543) in adults (18 years and older) who have 50% or greater scalp hair loss.


Eligibility Criteria:
Inclusion Criteria:

* Clinical presentation compatible with alopecia areata with a current episode lasting at least 6 months and not exceeding 10 years at the time of Screening. Total disease duration greater than 10 years is permitted.
* At least 50% scalp hair loss, as defined by a Severity of Alopecia Tool (SALT) score ≥50, at Screening and Baseline.
* Willing to comply with the study visits and requirements of the study protocol.

Exclusion Criteria:

* Treatment with other medications or agents within 1 month of Baseline or during the study that may affect hair regrowth or immune response.
* Active scalp inflammation, psoriasis, or seborrheic dermatitis requiring topical treatment to the scalp, significant trauma to the scalp, or other scalp condition that may interfere with the SALT assessment, or untreated actinic keratosis anywhere on the body at Screening and/or Baseline.
* Treatment with systemic immunosuppressive medications within 3 months of Screening or during the study, or biologics within 6 months of Screening or during the study.
* Females who are nursing, pregnant, or planning to become pregnant while in the study, and for 30 days after last dose of study drug.
* Clinically significant medical condition, psychiatric disease, or social condition, as determined by the Investigator, that may unfavorably alter the risk-benefit of study participation, adversely affect study compliance, or confound interpretation of study results.
Evaluation of the Effect of High-intensity Laser Therapy in Knee Osteoarthritis

The aim of this study is to evaluate the effects of high intensity laser therapy (HILT) on range of motion, pain, quality of life, muscle strength and femoral cartilage thickness in patients with knee osteoarthritis.

Patients who are admitted and diagnosed with knee osteoarthritis based on anamnesis, physical examination and imaging methods are included in the study.

Eligibility Criteria:
Inclusion Criteria:

1-40-70 years old 2-Diagnosis of knee OA according to ACR clinical and radiological diagnostic criteria 3-Kellgren Lawrence stage II or III 4-Knee pain for at least 6 months 5-Visual analog scale (VAS) score of at least 3 or more

Exclusion Criteria:

1. History of surgery or traumatic injury
2. Inflammatory arthritis
3. History of cancer, bleeding diathesis and psychiatric disease
4. Those who have a disease that limits their participation in exercises (severe chronic obstructive lung disease, severe heart failure, history of cerebrovascular events)
5. Hip and ankle problems
6. Participating in another physical therapy program in the last 3 months
7. History of intra-articular injections in the last 6 months
Microbiome Vaginae After Use of Oral Probiotics in Pregnancy.

Change of Vaginal microbiome in first trimester pregnant women after oral intake of Probiotic preparation with 4 lactobacilli strains

Although the research of the vaginal microbiome is taking faster pace in recent years than it was the case before, there is still lack of information, about its composition, how and when it changes and how that can affect processes in the female body.

During pregnancy, the microbiome physiologically gets increasingly stable. Diversity of bacteria decreases, which is the sign of a healthy microbiome, and Lactobacillus species increase their already pre-existing dominance. Acidic metabolites of those bacteria maintain the low pH and low diversity in vagina.

If the dominance of lactobacilli is not as large as it should be, the risk of preterm birth increases significantly. Low relative abundance of Lactobacillus species, especially Lactobacillus crispatus (marker of the healthy microbiome) and lactobacillus metabolites as well as high vaginal microbial diversity are most significantly connected with preterm birth.

Despite such a high relevance of vaginal microbiome for a healthy pregnancy, and for women's health in general, there's an insufficient proof that the intake of oral probiotics can change it. The aim of our study is to see if the intake of patented dietary supplement, containing four Lactobacillus strains can change the relative abundance of different bacteria in the vaginal microbiome. This could lay ground for further research in this area and even create new therapeutic approaches in the future.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women aged between 18 and 45
* infection screening during a prenatal consultation between 10+0 (10 weeks plus 0 days) and 16+0 (16 weeks plus 0 days) gestational weeks
* Singleton pregnancy

Exclusion Criteria:

* Vaginal infections such as Bacterial vaginosis, candida vaginitis, trichomoniasis, mycoplasma, gonococcal infection
* Antibiotic therapy in the last 4 weeks
* Probiotic therapy in the last 4 weeks
* Operation on gastrointestinal tract
* Diarrhoea, obstipation
* Vaginal bleeding
* Patients with hormone disorders of any kind
* Other chronic diseases (Diabetes, Autoimmune diseases etc.)
* HIV
* Gestational diabetes
Safety and Efficacy of Bendamustine, Gemcitabine, Rituximab, Nivolumab (BeGeRN) in Patients With r/r DLBCL

Despite the current advances in clinical oncology, the prognosis of patients with resistant diffuse large B cell lymphoma or relapse after high dose chemotherapy is dismal. Therefore there is a need for the introduction of novel treatment regimens. This phase I/II trial evaluates the safety and efficacy of combination bendamustine, gemcitabine, nivolumab and rituximab in patients with relapsed or refractory diffuse large B-cell lymphoma. The safety of combination treatment will be evaluated with the determination of recommended dose schedule prior to expansion of enrollment to evaluate the antitumor activity of bendamustine, gemcitabine, rituximab, and nivolumab.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis: Histologically confirmed diffuse large B-cell lymphoma
* Refractory or relapsed after at least two prior lines of treatment (i.e. induction and salvage regimen) for diffuse large B-cell lymphoma.
* Age 18-70 years old
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2
* Signed informed consent
* No severe concurrent illness

Exclusion Criteria:

* Uncontrolled bacterial or fungal infection at the time of enrollment
* Requirement for vasopressor support at the time of enrollment
* Karnofsky index \<30%
* Pregnancy
* Somatic or psychiatric disorder making the patient unable to sign informed consent
* Active or prior documented autoimmune disease requiring systemic treatment.
The Use of Thermal Suits as Preventing Hypothermia During Surgery

Unintentional hypothermia of a patient is a common adverse effect during surgical procedures. The aim of this prospective, randomised, controlled study is to determine whether the use of thermal suit could prevent surgical patient from experiencing thermal loss than conventional measures.

Hypothesis: The investigators assume that a difference of 0.5°C in body temperature between the groups is clinically relevant.

The aim of this study was to compare a thermal suit (T-Balance) and conventional warming methods to maintain a constant body temperature in patients undergoing robotic laparoscopic radical prostatectomy under general anesthesia.

A sample size calculation was made using a power analysis. Patients were randomly allocated into two groups.

Patients in the intervention group were put on the T-Balance 1 hour before anesthesia induction. Patients in the control group got conventional cotton clothes. Intra-operatively same warming methods were used in both groups. The measuring points of the temperature were esophagus (core temperature), left axilla, dorsal surface of the left middle finger and back of the left foot.

Anesthesia was induced via target-controlled infusion. All temperature data of the patients were collected and recorded electrically and continuously.

Eligibility Criteria:
Inclusion Criteria:

* radical prostatectomy, American Society of Anaesthesiologists class I-III, age 18-90

Exclusion Criteria:

* mental status with inability to give informed consent, neuromuscular disorders, Raynaud's disease, unstable angina pectoris
Prehabilitation to Improve Functional and Clinical Outcomes in Patients With Aortic Stenosis

Transcatheter aortic valve replacement (TAVR) is a treatment alternative among high-risk elderly with aortic stenosis, however, mortality remains high. Fifty percent of patients undergoing TAVR exhibit frailty, a syndrome associated with poor survival. It is unknown whether interventions to improve frailty before TAVR (prehabilitation) will improve outcomes after TAVR. This study plans to evaluate whether simple cardiac exercise interventions to improve physical performance before TAVR improves outcomes after TAVR.


Eligibility Criteria:
Inclusion criteria:

* Eligibility for TAVR
* SPPB\<9
* Able to exercise
* Able to come for follow-up visits
* Able to give informed consent

Exclusion criteria:

* New York Heart Association (NYHA) Class III/IV congestive heart failure (CHF)
* Presyncope or syncope as presentation
* Acute coronary syndrome
* Unable to exercise
* Dementia
* Sustained ventricular arrhythmia
* Stroke with neurological deficit
* Advanced Parkinson's
* Participated in an exercise program