cyrilzakka/clinical-trials huggingface dataset:
Scapulothoracic and Glenohumeral Stabilization Exercises in Boulderers

Introduction. In the block climbing, the fluidity with which the athlete climbs a certain route is fundamental. The speed with which the movements are executed and the number of grippers of upper limbs is related to sports performance. Shoulder injuries are very prevalent in this sport. The inhibition of the stabilizing musculature can alter joint positioning and its normal biomechanics.

Objective. To evaluate the efficacy of a program of stability exercises, scapulothoracic and glenohumeral, in the improvement of shoulder stability and sports performance, in boulder climbers.

Material and method. Forty randomized subjects will be recruit into two groups: experimental (scapulothoracic and glenohumeral stability exercises) and control (glenohumeral stabilization). The stability of the shoulder (Closed Kinetic Chain Upper Extremity Stability Test) and the sports performance (Climbing Test) will be evaluated. The intervention last 6 weeks, with two weekly sessions of 30 minutes each. Differences between evaluations will be analyzed with the t-sudent for related samples and the intra- and intersubject effect with the repeated measures ANOVA test.


Eligibility Criteria:
Inclusion Criteria:

* Being climbers
* Between the ages of 18 and 40 years
* Belonging to the Boulder Madrid Climbing Gym
* Who climbed at least twice a week
* Having at least 6 months of experience

Exclusion Criteria:

* Were participating in competitions at the time
* Presented pathologies of the upper limb
* Used any type of ergogenic aid
* Had not signed the informed consent document.
Evaluation of RTVue in Corneal Measurement

The purpose of this study is to evaluate RTVue measurement of the cornea in various ocular conditions to include normal, pathology, post refractive surgery and cataract.


Eligibility Criteria:
Inclusion Criteria:

Normal cornea:

* 18 years of age or older
* No corneal pathology
* No prior ocular surgery and no prior laser refractive surgery

Post laser refractive surgery:

* 18 years of age or older
* No corneal pathology
* No prior ocular surgery except laser refractive surgery
* At least 1 week post laser refractive surgery without complication

Corneal pathology:

* 18 years of age or older
* Clinical diagnosis of one or more type of corneal pathologies, including corneal scar and keratoconus, etc., excluding eyes in which corneal power measurement are not clinically relevant (e.g., eyes requiring corneal transplant)
* No prior laser refractive surgery

Cataract surgery:

* 18 years of age or older
* No corneal pathology
* No prior ocular surgery, no prior laser refractive surgery, and no prior cataract surgery
* Post surgery visit shall only include eyes without complication
A Phase I Safety, Pharmacokinetics and Pharmacodynamics Study of Recombinant Factor VIIa in Adult Patients With Hemophilia A or B

This study will assess the pharmacokinetics and pharmacodynamics of rhFVIIa at three dose levels. The results will help identify the most optimal doses to take forward to the Phase 2/3 studies where bleedings in hemophilia patients with inhibitors will be treated with rhFVIIa.


Eligibility Criteria:
Inclusion Criteria:

1. be male with a diagnosis of moderate or severe congenital hemophilia A and/or B (with or without inhibitors)
2. be 18 years or older, up to and including 75 years of age
3. be capable of understanding and willing to comply with the conditions of the protocol
4. have read, understood and provided written informed consent

Exclusion Criteria:

1. have any coagulation disorder other than hemophilia A or B
2. have a body weight \>105 kg (231 lb)
3. be immuno-suppressed (i.e., the patient should not receive systemic immunosuppressive medication \<30 days prior to enrollment, CD4 counts at screening should be \>200/µl)
4. have a known allergy or hypersensitivity to rabbits
5. have platelet count \<100,000/mL
6. have had within one month prior to first administration of the study drug in this study a major surgical procedure (e.g. orthopedic, abdominal)
7. have an active, ongoing bleeding for which the patient is being treated, or treatment for a bleeding was stopped within 24 hours of the time of study drug administration
8. have received a Factor VII or FVIIa containing product (either plasma derived or recombinant) within 72 hours prior to any study drug administration
9. have received an investigational drug within 30 days of the first study drug administration, or is expected to receive such drug during participation in this study
10. have a clinically relevant hepatic (hepatic enzymes \>3 times the upper limit of normal) and/or renal impairment (creatinine \>2 times the upper limit of normal)
11. have a history of arterial and/or venous thromboembolic events (such as myocardial infarction, ischemic strokes, transient ischemic attacks, deep venous thrombosis or pulmonary embolism) within 2 years prior to first dose of study drug, have an arterial stent in place or have clinically significant atherosclerotic disease (e.g., angina pectoris, peripheral vascular disease)
12. use any anticoagulant for arterial/venous obstructions and/or atrial fibrillation within 7 days prior to first study drug administration
13. have an active malignancy (those with non-melanoma skin cancer are allowed)
14. have any life-threatening disease or other disease or condition which, according to the investigator's judgment, could imply a potential hazard to the patient, interfere with the trial participation or trial outcome
Pilot Study on the Effect of Oral Controlled-Release Alpha-Lipoic Acid on Oxidative Stress in Adolescents With Type 1 Diabetes Mellitus

The long-term effects of high blood sugar include blindness, kidney failure, and nerve damage that can ultimately cause loss of limbs. Research has shown that high blood sugar increases the amount of reactive oxygen species (ROS) produced in diabetics, and that the increase in ROS causes damage to eyes, kidneys, and nerves by a process called "oxidative stress." We postulate that alpha-lipoic acid, a potent anti-oxidant, can stop ROS from forming, thereby preventing long-term complications in diabetes. In this pilot study, we will be giving 30 teenagers with type 1 diabetes (T1D) controlled-release alpha-lipoic acid for 3 months, and comparing the amount of oxidative stress before and after treatment. Ten teenagers with T1D will receive placebo instead of alpha-lipoic acid and undergo the same research protocol to aid in validation of outcome measures.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects must be pubertal (defined as Tanner stage II or greater), or post-pubertal, with an upper age limit of 21 years.
2. Subjects must have diabetes by 1997 ADA criteria:

   1. fasting plasma glucose \>= 126 mg/dL, or
   2. 2 hour postprandial glucose \>= 200 mg/dL
3. Subjects must have history of least one auto-antibody associated with T1D, either glutamic acid decarboxylase (GADA) or islet cell autoantigen 512 (ICA512), or history of diabetic ketoacidosis.

Exclusion Criteria:

1. Subjects must not have history of eye, kidney or nerve damage 2. Subjects must not be deemed unable or unlikely to comply with the protocol. Children who are unable to swallow pills, or are unwilling to take pills twice daily will be excluded from the study.

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Brivaracetam as add-on Treatment of Unverricht-Lundborg Disease in Adolescents and Adults

The study will compare the efficacy and safety of brivaracetam with placebo in patients with Unverricht-Lundborg disease.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with diagnosed Unverricht-Lundborg disease (ULD) ascertained by appropriate genetic testing for a homozygous or compound heterozygous mutation in the Cystatin B (CSTB) gene
* Subjects with moderate to severe myoclonus documented by an Action Myoclonus sum score of ≥ 30 (evaluation by investigator)
* Subjects currently being or having been treated with clonazepam up to the maximum recommended daily dose of 20 mg or up to their individual optimal dose as assessed by the investigator
* Subjects currently being or having been treated with valproate up to the maximum recommended daily dose 60 mg/kg or serum levels of 100 mcg/ml or up to their individual optimal dose as specified by the investigator

Exclusion Criteria:

* Subjects currently on felbamate or having been on felbamate within less than 18 months prior to Visit 1
* Subjects currently treated with phenytoin or having been on phenytoin in the last month prior to Visit 1
* Subjects currently on vigabatrine. Subjects having been on vigabatrine if no visual fields examination report available including standard static (Humphrey or Octopus) or cinetic perimetry (Goldman)
* Subject taking any drug with possible central nervous system (CNS) effects
* Subjects taking any drug that may significantly influence the metabolism of BRV (CYP2C or CYP3A potent inducers/inhibitors)
* Known clinically significant acute or chronic illness or illness which may impair reliable participation in the trial, necessitate the use of medication not allowed by protocol or represent a safety risk in the Investigator's opinion
* Subjects with history of severe adverse hematological reaction to any drug
* Impaired hepatic function: ALAT/SGPT, ASAT/SGOT, alkaline phosphatase, GGT value of more than three times the upper limit of the reference range
* History of suicide attempt during the last 5 years
* Subject with suicidal ideations within the last year or at risk of suicide attempt unless cleared by written confirmation from a psychiatrist and approved by the UCB physician
* Ongoing psychiatric disorder other than mild controlled disorder
Brain Imaging Changes Following Proton Therapy for Pediatric Primary Central Nervous System and Base of Skull Tumors

This trial gathers information from patients with primary central nervous system or base of skull tumors that receive proton beam therapy and see if certain imaging techniques can help detect radiation-related changes over time. This study may help providers learn more about proton beam radiotherapy and how to improve the way it is delivered.

PRIMARY OBJECTIVE:

I. To establish linear energy transfer (LET)-based models as early predictors for white matter changes on magnetic resonance imaging (MRI) and diffusion tensor imaging (DTI) sequences in pediatric patients following proton beam therapy for primary central nervous system (CNS) and base of skull tumors.

OUTLINE:

Patients' medical charts are reviewed.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have histologically confirmed central nervous system of skull base tumors
* Patient is going to undergo central nervous system (CNS) or base of skull proton beam therapy

Exclusion Criteria:

* Patients who have received prior therapeutic radiotherapy to the primary brain tumor site
* Patients who are unable to maintain follow-up through the Phoenix Children's Hospital and Mayo Clinic Arizona
Biatain Ag vs Biatain in the Treament of Leg Ulcers

the objective of this investigation is to demonstrate the effect of the foam dressing Biatain Ag, compared to Biatain foam dressing( a product which is similar but does not contain a silver complex, in the healing of leg ulcers that had failed to heal despite appropriate therapy


Eligibility Criteria:
Inclusion Criteria:

* • Patients over 18 who have given written informed consent

  * Patients with a venous or predominantly venous leg ulcer (ankle-brachial index \> 0.8) that is between 2 cm and 13 cm in all directions
  * Patients with a moderately or severely exudating leg ulcer in the phase of debridement or formation of granulation tissue
  * Patients with a leg ulcer that is not healing properly despite suitable and well-conducted local treatment in the four weeks prior to inclusion
  * Patients with a leg ulcer that has been treated with appropriate compression in the four weeks prior to inclusion
  * Patients who are available for monitoring for at least 10 weeks

Exclusion Criteria:

* • Patients whose leg ulcers are clinically infected (including erysipelas and cellulitis of the skin around the ulcer) requiring systemic antibiotic treatment

  * Patients who have undergone surgery on the saphenous trunk within the two months prior to inclusion
  * Patients whose leg ulcer being considered for the study has been treated with local antibiotics or antiseptics incl. dressings containing antibiotics or antiseptics in the four weeks prior to inclusion
  * Patients who have been taking systemic antibiotics in the two weeks prior to inclusion
  * Patients who have been taking systemic corticoids or cytostatics within the three months prior to inclusion
  * Patients with unbalanced diabetes at the discretion of the investigator
  * Patients with a known allergy to one of the components in Biatain Argent® or Biatain
  * Patients who are already taking part in another clinical study
  * Patients who are pregnant or breastfeeding
Prosperando: Fostering Resilience on Dialysis

Latinos with End-Stage Renal Disease (ESRD) represent 17% of the US adult ESRD community and suffer a disproportionate burden of social challenges that impacts their well-being. With support from the Amos award from the Robert Wood Johnson Foundation (RWJF), the investigators assessed the feasibility of a 1-arm intervention of a 5-visit lay Peer Navigator intervention to support Latino ESRD patients with social challenges and adherence (using motivational interviewing \& patient activation). This trial will build on the Amos work as a small Randomized Controlled Trial (RCT). The overall aims of this proposal are to: 1) engage key operational and clinical stakeholders early-on to develop a Peer Navigator-intervention; 2) conduct a pilot RCT of the peer navigator intervention versus standard care to test feasibility and acceptability; and 3) assess the efficacy of the intervention on interdialytic weight gain (primary outcome) as well as health-related quality of life, patient activation, and hemodialysis adherence (secondary outcomes).

The goal of this project is to assess the feasibility and acceptability of a pilot RCT of a culturally tailored peer-navigator (PN) intervention to improve patient-centered and clinical outcomes for Latino patients with end-stage kidney disease (ESKD). We will compare a culturally tailored intervention that includes a PN to control (standard care). In the culturally tailored intervention, the bilingual PN will provide support with social challenges during 5 visits. We will assess the feasibility of (1) referral, (2) recruitment, (3) retention, (4) intervention implementation, and (5) data collection. We will also assess various outcomes including inter-dialytic weight gain and other adherence and patient-centered outcomes.

Specific Aim 1: Conduct a pilot RCT of the peer navigator intervention to assess feasibility, acceptability, as well as outcomes of the proposed peer navigator intervention.

Hypothesis 1: A culturally tailored intervention that consists of a bilingual/culture-concordant peer navigator that provides support with social challenges and support with adherence using motivational interviewing for Latino end-stage kidney disease (ESKD) patients, is feasible and acceptable.

Eligibility Criteria:
Inclusion Criteria:

1. Self-identify as Latino
2. Age between 18 and 90 years
3. Diagnosed with end-stage kidney disease
4. Received standard (thrice-weekly HD) for at least 3 months
5. No active substance use (e.g. heavy etoh or opiates)
6. Speak English or Spanish as a primary language
7. Participants must be able to provide informed consent

Exclusion Criteria:

1. Active suicidal intent
2. Present or past psychosis or bipolar disorder
3. Patient to receive kidney transplantation in the next 3 months
To Demonstrate the Relative Bioavailability of Atenolol Tablets

To demonstrate the relative bioavailability of Atenolol tablets.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.
Comparison of Efficacy and Safety of Prandilin and NovoRapid in Newly Diagnosed Type 2 Diabetes

To compare the effect of the rapid-acting insulin analogues (RAIAs) NovoRapid (aspart) and Prandilin (lispro) on glycemic variations by Continuous glucose monitoring system (CGMS) in continuous subcutaneous insulin infusion (CSII) with metformin intensive therapy in newly diagnosed type 2 diabetes mellitus (T2DM).

The study was designed as a single blind randomized control trial. A total of 110 newly type 2 diabetic diagnosed patients with hemoglobin A1c (HbA1c%) above 9% were hospitalized, and were randomly divided into two groups: NovoRapid group (group Asp) and Prandilin group (group Lis) in CSII, combined with metformin therapy. Treatments were maintained for 2-3 weeks after the glycaemic target was reached. To complete the assessment of general information, fasting C-peptide (C-P0), 2-h postprandial C-peptide (C-P2h), fasting insulin (Ins0), 2-h postprandial insulin (Ins2h), HbA1c% and fructosamine on the baseline and endpoint. 4 days continuous glucose monitoring (CGM) was performed on after three days stable glucose.

Eligibility Criteria:
Inclusion Criteria:

1. voluntary to attend this study signed the informed consent; 2. between 18 and 75 years of age; 3. according to the who standards, the subjects should be newly diagnosed as type 2 diabetes; 4. BMI between 19 and 35kg/m2; 5.HbA1c\>9%; 6. using enough contraception and not pregnancy; 7. The patients do not attend any medical subjectsin in the last 3 months before enrollment; 8. the subjects agreed to maintain the original diet and exercise habits throughout the study period.

Exclusion Criteria:

1. Patients with severe cardiopulmonary disease; 2. Patients with acute complications (diabetic ketoacidosis, diabetic ketosis hypertonic coma, diabetes lactic acidosis, etc.); 3. Patients with intolerance to metformin allergy to metformin 4. Patients with history of mental disease, and not suitable for the use of insulin pump; 5. Researchers think that the patients does not fit for this research (such as alcoholism, drug abuse, etc.).
Evaluation of the High Dose Vitamin D3 Supplementation Effect and Influence of Polymorphism VDR Gene on Oxidative Stress and Inflammatory Process in Elderly

A vitamin D3 high dose would act as an antioxidant and anti-inflammatory improving markers of oxidative stress and inflammation in the elderly. Seniors exhibiting polymorphism in the VDR gene would become non-responsive to supplementation.

The high prevalence of hypovitaminosis D in the elderly can be identified as a risk factor for developing cardiovascular disease and consequent increase in oxidative stress and chronic inflammation. Polymorphisms in the gene that encodes the vitamin D receptor (VDR) can influence the cellular responses supplementation of vitamin D. The study objective is to evaluate the influence of supplementation of 200,000 in a single high dose of vitamin D3 in the inflammatory status and oxidative stress elderly and the influence of polymorphism of the VDR gene in this response. One randomized, placebo-controlled clinical trial, designed with non-institutionalized elderly in northeastern Brazil will be held. All volunteers will sign the Instrument of Consent and will undergo clinical, nutritional, anthropometric and biochemical evaluation. The purpose is to produce new knowledge helping to unravel the beneficial effects of vitamin D3.

Eligibility Criteria:
Inclusion Criteria:

* Aged 60 years; diagnosis of failure / vitamin D, preserved cognitive status, disability accepting participate and are not included in any of the exclusion criteria

Exclusion Criteria:

* excluded from the study in the elderly using vitamin D supplements; anticonvulsant drugs or for the treatment of HIV / AIDS; diagnosis of type I diabetes mellitus, nephrotic syndrome, acute or chronic renal failure, liver disease, hypothyroidism, hyperthyroidism, history of cerebrovascular accident (CVA) or acute myocardial infarction (AMI) Vascular past 6 months and chronic consumptive diseases, alcoholic or smoker chronic.
A Nurse Led Project to Introduce Hand Lettering as a Form of Creative Art Expression to Patients in an Ambulatory Oncology Setting

The investigators are conducting a project to provide a new type of resource called "hand lettering" to patients receiving chemotherapy. This is a type of art therapy. The goal of this project is to understand if it is feasible to use art-therapy and to describe anxiety before and after completing hand-lettering.

This study is being done to understand if it is feasible to use a form of art-therapy called hand-lettering at Dana-Farber Cancer Institute. We would also like to explore the anxiety a person has before and after using hand-lettering.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (\>age 18) with a cancer diagnosis receiving oral or IV chemotherapy at Dana-Farber on Yawkey 10.
* Able to read and speak English
* Has a minimum appointment time of 60 minutes

Exclusion Criteria:

-Individuals with visual impairment or blindness will be excluded