cyrilzakka/clinical-trials huggingface dataset:
Effect of Thermomechanical Stimulation Device and Virtual Reality Glasses During Peripheral Intravenous Catheterization

The study was conducted as a randomized controlled experimental study to determine the effect of Thermomechanical Stimulation Device (Buzzy®) and Virtual Reality Goggles (VRG) applied during peripheral intravenous catheterization (PIC) on pain and patient satisfaction in adult patients.

The research was carried out at the Emergency Department of the Etimesgut Şehit Sait Ertürk State Hospital in Ankara from April 2021 to February 2022. The sample of the study consisted of 126 adult patients. The patients were divided into three groups by randomization method. VRG was applied to the first group, Buzzy to the second group and the control group which was the third group using the standard procedure. Before the procedure of PIC, "Introductory Characteristics Form for Patients" was prepared by the researcher containing the sociodemographic characteristics of the participants (gender, marital status, age, educational status, etc. as such). This form was filled out by asking the patient by face-to-face interview method. After catheterization, the "Visual Comparison Scale for Pain" was used by the nurse practitioner to determine the pain of the patients and the "Visual Comparison Scale for Satisfaction" was used to determine the satisfaction status of the patients regarding the application to be performed. It is expected that pain and patient satisfaction scores in groups where a VRG and Buzzy® were used during PIC in adult patients will result more positively than in the control group. It is thought that the results obtained from the research will contribute to the literature.

Eligibility Criteria:
Inclusion Criteria:

* Shold be a volunteer to participate in the research
* Should be in the age of between 18-65 years old
* Should not use drugs that will have an analgesic effect in the last 24 hours before admission
* Should have successful of the first intravenous catheterization attempt
* Absence of any psychiatric illness
* Absence of any oncology and hematology disease
* Should have the ability to read and write in Turkish,
* Absence of vision, hearing and perception problems
* Should not have a febrile illness at the time of applications
* Should not have thin and damaged vascular structure
* Absence of a history of fainting during blood removal
* Should be conscious, fully oriented and cooperative, and open to communication

Exclusion Criteria:

* Failure of the first attempt to administer intravenous catheterization
* The unwillingness of the patient to continue the research
* Removing the virtual reality glasses before and during the procedure
* Discontinuing of Buzzy ® before and during the procedure
* Deterioration of the patient's health status during the procedure
ProSTAR: A Study Evaluating CPI-1205 in Patients With Metastatic Castration Resistant Prostate Cancer

This is a two-arm, open label Phase 1b/2 study with an oral administration of CPI-1205 in combination with either enzalutamide or abiraterone/prednisone in male patients with metastatic Castration Resistant Prostate Cancer. This study is designed to determine the maximum tolerated dose (MTD) and recommended Phase II dose (RP2D) based on safety, tolerability, pharmacokinetic, and efficacy profiles of CPI-1205 in combination with either enzalutamide or abiraterone/prednisone.

Following determination of MTD and RP2D will proceed to phase 2. Patients in phase 2 will receive CPI-1205 at the RP2D in combination with either enzalutamide or abiraterone/prednisone vs either enzalutamide or abiraterone/prednisone as a control arm.


Eligibility Criteria:
Inclusion Criteria:

* Adults (Age ≥ 18 years)
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Life expectancy of at least 12 weeks
* Histologically or cytologically confirmed adenocarcinoma of the prostate
* Progressive disease in the setting of medical or surgical castration (i.e. CRPC)
* Documented metastatic disease
* Must have undergone bilateral orchiectomy (surgical castration) or be willing to continue gonadotropin-releasing hormone (GnRH) analog or antagonist (medical castration)
* Serum testosterone \<50 ng/dL
* Receipt of prior line of second generation androgen inhibitor
* Demonstrate adequate organ function as defined below:

  * Absolute Neutrophil Count (ANC) ≥ 1,000/μL
  * Platelet Count ≥ 100,000/μL
  * Hemoglobin (Hgb) ≥ 8 g/dL
  * Serum creatinine ≤ 2 × upper limit of normal (ULN) OR
  * Creatinine clearance (CrCl) ≥ 40 mL/min as estimated by the Cockcroft and Gault formula1 in subjects with creatinine \> 2 X ULN
  * Bilirubin ≤ 1.5 × ULN unless evidence of Gilbert's disease in which case \< 3 x ULN
  * Aspartate aminotransferase (AST) ≤ 2.5 × ULN without liver metastases; must be ≤ 5 × ULN with liver metastases
  * Alanine aminotransferase (ALT) ≤ 2.5 × ULN without liver metastases; must be ≤ 5 × ULN with liver metastases

Exclusion Criteria:

* Known symptomatic brain metastases (NOTE: patients with treated epidural disease are allowed)
* Treatment with any of the following for prostate cancer within the indicated timeframe prior to day 1 of treatment:

  1. First generation: AR antagonists (e.g., bicalutamide, nilutamide, flutamide) within 4 weeks
  2. 5 alpha reductase inhibitors, ketoconazole, estrogens (including diethylstilbesterol \[DES\]), or progesterones within 2 weeks
  3. Chemotherapy within 3 weeks
  4. Biologic therapy within 4 weeks
  5. Investigational therapy within 3 weeks (or within a time interval less than at least 5 half-lives of the investigational agent \[if known\], whichever is longer).
  6. Immunotherapy within 4 weeks
  7. Prior radionuclide therapy within 4 weeks
Treatment of Sodium Retention in Liver Cirrhosis With Dexamethasone

Accumulation of salt and water in patients with liver disease (so called liver cirrhosis) is possibly related to the increased effect of steroid hormones on salt reabsorption in the kidney. By reducing overall steroid production with the dexamethasone the accumulation of salt and water could be prevented.


Eligibility Criteria:
Inclusion Criteria:

* patients with established liver cirrhosis (biopsy or biochemically)
* hepatorenal syndrome type 1 or 2 (with a serum creatinin \>175 umol/l)
* age between 18 and 75
* no bacterial infection
* no cardiovascular or extrahepatic disease (end of life)
* no structural kidney disease
* no hepatocellular carcinoma

Exclusion Criteria:

* age under 15 or over 75
* treatment with corticosteroids (dexamethasone included)
* bacterial infection
* cardiovascular or extrahepatic disease (end of life)
* structural kidney disease (indicated by hematuria, proteinuria)
* hepatocellular carcinoma
* mental disability
Estradiol-Receptor Blockade in Older Men and Women

Repletion of testosterone (Te) in older men drives GH secretion after its aromatization to estradiol (E2), which acts via the estrogen receptor (ER). Conversely, we postulate that estrogen deprivation in postmenopausal women attenuates growth hormone (GH) secretion and insulin-like growth factor-1 (IGF-I) production, thus favoring development of metabolic syndrome in men treated with toremifene, a new estrogen antagonist used adjunctively in prostatic cancer

Systemic concentrations of Te, E2, GH, IGF-I and insulin growth factor binding protein 3 (IGFBP-3) decline in healthy aging men and women. Relative sex-steroid deprivation accentuates GH and IGF-I depletion, since Te stimulates GH and IGF-I production in older men, hypogonadal males of all ages, and patients undergoing (genotypic female-to-male) gender reassignment. The estrogen-receptor antagonist, tamoxifen, blocks this effect of Te, suggesting involvement of E2 in GH's stimulation at least in young men. E2 alone stimulates GH secretion in young and older women. Because Te is converted to E2 by aromatization in the body, we postulate that E2 is the active moiety in both men and women. Moreover, we hypothesize that the decline of E2 in older men and women contributes to the fall in GH output. These basic concepts will be tested here.

Eligibility Criteria:
Inclusion:

1. 40 healthy women and men (ages 50 to 80 y); women will be post-menopausal (clinically defined by E2 \< 50 pg/mL, FSH \> 30Iu/L)
2. BMI 18-35 kg/m2
3. community dwelling; and voluntarily consenting

Exclusion:

1. recent use of psychotropic or neuroactive drugs (within five biological half-live);
2. obesity (outside weight range above);
3. Laboratory test results not deemed physician acceptable, viz potassium \<3.5 mEq/L, magnesium \<1.5 mEq/L, triglycerides \> 300, BUN \>30 or creatinine \> 1.5 mg/dL, liver functions tests twice upper limit of normal, anemia (hemoglobin must meet Blood Bank requirements - Hgb ≥ 12.5 g/dL)
4. drug or alcohol abuse, psychosis, depression, mania or severe anxiety;
5. acute or chronic organ-system disease, including renal failure (creatinine \> 1.5 mg/dL)
6. endocrinopathy, other than primary thyroidal failure receiving replacement
7. nightshift work or recent transmeridian travel (exceeding 3 time zones within 7 days of admission),
8. acute weight change (loss or gain of \> 2 kg in 6 weeks);
9. allergy to toremifene
10. unwillingness to provide written informed consent.
11. PSA \> 4.0 ng/mL in men
12. History or suspicion of prostatic disease (elevated PSA, indeterminate nodule or mass, obstructive uropathy, or breast cancer),
13. Other carcinoma (excluding localized basal cell carcinoma removed or surgically treated with no recurrence).
14. History of thrombotic arterial disease (stroke, TIA, MI, angina) or deep vein thrombophlebitis.
15. History of CHF, cardiac arrhythmias, congenital QT prolongation, and medications used to treat cardiac arrhythmias or other strong CYP3A4 inhibitors.
Association of Multiple Genetic Polymorphisms With Clozapine-Associated Metabolic Change in Schizophrenia

We are going to investigate the association of multiple genetic polymorphisms with the metabolic side effects in patients with schizophrenia taking clozapine.

The use of antipsychotics, especially clozapine and olanzapine is associated with metabolic side effects, which put patients with schizophrenia at risk for cardiovascular morbidity or diabetes.

The prevalence of the metabolic syndrome was 53.8% of patients who taking clozapine. The high interindividual variability in antipsychotic-induced metabolic abnormalities suggests that genetic makeup is a possible determinant.

The genotypes of the multiple gene such as HTR2C, LEP, adrenergic receptor,PPAR,GNB3 are suggested to have associations with the metabolic side effects (weight,glucose,lipid,BP,metabolic syndrome) in patients using antipsychotics.

We are going to investigate whether those multiple genetic polymorphisms are associated with the metabolic side effects in patients taking clozapine.

Eligibility Criteria:
Inclusion Criteria:

* age 18-65
* who can understand and sign the informed consent

Exclusion Criteria:

* who refuse to participate this study
Efficacy and Safety of Bromfenac Ophthalmic Solution

This is a safety and efficacy study of bromfenac ophthalmic solution


Eligibility Criteria:
Inclusion Criteria:

* Male or female greater than or equal to 18 years of age, and scheduled for cataract surgery

Exclusion Criteria:

* Active corneal pathology in either eye
Safety & Efficacy of Qurs E Fishar in Mild to Moderate Hypertensive Patients in Pakistan

The herbal medicine Qurs-e-Fishar to treat mild to moderate High blood pressure or hypertension comprises of Rauwolfia serpentina. A product of Hamdard Laboratories (Waqf) Pakistan.

A Phase III Safety \& Efficacy Open-label, Single-Arm, Interventional, Multicenter, Study in mild to moderate hypertensive, adults (30 to 60 years of age) prescribed with study product for 12 weeks (84 days).

Primary End Points:

1. Reduction in diastolic blood pressure less than 130 / 80 mmHg at the end of the study period (accepted by WHO) or if there was a fall of 20 / 10 mmHg or more in diastolic blood pressure as compared to baseline.
2. Type, frequency and severity of ADRs during the study period.

Secondary End Points:

1. Compliance of the prescribed study medication.


Eligibility Criteria:
Inclusion Criteria:

* Ability to sign ICD
* Participant(s) are willing and able to fulfill the requirements of the study protocol
* Mild to moderate hypertensive
* Mild hypertension range (140-159/90-99 mm Hg)
* Moderate hypertension range (160-179/100-109 mm Hg)
* Be between the age of 30 to 60 year

Exclusion Criteria:

* Patients with recent history of following will be excluded:

  * Severe hypertension,
  * Congestive cardiac failure,
  * Left ventricular failure,
  * Myocardial ischemia,
  * Renal failure or
  * Cerebrovascular accidents
PFO tRanscatether Occlusion Long-term Outcomes National Group (PROLONG) Registry

Patent foramen ovale (PFO) has been associated with cryptogenic stroke and transient ischemic attack (TIA) in young adults.

Evidence from randomized clinical trials (RCT) has shown that transcatheter PFO closure yields a 59% relative reduction in recurrent ischemic stroke compared to medical therapy in selected individuals.

However, the follow-up duration in these studies averaged around 4 years, while only two studies report a median follow-up beyond 10 years. Considering the relative youth of the patients undergoing this procedure (average age being under 50 years across all studies), we can reasonably anticipate a substantial post-PFO closure lifespan for these individuals. Consequently, it is imperative to gather more extensive long-term follow-up data among PFO closure recipients The PROLONG (PFO tRanscatether Occlusion Long-term Outcomes National Group) is an observational, retrospective, multicenter, national registry including men and women undergoing transcatheter PFO closure, with the aim of assessing the long-term (\>10 years) efficacy and safety of this procedure.

The PROLONG (PFO Transcatheter Occlusion Long-term Outcomes National Group) is an observational, retrospective, multicenter registry. It includes 1,360 subjects who underwent transcatheter patent foramen ovale (PFO) closure between 1999 and 2013 at 12 Italian high-volume Centers. Patients will have at least 10 years of follow-up post-procedure.

The primary objectives of the study are to evaluate the long-term clinical effectiveness of PFO closure by the incidence of left-sided embolic events and to evaluate safety by assessing serious device- or procedure-related adverse events. Secondary objectives include the incidence of new-onset atrial arrhythmias, the presence and severity of residual shunts, the incidence and severity of migraine symptoms, and bleeding events.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years;
* Confirmed Patent Foramen Ovale (PFO);
* Transcatheter Patent Foramen Ovale (PFO) closure with an Occluder device;
* PFO closure procedure performed between 1999 and 2013.

Exclusion Criteria:

* Age \< 18 years;
* Previous surgical or transcatheter PFO closure;
* Patients without follow-up data available.
Health Education for Physiotherapy in Soccer Players

INTRODUCTION. Health education based on interventions with new information and communication technologies.

OBJECTIVE. To compare the effectiveness of an educational physiotherapy intervention in footballers, in face-to-face mode (conference) versus an intervention mediated by ICT, on the risk of medical injury with the Functional Movement Screen \[FMS\].

MATERIAL AND METHODS. A randomized clinical trial (RCT) was carried out. The population consisted of 100 participants divided into two groups (ICT n = 50) and (Conference n = 50), with an average age of 18.2 versus 18.3 years for a conference. and ICT respectively.

Recruitment phase: In this phase the athletes were contacted to explain the objectives of the study and the interventions; those who agreed to participate filled out the questionnaire to verify the inclusion and exclusion criteria, later those who met the criteria gave written informed consent. This phase was held in a week in the sports team club Initial evaluation phase: In this phase, the contact form and the general characteristics of the population were filled out and the initial evaluation of knowledge about sports injuries was done in all the participants of the investigation. Likewise, the participants were assigned to each of the two interventions at random. For the random assignment, the Excel 2010® program was used, where random numbers were assigned to the sampling frame.

Intervention phase: The educational intervention in health was developed from physiotherapy in each of the groups (conference or mediated by ICT) according to the allocation group as explained below.

Final evaluation phase: The final evaluation of knowledge about the prevention of injuries in football was made to both groups of the investigation.

Eligibility Criteria:
Inclusion Criteria:

* Athletes over 18 years of age belonging to the La Equidad sports club.
* Athletes with a previous sporting age of more than three years.Athletes who have taken the entrance exam for the interdisciplinary team of the previous or initial physical condition of the La Equidad sports club.
* Resident in Bogotá or municipalities of Cundinamarca.

Exclusion Criteria:

* Alterations of perception or behavior that hinder educational interventions.
* Other co-morbidities reported by the user or in the clinical history of the sport that limit the intervention (Example: hearing loss, kyphosis, memory deficit or cognitive attention, visual limitation).
* Users who do not have training in educational computer skills.
* Not having a computer with an internet connection.
Desloratadine With Oxybutynin for the Treatment of Seasonal Allergic Rhinitis and Post-Nasal Drip (Study P04258)(COMPLETED)

This was a 1-week study of desloratadine (DL) plus oxybutynin (OXY) at two dose levels in the treatment of post-nasal drip in participants with seasonal allergic rhinitis. Participants received either desloratadine twice a day, oxybutynin twice a day, desloratadine plus lower-dose oxybutynin twice a day, desloratadine plus higher-dose oxybutynin twice a day, or placebo for 7 days.


Eligibility Criteria:
Inclusion Criteria:

Subjects must:

* be \>=18 years of age,
* be free of any clinically significant disease that would interfere with study, other than seasonal allergic rhinitis (SAR),
* have a documented diagnosis of SAR for \>=2 years,
* have had a positive skin-prick test,
* be sufficiently symptomatic at the Screening visit,
* for the 3 calendar days immediately prior to baseline visit, plus the AM of the baseline visit, the seven twice-daily run-in diary PRIOR total nasal symptom scores must have totaled \>=42, the Total Non-Nasal Symptoms score must have totaled \>=28, and the total Post Nasal Drip score must have totaled \>=14,
* be in general good health.

Exclusion Criteria:

Subjects who have:

* certain medical conditions or medical histories,
* allergies to any of the components in any of the study medications,
* nasal structure abnormalities,
* dependency to nasal, oral, or ocular decongestants, nasal topical antihistamines, or nasal steroids,
* used any investigational drug use in past 30 days,
* received immunotherapy (desensitization)
* are pregnant
Vestibular Rehabilitation and Dizziness

The purpose of this study is to determine whether vestibular exercises provide added benefit to balance rehabilitation in older adults with dizziness and normal vestibular function.

Dizziness is among the most prevalent complaints for which people seek medical help and the incidence increases with advancing age. Dizziness represents a diagnostic and treatment challenge because it is a subjective sensation, refers to a variety of symptoms (unsteadiness, spinning, sense of motion or lightheadedness), and has many potential contributory factors. Dizziness is often related to vestibular disease which is treated effectively with vestibular exercises. Successful management of dizziness is critical because dizziness is a major risk factor for falls in older adults.

There are parallels between the effects of age-related versus disease-related loss of vestibular function - in complaints of dizziness and increased risk for falls. The investigators' question, then, is whether the same exercises that are beneficial for patients with vestibular pathology are beneficial for older patients with dizziness but normal vestibular function.

Older adults with dizziness who have been referred to Audiology for vestibular evaluation will be randomized to receive either standard balance rehabilitation plus placebo eye exercises (CON) or standard balance rehabilitation plus vestibular-specific exercises (GS). Primary outcomes include symptoms, balance-related confidence, dynamic visual acuity, postural stability as measured by sensory organization test, fall risk as measured by dynamic gait index, and gait speed. Assessment will occur at baseline, discharge from physical therapy (PT), 1 and 6 months post-PT.

Eligibility Criteria:
Inclusion Criteria:

* at least 50 years of age
* documented balance or mobility problems
* normal vestibular function, including otolith function

Exclusion Criteria:

* cognitive impairment
* progressive medical issues that would impact mobility (e.g., Parkinson's disease, cerebellar atrophy)
* dizziness due to orthostatic hypotension or Benign Paroxysmal Positional Vertigo (BPPV)
Stem Cell Transplantation in Ocular Lesions of Behcet's Disease

The purpose of this study is to find if autologous stem cell transplantation can stop the progression of intractable eye lesions of Behcet's Disease or even to improve it.

To test in a pilot study the effect of autologous stem cell transplantation in stopping the progression of retinal damage of eye lesions in Behcet's Disease by repairing the vascular damage, and possibly to improve the lesions.

Eligibility Criteria:
Inclusion Criteria:

* Behcet's Disease
* Fulfilling the International Criteria for behcet's Disease (ICBD)
* Ocular lesions with retinal vasculitis
* Resistant to at least 3 months of combination therapy with pulse cyclophosphamide (1g/monthly), azathioprine (3 mg/kg/daily), and prednisolone 0.5 mg/kg/daily
* Visual acuity not less than 4 meters finger count
* Retinal edema confirmed by color photography and OCT

Exclusion Criteria:

* No Vision
* Active posterior uveitis
* Fundus not visible