cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Therapeutic Exercise vs. Treatment of Myofascial Trigger Points.

Background: Shoulder pain commonly affects the general population, with rotator cuff tendinopathy being the most common cause.

the most common cause, with rotator cuff tendinopathy diminishing function and quality of life, leading to a major socio-economic impact.

quality of life, leading to a major socio-economic impact. As a result, there are two treatment approaches with potential effectiveness: therapeutic exercise (TE) and myofascial trigger point treatment (TMT).

trigger point treatment (TTP).

Objective: The main objective of this randomised clinical trial is to determine the efficacy of ET versus treatment of MTPs in shoulder tendinopathies.

Methods: For this study, 20 participants were randomly divided into two groups: a ET group, with which a 10-exercise programme was initiated (n = 10), and a PGM group which was given an intervention protocol (n = 10).

intervention protocol (n = 10). Both received a total of 10 sessions. Pain intensity pain intensity, pressure pain threshold (PPT) and range of motion (ROM) were assessed before starting and after 10 sessions.

and after 10 sessions.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent form.
* Patients diagnosed by an orthopaedic surgeon with shoulder tendinopathy. tendinopathy.
* Symptoms of shoulder pain lasting more than 3 months.
* Pain on Jobe, Patte and infraspinatus assessment manoeuvres (highlighting abduction and abduction and external rotation).

Exclusion Criteria:

* Previous shoulder surgery.
* Radiating (non-referred) pain from cervical radiculopathy.
* Shoulder pain associated with other diagnoses (Examples: retractile capsulitis, subacromial syndrome, tendon rupture, posterosuperior conflict, etc.).

subacromial syndrome, tendon rupture, posterosuperior conflict, etc).

* Patients with multiple pathologies.
* Patients with neurological disorders.
An Intervention to Promote Use of Smoking Cessation Resources Among Adults Using Community Food Pantries

The primary objective of this pilot randomized controlled study is to raise awareness and use of an evidence-based tobacco cessation resource that is underutilized among smokers (the Ohio Tobacco Quitline), specifically targeting Cleveland-area residents who have experiences with food insecurity. The study will assess the feasibility and acceptability of conducting informational outreach on tobacco cessation resources in community settings in which there is a relatively high proportion of tobacco users (i.e., food pantries). The study will derive preliminary estimates regarding the effectiveness of tobacco cessation outreach, by assessing whether outreach activities result in changes in awareness/knowledge of the quitline and use/engagement of the quitline.


Eligibility Criteria:
Inclusion Criteria:

* Aged 21 or older
* Current tobacco smoker willing to receive information about quitting resources
* Lives in Cuyahoga County, Ohio
* Has a reliable telephone number and an email address

Exclusion Criteria:

* Aged 20 or younger
* Current non-smoker, or current smoking who is not willing to receive information about quitting resources
* Lives outside Cuyahoga County, Ohio
* Does not have a reliable telephone number and an email address
Modification of Chronic Inflammation by Inhaled Carbon Monoxide in Patients With Stable Chronic Obstructive Pulmonary Disease (COPD)

The purpose of this study is to determine whether carbon monoxide is effective in the treatment of stable COPD.

COPD is characterised by a chronic pulmonary inflammation and a shifted oxidant/antioxidant balance. The main cause of this inflammation is smoking. After smoking cessation, this inflammation and shifted oxidant/antioxidant balance continues. This causes an increased deterioration of lung function compared to healthy persons of matching age.

The ongoing inflammation appears to be relatively insensitive to corticosteroid therapy.

Until now, there is no therapy for this inflammation. Both in vitro and in vivo studies show that carbon monoxide has, besides an antioxidant capacity, anti-inflammatory properties. The aim of this trial is to study whether the inflammation can be reduced by inhalation of carbon monoxide.

Eligibility Criteria:
Inclusion Criteria:

* Men and women, age \> 40 years. Women must be post-menopausal (i.e. at least one year must have passed after the last menstruation), surgically sterile or using acceptable contraceptives, as judged by the investigator.
* A diagnosis of COPD according to the criteria of the American Thoracic Society (ATS); a disease state characterised by the presence of chronic airway obstruction due to chronic bronchitis (cough/sputum on most days a week for 3 months a year for at least two successive years); or emphysema.
* FEV1 \> 0.7 litres
* FEV1/FVC ratio \< 70% (equation retrieval system \[ERS\] equations)
* A smoking history of \> 10 pack years
* Completely stopped smoking \> 1 year ago
* No upper or lower respiratory tract infection in the last 4 weeks
* In a stable phase of COPD, as judged by the investigator
* Signed and dated informed consent obtained before any study related procedures (including withdrawal of concomitant medication) are conducted

Exclusion Criteria:

* Treatment with immune-modulating agents for any other disease
* History of asthma; former diagnosis of asthma
* Arterial oxygen tension (PaO2) \< 8.0 kPa
* Any significant other pulmonary disease or disorder (e.g. alpha1-antitrypsin deficiency, bronchiectasies), as judged by the investigator
* Patients with other significant disease or disorder (like cardiovascular, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic \[including diagnosed diabetes\], malignant, psychiatric, major physical impairment), which, in the opinion of the investigator may either put the patient at risk because of participation in the study; or may influence the results of the study, or the patient's ability to participate in the study.
* Patients unable to blow reproducable lung function measurements
* Patients using medicine with anti-oxidant character like n-acetyl-cysteine.
Prosthetic Valve Sweing Ring Injection by Antiboitics Can Affect the Rate of Postoperative Infective Endocarditis?

Follow-up of patients undergoing cardiac valve replacements with prosthetic valve after injection of sewing ring of prosthetic valve with aminoglycoside for prevention of infective endocarditis.


Eligibility Criteria:
Inclusion Criteria:

* patients who need cardiac valve replacement for rheumatic or degenerative causes

Exclusion Criteria:

* Patients undergoing open heart surgery for any cause other than valve replacement
* patients who are younger than 20 years old.
* Patients undergoing valve repair.
Justification of Incidental Appendectomy With Respect to Pathohistological Findings

This study seeks to justify performing an incidental appendectomy according to the following hypotheses:

1. The frequency of neoplasms in pathohistological (PHD) findings of incidental appendectomy (IA) is significantly higher than in PHD findings in appendectomies for acute appendcitis (AA)
2. The number needed to treat (NNT) for appendiceal tumors in the elderly is less than 500.
3. The rate of complicated AA in the elderly population is significantly higher than in the younger age group
4. NNT IA for complicated appendicitis in the elderly is less than 300.
5. NNT IA for potential death due to AA in the elderly is less than 500.

A retrospective cross-sectional study will be done. The archive of all PHD findings will be searched, and then the relevant medical histories at the Clinic of Surgery, University Hospital Center Split in the period from 01.01.2017. to 31.12.2021. The data collection will be done in the period from 01.02.2022. to 31.03.2022. The data collection (extraction) will be done by the main researcher (graduate, Ante Tavra) with at least two other colleagues from the Department of Abdominal-Coloproctological Surgery, University Hospital Center Split (Damir Quien, MD and Dora Bjelanović, MD).

Data will be collected directly from medical history and entered into an overview table. The identity of the respondents will remain secret, and the respondents will be marked exclusively with an identification number. This type of research does not require the informed consent of the patient, and all data collected will be kept in accordance with the provisions of Annex 2 of the Application to Institutional advisory board of UHC Split (approval pending).

Eligibility Criteria:
Inclusion Criteria:

Adult patients operated for colon tumors who have data on age, sex, data on a previously diagnosed colon tumor, data on incidental appendectomy, and a PHD finding for a removed appendix. Adult patients who have been diagnosed with acute appendicitis and have data on age, sex, data on the diagnosis of acute appendicitis and accompanying PHD findings, newly performed appendectomies.

Exclusion Criteria:

We will exclude from the analysis patients who had previous appendectomy, appendectomy has not been performed or we do not have an accompanying PHD finding of the appendix, and patients younger than 18 years.
Effects of Acetylsalicylic Acid Compared With the Combination of Acetylsalicylic Acid + Modified-release Dipyridamole on Serum Thromboxane B2 Formation and Platelet Aggregation in Healthy Volunteers

To compare the combination of acetylsalicylic acid (25 mg) + modified-release dipyridamole (200 mg) bd versus acetylsalicylic acid (75 mg dispersible tablet once daily) in its effect on inhibition of thromboxane B2 formation


Eligibility Criteria:
Inclusion Criteria:

* Male or female healthy volunteers aged 20 to 50 years
* Clinically normal medical history
* Clinically normal findings on physical examination
* Capable of comprehending and communicating effectively with the investigator and staff and of providing informed consent
* Willing to give informed consent prior to participation in the trial (i.e. prior to any trial-specific procedures)

Exclusion Criteria:

* Any clinically significant disease. (A significant disease is defined as a disease which in the opinion of the investigator may either put the subject at risk because of participation in the study or a disease which may influence the results of the study or the subject's ability to participate in the study)
* Clinically significant abnormal baseline haematology, blood chemistry or urinalysis findings
* Serum glutamate-oxaloacetate transferase (SGOT) or serum glutamate-pyruvate transferase (SGPT) \> 80 IU/L, bilirubin \> 34 µmol/L or creatinine \> 176 µmol/L regardless of clinical condition. Repeat laboratory evaluation will not be conducted in these subjects
* Use of dipyridamole, aspirin or any non-steroidal anti-inflammatory agent (NSAID) during the previous two weeks
* Active peptic ulceration or history of peptic ulcer disease
* Known history of or suspected hypersensitivity to dipyridamole, aspirin, any NSAID or any other component of the test drugs
* History of any bleeding disorders
* History of cerebral haemorrhage
* Resting, seated blood pressure less than 90/60 mmHg
* Participation in any drug clinical trial within sixteen weeks prior to the start of the trial
* Any indication of current or previous abuse of alcohol, solvents or drugs
* Any chronic illness
* Asthma
* Requirement for any other medication one month before or during the study
* Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception (e.g. oral contraceptives, intrauterine devices or surgically sterile) were to be excluded
* Previous participation in the randomisation phase of this clinical trial
Predicting Postoperative Pulmonary Infection in Elderly Patients Undergoing Major Surgery: a Study Based on Logistic Regression and Machine Learning Models

Although a number of clinical predictive models were developed to predict postoperative pulmonary infection, few predictive models have been used in elderly patients. In this study, the researchers aim to compare different algorithms to predict postoperative pulmonary infection in elderly patients and to assess the risk of postoperative pulmonary infection in elderly patients.


Eligibility Criteria:
Inclusion Criteria:

1. age ≥ 65 years
2. patients who were mechanically ventilated under major surgery

Exclusion Criteria:

1. preoperative tracheal intubation
2. preoperative pneumonia
3. organ transplantation
4. missing data
Antimicrobial Photodynamic Therapy Applied in Orthodontic. Orthodontic Patients.

We demonstrated the use of the Antimicrobial Photodynamic Therapy as a coadjutant oral decontamination agent. It was also shown that SDS surfactant improves the antibacterial action of APDT when using Curcumin as the photosensitizer. The decontamination levels obtained with APDT are comparable with the levels observed with the use of Chlorhexidine. The clinical relevancy is the control of oral microbial load which will improve the patients' quality of life and will decrease the possibility of cross contamination in the dental office.

The installation of the orthodontic appliances promotes an increase in the retentive area available for microbial aggregation, difficult the oral health promotion and, in addition, promotes the artificial selection of biofilms containing a higher load of pathogenic microorganisms. In this way, it becomes of critical importance, the development of techniques that might aid in the reduction of the oral microbial load. One possible approach is the use of the Antimicrobial Photodynamic Therapy (APDT). In this direction, the objective of this study was to assess the clinical utility of the APDT and the association of the APDT with the SDS surfactant as oral decontamination agents in orthodontic patients. The selected patients (n=24) were randomly distributed within seven experimental groups: G1 - Negative control, G2 - Curcumin mouthwash, G3 - Curcumin mouthwash+SDS, G4 - light irradiation, G5 - APDT, G6 - APDT+SDS and G7 - Positive Control (Chlorhexidine mouthwash). Nonstimulated saliva samples were collected from each one of the patients in three steps (S), as follows: S1- Initial condition, S2 - Treatment with mouthwashes (water, Chlorhexidine or Curcumin) and S3 - After APDT treatment. The efficacy of the proposed treatment protocols was assessed in function of the survival fraction observed in each group. The obtained results were statistically analyzed using variance analysis (ANOVA) and the Kruskal-Wallis test.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria were: being under fixed orthodontic treatment, absence of clinical signs of periodontal disease, not used antibiotics 90 days prior to the participation on this study and not use fluoride mouthwashes.

Exclusion Criteria:

* Exclusion criteria were: signs of uncontrolled systemic diseases (diabetes, high blood pressure and heart conditions), breast feeding or pregnant women, patients with oral tumors and patients with history of allergy to any of the materials used, such as Curcumin and Chlorhexidine.
Psychosocial Adjunctive Treatment for Hypersomnia (PATH)

Current pharmacological treatments for chronic hypersomnia (narcolepsy, idiopathic hypersomnia) can effectively reduce excessive daytime sleepiness but a high proportion of patients experience depressive symptoms and poor health-related quality of life. Unfortunately, there are currently no psychosocial interventions that directly addresses this issue. Therefore, the overall goal of this project is to gather initial outcome data and work out methodological issues to determine if a future pragmatic clinical trial is warranted.

Chronic hypersomnia (CH) is a serious and debilitating condition involving persistent excessive daytime sleepiness (EDS) and includes narcolepsy and idiopathic hypersomnia (IH). Currently, pharmacotherapy is the only empirically-validated treatment for reducing EDS in this patient population but the burden of long-term management and adverse effects of the medication lead to poor health-related quality of life (HRQoL) and elevations in depressive symptoms

Evidence-based psychosocial interventions have been developed in other areas to improve HRQoL related to chronic illnesses, such as cancer and chronic pain. These interventions typically involve a package of cognitive and behavioral techniques teaching coping skills (e.g., emotion-focused and problem-focused coping), behavioral management of the chronic illness symptoms (e.g., relaxation for pain management), and other strategies to improve psychosocial functioning (e.g., mindfulness). However, no such interventions have been developed or used for people with CH. Therefore, a major research gap exists for an empirically-validated psychosocial intervention which is aimed directly at improving emotional functioning and HRQoL for people with CH.

The purpose of this project is to develop a cognitive-behavioral treatment for hypersomnia (CBT-H) and conducting a feasibility trial of CBT-H. The specific aims for this project are to: 1) develop and refine a treatment protocol for CBT-H; 2) identify the optimal delivery format of CBT-H; and 3) gather feasibility data on recruitment, retention, and selection criteria for a future clinical trial. The overall significance of this project is to improve the quality of care for people with CH by using a psychosocial intervention with medical management of hypersomnia.

Eligibility Criteria:
Inclusion Criteria:

1. Males and females age 18 and older.
2. Meets criteria for Narcolepsy (Type I or II) or Idiopathic Hypersomnia (IH).
3. Moderate to severe symptoms of depression.
4. Established standard care for CH at a sleep clinic.

Exclusion Criteria:

1. Hypersomnia not of central origin.
2. Current suicidal ideation or intent.
3. Uncontrolled medical conditions or physical limitations that require immediate medical treatment that would prevent ability to engage in the treatment protocol.
4. Inability to engage in the treatment protocol due to a psychiatric or cognitive issue.
5. Untreated moderate-to-severe sleep-related breathing disorder.
6. Unable to attend intervention sessions due to accessibility or availability.
Creating Access to Resources and Economic Support

The goal of this study is to test the ability of small grants and/or peer support to improve mental health among transgender people experiencing material hardship. The main questions the study will answer are:

1. Do microgrants with or without peer mentoring improve mental health?
2. Do microgrants with or without peer mentoring improve mental health by reducing material hardship and/or increasing a sense of community connection?

Researchers will compare mental health outcomes among three groups of participants:

A. Participants who receive one small grant and monthly financial education videos B. Participants who receive a small grant every month and monthly financial education videos for a total of 6 months.

C. Participants who receive a small grant every month, peer mentoring support, and monthly financial education videos for a total of 6 months.


Eligibility Criteria:
Inclusion Criteria:

* age 18 years or older
* gender identity different from sex assigned on original birth certificate
* access to a mobile phone or email
* score \> 0 on the material hardship index

Exclusion Criteria:

* inability to provide informed consent in English
Comparing UroLift Experience Against Rezūm

C.L.E.A.R. Study is poised to compare the patient experience post procedure, including catheterization needs as well as retreatment and BPH medication rates following treatment with either the UroLift® System or Rezūm™ System through 12 months.

Patients will be randomized to either the UroLift or Rezum arm. Post-procedure, subjects who receive a catheter between post-procedure and prior to discharge, will return to office to complete a voiding assessment.

All subjects will be expected to complete questionnaires and assessments, as part of SOC (varies by institution), at day 3, day 7, 2 weeks, 1 month, 3 months and 12 months post-procedure.

Eligibility Criteria:
Inclusion Criteria:

1. Male gender
2. Age ≥ 50 years
3. Diagnosis of symptomatic BPH
4. Prostate volume 30cm3 ≤ 80cm3
5. Willing to sign study informed consent form

Exclusion Criteria:

1. Current urinary tract infection
2. Current catheter dependent urinary retention or PVR \>= 500 mL
3. Urethra conditions that may prevent insertion of delivery system into bladder
4. Previous BPH surgical procedure
5. Urinary incontinence presumed due to incompetent sphincter
6. Current gross hematuria
7. Patients with a urinary sphincter implant
8. Patients who have a penile prosthesis
9. Currently enrolled in any other investigational clinical research trial that has not completed the primary endpoint
Maribavir for Treatment of Resistant or Refractory CMV Infections in Transplant Recipients

This study will assess safety, antiviral activity, and pharmacokinetics of different doses of maribavir administered orally for up to 24 weeks for treatment of CMV infections that are resistant or refractory to treatment with ganciclovir/valganciclovir or foscarnet in recipients of stem cell or solid organ transplants.


Eligibility Criteria:
Inclusion Criteria

1. Be ≥12 years of age.
2. Weigh ≥ 40 kg.
3. Be a recipient of stem cell or solid organ transplantation.
4. Have documented CMV infection in blood or plasma, with a screening value of ≥1,000 DNA copies/mL.
5. Have a current CMV infection that is resistant (known CMV genetic mutations) or refractory (clinical failure to respond) to treatment with ganciclovir/valganciclovir and/or foscarnet.
6. If female, be either postmenopausal, surgically sterile, or have a negative pregnancy test prior to randomization.
7. Be able to swallow tablets.
8. If adult, provide written informed consent. If child (age \<18 years), have a parent/legal guardian who is willing and able to provide written informed consent (with assent from the child when appropriate).
9. Be assessed by the investigator to determine whether prophylaxis for non-CMV herpesvirus infections (e.g., herpes simplex virus \[HSV type 1 and type 2\] and varicella zoster virus \[VZV\]) is appropriate according to institutional guidelines or standard practices, keeping in mind that maribavir is not active in vitro against these viruses.

Exclusion Criteria

1. Be receiving any other anti-CMV agent(s).
2. Have a current CMV infection that is considered resistant or refractory due to inadequate adherence to prior oral anti-CMV treatment.
3. Have severe vomiting, diarrhea, or other severe gastrointestinal illness within 24 hours prior to the time of enrollment.
4. Have severe hepatic impairment.
5. Require mechanical ventilation or vasopressors for hemodynamic support at the time of enrollment.
6. Have expected survival less than 6 weeks.
7. Be pregnant or breastfeeding.
8. Other clinically significant medical or surgical condition.
Intra-Articular Injection of Etanercept in Patient Suffering From Rheumatoid Arthritis : a Double-Blind Randomized Study

Intra-articular injection of etanercept in patient suffering from rheumatoid arthritis: a double-blind randomized study for evaluation of efficacy and safety of etanercept versus intra-articular steroid injection in acute synovitis (knee,wrist,ankle,elbow)


Eligibility Criteria:
Inclusion Criteria:

* must be able to understand the information about the study
* diagnosis of rheumatoid arthritis for 6 month at least
* suffering for 2 weeks at least
* with evaluation of pain over 4/10
* with stable DMARDs treatment for three month at least

Exclusion Criteria:

* infection or surgery on the target joint
* treated with infliximab,adalimumab or anakinra