cyrilzakka/clinical-trials huggingface dataset:
Hot Water Immersion After Myocardial Infarction

Myocardial infarction (MI) is a leading cause of death in developed countries, including Sweden. Standard treatment for patients after MI includes exercise-based cardiac rehabilitation which contributes to improved cardiovascular function and reduces the risk of hospital readmissions, new cardiovascular events and mortality. Thermotherapy may also have beneficial effects on cardiovascular disease by a reduction in inflammatory status and improved metabolism and vascular function. Given the well-documented effects of exercise training on cardiac rehabilitation and recent evidence that thermotherapy may improve cardiovascular function, we wish to investigate the effect of exercise combined with hot water immersion (HWI) in cardiac rehabilitation post-MI.

This is a single-centre, randomized controlled clinical trial in patients with recent MI. Our aim is to investigate whether exercise training combined with HWI improves inflammatory and metabolic status, cardiovascular function as well as psychological well-being, compared with exercise training alone. Patients will be randomized 1:1 to an 8 week intervention with exercise training 2 times per week followed by 15 minutes of hot water immersion, or to a control group with exercise training alone. The primary endpoint is changes in the inflammatory marker interleukin (IL-) 6 between groups at 8 weeks. Secondary endpoints include other biomarkers of inflammation, metabolism, effects on cardiovascular function and psychological benefits.

Secondary prevention after MI has improved during the last decades but readmissions and death following acute MI remain large health challenges. If HWI in addition to standard cardiac rehabilitation can lower inflammation more than standard therapy alone, and improve metabolic, cardiovascular and psychological status, it could be a cost-effective and safe complementary strategy for secondary prevention after MI, particularly for those with limited exercise capability.


Eligibility Criteria:
Inclusion criteria

* Patients with a diagnosis of ST-elevation myocardial infarction (STEMI) or non-STEMI
* Concomitant participation in standard care exercise-based cardiac rehabilitation
* Male or female patients ≥ 18 years
* Written informed consent

Exclusion criteria

* Regularly performing hot water immersion, sauna or other types of thermotherapy
* Not willing to perform hot water immersion regularly
* Febrile illness or acute, ongoing infection
* \<18 years of age
* Inability to provide informed consent
Global Strain and Mechanical Dispersion May Predict Death and Ventricular Arrhythmias Better Than Ejection Fraction

The aim of the study is to investigate if global strain and mechanical dispersion may predict death and ventricular arrhythmias better than ejection fraction(EF) in patients with myocardial infarction and heart failure regardless of cause.

1. The main aim of this study is to investigate if global strain and mechanical dispersion may predict death and ventricular arrhythmias better than left ventricular ejection fraction in patients with myocardial infarction and heart failure.
2. In patients who receive internal cardioverter defibrillator(ICD) the main aim is to investigate if mechanical dispersion may predict ventricular arrhythmias better than EF.

3) No interventions,only evaluation of the measurements obtained with transthoracic echocardiography.

4) Follow up for 3 years, extended from 3 to 5 years.

Eligibility Criteria:
Inclusion Criteria:

* All patients with

  1. myocardial infarction
  2. heart failure( defined as heart failure symptoms: reduced left ventricular function/ and or heart failure signs on chest x ray.
  3. planned for primary prophylactic ICD
* over 18 years of age
* Informed consent

Exclusion Criteria:

-
A Phase 2a of RSLV-132 in Subjects With Systemic Lupus Erythematosus (SLE)

This study evaluates the impact of 13 bi-weekly intravenous infusions of RSLV-132 on the cutaneous manifestations in subjects with systemic lupus erythematosus.


Eligibility Criteria:
Inclusion Criteria:

* CLASI score greater than or equal to 10 at Baseline
* Positive for one or more RNA autoantibodies

Exclusion Criteria:

1. severe, active central nervous system (CNS) involvement at Screening;
2. severe renal involvement at Screening (urine protein/creatinine ratio of \>200 mg/mmol, or an estimated creatinine clearance of \<30 mL/min);
3. use of cyclophosphamide within 3 months of the Baseline visit;
4. use of rituximab within 6 months of the Baseline visit;
5. use of belimumab within 3 months of the Baseline visit;
6. use of background medications within 1 month of Baseline in excess of: i. mycophenolate mofetil \> 3 g/day; ii. azathioprine \> 200 mg/day; iii. methotrexate \> 25 mg/day; iv. hydroxychloroquine \> 400 mg/day; v. prednisone (or equivalent) \> 15 mg/day;
7. use of an intravenous steroid "pulse" within 2 months of Baseline;
8. use of an intramuscular steroid injection within 1 month of Baseline;
9. change in SLE medications within 1 month of Baseline;
10. the presence of a clinically significant infection in the judgement of the Investigator within seven days prior to the receipt of the first dose of study drug;
11. positive viral load test for hepatitis B, C, or HIV at Screening;
12. participation in another clinical trial with receipt of an investigational product within 3 months or 5 half- lives, of last administration (whichever is longer) from Baseline;
13. positive pregnancy test at Screening or at Baseline;
14. female subjects currently breast feeding at Baseline;
15. inability or unwillingness to comply with protocol-specified procedures which, in the opinion of the Investigator, would make the subject unsuitable for study participation.
Study of the Microbiota, Metabolome, and Environmental Toxins in Relation to Reproductive Health in Rwandan Women

The overall objective of this clinical pilot study is to determine at a random sampling time, the vaginal microbiome and metabolome of pregnant women, and to see if infection (bacterial vaginosis, vulvovaginal candidiasis, malaria) and exposure to environmental toxins affects could alter pregnancy and conception outcomes. It is hypothesized that infection and toxins will alter the vaginal microbiome and metabolome, increasing the risk of preterm labour and infertility in Rwandan women. In a sub-group of subjects, a preliminary assessment of the ability of orally administered probiotic lactobacilli to restore the vaginal microbiota to a healthy state and lower environmental toxins will be completed.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women between the ages of 18 and 55.

Exclusion Criteria:

* \*Current infection of gonorrhoea, \*Chlamydia, genital warts, \*active genital herpes lesions, \*active syphilis; \*urinary tract infection including pyelonephritis (an ascending urinary tract infection); \*receiving drug therapy that may affect the vaginal flora; \*had unprotected sexual intercourse (vaginal or oral) within the past 48 hours; \*have used a vaginal douche, genital deodorant, or genital wipe products in the past 48 hours; \*have taken any 'acidophilus' 'bifidobacteria' or probiotic health food supplements in the past 48 hours; \*are menstruating at time of clinical visit.
Trial Comparing Prone and Supine Intensity-modulated Radiotherapy (IMRT) After Breast-conserving Surgery in Patients With Large Breast Volume at High Risk for Skin Toxicity and Fibrosis

84 patients with a cup size C or more will be randomized to receive intensity-modulated radiotherapy in supine or prone position.


Eligibility Criteria:
Inclusion Criteria:

* female patients
* multidisciplinary decision of adjuvant whole-breast irradiation (WBI) after lumpectomy for breast cancer
* minimum 18 years
* informed consent obtained, signed and dated before specific protocol procedures

Exclusion Criteria:

* mastectomy
* need for axillary irradiation
* bilateral breast irradiation
* previous irradiation at the same time
* mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study
* patient unlikely to comply with the protocol; i.e. uncooperative attitude, inability to return for follow-up visits, and unlikely to complete the study.
Effects Of Deep Neck Flexor And Extensor Exercises

Deep cervical flexor and extensor muscles show decreased strength in patients with Mechanical neck pain. Exercises involving deep cervical muscles has improved coordination and motor control. This study aim to determine the effects of deep flexor muscle exercises along with deep extensor muscle exercises on pain, range of motion and muscle strength in mechanical neck pain.

This study will be a randomized controlled trial and will be conducted in Riphah Rehabilitation Clinic Lahore and Physiotherapy outpatient department of WAPDA Teaching Hospital Lahore. Non-probability consecutive sampling will be used to collect the data. Sample size of 36 subjects with age group between 18-40 years will be taken. Data will be collected from the patients having present complaint of Mechanical Neck pain. Outcome measures will be taken using Numeric pain rating scale (NPRS) for pain, Manual Muscle Testing (MMT) for muscle strength and Universal Goniometer (GU) for Range of motion. An informed consent will be taken. Subjects will be selected on the basis of inclusion and exclusion criteria and will be equally divided into two groups by random number generator table. Both the Groups will receive Hot Pack, superficial neck muscles stretching and Neck isometrics, while Group A will receive deep neck flexor and extensor exercises, and Group B will receive conventional treatment. Outcome measures will be measured at baseline and after 4 weeks. Data analysis will be done by SPSS version 25.

Eligibility Criteria:
Inclusion Criteria:

* Males and Females
* 18 and 40 years of age
* Forward Head Posture
* Manual Muscle testing (MMT) grade less than 6
* Deep Flexor strength measured by pressure biofeedback unit (20 mmHg), patients who cannot hold craniocervical flexion (indicating yes) for 10 seconds

Exclusion Criteria:

* Cervical radiculopathy
* History of whiplash injury
* History of cervical and thoracic spine surgery
* Neck pain associated with vertigo
* History of spinal osteoporosis
* Vertebral Fractures
* Tumors
* Diagnosed psychological disorders
Proactive Counselling Towards Follow-ups in Newborn Hearing Screening

The study aims to investigate if proactive parental educating and counselling can minimize loss to follow-ups of parents whose infant fail newborn hearing screening.


Eligibility Criteria:
Inclusion Criteria:

* The parents whose infants do not pass hearing screening

Exclusion Criteria:

* The parents whose infants have illnesses and are not ready for hearing screening
* The parents who decide to migrate to other areas
Comparison Between Two Different Technique in Treatment of Chronic Pilonidal Disease

Comparison between limberg flap and Karydakis flap for treatment of pilonidal disease.

The authors prospectively studied patients with sacrococcygeal pilonidal disease (SPD) at Mansoura University Hospital, Mansoura, Egypt, .Patients were randomly assigned to undergo either Limberg rhomboid flap or Karydakis flap reconstruction . The follow-up period ranged from 8 months to two years, with the mean follow-up period about 18 months. Surgical findings, complications, recurrence rate and degree of patient satisfaction were compared. This a randomized controlled study to evaluate both rhomboid excision and limberg flap closure versus Karydakis flap for treatment of chronic pilonidal disease.

Karydakis flap reconstruction was performed in conformity with the original procedure described by Karydakis. The technique consisted of a vertical eccentric elliptical incision carried down to the post sacral fascia, complete removal of unhealthy tissue with the normal tissue around the cyst and sinus tracts, mobilization of the medial wound edge by undercutting the adipose tissue at a depth of 1 cm, the advancement of the flap across the midline to the post sacral fascia and suturing of its edge to the lateral one.

Lamberg flap technique: the area to be excised was mapped on the skin in a rhomboid form . The skin incision was deepened to the presacral fascia centrally and to the gluteal fascia laterally. After removing the specimen, the Limberg fasciocutaneous flap was prepared by extending the incision down to and through the right gluteus maximus fascia (Fig3a). The size of the prepared flap was equal to that of the rhomboid area. Meticulous hemostasis was accomplished by electrocauterization. The fasciocutaneous flap was transposed medially so that the defect would be covered without any tension. Sutures were placed between gluteus fascia of the flap and presacral fascia with 2/0 polyglactin to prevent dead space

Eligibility Criteria:
Inclusion Criteria:

* PATINTS WITH PILONIDAL SINUS

Exclusion Criteria:

* PILONIDAL ABSCESS
Evaluating Ileostomy Hydration Protocol

This is a prospective observational study on patients who undergo an ileostomy creation after implementing a hydration algorithm as routine care at Robert Packer Hospital. The Department of Surgery will be implementing a protocol to prevent dehydration for patients with high output ileostomies. Patients with high output ileostomies are at an increased risk for readmission for dehydration. By reviewing the data after applying this standardized hydration protocol, we can assess its efficacy on readmission rates and comorbidities stemming from dehydration.

As of January 1, 2021, Robert Packer Hospital will implement a standardized hydration protocol for patients at high risk for readmission due to dehydration.

All postoperative ileostomy patients will be provided the following instructions at the bedside to ensure complete comprehension:

1. Stoma maintenance education
2. Hydration recommendations
3. Intake and Output Worksheet education and trial

The colorectal surgeons standardized the postoperative medical management of ileostomy output.

Before discharge, the healthcare providers will complete a "Discharge Assessment Checklist".

On the day of discharge, patients will be categorized by the "Discharge Algorithm for Patients with Ileostomies." The algorithm will assign patients by their ileostomy output and determine their next management steps.

After discharge, all patients will record their fluid input and output using the "Daily Measurement of Intake/Output Worksheet" which will be used to monitor hydration over time. Patients who are high risk will receive outpatient intravenous hydration therapy. At each intravenous therapy appointment, the health care provider will review the Outpatient Intravenous Hydration Algorithm to determine the volume of fluid to distribute or if re-evaluation is necessary.

Data Collection After starting the standardized hydration protocol, researchers will prospectively collect data from monthly reports of patients who received an ileostomy creation.

Researchers will not mask the patients, care providers, investigators, and outcomes assessors.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years of age will be eligible for this study.
* Patients who received emergent or elective end or loop ileostomy during the index admission will be eligible for this study.

Exclusion criteria:

- Patients who have not received an ileostomy creation at Robert Packer Hospital will be ineligible.
Remote Ischemic Conditioning for Efficacy in Patients With Aneurysmal Subarachnoid Hemorrhage

Several recent large-scale clinical trials aimed at improving subarachnoid hemorrhage(SAH) outcomes have concluded with negative results, failing to enhance the prognosis for these patients. Consequently, there is an urgent demand for novel treatment strategies and approaches to address the challenges posed by SAH.

Remote ischemic conditioning(RIC) has gained considerable attention in the treatment of stroke, particularly ischemic stroke, with numerous studies demonstrating its potential to enhance neurological outcomes compared to conventional treatments alone.RIC for the treatment of SAH is an investigative strategy in its initial stages. The neuroprotective effects of RIC, particularly its potential to preserve cranial nerve function and ameliorate neurological deficits, confer significant value in the treatment of SAH patients.

The precise manner in which SAH patients may benefit from RIC treatment, and the mechanisms by which it improves neurological function, remain to be fully understood. Consequently, randomized controlled trials are necessary to validate the efficacy of RIC in this patient population and to delineate the optimal therapeutic protocols for its application.

Based on the above discussion, this study aims to explore the efficacy and safety of RIC in the treatment of SAH.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with aneurysmal subarachnoid hemorrhage confirmed by imaging examination (diagnosed by computed tomography and confirmation of an intracranial aneurysm by CT angiography or digital subtraction angiography);
2. The Hunt-Hess grade is 2-3 at admission;
3. Onset of aneurysmal subarachnoid hemorrhage ≤72 hours;
4. The responsible aneurysm has been treated by endovascular interventional therapy;
5. 18≤ age ≤80 years old;
6. Informed consent must be obtained from participants or legally authorized representatives.

Exclusion Criteria:

1. Patients with other intracerebral hemorrhage or other types of subarachnoid hemorrhage;
2. Previous neurological deficits (mRS Score ≥1) or psychiatric disorders that can confound neurological or functional assessments;
3. With severe comorbidities and a life expectancy of less than 90 days;
4. Refractory hypertension (Systolic blood pressure\> 180 mmHg or diastolic blood pressure \>110 mmHg);
5. Contraindications of RIC: severe soft tissue injury of the lower limbs, etc;
6. Concurrent participation in another protocol investigating a different experimental therapy;
7. Any condition that the investigator believes may increase the patient's risk.
Baseline Physiology Studies in Carriers of Gene Variant X Conferring Major Risk of CVD-prone Metabolic Disorders

The purpose of the present study is to conduct a thorough and relevant physiology study of carriers and non-carriers of the gene variant X in order to determine the effect of the genetic variant on various metabolic parameters.


Eligibility Criteria:
Inclusion Criteria:

* Male
* 18-70 years of age
* Member of Biobank Vejle
* BMI\<30

Exclusion Criteria:

* Diabetes mellitus
* Severe illness
Thrombophilic Risk Factors in Pediatric Patients Diagnosed at the Ha'Emek Medical Center

The study will assess the clinical and laboratory data of about 100 pediatric patients diagnosed and treated at the Pediatric Hematology Unit during the years 1980 until 2007 because of thrombotic events.

The results, the treatment given, and the outcome of the patients will be summarized.


Eligibility Criteria:
Inclusion Criteria:All the patients diagnosed since 1980.

Exclusion Criteria:Patients with insufficient data records.
An Investigation Into Beneficial Effects of Interferon Beta 1a, Compared to Interferon Beta 1b And The Base Therapeutic Regiment in Moderate to Severe COVID-19: A Randomized Clinical Trial

The present study is a randomized clinical trial, with the approval of the ethics committee will be conducted on patients who have a positive test confirming COVID-19 in Loghman Hakim Medical Education Center in Tehran. Patients will be randomly assigned to the three arms of the study and after completing the course of treatment and collecting and analyzing the necessary information from each patient, the results of the study will be published both on this site and in the form of an article in a reputable international journal.

According to previous studies, IFN-β has strong antiviral activity and also has an acceptable safety profile. Based on possible therapeutic effects, We decided to lead An Investigation into Beneficial Effects of Interferon Beta 1a, Compared to Interferon Beta 1b And The Base Therapeutic Regiment in Moderate to Severe COVID-19. In a 2003 study, SARS was treated with different human interferons and found that IFN-β was 5 to 10 times more effective than other types of interferons and the strongest antiviral drug possible against SARS-CoV.

The present study is a randomized clinical trial, with the approval of the ethics committee will be conducted on patients who have a positive test confirming COVID-19 in Loghman Hakim Medical Education Center in Tehran.

Patients will be allocated to three therapeutic arms (Hydroxychloroquine + Lopinavir / Ritonavir + Interferon-β 1a group and Hydroxychloroquine + Lopinavir / Ritonavir + Interferon-β 1b group and the Base Therapeutic Regiment Group, i.e., Hydropinchloroquine + / Ritonavir. For this purpose, we will use the method of Balance Block Randomization for three groups.

After completing the course of treatment and collecting and analyzing the necessary information from each patient, the results of the study will be published both on this site and in the form of an article in a reputable international journal.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18
* COVID-19 Confirmed Cases By Means of RT-PCR
* Oxygen saturation (SPO2) ≤ 93% OR respiratory rate ≥ 24
* At least one of the following: Calibrated contactless infrared forehead thermometry temperature of ≥37.8, cough, sputum production, nasal discharge, myalgia, headache or fatigue on admission.
* Time of onset of the symptoms should be acute ( Days ≤ 14)

Exclusion Criteria:

* Refusal to participate expressed by patient or legally authorized representative if they are present
* Patients with prolonged QT or PR intervals, Second or Third Degree heart block, Arrhythmias including torsade de pointes
* Patients using drugs with potential interaction with Hydroxychloroquine + Lopinavir/Ritonavir, Interferon-β 1a، Interferon-β 1b.
* Pregnant or lactating women.
* History of alcohol or drug addiction in the past 5 years.
* Blood ALT/AST levels \> 5 times the upper limit of normal on laboratory results.