cyrilzakka/clinical-trials huggingface dataset:
Eccentric Resistance Training Among Individuals With Chronic Heart Failure

To determine the effects of eccentric resistive training on ventricle functions and aerobic capacity as compared to a resistance and aerobic training among Heart failure (HF)


Eligibility Criteria:
Inclusion Criteria:

* Patient able to safely perform lower limb exercise will be check by six- minute walk test (6 MWT)
* Diagnosis of Chronic HF and currently on optimal medical therapy

Exclusion Criteria:

* Already participating in cardiac rehabilitation

  * New York Heart Association (NYHA) Classification of HF class IV HF symptoms
  * Co-existent other disease such as asthma/ COPD/interstitial lung disease.
  * Symptomatic Second degree or third degree heart block.
  * ECG with uncontrolled ventricular arrhythmia
  * limited Exercise ability due to neurologic or orthopedic impairments of the legs (will cross-check with 6 MWT)
The Epidemiology, Management, and the Associated Burden of Related Conditions in Alopecia Areata

This study series consists of four related studies and aims to explore and describe many important elements of alopecia areata over three key areas: (1) the current epidemiology of alopecia areata, (2) the prevalence and incidence of psychiatric co-morbidities in people with alopecia areata, (3) the prevalence and incidence of autoimmune and atopic conditions in people with alopecia areata, and (4) the incidence of common infections in people with alopecia areata.

The overall purpose of the first study (Study 1) is to describe the epidemiology of Alopecia areata (AA) and to assess the current level of primary care service utilisation and management patterns associated with patients diagnosed with AA.

The overall purpose of the second study (study 2) is to assess the prevalence and incidence of mental health conditions (depressive episodes, recurrent depressive disorder and anxiety disorder) in adult patients diagnosed with AA relative to a control population of patients without a diagnosis of AA. In addition, the study will determine both the treatment, 'sick day' and unemployment burden. Treatment burden comprises that of medications and psychological interventions used to treat mental health conditions in adult patients diagnosed with Alopecia areata.

The overall purpose of the third study (Study 3) is to assess the prevalence and incidence of atopic and autoimmune conditions in adult patients diagnosed with AA relative to a control population of patients without AA.

The overall purpose of the fourth study (Study 4) is to assess the incidence of common infections in adult patients diagnosed with AA relative to a control population of patients without AA.

Eligibility Criteria:
Inclusion Criteria:

* Patients contributing to Royal College of General Practitioners Research and Surveillance Centre(RCGP RCS) primary care database between January 1, 2009 and December 31, 2018, will be eligible for inclusion.
* Only patients aged ≥18 will be eligible for studies 2 and 3.
* Only patients aged ≥ 18 and ≤ 65 will be included in the unemployment and sick day analysis (study 2)

Exclusion Criteria:

* People with the alternative non-AA diagnoses.
* People with AA diagnosis within 6 months of registration.
* People with less than 1 year of follow up available
A Natural History Study In Chinese Male Patients With Duchenne Muscular Dystrophy

This is a multicenter, prospective, single cohort study designed to describe the natural history of DMD in Chinese male patients. A total of approximately 330 subjects will be enrolled with the target number of subjects in each group as below:

* Group 1, Ambulatory subjects aged \<6 years, approximately 100 subjects;
* Group 2, Ambulatory subjects aged \>=6 years, approximately 180 subjects;
* Group 3, Non-ambulatory subjects, approximately 50 subjects. Subjects will visit sites every 6 months. Each subject will be observed for at least 24 months. All subjects will remain enrolled until the study completion date, such that some will have data collected after Month 24. Subjects, who complete Visit 5/Month 24 at least 6 months prior to study completion, will be asked to complete an additional visit at Month 30.


Eligibility Criteria:
Inclusion Criteria:

1. Chinese male patients with any age, diagnosed with DMD. Diagnosis must be confirmed in subject's medical history and by genetic testing obtained during routine clinical care for diagnostic purposes as reported from an appropriate regulated laboratory using a clinically validated genetic test (genetic testing is not provided by the sponsor).
2. Subjects who are \>=4 years old must be receiving glucocorticosteroids for a minimum of 6 months prior to signing informed consent. There should be no significant change (\<0.2 mg/kg) in dosage or dose regimen (not related to body weight change) for at least 3 months immediately prior to signing the informed consent. Subjects who are aged \>4 years will be exempt from this requirement; those not taking GC will be eligible if the initiation of GC treatment in these subjects is considered inappropriate in the opinion of Investigators.

Exclusion Criteria:

1. Any injury which may impact functional testing. Previous injuries must be fully healed prior to consenting. Prior lower limb fractures must be fully healed and at least 3 months from injury date.
2. Presence or history of other musculoskeletal or neurologic disease or somatic disorder not related to DMD including pulmonary, cardiac, and cognitive diseases.
3. Subjects \>=4 years old who have not completed the varicella vaccination.
4. Participation in other studies involving investigational drug(s) for a minimum of 90 days prior to signing the informed consent and/or during study participation.
A Controlled Study on Regulation of Systemic Inflammation by Fecal Bacteria Transplantation in Patients With COVID-19.

A total of 30 hospitalized patients with COVID-19 over 60 years old were enrolled in this study and were divided into the experimental group (n=15) and the control group (n=15) at a ratio of 1:1. Both groups were treated according to the 2022 Shanghai guidelines for Diagnosis and Treatment of COVID-19 infection and the hierarchical diagnosis and treatment process. The experimental group was treated with fecal microbiota transplantation (FMT) capsules for 1 week, and the control group was treated with empty capsules. Patients in both groups were followed up for 1 month after discharge. To observe the effect of combined FMT capsule treatment on the regulation of inflammatory factors in peripheral blood and the remodeling of intestinal flora, and to verify its safety.


Eligibility Criteria:
Inclusion Criteria:

* 1. Over 60 years old, male or female;

  2. Meet the diagnostic criteria of COVID-19;

  3. The patient signed the informed consent, agreed to receive FMT capsule treatment, agreed to cooperate with the whole process of the clinical trial, and agreed to collect clinical data and blood, saliva, urine, stool and other samples;

  4. The patient was able to swallow 3# capsules by herself.

Exclusion Criteria:

* 1. Confirmed diagnosis of non-COVID19 pneumonia;

  2. Critically ill patients requiring mechanical ventilation, or patients who are unable to eat by mouth and swallow 3# capsules;

  3. Patients who had undergone gastrointestinal surgery;

  4. Presence of intestinal organic lesions such as congenital megacolon, intestinal obstruction, intussusception, etc.

  5. Pathological intestinal inflammatory changes, such as inflammatory bowel disease;

  6. Planned use of antacids, probiotics, antibiotics, FMT and other treatments affecting intestinal flora within the past 3 months or the following 2 months;

  7. Patients and their families did not agree to receive FMT treatment;

  8. Patients unable to cooperate with follow-up visits.
Acetylcysteine Against Acute Renal Insult During Cardiopulmonary Bypass.

The purpose of this study is to determine whether N-acetylcysteine is effective in the prophylaxis of post-cardiopulmonary bypass acute renal impairment.

BACKGROUND Reactive oxygen species have been shown to cause contrast-induced nephrotoxicity (CIN). According to previous studies, the N-acetylcysteine has been proved to be advantageous in the avoidance of CIN. We seek to evaluate the efficacy of the antioxidant N-acetylcysteine in limiting the nephrotoxicity after cardiovascular surgery with cardiopulmonary bypass.

METHODS We will prospectively study 60 patients who will receive a cardiovascular surgery with cardiopulmonary bypass. Patients will be randomly assigned to receive either N-acetylcysteine (600 mg orally twice daily for 4 doses) with 0.45% saline intravenously, before and after cardiopulmonary bypass, or placebo with 0.45% saline. Serum creatinine and blood urea nitrogen will be measured before, 48 h and 5 days after the operation procedure.

Expected results Prophylactic oral administration of the antioxidant N-acetylcysteine, along with hydration, will significantly reduce the acute renal damage induced by CPB in patients with chronic renal insufficiency that need cardiovascular procedures.

Eligibility Criteria:
Inclusion Criteria:

* All patients who will received cardiac surgery with cardiopulmonary bypass

Exclusion Criteria:

1. Dialyzed patients
2. Acute renal failure
3. Advanced left ventricular systolic dysfunction defined as left ventricular ejection fraction ≦ 35%.
4. Acute chronic obstructive lung disease or asthma exacerbation
5. Allergy to N-acetylcysteine
CoolSculpting Treatment in the Upper Arms

Evaluate the safety and efficacy of the ZELTIQ CoolSculpting System using specialized vacuum applicators for non-invasive subcutaneous fat reduction of the upper arms.

Subcutaneous fat reduction of the upper arms using 2 vacuum applicator types will be done concurrently, such that a subject will have an applicator placed on each arm simultaneously.

Eligibility Criteria:
Inclusion Criteria

* Male or female subjects \> 22 years of age and \< 65 years of age.
* Subject has clearly visible fat sufficient for treatment on the upper arm, which in the investigator's opinion, may benefit from the treatment.
* No weight change exceeding 5% in the preceding month.
* Subject agrees to maintain his/her weight (i.e., within 5% of total body weight) by not making any major changes in their diet or exercise routine during the course of the study.
* Subject has read and signed the study written informed consent form.

Exclusion Criteria

* History of a fat reduction procedure (e.g., liposuction, surgery, lipolytic agents, etc.), or implants in or adjacent to the area of intended treatment.
* History of prior surgery in the arms.
* Known history of cryoglobulinemia, cold urticaria, cold agglutinin disease, or paroxysmal cold hemoglobinuria.
* Known history of Raynaud's disease, or any known condition with a response to cold exposure that limits blood flow to the skin.
* History of bleeding disorder or is taking any medication that in the investigator's opinion may increase the subject's risk of bruising.
* History of carpal tunnel syndrome, compartment syndrome or deep vein thrombosis in the upper extremities.
* Currently taking or has taken diet pills or weight control supplements within the past month.
* Any dermatological conditions, such as scars, infection, in the location of the treatment area that may interfere with the treatment or evaluation.
* Active implanted device such as a pacemaker, defibrillator, or drug delivery system.
* Pregnant or intending to become pregnant in the next 5 months.
* Lactating or has been lactating in the past 6 months.
* Unable or unwilling to comply with the study requirements.
* Currently enrolled in a clinical study of any other unapproved investigational drug or device. Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject.
Effect of Neurokinin-1 Receptor (NK1R) Antagonism on Pruritus in Patients With Sezary Syndrome

The purpose of this randomized, double-blinded, placebo-controlled study is to test the hypothesis that administration of aprepitant will decrease the severity of pruritus in patients with Sèzary Syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Known Sezary Syndrome
* Pruritus uncontrolled by conventional treatment. Baseline visual analogue scale \> 4.
* Age 18 through 80 years of age.
* Stable medication regimens for both Sezary Syndrome and pruritus for 3 months prior to study participation.

Exclusion Criteria:

* Known hepatic impairment (defined as liver function tests \>3 times the upper limit of normal).
* Pregnancy (all women of child-bearing potential will undergo urine beta-hcg testing).
* Concurrent use of pimozide, terfenadine, astemizole, or cisapride.
Epithelioid Sarcoma Natural History Study

This study is a multi-center, non-interventional retrospective medical records review. The study will involve identification of medical records of patients with confirmed locally advanced unresectable or metastatic ES, who initiated systemic therapy between January 1, 2000 and December 31, 2017.

Data for the chart review will be extracted retrospectively from eligible subjects' charts (electronic or paper). Information on prior surgical treatment and neoadjuvant/adjuvant therapies for ES will also be collected for ineligible subjects with a locally advanced or metastatic ES diagnosis who did not initiated systemic therapy. Data collected will be anonymized by the investigators and will not be traceable back to individual subjects by the sponsor (i.e., no protected health information \[PHI\] will be collected).

The sampling period will span from January 1, 2000 to December 31, 2017. As the chart abstraction dates may be different across institutions due to contracting and other logistical issues, to avoid seeing biased outcomes that may be related to this type of heterogeneity, a consistent study end date will be imposed for all patients when conducting the analysis. Information before this study end date will be analyzed and used to conduct the analysis.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with histologically confirmed, locally advanced unresectable or metastatic Epithelioid Sarcoma (ES) requiring systemic therapy during between January 1, 2000 and December 31, 2017. The date of the confirmed locally advanced unresectable or metastatic ES diagnosis is designated as the index date.
* Patients may have a date of ES diagnosis at an earlier stage prior to 2000 and still be eligible for the study
* Initiation of treatment with any systemic anti-cancer therapy for the treatment of their locally advanced unresectable or metastatic ES between January 1, 2000 and December 31, 2017
* At least 10 years of age at the index date
Study to Evaluate Reactogenicity and Immunogenicity of Revaccination With Adjuvanted Influenza Vaccine in Elderly Adults

Since influenza vaccines are normally administered every year because of the frequent change in their antigenic composition, the safety and immunogenicity profiles of the adjuvanted influenza vaccine need to be re-evaluated after repeated vaccine administration. In this study, subjects enrolled in a previous study will receive a booster dose with the 2006-2007 season's formulations of Fluarix or the adjuvanted vaccine.


Eligibility Criteria:
Inclusion Criteria:

* The subjects must be healthy adults ages 18-40 years or \>/= 65 years previously vaccinated with either Fluarix or the adjuvanted vaccine.

Exclusion Criteria:

* Subjects will be excluded if they take/have taken chronically high doses of immunosuppressants or other immune modifying drugs within six months before vaccination, or immunoglobulins or blood products within three months before vaccination, or any investigational product within 30 days before vaccination
* Have a history of influenza infection since previous vaccination
* Women who are pregnant
* Subjects who have an acute or chronic clinically significant disease or an immunosuppressive/deficient condition, or have contra-indications to influenza vaccination
Effect of Oral L-carnitine Supplement on Lipid Profile, Anemia, and Quality of Life of Patients

The purpose of this study is to determine Effect of oral L-carnitine supplement on lipid profile, anemia, and quality of life.

In patients under maintenance hemodialysis several factors reduce the body stored carnitine which in turn affected dyslipidemia, anemia, and general health in these patients. The investigators evaluated the effect of oral L-carnitine supplementation on lipid profiles, anemia, and quality of life in hemodialysis patients.

Eligibility Criteria:
Inclusion Criteria:

being in the age range of 18-75 having the history of at least 12 weeks of hemodialysis and at least three times a week and each session almost for four hours having serum triglyceride or total cholesterol concentration \>200 mg/dl or serum HDL concentration \>40 mg/dl in the beginning of the study.

Exclusion Criteria:

taking carnitine supplement or the drug that interact with carnation lowering the seizure threshold in the last month being affected by liver function abnormalities, hypothyroidism, chronic infectious diseases (such as hepatitis), inflammatory diseases, CNS mass having the history of seizure.
Natural Matrix Protein™ (NMP™) Fibers in Cervical and Lumbar Interbody Fusion

The aim of this study is to evaluate the effectiveness and safety of Natural Matrix Protein™ (NMP™) fibers when used in cervical or lumbar interbody fusion in patients with degenerative disc disease (DDD), spinal stenosis, spondylolisthesis undergoing cervical or lumbar interbody spine fusion at no more than 3 adjacent levels.

The study involves a retrospective review of patients' medical records and prospective collection of X-rays, and patient outcome questionnaires.

The study population will include 100 consecutive lumbar interbody fusion and 100 consecutive cervical interbody fusion patients who meet the inclusion criteria and do not meet the exclusion criteria.

There will be 4 prospective study visits following consent. Follow-up will occur in accordance with standard of care practice and will continue to 12 months post-surgery

Eligibility Criteria:
Inclusion Criteria:

1. Subject was diagnosed with DDD, spinal stenosis, or spondylolisthesis;
2. Subject has undergone cervical or lumbar interbody spine fusion at no more than 3 adjacent levels between C2 and T1 or between L1 and S1;
3. Subject has undergone cervical or lumbar interbody spine fusion using NMP Fibers;
4. Subject must be 18 years of age or older at the time of consent;
5. Subject must be willing and able to sign an informed consent document;
6. Subject must be willing and able to return to the study clinic for all follow-up visits, agree to participate in post-operative clinical and radiographic evaluations.

Exclusion Criteria:

1. Subject is under 18 years of age at the time of consent;
2. Subject is currently experiencing major mental illness (psychosis, schizophrenia, major affective disorder) which in the opinion of the investigator may indicate that the symptoms are psychological rather than of physical origin;
3. Subject is currently imprisoned.
Cognitive Training and Brain Stimulation in Women With Post-chemotherapy Cognitive Impairment

The aim of this study is to investigate whether a high definition tDCS-accompanied intensive cognitive training of working memory leads to performance improvement in women with post-chemotherapy cognitive impairment after breast cancer treatment.

Patients who have undergone chemotherapy, may develop post-chemotherapy cognitive impairment (PCCI), which may occur in several cognitive domains and persist for many years. These declines in cognitive functions can lead to psychological distress and affect overall patients' quality of life. The goal of the present study is to assess behavioral effects of a multi-session cognitive training combined with high-definition transcranial direct current stimulation (tDCS) in women with PCCI. First studies have shown positive effects of cognitive training on trained and untrained functions and the subjective perception of stress, however the effects are small and transfer effects are inconsistent. A promising approach to elongate and increase the effects of cognitive training is to combine the training with tDCS. Therefore, in this study women with PCCI will participate in a three-week cognitive training with concurrent online high-definition tDCS application. Cognitive performance (primary), as well as Quality of Life scores and Sleep data will be examined before, during and after the intervention. In order to draw conclusions about the effect of tDCS in addition to cognitive training, a control group, receiving sham stimulation during training, will be assessed. A Follow-up session to assess long-term effects is planned four weeks after the post assessment. The results of the study will offer valuable insights into efficacy of combined tDCS and cognitive training intervention in women with PCCI in order to establish its potential to induce improvements in cognitive functions, and to beneficially affect patient-reported outcome measures.

Eligibility Criteria:
Inclusion Criteria:

1. Chemotherapy to treat breast cancer (≥ 6 months post-treatment).
2. Self-reported concerns regarding cognitive functioning.
3. Age: 18-65 years.
4. right-handedness

Exclusion Criteria:

1. History of dementia before treatment of cancer.
2. Other neurodegenerative neurological disorders; epilepsy or history of seizures.
3. Severe and untreated medical conditions that preclude participation in the training, as determined by responsible physician.
4. History of moderate to severe substance use disorder according to DSM-5
5. Moderate to severe acute psychiatric disorders according to DSM-5
6. Contraindication to tDCS application (Antal et al., 2017)