cyrilzakka/clinical-trials huggingface dataset:
Resistance Exercise Program and Branched Chain Amino Acid Supplementation in Heart Failure Patients

Heart Failure (HF) is a complex syndrome which can include the physiological, neural hormonal and metabolic complications known as "Cardiac Cachexia" (CC). In the development of CC there is a release of catabolic cytokines (Tumor Necrosis Factor-α, interleukins 1 and 6)that cause a decrease of fat free mass and fat mass. These changes in body composition might be reversed with a therapeutic combination of resistance exercise and branched chain amino acid supplementation (BCAA). Thus the purpose of this study is evaluate changes in body composition after a resistance exercise program and BCAA supplementation in patients with HF.

Heart failure (HF) is a complex syndrome which results from structural and/or functional alterations that limit the ability to respond to physiological demands(1,2).These abnormalities involve metabolic and neuro-hormonal factors such as tumor necrosis factor-α (TNF-α), one of the most important catabolic cytokines related with changes in body composition, interleukin 1 (IL-1), IL-6, interferon Y, and transmission growth factor β (3-9), which produce catabolic and anabolic imbalance and promote loss of fat free mass (FFM) with or without loss of fat mass (FM) in patients with HF. This syndrome is called "Cardiac Cachexia" (CC) (10). Signs and symptoms such as fatigue, anorexia and decreased muscle strength reflect altered body composition (9, 10). There are two possible ways to counteract these catabolic factors and restore body compartments. In one of them, protein supplementation promotes protein synthesis and inhibits proteolysis (3,11,12); in the other resistance exercise (RE) increases muscle mass and muscle strength, maintaining heart rate (13,14). Previous studies report the association of protein supplementation (15-17) and exercise (18-23) with changes in muscle strength in some cases and exercise capacity in HF patients. However, these therapies were not combined, and the studies did not provide enough information about changes in body composition. Based on these reports, our hypothesis is that the combination of RE and protein supplementation in form of branched chain amino acids (BCAA) might have an anabolic effect in patients with HF since the supplementation of BCAA could be helpful as "fuel" during the exercise and maintain the muscle mass metabolism (24).

Eligibility Criteria:
Inclusion Criteria:

* More than 18 years
* Confirmed stable heart failure (2)

Exclusion Criteria:

* No myocardial revascularization
* Unstable angina or stroke in the previous 3 months
* With no other chronic illness which contributed to loss of muscle mass (arthritis, renal failure, cancer, HIV) previous study inclusion
* Extra cardiac conditions that made patients unable to perform exercise
Prognostic Value of Sarcopenia and Nutritional Status in Early-stage Non-small Cell Lung Cancer

Growing evidence has confirmed that the prognosis of lung cancer is not only related to the stage of disease, but also to the physiological and psychological situation of the patients. Malignant tumors are often associated with weakness and cachexia, leading to less physical activities and worse moods. However, few studies that have attempted to investigate the impact of nutritional status on the prognosis of NSCLC. Existing applications of nutritional scoring systems in early-stage of NSCLC are very limited. Therefore, this study aims to observe the correlation between nutritional status and the prognosis of patients with early-stage NSCLC, to clarify the value in predicting the overall survival rate and progression-free survival rate of NSCLC patients, and to offer evidence for alleviating the social and economic burden of NSCLC.

The prognosis of lung cancer is not only related to the stage of disease, but also to the physiological and psychological situation of the patients. Malignant tumors are often associated with weakness and cachexia, leading to less physical activities and worse moods. However, few studies that have attempted to investigate the impact of nutritional status on the prognosis of NSCLC. Existing applications of nutritional scoring systems in early-stage of NSCLC are very limited. Therefore, this study aims to observe the correlation between nutritional status and the prognosis of patients with early-stage NSCLC, to clarify the value in predicting the overall survival rate and progression-free survival rate of NSCLC patients, and to offer evidence for alleviating the social and economic burden of NSCLC.

Eligibility Criteria:
Inclusion Criteria:

* The patients with non-small cell lung cancer diagnosed by cytology or pathology meet the standards of clinical diagnosis and treatment guidelines for lung cancer of Chinese Medical Association (2018 Edition)
* TNM staging diagnosis of lung cancer meets the stage IA-IIIA

Exclusion Criteria:

* Severe heart failure, acute progressive pulmonary inflammation, acute liver and kidney dysfunction in recent 2 weeks
* Incomplete clinical and follow-up data or disagreement or inability to conduct regular follow-up CT imaging evaluation
* A history of other malignant tumors and related tumor chemotherapy within half year, and previous history of radiotherapy
* Unable to walk, fail to complete the walking test, and the risk of fall down
* Unable to complete BIA examination due to pacemaker implantation and other reasons
* Withdraw from the study for any reasons
UPURS Trial for Patient-centered Management of Symptomatic Obstructing Stones

A prospective, non-blinded, randomized controlled trial studying the management of symptomatic ureteral stones. This study will compare upfront ureteroscopy vs observation and delayed intervention for patients presenting to the emergency department with a symptomatic ureteral stone.

Management of symptomatic ureteral stones is variable across the United States due to a lack of clear, patient-centered guidelines. For patients who do not meet criteria for emergent stenting, the decision to recommend upfront definitive treatment (ureteroscopy, ESWL) or medical expulsion therapy is influenced by factors such as practice setting, insurance status, and day of the week. This has resulted in health disparities and delays in care that disproportionately affect vulnerable patient populations.

For patients presenting to the emergency department with a symptomatic ureteral stone investigators will randomize into Group A: Upfront Ureteroscopy or Group B: Delayed intervention and observation. Both arms are considered standard of care for patients presenting with the above diagnosis.

Eligibility Criteria:
Inclusion Criteria:

* Presenting to the Emergency Department (ED)
* Adult (\> 18 yo)
* ≥5mm ureteral stone diagnosed on CT scan
* Presence of symptoms (pain, nausea, vomiting, hematuria)

Exclusion Criteria:

* Strict indication for stent
* Stone burden not amenable to Ureteroscopy (URS)
* Dirty urine analysis (UA) or positive urine culture (UCx)
* Transplant kidney
* Presence of conduit
* Comorbidities not optimized for surgery
* Strong preference for surgery or observation
Efficacy and Tolerability of Sifrol® (Pramipexole) in Patients With Advanced Idiopathic Parkinson's Disease

Assessment of daily maintenance dose of Sifrol®, L-dopa sparing effect, effect on tremor, depression, anhedonia and tolerability


Eligibility Criteria:
Inclusion Criteria:

* Patients with advanced idiopathic Parkinson's disease for whom combined treatment with Sifrol and L-dopa was indicated

Exclusion Criteria:

* NA
Odense Androgen Study - The Effect of Testim and Training in Hypogonadal Men

The purpose of this study is to determine the effect of training and testim on Hypogonadism.

The effect of testim and training in hypogonadal men.

Eligibility Criteria:
Inclusion Criteria:

* Male 65-78
* Bioavailable testosterone \< 7.3 nmol/L
* Waist \> 94 cm

Exclusion Criteria:

* Haematocrit \> 0.50
* Known c. prostate or PSA \> 3 Myg/L
* Known malignant disease
* Alcohol or drug abuse
* BMI \> 40 kg/m2
* Use of 5 alpha reductance inhibitors
* Plan to father children
Bioavailability, Pharmacokinetics and Safety of ESR 1150 CL in Healthy Adult Male Volunteers

To investigate the bioavailability of ESR 1150 CL by the time course determination of plasma concentration (pharmacokinetics) of no-transformed ESR 1150 after single administration to healthy adult male volunteers. Secondary objective is to investigate the safety of ESR 1150 CL.


Eligibility Criteria:
Inclusion Criteria:

* healthy male subjects
* age: \>= 20 and \<= 35 years
* weight: \>= 50 to \<= 80 kg and within +/- 20 % of standard weight
* blood pressure: systolic 100 - 138 mmHg and diastolic of less than 84 mmHg
* pulse rate: 45 to 80 beat/min
* volunteer whose participation in the trial is judged valid by the investigator based on the results of preliminary check-up and pre-administration check-up

Exclusion Criteria:

* history of diseases including cardiac, pulmonary, hepatic, renal or gastrointestinal disease
* history of drug allergy
* history of drug dependency, alcohol dependency, etc.
* use of other trial drug within 6 months before study drug administration
* use of any drugs within 7 days before study drug administration
Lithium Disilicate (CAD/CAM) Fixed Partial Dentures (FPD) Clinical Study

This investigation will be a clinical trial to study the performance of a high strength ceramic material for bridges to replace missing teeth. The ceramic material has been approved by the FDA for patient treatment. A computer technique will be used to make the bridges. The bridges will be cemented using an adhesive resin cement (MultiLink Automix/Ivoclar). The bridges are planned be evaluated for clinical performance at 6 months, 1 year, 2 years, 3 years, and if funding permits, 4 years, and 5 years. The purpose of the study is to measure how well the high strength bridges function over an extended period of time.

The study will be composed of 30 bridges placed in adult patients that have been identified as requiring replacement of a single tooth. All the bridges will be made from the same high strength ceramic material (emaxCAD/Ivoclar) using a computer to make the entire bridge. All the crowns will be cemented using the most current marketed version of the manufacturer's adhesive resin cement (MultiLink Automix/Ivoclar). At each recall appointment an evaluation of the bridge will be completed as well as clinical photographs, an intraoral digital scan, and impression of the bridge. The purpose of the study is to measure how well the high strength bridges function over an extended period of time.

Eligibility Criteria:
Inclusion Criteria:

* missing one anterior or premolar tooth that is appropriate for replacement with a bridge. The second premolar tooth will be the most distal tooth acceptable as a pontic for inclusion in the study.
* healthy periodontal status for the adjacent abutment teeth with 1:1 crown:root ratio
* abutment teeth must be asymptomatic prior to treatment
* Endodontically treated teeth will be acceptable for abutments as long as nonmetallic cores can be placed to retain the FPD since the lithium disilicate will be bonded to the abutments.
* no more than one bridge will be placed per patient. If a patient presents with more than one missing teeth acceptable for the study, premolar teeth will be included prior to anterior teeth. Each bridge will be three units and include only one missing tooth.

Exclusion Criteria:

* sensitive abutment teeth
* teeth with a history of direct or indirect pulp capping procedures
* patients with significant untreated dental disease to include periodontitis and caries
* pregnant or lactating women
* patients with allergies to any material in the study
* patients unable to return for recall appointments
AGS-1C4D4 in Patients With Advanced Hormone Refractory Prostate Cancer

The present study will investigate the safety, tolerability and spectrum of side effects of AGS-1C4D4. As such, this study will characterize the dose limiting toxicities (DLT) and potentially the maximum tolerated dose (MTD) of AGS-1C4D4 in patients with advanced HRPC.

Cohorts of 1-6 patients will be administered AGS-1C404 in sequentially rising dose levels. Dose escalation will continue until the MTD of AGS-1C4D4 is established or the maximum planned dose is reached.

Eligibility Criteria:
Inclusion Criteria:

* Patient has hormone-refractory metastatic prostate cancer

Exclusion Criteria:

* Patient has had chemotherapy, radiotherapy, or biological therapy within the past 4 weeks or has not recovered from side effects
* Patient is currently participating or has participated in an investigational study within the past 30 days
* Patient has illness or circumstance that could limit compliance with the study requirements
* Patient uses illicit drugs or had a recent history of drug or alcohol abuse within the last year
* Patient has Hepatitis B or C
PGE1 as Additive Anticoagulant in ECMO-Therapy

Bleeding complications and thromboembolic complications are frequent during extracorporeal membrane oxygenation (ECMO). Retrospective data suggest that platelet inhibition using prostaglandins, in this case PGE1, may reduce thromboembolic complications without increasing the bleeding risk. This randomized, double-blind trial aims to investigate the effects of PGE1 on bleeding risk, thromboembolic complications and the function of the ECMO.

Prostaglandins may inhibit platelet activation via the P2Y1 ADP receptor. Platelets may contribute to thromboembolic complications and coagulation activation during ECMO therapy. Retrospective data suggest that treatment with PGE1 may serve beneficial by reducing the amount of heparin needed for inhibition of coagulation activation, and by reducing the thromboembolic risk without increasing the risk of bleeding.

Inhibition of platelets via PGE1 (Alprostadil) may be interesting in this setting, because, in contrast to other platelet inhibitors, it has a very short half-life and platelets remain susceptible for activation by more potent agonists (i.e. thrombin, ADP). Thus, although reducing the contribution of platelets to coagulation activation, it may not affect safety of participating subjects.

This randomized, double-blind, placebo controlled trial will investigate whether treatment of patients with ECMO therapy proves beneficial.

Eligibility Criteria:
Inclusion Criteria:

* minimum age 18 years

  * Veno-Venous- ECMO
  * Minimum of 24h planned ECMO- therapy

Exclusion Criteria:

* • Long- term therapy with other antiplatelet drugs including Acetyl Salicylic Acid

  * known Heparin induced thrombocytopenia
  * Bleeding diathesis = contraindication for heparin (e.g. GI-bleeding, Intracerebral bleeding)
  * Platelets \< 50 G/L
  * Thromboplastin time \< 50%
  * Pregnancy
  * Patient \< 18 years
  * prothrombin time \<50%

Drop out criteria:

* Major bleeding (from Type 3 bleeding; see "primary objective")
* Occurrence of HIT (4 T- Score: Number of platelets, development over time, manifestation of thrombosis, other reasons for thrombocytopenia \[10\])
* Plt \< 50 G/l
The Effects of Connective Tissue Manipulation on Balance and Proprioception

There are various exercises and manual techniques to improve balance and proprioception. Most of these manual therapy techniques are mobilization, manipulation, post-isometric relaxation, myofascial relaxation and traction massage. At the same time, it has been observed that many parameters such as range of motion, tissue tension, wound healing process and pain perception were examined in the studies in the literature, but the effects of CTM on balance and proprioception have not been investigated.

The aim of the study was to investigate the effects of CTM on balance and proprioception among healthy individuals. 40 volunteers studying in Bahcesehir University were divided into 1) exercise and 2) study (CTM with exercise) groups equally. Both exercise and study groups were instructed to perform home exercises for 2 sessions in a week for 6 weeks (12 sessions in total). Additionally, CTM was applied to the volunteers in study group for 6 weeks, 2 sessions in a week. CTM applied to the lower and the upper back, and also neck.

Balance, cervical and lumbar proprioception was measured to understand the effectiveness of the CTM. Biodex Balance System was used for evaluation of static and dynamic balance. The cervical proprioception was measured by using a cervical range of motion (CROM) device while lumbar proprioception was measured by StabilizerTM Pressure Biofeedback Unit. Additionally, heart rate and blood pressure were measured by M3 Comfort Digital blood Pressure Monitor. All measurements applied at the beginnig and end of the study.


Eligibility Criteria:
Inclusion Criteria:

* Being voluntary
* Being healthy enough not to be constantly under the control of a health institution
* Being over 18 years old

Exclusion Criteria:

* Having neurological or orthopedic problems that can influence lower extremity functions and balance,
* Having any kind of vestibular system problems (Vertigo, Meniere etc.)
* Having a surgery from lumbar, thoracic or/and cervical regions.
Artificial Intelligence-assisted Colonoscopy for Detection of Colon Polyps

All subjects shall sign informed consent before screening, and subjects shall be included according to inclusion and exclusion criteria.

A total of four endoscopists were included in the study, two in each group of senior endoscopists and two in each group of junior endoscopists.

Patients were randomly enrolled into the senior endoscopy group and the junior endoscopy group, and received artificial intelligence assisted colonoscopy and conventional colonoscopy successively. The two colonoscopy methods were performed back to back by different endoscopy physicians with the same seniority.

All patients were examined and treated according to routine medical procedures. The routine colonoscopy group and the artificial-intelligence-assisted colonoscopy group made detailed records of the patients' withdrawal time, entry time, number of polyps detected, polyp Paris classification, polyp size, polyp shape, polyp location and intestinal preparation during the colonoscopy process

This is a prospective randomized clinical study.This study was conducted in the Endoscopy Center of the Nanfang Hospital, China. Routine bowel preparation consisted of 4 L of polyethylene glycol, given in split doses. Colonoscopies were performed with high definition colonoscopes and high-definition monitors.

All subjects shall sign informed consent before screening, and subjects shall be included according to inclusion and exclusion criteria.

A total of four endoscopists were included in the study, two in each group of senior endoscopists (\>1000 colonoscopies) and two in each group of junior endoscopists ( \<1000 colonoscopies).

Patients were randomly enrolled into the senior endoscopy group and the junior endoscopy group, and received artificial intelligence assisted colonoscopy and conventional colonoscopy successively. The two colonoscopy methods were performed by different endoscopy physicians back to back with the same seniority.

All patients were examined and treated according to routine medical procedures (outpatient patients and inpatients who did not sign the consent form for polypectomy were not resected for the lesions detected during the examination, while inpatients who signed the consent form for polypectomy were left in the original position after the first colonoscopy and removed at the end of the second examination).

The routine colonoscopy group and the artificial-intelligence-assisted colonoscopy group made detailed records of the patients' withdrawal time, entry time, number of polyps detected, polyp Paris classification, polyp size, polyp shape, polyp location and intestinal preparation during the colonoscopy process.

Eligibility Criteria:
Inclusion Criteria:

Chinese population aged 18-80 years old; Patients voluntarily signed informed consent form; In accordance with the indications of colonoscopy.

Exclusion Criteria:

(IBD) history of inflammatory bowel disease; History of colorectal surgery; Previous failed colonoscopy; Polyposis syndrome; Highly suspected colorectal cancer (CRC)
Physical Therapy in Patients Undergoing Allo-HSCT With cGVHD

Allogeneic Hematopoietic Stem Cell Transplantation (alloHSCT) represents the only curative option for many patients diagnosed with various hematologic neoplasms. Procedure-related morbidity and mortality pose challenges to long-term outcomes and quality of life, especially among patients who develop chronic graft-versus-host disease (cGVHD). There is a gap in healthcare that comprehensively addresses the specific needs of these patients. Physical therapy as an adjuvant treatment, through therapeutic exercise involving muscle strength and cardiorespiratory endurance, has shown positive influences on health markers and serves as a strong medical ally in similar profiles. Although these strategies could be reproducible and potentially beneficial for cGVHD patients, research has been limited to date, with the role of physical therapy possibly underutilized in this field. Justification: Unaddressed medical gap with no rigorously scientific responses specific to cGVHD. Objectives: This project aims to conduct the first randomized clinical trial from a physical therapy perspective as an adjuvant treatment for patients undergoing alloHSCT diagnosed with cGVHD.

Design: Prospective controlled clinical trial.

Location: Virgen del Rocío University Hospital, Hematology Unit.

Statistical analysis plan:The data will be analyzed using SPSS v.26 software for Windows and Epidat 4.2. All statistical tests will be conducted considering a 95% confidence interval (p-value \<0.05). To compare the score of the main outcome measure, quality of life (score range 0-200), between the experimental and control groups, the t-test or Mann-Whitney test will be employed (depending on the normality of the data). The comparison will be conducted at three time points (T0, T1, and T2). Furthermore, multivariate analysis will be performed using generalized equations of repeated measures to determine score changes between the groups. Since it is a Likert scale-based score, the Friedman test will be used to compare score changes, employing the Bonferroni test for pairwise comparisons.

Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic Graft-Versus-Host Disease (cGVHD) treated at Virgen del Rocío University Hospital will be invited to participate in the trial (n=108), under the following eligibility criteria: Inclusion criteria:
* Adult (18 years or older); Underwent allogeneic hematopoietic stem cell transplantation (alloHSCT) diagnosed with cGVHD; No medical contraindication for moderate or high-intensity exercise; Proficiency in the Spanish language; Have access to the internet.

Exclusion Criteria:

* Unable to perform initial or final physical assessments; Having serious pre-existing conditions before the oncological diagnosis or diseases that are not or poorly controlled; Not signing or delivering the informed consent on the indicated date.