cyrilzakka/clinical-trials huggingface dataset:
Smart and Fit for Kidney Transplantation

This study is a randomised controlled intervention trial for patients with chronic kidney disease who are on the waiting list for a kidney transplantation (n=200). The aim of this study is to test the effectiveness of intensive individual nutritional and exercise support combined with comprehensive rehabilitation before transplantation in comparison to a control group.

Patients are randomised to either the intervention or control group at the beginning of the study. Both groups are evaluated at the beginning after 6 months and after 12 months regarding their body composition, physical performance, blood values, quality of life and nutritional status. The control group only receives support via app during the study period (1 year), through which they receive detailed information about dialysis. In addition to access to the app, the intervention group receives individual recommendations for nutrition and exercise as well as a three-week inpatient rehabilitation.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be on dialysis
* Patients ≥ 18 years of age
* Patients who own a smartphone
* Patients must be willing to undergo inpatient rehabilitation within the project period
* signed informed consent and data protection regulation

Exclusion Criteria:

* Patients who are not psychologically or physically able to take part in exercise promotion measures and/or nutritional counselling as well as psychological offers
* Patients who have already participated in a similar project
Addressing Post-COVID-19 Musculoskeletal Symptoms

The purpose of the study will be to evaluate the effect of a rehabilitation program on the improvement of patients with post-COVID-19 musculoskeletal symptoms, as well as to quantify the impact of telemedicine that evaluates the evolution of pain, functionality, and quality of life.

A randomized clinical trial will be conducted in 100 patients with post-COVID-19 musculoskeletal symptoms who will undergo a multicomponent rehabilitation program, together with an intervention and a follow-up using programmed telemedicine sessions. Data will be collected on the improvement of functional capacity and quality of life, in addition to assessing the evolution of musculoskeletal symptomatology, as well as pain and psychological variables. The telemedicine sessions will improve user adherence and follow-up, and the results are expected to be disseminated to the scientific community during and after the end of the study.

Eligibility Criteria:
Inclusion Criteria:

* Need to be post-COVID-19 patients (ICU or non-ICU)
* Musculoskeletal symptoms
* Be of adult age (over 18 years)

Exclusion Criteria:

* Myocardial infarction
* Uncontrolled arrhythmia
* Recent pulmonary thromboembolism
* Terminal illness
* Patients undergoing lower limb unloading
* Lower or upper limb fractures in the last three months
* Severe pain (score greater than 7 on the VAS of 10 points)
* Suffering from the previous pathology that causes neuromuscular weakness
* Be younger than 18 and older than 65 years old
* Influenced by medication that does not allow assessment of the real muscular functionality of the patient
* Patients with cognitive impairment that would prevent them from understanding and collaborating in the performance of the rehabilitation program plus telemedicine
* Patients with cardiorespiratory instability and uncontrolled arterial hypertension
* Systemic illness (tumor and rheumatologic diseases)
* Recent unrelated trauma
* Limiting psychiatric pathology
Evaluation of WIRION™ EPS in Lower Extremities Arteries

Demonstrate the safety and performance of the WIRION™ EPS in subjects undergoing lower extremity atherectomy for the treatment of Peripheral Arterial Disease (PAD)


Eligibility Criteria:
Inclusion Criteria:

1. Subject is at least 18 years of age
2. Subject or authorized representative, signed a written Informed Consent form to participate in the study, prior to any study related procedures
3. Subject is willing to comply with the protocol requirements and return to the treatment center for all required clinical evaluations
4. Rutherford classification 2-4
5. Has moderate to severe calcification visualized on angiogram in the femoropopliteal arteries
6. Planned atherectomy of the native femoropopliteal arteries
7. Reference vessel diameter for intended filter location must be visually estimated to be ≥3.5mm and ≤6.0mm
8. An adequate "landing zone" for placement of the WIRION™ device distal to the target lesion of at least 30mm
9. A female subject is eligible if not of child bearing potential or has a negative pregnancy test within the previous 7 days and agrees to remain on birth control throughout the study

Exclusion Criteria:

1. Any planned surgical or endovascular intervention within 30 days before or after the index procedure
2. A lesion deemed not accessible by the WIRION™ EPS
3. Inability to take aspirin or ADP receptor antagonists
4. History of bleeding diathesis or coagulopathy or will refuse blood transfusion if deemed necessary
5. Has perforation, dissection, or other injury of the access or target vessel requiring additional stenting or surgical intervention before enrollment
6. Subject is enrolled in another drug or device study protocol that has not reached its primary endpoint (participating in registry studies is not excluded)
7. Life expectancy less than 12 months
8. Known severe renal insufficiency (eGFR \<30 ml/min/1.72m2).
9. ≤1-vessel tibial run-off status
Safety and Effectiveness of OBG vs.a Bandage Contact Lens for Large Corneal Epithelial Defects in Patients Post-PRK.

This is a prospective, randomized (Reading Center), masked, controlled study in up to 45 subjects who have undergone bilateral PRK with epithelial removal using alcohol in a 9.0 mm well or trephine at the time of surgery to ensure consistency of the size of the ablation area.

This is a prospective, randomized (Reading Center), masked, controlled study in up to 45 subjects who have undergone bilateral PRK with epithelial removal using alcohol in a 9.0 mm well or trephine at the time of surgery to ensure consistency of the size of the ablation area. Subjects will be assigned to one of three treatment arms on Day 0.

Eligibility Criteria:
Inclusion Criteria:

* Able and willing to comply with the protocol

Exclusion Criteria:

-
Effect of Anti-inflammatory Topical Prednisolone, Nepafenac and Ketorolac in Intra-operative Mydriasis in Facetectomies

The main objective of this study is to compare the effect of preoperative use of anti-inflammatory topical prednisolone acetate 1%, nepafenac 0.1% and ketorolac tromethamine 0.4% of, plus a placebo, in maintaining the intra-operative mydriasis in extraction.

Will be conducted with a randomized clinical trial volunteers with indication of extraction in Recife, Brazil. The surgical technique is employed phacoemulsification with implantation of intraocular lens. Digital photos are taken of the eye at the beginning and end of surgery and with them will be digitally determined the relationship between the corneal area and pupillary area. Each volunteer will be drawn to one of four groups of study (group 1, prednisolone acetate 1%, group 2, of ketorolac tromethamine 0.4%, 0.1% nepafenac group 3 and group 4, placebo). For the volunteers randomly selected for each group will be prescribed medication in its presentation as eye drops (Prednisolone acetate 1%, Pred Fort ®, Allergan ®; of ketorolac tromethamine 0.4%, incite l ®, Allergan ®; Nepafenac 0.1%, Nevanac ® Alcon ® and 0.5% methylcellulose, Fresh Tears ®, Allergan ®), 01 drop every 8 hours for 48 hours before surgery. For all volunteers will also be prescribed gatifloxacin (Zymar ®), 01 drop every 8 hours starting 48 hours before surgery. Was scheduled a minimum sample of 60 volunteers (15 per group).

Eligibility Criteria:
Inclusion Criteria:

* Carriers of senile cataract (\> 50 years of age) with indication for cataract extraction with implantation of intraocular lens, with local anesthesia

Exclusion Criteria:

* Diabetic
* Using systemic anti-hormonal and non-hormonal
* Using topical ocular medication (including anti-glaucomatous)
* Individuals with congenital ocular abnormalities and cases in which there is intra-operative complications (hernia or trauma in the iris, posterior capsule rupture or zônula and prolonged phacoemulsification time of ≥ 1 minute).
* Volunteers with incipient nuclear cataract (density 1) or advanced (density 4) by the LOCS II classification (density of nuclear cataract ranked 1 to 4 (Chalk et al, 1989)
Iyengar Yoga for Young People With Rheumatoid Arthritis

The purpose of this study is to compare a standardized 6 week Iyengar Yoga program (IYP) for adolescents and young adults with rheumatoid arthritis to a standard care wait-list condition. In addition to effects on function and pain, this study will explore intervention effects on disease activity, immune response, HRQOL, functionality, and mood. Results will shed light on the feasibility and potential efficacy of a novel intervention (Iyengar yoga) for rheumatoid arthritis symptoms.

The hypotheses are:

1. The IYP will be safe, acceptable and feasible: at least 80% of subjects will complete the IYP.
2. Following the IYP, participants will show significantly improved disease status, general functioning, arthritis-functioning and HRQOL relative to controls. The benefits will be apparent post-treatment and at two-month follow-up.
3. Following the IYP, participants will report significantly improved pain, immune response and mood compared to controls. These improvements will be evident at both post-treatment and at two-month follow-up.


Eligibility Criteria:
Inclusion Criteria:

* People with rheumatoid arthritis between the ages of 16-35
* Diagnosis of RA, according to the revised 1987 ACR criteria, or juvenile idiopathic arthritis (JIA) for at least 6 months
* Concomitant use of disease modifying antirheumatic medications (hydroxychloroquine, sulfasalazine, methotrexate, leflunomide, etc) biologic agents (infliximab, etanercept, adalimumab, abatacept, rituximab, anakinra) is permitted provided that the dose(s) have been stable for 4 weeks prior to screening, and may reasonably be expected to remain on stable doses throughout the duration of the trial
* Concomitant use of non-steroidal anti-inflammatory drugs (NSAIDs) and low dose corticosteroids (e.g prednisone at doses of 10 /day prednisone or equivalent is permitted provided that the dose(s) have been stable for 4 weeks prior to screening, and may reasonably be expected to remain on stable doses throughout the duration of the trial
* Disease activity, as defined using a 28 joint count by \> 5 tender joints, \> 5 swollen joints, and one of the following: ESR \> 28 mm/hour, CRP \> 1.5 mg/dL, duration of a.m. stiffness \> 45 minutes
* Ability to provide written informed consent
* Ability to speak and understand English

Exclusion Criteria:

* Intra-articular steroid injections within 4 weeks of screening
* Treatment with any investigational agent within 8 weeks of screening or 5 half-lives of the investigational drug (whichever is longer)
* History of drug, alcohol, or chemical abuse within 6 months prior to screening
* Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion that might affect the interpretation of the results or render the patient at high risk from treatment complications
* Inability to comply with study and follow-up procedures
* Currently pregnant
* Inability to speak or understand English
* Any recent injury.
Effect of H. Pylori Eradication on the Reversibility of Atrophic Gastritis and Intestinal Metaplasia in Korean Patients

Helicobacter pylori (H. pylori) infection has been associated with a development of atrophic gastritis and intestinal metaplasia. H. pylori related atrophic gastritis and intestinal metaplasia have been regarded as pre-malignant lesion. However, the role of H. pylori eradication treatment in the reversibility of atrophic gastritis and intestinal metaplasia has not been clearly defined. The aim of the present study was to investigate the relationship between H. pylori eradication and the reversibility of atrophic gastritis and intestinal metaplasia in Korean patients.

It is a prospective, case-control study to compare the status of atrophic gastritis and intestinal metaplasia from the patients who undergo H. pylori eradication treatment or not. After enrollment, each patient will be receive annual surveillance upper gastrointestinal endoscopy. The present investigators will monitor the status of atrophic gastritis and intestinal metaplasia annually and finally compare the reversibility of them.

Eligibility Criteria:
Inclusion Criteria:

- Patients who diagnosis of H. pylori infection

* Patients presenting with H. pylori related gastrointestinal disease and/or
* Patients do not have H. pylori related gastrointestinal disease. But, want H. pylori eradication

Exclusion Criteria:

- Age under 18 years Previous eradication treatment for H. pylori Patients who took any drug which could influence the study results such as proton pump inhibitor, antibiotics within 4 weeks History of gastrectomy Advanced gastric cancer or other malignancy Abnormal liver function or liver cirrhosis Abnormal renal function or chronic kidney disease Other severe concurrent diseases Previous allergic reactions to the study drugs Pregnant or lactating women
Radical Prostatectomy and Perioperative Fluid Therapy

The optimal amount of fluid a patient need under surgery is not clear. Both to much and to little fluid can damage the organ functions.

A strategy called "Goal directed therapy", where the fluid amount a patient need is guided by the stroke volume, has shown to minimize post-operative nausea and vomiting.

The investigators intend to investigate if patients treated after these standards, has a better outcome then patients treated after normal regimes, regarding post-operative orthostatic-intolerance.


Eligibility Criteria:
Inclusion Criteria:

* Patients with cancer in there prostate

Exclusion Criteria:

* Patients who don't understand the information
* ASA \> III
* Patients that are under treatment with the drug triazolam
* Patients with af known renal decease
* Patients with a psychiatric decease
* Alcohol abuse
* Severe haemorrhagic decease
* Cancer in the mouth,pharynx, larynx or oesophagus
Laparoscopic Splenectomy and Azygoportal Disconnection With Intraoperative Endoscopic Variceal Ligation

This study aimed to evaluate whether synchronous vagus nerve-preserving laparoscopic splenectomy and azygoportal disconnection with intraoperative endoscopic variceal ligation (SVEL) is effective and safe, and to determine whether SVEL can effectively decrease the incidence of postoperative esophageal variceal re-bleeding.

After successful screening the cases of cirrhosis of liver irrespective of the etiology who have prior esophageal/gastroesophageal variceal bleeding will be enrolled. The baseline parameter will be recorded and the patient will be randomized into either interventional (synchronous vagus nerve-preserving laparoscopic splenectomy and azygoportal disconnection with intraoperative endoscopic variceal ligation (SVEL)) or control (single vagus nerve-preserving laparoscopic splenectomy and azygoportal disconnection without intraoperative endoscopic variceal ligation (SVEL)) group. From postoperative day 3, all patients will receive 100 mg oral aspirin enteric-coated tablets (Bayer, Leverkusen, Germany) once daily for 1 year, low-molecular-weight heparin (CS Bio, Hebei, China) subcutaneously (4.100 IU/day) for 5 days, and 25 mg of oral dipyridamole (Henan Furen, Henan, China) thrice daily for 3 months. At months 3, 6, and 12 after operation, endoscopic intervention will be done for all patients. Endoscopic variceal ligation was made if the diameter of the esophageal varices was \>5 mm. Postoperative complications of esophageal variceal re-bleeding and death due to re-bleeding will be recorded during the postoperative first year monitoring in the both groups as per the primary or secondary outcome.

Eligibility Criteria:
Inclusion Criteria:

* A clinical, radiological or histologic diagnosis of cirrhosis of any etiology
* Splenomegaly with secondary hypersplenism
* esophageal/gastroesophageal variceal bleeding
* No evidence of portal vein system thrombosis by ultrasound evaluation and angio-CT
* Informed consent to participate in the study

Exclusion Criteria:

* Hepatocellular carcinoma or any other malignancy,
* Hypercoagulable state other than the liver disease related
* DRUGS- oral contraceptives, anticoagulation or anti-platelet drugs.
* Child - Pugh C
* Recent peptic ulcer disease
* History of Hemorrhagic stroke
* Pregnancy
* Uncontrolled Hypertension
* Age\>75 yrs
* Human immunodeficiency virus (HIV) infection
Total Knee Arthroplasty Comparing Cementless to Cemented Fixation

The purpose of this study is to determine if there are any clinical or radiographic differences in cemented and cementless fixation in total knee replacement.

Out comes measures were to determine:

1. whether the knee and function scores and the radiographic results of the knees with a Nexgen cemented knee prosthesis would be better than those with an Nexgen cementless prosthesis.
2. whether the patients with a Nexgen cemented knee prosthesis would have a better range of knee motion than those with an Nexgen cementless prosthesis.
3. whether patient satisfaction and preference would be better in the patients having a Nexgen cemented knee prosthesis than those of patients having an Nexgen cementless knee prosthesis
4. whether complication rate would be less in the knees with a Nexgen cemented knee prosthesis than in the knees with an Nexgen cementless prosthesis.

Eligibility Criteria:
Inclusion Criteria:

* End-stage osteoarthritis of the knee joint requiring total knee arthroplasty with bilateral disease

Exclusion Criteria:

* Inflammatory disease
* patient with other Lower extremity disease which may affect functional outcome
* Neurologic disease effecting patients lower extremity
* Revision surgery
* Patient not medically cleared for bilateral surgery
Norepinephrine Infusion Different Doses in Cesarean Delivery

three doses (0.025 mcg/Kg/min, 0.050 mcg/Kg/min, and 0.075 mcg/Kg/min) of norepinephrine will be compared for prophylaxis against Post-spinal anesthesia hypotension during Cesarean delivery.

Maternal hypotension is a common complication after spinal anesthesia for cesarean delivery (CD). Using vasopressors have been considered a gold standard for prevention of post-spinal hypotension (PSH) during CD.

Norepinephrine (NE) is a potent vasopressor characterized by both α adrenergic agonist activity in addition to a weak β adrenergic agonist activity; thus, NE is considered a vasopressor with minimal cardiac depressant effect; these pharmacological properties would make NE an attractive alternative to phenylephrine and ephedrine (the most commonly used vasopressors in obstetric anesthesia).

Norepinephrine has been recently introduced as a prophylactic vasopressor during CD with promising results; However, the optimum dose for efficient prophylaxis with the least side effects is not known.

In this study, three doses (0.025, 0.050, 0.075 mcg/Kg/min) of norepinephrine will be compared for prophylaxis against PSH during CD.

Eligibility Criteria:
Inclusion Criteria:

* full term
* singleton
* pregnant women
* scheduled for elective cesarean delivery

Exclusion Criteria:

* cardiac morbidities
* hypertensive disorders of pregnancy
* peripartum bleeding
* baseline systolic blood pressure (SBP) \< 100 mmHg
* body mass index \> 35 will be excluded from the study.
Open-Label Extension Study of Trofinetide for Rett Syndrome

To investigate the safety and tolerability of continued long-term treatment with oral trofinetide in girls and women with Rett syndrome


Eligibility Criteria:
Inclusion Criteria:

1. Has completed the EOT visit of the antecedent trofinetide Study ACP-2566-004 (i.e., has completed 40 weeks)
2. May benefit from continued treatment with open-label trofinetide in the judgment of the Investigator
3. Can still swallow the study medication provided as a liquid solution or can take it by gastrostomy tube
4. The subject's caregiver is English-speaking and has sufficient language skills to complete the caregiver assessments

   Childbearing Potential
5. Subjects of childbearing potential must abstain from sexual activity for the duration of the study and for at least 30 days thereafter. If a subject is sexually active or becomes sexually active during the study, she must use 2 clinically acceptable methods of contraception (e.g., oral, intrauterine device \[IUD\], diaphragm plus spermicide, injectable, transdermal or implantable contraception) for the duration of the study and for at least 30 days thereafter. Subject must not be pregnant or breastfeeding.

Exclusion Criteria:

1. Began treatment with growth hormone during the antecedent study
2. Began treatment with IGF-1 during the antecedent study
3. Began treatment with insulin during the antecedent study
4. Has developed a clinically significant cardiovascular, endocrine (such as hypo- or hyperthyroidism, Type 1 diabetes mellitus, or uncontrolled Type 2 diabetes mellitus), renal, hepatic, respiratory, or gastrointestinal disease (such as celiac disease or inflammatory bowel disease)
5. Subject is judged by the Investigator or the Medical Monitor to be inappropriate for the study due to AEs, medical condition, or noncompliance with investigational product or study procedures in the antecedent study
6. Has a clinically significant abnormality in vital signs at Baseline
7. Has an average QTcF interval of \>450 ms on the Baseline ECG performed before the first dose of trofinetide is given in the present study (i.e., the ECG performed at the EOT visit of the antecedent study)
8. Has developed a clinically significant ECG finding during the antecedent study

Additional inclusion/exclusion criteria apply. Patients will be evaluated at baseline to ensure that all criteria for study participation are met. Patients may be excluded from the study based on these assessments (and specifically, if it is determined that their baseline health and condition do not meet all pre-specified entry criteria).
Lymphedema Severity on Shoulder Joint Function and Muscle Activation Patterns in Breast Cancer Survivors

Breast cancer-related lymphedema (BCRL) is a common complication affecting the upper extremity following breast cancer treatment. This study aims to investigate the relationship between lymphedema severity and shoulder joint function and muscle activation patterns in breast cancer survivors.


Eligibility Criteria:
Inclusion Criteria:

* Female
* Adults (18 years or older)
* Diagnosis of breast cancer-related lymphedema for a minimum of 3 months
* No current evidence of active cancer
* Able to provide informed consent

Exclusion Criteria:

* Pre-existing musculoskeletal conditions affecting the upper extremities (e.g. adhesive capsulitis, rotator cuff tear)
* Previous upper extremity surgery
* Physical inability to perform the required physical movements and assessments