cyrilzakka/clinical-trials huggingface dataset:
A Single Center, Randomized, Double-blind, Crossover Pilot Trial Comparing the Onset of Action of Parcopa™ With Sinemet® in Subjects With Stable Parkinson's Disease

To test whether Parcopa, a new Orally Disintegrating Tablet of Carbidopa-Levodopa, has a faster onset of action, changes in the UPDRS Motor Exam score at intervals after a single dose of Parcopa or Sinemet are being compared in 10 subjects with Parkinson's disease. Subjects 40 years or older having idiopathic PD with Hoehn and Yahr state II or III are eligible if taking a stable dose of \< 200 mg carbidopa and \< 2000 mg levodopa daily. At both treatment visits, either Parcopa or Sinemet, plus a placebo of the opposite tablet (ODT or conventional) are administered. The dose is the same as the subject's prestudy regimen. The primary efficacy variable, time to onset of action, is the first postdose time when a 30% decrease (30% improvement) in the total score is achieved. All UPDRS evaluations are done by a rater blinded to the active treatment received by the subject.

See approved Package Insert for Adverse Event information.

Eligibility Criteria:
Inclusion Criteria:

* Stable Parkinson's disease

Exclusion Criteria:

* idiopathic PD with Hoehn and Yahr state II or III
RFMN in Combination With 1927 nm Thulium Laser for Treating Photoaged Skin

The appearance of the aging skin is influenced by different factors including by the reduced elasticity and increased laxity of the skin, the decreasing volume as well as pigmentation disorders and dilated vascular markings. Currently, there are different methods available to treat the aging skin. Here, the combined treatment of radiofrequency micro needling (RFMN) and thulium laser has been commonly used in clinical practice.

The aim of this clinical study is to investigate the efficacy, patient satisfaction, safety of RFMN and thulium laser treatment in patients with facial, age-related skin laxity, wrinkles, and pigmented lesions.


Eligibility Criteria:
Inclusion Criteria:

* Men and women from the age of 30 years
* good general condition, no relevant previous diseases
* Presence of wrinkles, dermatochalasis on the face, pigment spots, which are an indication for RFMN and thulium laser or comparable methods
* Cognitive ability and willingness to give consent (informed consent)
* Be willing and able to attend follow-up visits

Exclusion Criteria:

* Age \< 30 years
* Pregnancy or breastfeeding
* Excessive subcutaneous fatty tissue under the cheeks
* Significant scarring of the region to be treated
* open wounds or lesions of the region to be treated
* Severe or cystic facial acne
* Metallic implants in the face or neck region
* Mental illnesses (psychoses, body perception disorders)
* Use of isotretinoin or other retinoids, psychotropic drugs, coumarins or heparins in the last 2 weeks
* Fillers in the region to be treated \< 4 weeks prior and during the study period
* Resurfacing (fractional, ablative, nonablative) of the region of interest \< 2 months prior and during the study period
* Plastic aesthetic procedures or other surgical procedures \< 6 months prior and during the study period
* Tendency to have excessive scarring
* Lack of informed consent
Trial of SK-1404 for Nocturia Due to Nocturnal Polyuria in Japanese Subjects

The purpose of this trial is to demonstrate efficacy of SK-1404 against placebo for the treatment of subjects with nocturia due to nocturnal polyuria, during 4 weeks of treatment.


Eligibility Criteria:
Inclusion Criteria:

* 5 \> nocturnal voids ≥2
* NPI \>0.33

Exclusion Criteria:

* Polydipsia
* Cardiac failure
* Syndrome of inappropriate antidiuretic hormone secretion
* Hyponatraemia
* Uncontrolled diabetes mellitus
* Uncontrolled hypertension
* Moderate or severe over-active bladder (OAB)
* Severe benign prostate hyperplasia (BPH)
* Sleep apnoea
* Interstitial cystitis
* Stress urinary incontinence
* Diabetes insipidus
* Complication or a history of urological cancer
Ranibizumab for Recalcitrant Wet Age-related Macular Degeneration in Eyes Previously Switched From Bevacizumab and/or Ranibizumab to Aflibercept.

The purpose of the study is to determine the effectiveness of Ranibizumab 0.5 mg or 1.0 mg in subjects who were previously treated with Bevacizumab and subsequently switched to Aflibercept. These subjects have demonstrated a sub-optimal therapeutic response to the previous therapies; therefore, the study aims to see if Ranibizumab may have a greater treatment effect.


Eligibility Criteria:
Inclusion Criteria:

* Ability to provide written informed consent and comply with study assessments for the full duration of the study
* Age greater than or equal to 50 years
* Best-corrected ETDRS VA between 20/25 to 20/320
* Total area of subretinal hemorrhage and/or fibrosis comprising less than 50% of lesion
* Any neovascular lesion type of ARMD having previously received at least 3 doses 1.25 mg of bevacizumab and/or ranibizumab (minimum 3 monthly injections) followed by 3 monthly doses of aflibercept 2.0 mg (with last injection being within 8 weeks) with evidence of recalcitrant ARMD, defined by at least one of the following: persistent subretinal fluid with or without intraretinal cystic edema on SD-OCT and/or leakage on fluorescein angiography

Exclusion Criteria:

* Pregnancy (positive pregnancy test) or lactation or pre-menopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch
* Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
* Participation in another simultaneous medical investigation or trial
* History of prior vitrectomy surgery
* Previous treatment with photodynamic therapy, radiation, or any other intravitreal drug delivery, such as dexamethasone or triamcinolone
* Subretinal hemorrhage involving the central fovea \> 1 disc area, subfoveal atrophy
* CNVM secondary to causes other than ARMD
* Previous retinal pigment epithelial tear
Effect of Endovascular Inferior Mesenteric Artery Embolization on Colonic Perfusion Prior to Rectal Surgery for Rectal Tumor or Sigmoid Colon Surgery

The investigators hypothesize that a primary embolization, 3-4 weeks before surgery, would allow development of vascular collaterality, in particular for the marginal artery which will ensure a better colonic perfusion.


Eligibility Criteria:
Inclusion Criteria:

* The patient must have given their free and informed consent and signed the consent form
* The patient must be a member or beneficiary of a health insurance plan
* The patient is at least 18 years old and less than 80 years old
* Patient has rectal cancer or sigmoid colon cancer requiring surgical treatment

Exclusion Criteria:

* The subject is participating in another study, or is in a period of exclusion determined by a previous study
* The subject refuses to sign the consent
* It is impossible to give the subject informed information
* The patient is under safeguard of justice or state guardianship
* Patient has a history of abdominal surgery
* Patient suffers from a hemostasis disorder (hemophilia, von Willebrand disease, thrombocytopenia) and is on anticoagulant therapy.
* Patient whose general condition appears too precarious or is taking corticosteroids or immunosuppressants leading to an unacceptable surgical risk.
* Renal insufficiency with clearance \<45ml / min
* Known allergy to contrast media
* Patient who had treatment of the abdominal aorta or its branches Reported pregnancy (the existence of effective contraception will be verified for women of childbearing age).
* Anatomical variant at risk or absence of marginal artery highlighted at the time of arteriography.
* Abnormality of the superior mesenteric artery
* Historic occlusion of the inferior mesenteric artery
PK Study of N91115 in Cystic Fibrosis Patients

This Phase 1 study in F508del-CFTR homozygous CF patients is being conducted to assess the pharmacokinetics and absorption dynamics of N91115 compared with healthy subjects in order to identify an initial starting dose for Phase 2 trials.

This is an open-label pharmacokinetic (PK) study of twice daily doses of 50 mg of N91115 administered for 14 days in F508del-CFTR homozygous CF patients. Six patients are planned for enrollment. Each patient will undergo screening (Day 28 to Day 3) and, if eligible, will return to the clinical site on Day 1 or optionally on Day 1. Eligibility will be reconfirmed and the patient will be admitted to a clinical research unit (CRU). Patients will stay overnight from Day 1 to Day 2 and will be discharged on Day 2 after all procedures and assessments are completed. Patients will return to the CRU as outpatients on Days 4, 7, 11, 14, and 15 for PK sample collection and other assessments. They will receive an oral dose of investigational medicinal product (IMP), N91115, twice daily on Days 1 through 14 and will be followed for PK through Day 15. Telephone calls to assess safety and ensure compliance with dosing will be made on days that patients do not make clinic visits (Days 3, 5, 6, 8, 9, 10, 12, and 13). Follow-up safety calls will then be made on Day 21 (adverse events) and Day 28 (serious adverse events only). Participation of an individual patient may last approximately 56 days from the time of screening until the end-of-study (Day 28) follow-up call.

Eligibility Criteria:
Inclusion Criteria:

1. Confirmed diagnosis of CF, homozygous for the F508del-CFTR mutation
2. Weight ≥ 40 kg at screening
3. FEV1 ≥ 40% of predicted normal for age, gender, and height (Hankinson standards) pre or post-bronchodilator value, at screening
4. Hematology, clinical chemistry, and urinalysis results with no clinically significant abnormalities that would interfere with the study assessments at screening

Exclusion Criteria:

1. History of any illness or condition that in the opinion of the investigator could confound the results of the study or pose additional risk when administered IMP
2. Any acute infection, including acute upper or lower respiratory infections and pulmonary exacerbations that require treatment or hospitalizations within 4 weeks of Study Day 1
3. Any change in chronic therapies for CF lung disease (e.g., Ibuprofen, Pulmozyme®, hypertonic saline, Azithromycin, TOBI®, Cayston®) within 4 weeks of Study Day 1
4. History, including the screening assessment, of ventricular tachycardia or ventricular arrhythmias
5. History, including the screening assessment, of prolonged QT and/or QTcF (Fridericia's correction) interval (\> 450 msec)
6. History of solid organ or hematological transplantation
7. History of alcohol abuse or drug addiction (including cannabis, cocaine, and opioids) in the year prior to screening
8. Use of continuous (24 hr/day) or nocturnal supplemental oxygen
Intelligent Cardiopulmonary Rehabilitation System for Patients With Chronic Stroke

By comparing with traditional aerobic exercise training (TAET), we investigate the effects of an intelligent cardiopulmonary rehabilitative system (ICRS) on cardiopulmonary fitness and patient satification among patients with chronic stroke.

Cycle ergometer training is one of the common indoor aerobic exercises for enhancing cardiorespiratory fitness in patients after stroke. However, studies had suggested that patients may be undertrained for reasons such as a tight time schedule for other rehabilitation programs and lack of objective evaluation on the training intensity.

To address the issue of inadequate cycle ergometer training in poststroke patients, in this study, an intelligent cardiopulmonary rehabilitation system was developed and incorporated into a bicycle ergometer, allowing dynamically auto-adjust paddling resistance considering the instant heart rate and cadence, with a goal to maintain the hear rate within the pre-determined heart rate zone. The purpose of the current study is to investigate the feasibility of the ICRS in stroke patients and whether it outweighs the traditional feedback on training intensity.

A single-blind crossover trial is adopted with 40 participants estimated to be recruited and randomly assigned to the group A and group B. Group A received training with ICRS while Group B received training with TAET at the beginning. The intensity of ICRS is set as 60%\~80% heart rate reserve (HRR) which is obtained from cardiopulmonary exercise testing (CPET) at pretest. The intensity of TAET is set as subjective rating of perceived exertion at "somewhat hard" to "hard" level. Both groups will receive 30 minutes of training per session, 3 sessions a week for four weeks followed by a washout period of 4-week break. Subjects are crossed-over to the alternate treatment afterwards. CPET evaluations will be conducted in a total of 4 times before and after treatment.

Eligibility Criteria:
Inclusion Criteria:

* Aged 20-75 y/o
* Healthy people
* Chronic stroke \> 6 months
* Able to walk independently \> 6 minutes with or without orthosis
* Able to use stationary bike
* MRS(Modified Rankin Scale) ranged 1 to 3

Exclusion Criteria:

* Patients whose heart rate can not be used as the indicator of training intensity (eg, ar-rhythmia, atrial fibrillation, beta-blockers users)
* With any reason that the patient is not suitable to undergo aerobic training
* Patients who are unable to do cycling due to musculoskeletal problems
* Patients who can not follow the instruction of trainers due to cognitive or emotional-problems.
* Patients whose medical condition is not unstable.
Wavefront Analyzes and Visual Performance of Three Multifocal Intra-ocular Lenses

The purpose of this study is to determine if differences in the design of multifocal intra-ocular lenses would mean different values of higher-order aberrations and different performance in objective parameters such as modulation transfer function.


Eligibility Criteria:
Inclusion Criteria:

* Patients with bilateral visually significant cataract with corneal astigmatism lower than 1.0D

Exclusion Criteria:

* Any ocular diseases, such as:

  * corneal opacities or irregularity
  * dry eye
  * amblyopia
  * anisometropia
  * glaucoma
  * retinal abnormality
* Surgical complications
* IOL tilt
* IOL decentration greater than 0.4 mm (estimated by retroillumination)
* Incomplete follow-up
Rehabilitation Protocol for Reconstruction of Anterior Cruciate Ligament and Anterolateral Knee Ligament Surgery

Introduction: Individuals with an ACL lesion present abnormal rotational stability. Among the structures located in the anterolateral region of the knee that could act as restraints of the rotational knee lassitude, there is the Anterior Lateral Ligament (ALL), and its reconstruction associated with ACL reconstruction could reduce recurrence injury rates. Objective: to develop a rehabilitation protocol for patients undergoing combined reconstruction of ACL and ALL. METHOD: Articles published with patients submitted to ACL reconstruction with an anatomic technique and flexor tendon graft, (which is the same one adopted in this study), were selected as a base to this protocol. Discussion: The results will provide important information on clinical practice, since it can help identify the necessity or not of restraining the knee range of motion in combined surgeries. It can guide the therapeutic planning, including the cost of knee restraint devices, in addition to estimating these patients prognosis. The protocol with partial restriction of knee range of motion in the first 6 weeks of postoperative is the most indicated program in the rehabilitation of the combined surgeries of ACL and ALL reconstruction.

Currently, the anatomical reconstruction of the ACL has been widely used, with the purpose of increasing the knee rotational control after the injury, and thus, to improve the clinical evolution in the long term. The concept involves restoring knee kinematics by improving function by reducing the number of graft failures, delaying or preventing degeneration of the joint. Normally, rehabilitation protocols in these cases are more careful with respect to knee ROM gain and use of exercises in open kinetic chain, with the purpose of preserving the graft.

Allied to this concept, the use of extra-articular reconstruction associated with ACL reconstruction, gained new horizons with the discovery of ALL, signaling to the possibility of a better rotational control and, consequently, a decrease in the number of graft failures.

Due to the particularities of each surgical technique, it is necessary that the rehabilitation protocols adapt to the different methods, guaranteeing the functional recovery, but without damages to the reconstruction.

With the proposal of ACL reconstruction surgery associated with ALL reconstruction, it is necessary to develop a specific rehabilitation protocol for these patients, considering some postoperative specificities of extra-articular reconstructions, since they are data that are not available in the literature until now.

Eligibility Criteria:
Inclusion Criteria:

* Males
* Aged from 18 to 40 years
* Documented and symptomatic anterior cruciate ligament (ACL) injury followed by ACL+ anterolateral ligament (ALL) ligament reconstruction

Exclusion Criteria:

* Patients with multiple ligament injuries
* Bilateral ACL injury
Exercise Periodization and Older Adults

The present study aimed at investigating the effects of two different resistance training protocols - nonperiodized (NP) and daily undulating periodization (DUP) - on hemodynamic, morphofunctional and cognitive parameters of robust older women. Methods: Forty-two older women were randomized allocated into one of the three experimental groups: NP, DUP, and control group (CG). Evaluations of the hemodynamic, morphofunctional and cognitive parameters occurred before, during and after six months. The exercise groups performed the program of exercise twice a week over 22 weeks. In NP, the two weekly sessions were based on 3 sets of 8-10 repetitions at a difficult intensity. However, in DUP, a power exercise session based on 3 sets of 8-10 repetitions at a moderate intensity was added in the first session of the week.


Eligibility Criteria:
Inclusion Criteria:

* Aged ≥60 years;
* Female;
* Not having been part of a systematic program of physical exercises in the last 6 months;
* MEEM score \>19 points;
* Kihon checklist score \>10 points;
* Capacity to perform the basic and instrumental activities of daily living according to Katz and Pfeffer indexes;
* Self-reported good memory;
* Complete all measurements.

Exclusion Criteria:

* Changes on antihypertensive medication in the past 6 months prior to inclusion in the study;
* Cardiovascular disease (i.e., acute myocardial infarction, stroke, peripheral arterial disease, and transient ischemic disease)
* Metabolic disease (i.e., diabetes mellitus type I or II), pulmonary disease (i.e., emphysema)
* Neurological and/or psychiatric disease (i.e., Parkinson's or Alzheimer's disease)
* Skeletal muscle disorders
* Comorbidities associated with greater risk of falls
* Recent history of smoking or alcohol abuse
* Hormone replacement therapy and/or psychotropic drugs.
Stress Doses of Hydrocortisone on Coagulation Dysfunction in Patients With Septic Shock

The purpose of this study is to find out whether stress doses of hydrocortisone attenuate coagulation dysfunction in patients with septic shock. And discuss the probable mechanism by which little doses of hydrocortisone influence coagulation system in sepsis.

Patients were randomized to receive either low-dose hydrocortisone or matching placebo.Severity of coagulopathy was estimated using ISTH DIC score. We determined the complications and mortality in two groups, and analyzed the relationship between hydrocortisone and coagulopathy.

Eligibility Criteria:
Inclusion Criteria:

* All patients(age≧18y)
* Admitted for septic shock were considered eligible if they had no life-threatening systemic disease (ASA groups 1\~3)

Exclusion Criteria:

* Lactation
* Mental disorders
* Disseminated cancer
* Secondary cancers
* Inflammatory bowel disease, or diseases hindering epidural analgesia
Inspiring Seniors Toward Exercise Promotion

The goal of this clinical trial is to test the benefits of beat-accented music stimulation (BMS) for behavioral changes of physical activity (PA) in older adults. Specific Aims are to determine (1) whether BMS beneficially influences PA behaviors and psychological responses to PA in older adults for 6 months, and (2) whether exercising with BMS differently influences physical and cognitive functioning as well as quality of life in older adults.

To test the effects of BMS on PA, participants will be randomly assigned to an exercise intervention that either includes BMS or does not include BMS. Participants will attend a supervised group strength training (ST) (30 min/day) and aerobic exercise (AE) (30-50 min/day) session for 3 days/week for the first 2 months, 1 day/week for the next 2 months (while encouraging participants to independently perform both AE and ST on other days), and independently for the final 2 months (always with a goal of performing \>150min/week AE and 3 days/week of ST for 30 min/day.


Eligibility Criteria:
Inclusion Criteria:

* At least 65 years old.
* Ambulatory/capable of walking for 6 minutes without pain or aid such as a walker/cane.
* Able to speak and read English.
* Healthy enough to exercise at moderate intensity with or without medical clearance by a primary care physician.
* Living in the community for the duration of the study (6 months).
* Having a reliable means of transportation.
* Having a safe place (at least 6 feet by 6 feet of open space) at home for unsupervised exercise training.
* Having no diagnosis or symptoms of cognitive impairment.
* Having no symptoms of suicidal ideation and not meeting criteria for depressive disorder.
* Physically low-active by doing \< 60 min/week of moderate-intensity aerobic exercise and no strength training for the last 3 months.

Exclusion Criteria:

* Diagnosis of neurological disorder or spinal cord disorder.
* Known exercise contraindications.
* Current cancer treatment.
* Stroke or neural impairment in the past 6 months.
* Hip/knee/spinal fracture or surgery in the past 6 month.
* Unable or unwilling to attend intervention classes 3x/week in Months 1-2 and 1x/week in Months 3-4.
* Currently participating in any other physical activity or fitness-related research study.
* Use of medication for Alzheimer's disease.
* Change in dosage of medications prescribed for anxiety or depression within the previous 6 months.
* Regularly drink \> 14 alcoholic beverages a week or current illicit drug use.
* Having no diagnosis or symptoms of cognitive impairment.
* Meet the threshold for clinical depression.
* Uncorrected hearing or visual impairments.
* Unable to understand the study procedures.
* One of the household members is participating in this study.
Efficacy of Using Large Language Model to Assist in Diabetic Retinopathy Detection

With the increase in population and the rising prevalence of various diseases, the workload of disease diagnosis has sharply increased. The accessibility of healthcare services and long waiting times have become common issues in the public health medical system, with many primary patients having to wait for extended periods to receive medical services. There is an urgent need for rapid, accurate, and low-cost diagnostic services.


Eligibility Criteria:
Inclusion Criteria The study will include adults aged 18 years and above who have been diagnosed with Type 2 diabetes but have not previously been screened for DR. Participants must demonstrate good compliance with clinical examinations, and provide informed consent.

Exclusion criteria The study will exclude patients who have previously been diagnosed with DR, those who have recently undergone eye surgery, and those with other significant eye diseases that could potentially confound the results of DR screening. Individuals with ocular, auditory, or cognitive impairments that prevent the use of mobile phones or reading will also be excluded.