cyrilzakka/clinical-trials huggingface dataset:
An Observational Study on the Sorin Group New Brady Leads XFine and Beflex

This observational study is a non-interventional multi-centre, prospective study.

The aim of the study is to evaluate the Sorin Group new passive- and active- fixation pacing leads. We plan to assess the acute and short term lead dislodgment rate (within the first three months following implantation) correlated with the type of lead (active- or passive- fixation). Further, we are collecting data related to leads handling and leads electrical performances

The primary objective of this observational study is to assess the acute rate of dislodgment of the new Sorin group range of active- and passive- fixation leads up to 3 months following implant.

Assessment of electrical performances (pacing threshold, sensing amplitude, impedance) of the leads at implant and during follow-up.

Eligibility Criteria:
Inclusion Criteria:

* The implanted lead must allow the measurement of pacing threshold at 0.5ms, R-wave or P-wave amplitude and impedance of the lead.
* Included patients may receive more than one lead under evaluation.

Exclusion Criteria:

* Any contraindication to endocavitary lead implantation;
* Inability to understand the purpose of the study or refusal to co-operate.
* Geographically unstable or unavailability for scheduled M1-M3 follow-up at the implanting centre as defined in the investigational plan.
* Patient of minor age (\<18)
* Pregnancy.
Phacoemulsification in Patients With Corneal Opacities

In this retrospective case series, the feasibility of performing phacoemulsification using slit illumination in eyes with corneal opacity was assessed.

Corneal opacity is often encountered in patients seeking senile cataract surgery in developing countries. Corneal opacity impairs the intraoperative visualization during cataract surgery which increases the risk of copmlications.

Several techniques were described to enhance the intraoperative visualization such as the use of anterior endoscopy, chandeiler retroillumination, and anterior chamber endoillumination. All these techniques require costly instrumentation.

the aim of this study was to assess the feasibility of performing phacoemulsification using slit illumination of the surgical microscope without the need of additional instruments, and report the visual outcome.

Eligibility Criteria:
Inclusion criteria:

* The presence of visually significant senile cataract.
* A recent history of progressive diminution of vision within few months.
* Stable density and size of a preexisting trachomatous corneal opacity that does not impair the pupil or lens visualization after pupillary dilatation.

Exclusion Criteria:

* History of trauma, infectious corneal ulcers, or intraocular surgery.
* Coexisting ocular diseases e.g. glaucoma, retinal detachment, and vitreous hemorrhage.
Comparison of Clinical Efficacy of Liver Resection, RFA, TACE, and Drug Therapy in Patients with GIST LM

The goal of this observational study is to evaluate the overall survival benefits of local treatment combined with imatinib(IM) and IM alone in patients suffering from GIST liver metastases. The main question it aims to answer is:

• Whether IM combined with hepatic resection (HR) or other local treatments such as radiofrequency ablation (RFA) and transarterial chemoembolization (TACE) has better long-term survival benefits compared to IM monotherapy.

Patients are divided into different treatment groups:

* IM group
* IM combined with HR group
* IM combined with RFA or TACE group

Researchers will compare the IM + HR group and IM + RFA/TACE group with the IM group to see if it has a better Overall survival (OS).

Gastrointestinal stromal tumors (GISTs) represent the most prevalent type of mesenchymal tumor within the gastrointestinal tract, and the liver is the most common site of metastasis from GIST. Imatinib (IM) has significantly enhanced clinical outcomes for patients with advanced disease. Since its approval in February 2002 for treating metastatic or unresectable GISTs, 38% of patients have shown a partial response, while 13.6% have experienced disease progression within 1 to 3 months of IM administration. Over half of the patients with metastases experienced disease progression within two years of IM treatment, attributed to secondary drug resistance. Few studies are comparing the survival benefits of different surgical modalities. The investigators aimed to evaluate IM combined with hepatic resection (HR) or other local treatments such as radiofrequency ablation (RFA) and transarterial chemoembolization (TACE), compared to IM monotherapy in long-term survival benefits in patients suffering from GIST liver metastases.

Eligibility Criteria:
Inclusion Criteria:

* Pathological evidence of GIST of primary tumors
* Liver metastases evidenced by biopsy or radiological findings
* Sufficient liver, hematologic, and renal function, coupled with an Eastern Cooperative Oncology Group performance status score ranging from 0 to 1

Exclusion Criteria:

* IM was not used during treatment
* Liver metastases appeared on second-line or later subsequent lines of TKI
* Combined with other malignant tumors
* Failure to follow up
Lakeshore Examination of Activity and Disability Exercise Response Study

This study will examine the effectiveness of two types of group exercise classes on the health and functional status in inactive adults age 18-65 with neurological conditions including Multiple Sclerosis, stroke, and spinal cord injury (SCI). Participants will be randomly assigned to one of three groups; Movement to Music, Adapted Yoga, or a waitlist group who will complete a home-based exercise intervention of either Movement to Music or Adapted Yoga.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with stroke
* MS - mild to moderate disability (Patient Determined Disease Steps Score 0-6)
* Able to use arms or arms/legs for exercise
* Ambulatory or use manual wheelchair

Exclusion Criteria:

* Cognitive impairment (Mini-Mental State Exam score \< 24)
* Recent weight change (+/- 25 pounds in 1 year)
* Poorly controlled blood pressure
* Cardiovascular disease event within the past six months
* Severe pulmonary disease
* Renal failure
* Current tobacco user or quit within the last six months
* Current use of medications for psychosis
* Active pressure ulcers
A Study of Safety and Efficacy of Pimavanserin (ACP-103) in Patients With Parkinson's Disease Psychosis

This study will evaluate the safety and efficacy of two dose levels of pimavanserin (ACP-103) compared to placebo in patients with Parkinson's disease psychosis.


Eligibility Criteria:
Inclusion Criteria:

* A clinical diagnosis of Parkinson's disease with a minimum duration of 1 year
* Presence of visual and/or auditory hallucinations, and/or delusions, occurring during the four weeks prior to study screening
* Psychotic symptoms must have developed after Parkinson's disease diagnosis was established
* Subject must be on stable dose of anti-Parkinson's medication for 1 month prior to Study Day 1 (Baseline) and during the trial
* Subject that has received stereotaxic surgery for subthalamic nucleus deep brain stimulation must be at least 6 months post surgery and the stimulator settings must have been stable for at least 1 month prior to Study Day 1 (Baseline) and must remain stable during the trial
* The subject is willing and able to provide consent
* Caregiver is willing and able to accompany the subject to all visits

Exclusion Criteria:

* Subject has a history of significant psychotic disorders prior to or concomitantly with the diagnosis of Parkinson's disease including, but not limited to, schizophrenia or bipolar disorder
* Subject has received previous ablative stereotaxic surgery (i.e., pallidotomy and thalamotomy) to treat Parkinson's disease
* Subject has current evidence of a serious and or unstable cardiovascular, respiratory, gastrointestinal, renal, hematologic or other medical disorder
* Subject has had a myocardial infarction in last six months
* Subject has any surgery planned during the screening, treatment or follow-up periods

Patients will be evaluated at screening to ensure that all criteria for study participation are met. These evaluations will include specific measures of psychosis severity, delirium, dementia, cardiovascular condition, and pregnancy status. Patients may be excluded from the study based on these assessments (and specifically if it is determined that their baseline health and psychiatric condition do not meet all protocol-specified entry criteria).
RCT Comparing Upper Body vs. Combined Exercise Protocols During Active Diabetic Foot Ulcer Treatment

This randomized controlled trial (RCT) aims to evaluate the effectiveness of two different structured exercise interventions compared to standard care during active diabetic foot ulcer (DFU) treatment. Participants will be allocated to one of three groups: Upper Body Exercise (UBE), Combined Exercise (CE), or Standard Care Control (SC). The interventions are designed to improve cardiorespiratory fitness-as measured by changes in VO₂peak-and other secondary clinical, metabolic, vascular, inflammatory, muscular, and quality-of-life outcomes while ensuring proper offloading and wound management.


Eligibility Criteria:
Inclusion Criteria:

Age: Adults aged 18 years or older. Diagnosis: Confirmed diagnosis of Type 1 or Type 2 diabetes. Active DFU: Presence of a diabetic foot ulcer under active treatment, as documented by the wound care team.

Wound Stability: Ulcer size that meets protocol criteria (e.g., \<2 cm² or ≥2 cm²) and without critical limb ischemia.

Ability to Exercise: Medical clearance from a physician to safely participate in unsupervised upper body and non-weight bearing exercises.

Compliance: Capacity and willingness to adhere to the study protocol, including scheduled exercise sessions and offloading procedures.

Glycemic Control: Stable glycemic control medications regimen for at least 4 weeks prior to enrollment.

Informed Consent: Ability to provide written informed consent.

Exclusion Criteria:

Critical DFU Complications: Ulcers with signs of critical limb ischemia, severe infection (e.g., osteomyelitis), or wound deterioration that contraindicates participation.

Cardiovascular Limitations: Unstable cardiac conditions (e.g., uncontrolled arrhythmias, recent myocardial infarction within 6 months), severe heart failure, or any other condition contraindicating exercise.

Neurological or Musculoskeletal Limitations: Conditions that significantly impair upper body or core exercise performance (e.g., severe arthritis, recent upper body injury).

Cognitive Impairment: Significant cognitive or psychiatric disorders that would limit the ability to provide informed consent or adhere to the intervention protocol.

Concurrent Participation: Enrollment in another clinical trial or exercise program that conflicts with the study protocol.

Other Medical Risks: Any other condition, as determined by the study physician, that places the participant at increased risk of adverse events during exercise (e.g., severe peripheral vascular disease not amenable to offloading).
Effect of Short-Term Mindfulness-Based Training For Major Depression Disorder: An Eye-Tracking Study

The purpose of this study is to investigate the short-term effects of mindfulness-based training in individuals suffering from major depressive disorder (MDD) as assessed by clinical interviewing, self-report assessment, cognitive evaluation and eye-tracking task.


Eligibility Criteria:
Inclusion Criteria:

* Meet Diagnostic and Statistical Manual (DSM-IV) diagnosis of depression
* Consent to participate in the study and to be randomized to one of two groups

Exclusion Criteria:

* Current or past substance abuse, psychotic disorder,obsessive compulsive disorder , Post-Traumatic Stress Disorder, in the past 6 months
* History of epilepsy or head trauma
* Eye disorders
* History of electroconvulsive therapy in the past 4 weeks.
The Impact of the Fluid Resuscitation on the Venous Volume and Flow Characteristics in Hypovolemic Shock

We hypothesis that in various situation when the effective blood volume decreased the venous volume flow characteristics change according to the fluid resuscitation

Patients with clinical signs of loss of the effective blood volume will undergo ultrasound examination of several major veins. The purpose of this examination is to determine vein volume(size) and flow. The ultrasound examination will be done before fluid resuscitation, after fluid administration,and three days after admission

Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years old
* decreased effective blood volume
* Systolic blood pressure \< 100
* Pulse rate \> 110

Exclusion Criteria:

* age \<18 years old
* pregnancy
* patient requires urgent surgical intervention
A Comparative Efficacy and Safety Study of Compound Carraghenates Cream With Mayinglong Musk Hemorrhoid Ointment in the Treatment of Hemorrhoids

The purpose of this study is to compare the therapeutic effect and safety of compound carraghenates cream with Mayinglong musk hemorrhoid (swollen veins in the lower part of the rectum or anus) ointment in the treatment of hemorrhoids, especially regarding the relief of pain.

This is an open-label (all people know the identity of the intervention), randomized (study drug assigned by chance), multi-center (when more than one hospital or medical school team work on a medical research study), controlled clinical trial and comparative study of safety and efficacy of compound carraghenates cream with Mayinglong musk hemorrhoid ointment in the treatment of hemorrhoids, especially regarding the relief of pain. Participants will be randomly assigned to either of the two treatment groups that are carraghenates cream (Titanoreine) group or Mayinglong musk hemorrhoid ointment group. The total duration of the study will be 1 Week (7 days). In carraghenates cream group, 3-4 gram (g) cream will be administered each time through anal canal, twice a day, once in the morning and once in the evening for consecutive 6 days and in the Mayinglong musk hemorrhoid ointment group, 2 g ointment will be administered each time through anal canal, twice a day, once in the morning and once in the evening for consecutive 6 days. Efficacy will be assessed by using Numeric Rating Scale (NRS) and participants' safety will be monitored throughout the trial.

Eligibility Criteria:
Inclusion Criteria:

* Participants who agree to participate in the current study
* Participants having painful hemorrhoids (swollen veins in the lower part of the rectum or anus \[external hemorrhoid, mixed hemorrhoid, etc.\])
* Participants who did not use other topical drugs to treat their hemorrhoids a day before the inclusion
* Participants who do not use drugs other than the study drug and the control drug to treat their hemorrhoids during the study period

Exclusion Criteria:

* Participants having other anorectal diseases , such as anal fistula , anal cleft , perianal abscess , and anorectal occupied lesions etc
* Participants having hypersensitive predisposition or hypersensitive to any of components of the study drugs
* Female participants under pregnancy or during breastfeeding period
* Participants who fail to accept the scheduled visits or are lost to the visits
* Participants complicated by serious cardio cerebro vascular diseases, hepatic and renal diseases, diseases of hemopoietic system or mental disorders
Feasibility of ETCO₂ Changes During Passive Leg Raise for Fluid Management in Lung Surgery

Aim: End tidal carbondioxide pressure (EtCO2) is an indirect indicator of cardiac output (CO) which is monitored in every patient at perioperative setting. The investigators aimed to use increase of EtCO2 as a response to passive leg raising maneuver (PLR) to indicate fluid responsiveness in patients who underwent lung resection with video-assisted thoracoscopic surgery (VATS).

Materials and Methods: 50 patients included who are eligible according to inclusion criteria of the study who underwent lung resection operation via VATS between Agust 2020-March 2021. After a standardized anesthesia induction protocol and intubation, PLR is applied to all patients as soon as anesthesia depth and ventilation stabilized. An increase of 2 mmHg at EtCO2 at first minute of PLR evaluated as "fluid responsive" due to an increase of venous return. Responsive patients divided into two groups as "study" and "control" when unresponsive patiens inclueded into "unresponsive" group. Patients at study group received a fluid bolus (250 ml (and an additional 250 ml if mean arterial pressure remained below 65 mmHg )) in addition to maintainence fluid as control group and unresponsive group received only maintainence fluid. Hemodynamic data, surgery duration, total iv fluid administration, use of blood products, bleeding and urine output during surgery of all patients recorded. Preopretive and postoperative urea, creatinine and lactate levels of all patiens compared. Total iv fluid administration and urine output recorded during postoperative 24 hours.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing lung resection surgery via VATS
* ASA I-II-III
* Patients older than 18 years

Exclusion Criteria:

* ASA IV or more
* Post operative ICU stay
* Resections greater than lobectomy
* History of renal and heart failure
* Patients younger than 18 years.
Study of 225Ac-SS0110 in Subjects With ES-SCLC or MCC (SANTANA-225 )

This study aims to determine safety, tolerability, recommended phase 2 dose (RP2D), and preliminary antitumor activity of 225Ac-SSO110 with standard of care (SoC) therapy in patients with somatostatin receptor 2 expressing (SSTR2+) extensive-stage small cell lung cancer (ES-SCLC) and recurrent locally advanced or metastatic Merkel cell carcinoma (MCC).


Eligibility Criteria:
Key Inclusion Criteria:

Signed Informed Consent Form and willing to comply with all study procedures.

Participants with ES-SCLC (defined as Stage IV per NCCN guidelines Version 1.2024) or recurrent locally advanced or metastatic MCC (per NCCN guidelines Version 1.2024) documented by histology or cytology.

Participants eligible to receive immune checkpoint inhibitor (CPI) monotherapy at the start of treatment with 225Ac-SSO110 or patients already on CPI monotherapy for 7 weeks.

ECOG performance status of 0 or 1. Life expectancy of at least 6 months.

Positive 68Ga-SSO120 scan (Investigator-assessed) during screening.

Key Exclusion Criteria:

Participants with unstable spinal cord compression.

Any previous systemic radioligand therapy or extensive radiotherapy.

Participants receiving or planned to receive consolidative chest radiation.

History of primary immunodeficiency, transplantation or CAR-T cell therapy.

Major surgical procedure except diagnostic biopsy within 28 days prior to enrolment or scheduled to have major surgery during the study.

Inadequate organ or marrow function.
Mesotherapy In Lateral Epicondylitis

Investigate the short- and long-term efficacy and safety of intradermal NSAIDs and lidocaine (delivered through mesotherapy) for the treatment of LE comparing it with empty intradermal injections.


Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis defined as pain over the lateral epicondyle provoked by palpation;
* A visual analogue scale (VAS) score for pain greater than 40mm;
* symptoms duration for more than 1 month.

Exclusion Criteria:

* other diseases that can alter clinical evaluation detected through history, clinical examination, ultrasound or other exams for comorbidities such as carpal tunnel syndrome, cervical radiculopathy, elbow arthritis, intra-articular loose bodies, previous elbow surgery or clinically significant or recent trauma, fibromyalgia and major psychiatric conditions;
* VAS score for pain less than 40mm;
* any of the following treatments during the previous 4 weeks before baseline visit: physical therapy, bandage, mesotherapy and local corticosteroid injection or a combination of these: NSAIDS taken during the week previous to inclusion;
* pregnancy;
* allergy to any of the study drugs;
* severely immunosuppressed patients;
* known coagulopathies. During the study period, enrolled patients are not allowed to take oral corticosteroids, NSAIDs or receive any other medical intervention during the treatment period (physical therapy, bandage, mesotherapy and local corticosteroid injection or a combination of these).
Clinical Outcomes of Joint Arthroplasty

The purpose of this study is to document the clinical outcomes of partial knee replacement surgery using robotic-arm assisted knee joint surgery at 3 weeks, 6 weeks, 12 weeks, 6 months, 1 year, 2 years, 5 years and 10 years post operative.

The purpose of this study is to document the clinical outcomes of partial knee replacement surgery using robotic-arm assisted knee joint surgery at 3 weeks, 6 weeks, 12 weeks, 6 months, 1 year, 2 years, 5 years and 10 years post operative.

Eligibility Criteria:
Inclusion Criteria:

* All patients over 21 years of age who require a primary robotic-arm assisted unicompartmental knee arthroplasty or bicompartmental knee arthroplasty. These patients will have failed non-operative management of their joint disease and are candidates for partial joint replacement because of pain and stiffness that interferes with their performances or normal daily activities.

Exclusion Criteria:

* Patient had an active infection
* Onlay implants were implanted without bone cement
* Patient does not have enough bone stock to allow for insertion and fixation of the components
* Patient does not have sufficient soft tissue integrity to allow for stability
* Patient has a neurological or muscular deformity that did not allow for control of the knee
* Patient will be excluded from participation in the study if they are cognitively unable to answer study questions
* Pregnant women are excluded.
A Observational Study to Evaluate the Efficacy and Safety of Pacitol Inj.

The purpose of this study is to evaluate the efficacy and safety of pacitol Inj.(paricalcitol) for secondary hyperparathyroidism with stage 5D chronic kidney disease (CKD 5D) receiving hemodialysis


Eligibility Criteria:
Inclusion Criteria:

* Among hemodialysis patients with secondary hyperparathyroidism due to chronic kidney disease (CKD 5D), those who are scheduled to administer Pacitol Inj. according to the product information.
* Those who voluntarily signed a written personal information collection and usage agreement to participate in this clinical study after receiving an explanation about the objective and methods of the study.
* Those able to understand this study, be cooperative in the execution of the study, and participate in the study until its completion.

Exclusion Criteria:

* Those with a history of hypersensitivity reactions to this drug or its components
* Those with evidence of vitamin D toxicity
* Those with hypercalcemia at enrollment
* Pregnant or lactating women
* Those with evidence of parathyroid adenoma who is scheduled to undergo parathyroidectomy.
* Those who have been administered with investigational drugs of other clinical trials within 12 weeks from the baseline(Visit 1).
* Those who are judged by the principle Investigator or sub-Investigator to be ineligible to participate in the study.