cyrilzakka/clinical-trials huggingface dataset:
Repeated Transcranial Magnetic Stimulation in the Elderly With Cognitive Impairment

Introduction and Purpose:

In recent years, non-pharmacological treatment methods for dementia patients have been gradually explored. Among these, Transcranial Magnetic Stimulation (TMS) has been proposed as a non-invasive treatment option. However, the optimal frequency and stimulation site for repetitive transcranial magnetic stimulation have not been definitively determined.

Methods:

This study is a randomized controlled trial. We randomly assigned 30 patients with mild cognitive impairment or dementia to the high-frequency transcranial magnetic stimulation group (40 Hz rTMS) or the moderately high-frequency transcranial magnetic stimulation group (10 Hz rTMS). Stimulation was applied to the bilateral dorsolateral prefrontal cortex (DLPFC). Each patient received a course of treatment for 10 consecutive working days. The high-frequency group received pulses at 40 Hz with an intensity of 40% of the maximum intensity for 2 seconds followed by a 58-second rest period, per set. The moderately high-frequency group received pulses at 10 Hz with an intensity of 90% of the maximum intensity for 4 seconds followed by a 56-second rest period, per set. Each day, patients received 30 sets of stimulation (15 times on the left side and 15 times on the right side), totaling 2400 pulses. Cognitive assessments were conducted on patients before and after the treatment course. Quantitative analysis will be performed using the Statistical Package for the Social Sciences statistical software. The Kolmogorov-Smirnov test will be used to check if the data follows a normal distribution. The chi-squared test will compare differences in baseline categorical variables between the groups, while independent t-tests or the Mann-Whitney U Test will compare baseline differences in continuous variables to assess the effectiveness of random assignment. Analysis of variance (ANOVA) and post-hoc comparisons will be used to compare intergroup and intragroup differences. The significance level is set at α = 0.05.


Eligibility Criteria:
Inclusion Criteria:

1. Age 60 and above.
2. Have received at least 2 years of education.
3. Diagnosed with dementia or Mild Cognitive Impairment (MCI).
4. Clinical Dementia Rating (CDR) score of ≥0.5.

Exclusion Criteria:

1. Mental illness.
2. Alcohol or substance addiction.
3. History of heart rhythm disorders.
4. History of epilepsy.
5. History of brain injury.
6. Underwent neurosurgery.
Acupuncture and Laser Acupoint Treatment on Hypertension

To determine the effect of acupuncture and laser acupuncture point treatment on hypertensive subjects.

The specific aims of the study are to test the effectiveness of acupuncture and laser acupoint on hypertension. The hypothesis is: the stimulation of a pattern of acupoints with acupuncture and laser will result in significant reductions in blood pressure. The points that are going to be used for the study are: Zusanli (St36), Tianshu (St25), Quchi (LI11).

Eligibility Criteria:
Inclusion Criteria:

* Male or female over 18 and under 70 years of age with hypertension (blood pressure over 140/90 mmhg).

Exclusion Criteria:

* Individuals with heart, kidney, thyroid disorders, diabetes, chronic disease or illness, neurological diseases, skin or bleeding disorders, and currently taking drugs or medications will not be recruited in the study. A health history questionnaire will be used to screen the subjects.
ICP-022 Versus Chlorambucil Combined With Rituximab in the Treatment of Untreated CLL/SLL

This is a randomized, multicenter, open-label, Phase 3 study to evaluate the efficacy and safety of ICP-022 versus Chlorambucil plus Rituximab in subjects with Previously Untreated Chronic Lymphocytic Leukemia.


Eligibility Criteria:
Key Inclusion Criteria:

1. Male or female, age ≥65 years old or age \>18 years old or \<65 years old, age \>18 years old or \<65 years old shall meet any of the following criteria simultaneously: A.Disease accumulation score (CIRS) \> 6;B. Creatinine clearance at 30-69 mL/ min (Cockcroft-Gault assessment)
2. Enhanced computed tomography/magnetic resonance imaging (CT/MRI) detection had measurable lesions: at least one lymph node had a maximum axis of more than 1.5 cm and had a measurable vertical dimension
3. ECOG physical strength score is 0-2.
4. Expected survival time \>6 months.
5. Voluntary written informed consent prior to screening.

Key Exclusion Criteria:

1. Patients with stroke or intracranial hemorrhage in the first 6 months were randomly assigned.
2. Hypersensitivity to ICP-022, nitrogen mustard benzoate, rituximab or any other component of the applicable study drug.
3. Any mental or cognitive impairment that may limit their understanding of the informed consent, their implementation and their compliance with the study.
4. Pregnant and lactating women, or subjects of childbearing age who do not want to use contraception within 180 days from the end of the study period to the end of the study period.
5. Conditions in which a potentially life-threatening illness or severe organ dysfunction is not considered appropriate by the investigator.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
A Long-Term Extension Trial From Phase II/III of SPM 962 in Early Parkinson's Disease Patients

Safety of SPM 962 in a once-daily repeated long-term treatment in Parkinson's disease patients who are not concomitantly treated with L-dopa will be investigated with a doses.


Eligibility Criteria:
Inclusion Criteria:

* Subject completed the preceding trial 243-07-001 (NCT00537485)

Exclusion Criteria:

* Subject discontinued from the preceding trial 243-07-001.
* Subject had a serious adverse event which association with the investigational drug was not ruled out during trial 243-07-001.
* Subject has a persistent serious adverse event at the baseline, which was observed and association with the investigational drug was ruled out during trial 243-07-001.
* Subject had persistent hallucination or delusion during trial 243-07-001.
* Subject has psychiatric conditions such as confusion, excitation, delirium, abnormal behaviour at the baseline.
* Subject has orthostatic hypotension or a systolic blood pressure (SBP) \<= 100 mmHg and has a decrease of SBP from spine to standing position \>= 30 mmHg at baseline.
* Subject has a history of epilepsy, convulsion etc. during trial 243-07-001.
* Subject develops serious ECG abnormality at the baseline.
* Subject has QTc-interval \>= 500 msec at the baseline or subject has an increase of QTc-interval \>= 60 msec from the baseline in the trial 243-07-001 and has a QTc-interval \> 470 msec in female or \> 450 msec in male at the baseline.
* Subject has a serum potassium level \< 3.5 mEq/L at the end of the taper period in trial 243-07-001.
* Subject has a total bilirubin \>= 3.0 mg/dL or AST(GOT) or ALT(GPT) greater than 2.5 times of the upper limit of the reference range (or \>= 100 IU/L) at the end of the period in trial 243-07-001.
* Subject has BUN \>= 30 mg/dL or serum creatinine \>= 2.0 mg/dl at the end of the taper period in trial 243-07-001.
* Subject who plans pregnancy during the trial.
* Subject has dementia.
* Subject is unable to give consent.
* Subject is judged to be inappropriate for this trial by the investigator for the reasons other than above.
Tranexamic Acid Contribution in the Prevention of Perioperative Bleeding in Thoracic Surgery

Bleeding after thoracic surgery is a major cause of perioperative hemodynamic instability and transfusion requirement, which can lead to a rise of morbidity, mortality and costs.

The objective of this study is to evaluate the efficiency of tranexamic acid (TA) in the prevention of perioperative bleeding in thoracic hemorrhagic surgery.

It's a randomized, double-blind, prospective study including patients over the age of 18 years old, programmed for potentially hemorrhagic thoracic surgery, such as pulmonary resection for aspergilloma, pulmonary tuberculosis, pleural decortication, lobectomy with parietectomy or redux. Demographic, clinical, biological data as well as transfusion requirements, blood loss and perioperative complications were identified.

Two groups of patients:

* TA group: receiving tranexamic acid (25mg/kg) in bolus at induction followed by 2mg/kg/h in continuous infusion until the end of the act.
* Serum saline isotonic (SSI) group: placebo with isotonic saline serum.

Eligibility Criteria:
Inclusion Criteria:

* over the age of 18 years old, programmed for potentially hemorrhagic thoracic surgery, such as pulmonary resection for aspergilloma, pulmonary tuberculosis, pleural decortication, lobectomy with parietectomy or redux.

Exclusion Criteria:

* Patients who have had a major complication of surgery other than bleeding requiring revision within 24 hours or a complication related to anesthesia, and cases of non-compliance with the anesthetic protocol are excluded.
Use of Myo-inositol as Adjuvant Therapy in Patients With Polycystic Ovary Syndrome (PCOS) in Vitro Fertilization (IVF)

The original mechanism of action of myo-inositol and preliminary results available in the literature on its use in IVF suggest its value as adjuvant gonadotropin therapy to reduce the risk of OHSS in PCOS patients.

The aim of the study is to demonstrate that administration of myo-inositol decreases the incidence of ovarian hyperstimulation syndrome (OHSS) in high-risk infertile with PCOS supported in IVF patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients PCOS (Rotterdam ESHRE / ASRM criteria)

Combination of at least two of the following three criteria:

* Cycle disorder
* Clinical hyperandrogenism and / or biological
* Account antral follicles\> 24
* Age ≤ 18 ≤ 38 years
* BMI \<35 kg / m²
* Able to understand the protocol and signed informed consent

Exclusion Criteria:

* Patients not having the Rotterdam criteria
* Patients\> 38 years and / or BMI\> 35 kg / m²
* Woman enjoying a measure of legal protection
* Hypersensitivity to any component of the Inofolic (myo-inositol, soy, folic acid, glycerol, gelatin, coloring E171)
* Participation in another interventional biomedical research with treatment administered may disrupt ovarian stimulation
Feasibility and Smokers' Reactions to DNA Feedback

The purpose of the study is to explore how feedback of cellular DNA (Deoxyribonucleic Acid) damage, as a marker of exposure to the genotoxic agents of tobacco smoke, promotes cessation.

The study aims to recruit 50 smokers who are not engaged in quitting. The study will involve two in-person visits. During visit 1, participants will complete a baseline survey and have their blood drawn. Approximately two weeks later, in visit 2, smokers will be randomized in a 1:2:2 ratio to one of three arms:

1. education about harms of smoking (control group);
2. same education plus information on DNA damage and biomarker feedback (biomarker arm) without visual of damage; or
3. same as arm 2 except accompanied with visuals of participants' normal and DNA damage cells. Participants in the this arm will be informed of their proportion of leucocytes showing DNA damage with pictures of their normal and damaged cells.

The goal of the analyses is to obtain effect size estimates (direction, confidence intervals) to inform if results align with hypotheses and obtain insights about reactions about the feedback (Aim 1). The study will collect feasibility data from baseline to three months (e.g., percentage who show up to the sessions, attrition).

Eligibility Criteria:
Inclusion Criteria:

* ages 18+
* smoke \> 5 cig/day during the last week
* be open to biomarker feedback
* not actively trying to quit

Exclusion Criteria:

* smoker carbon monoxide level(CO \< 10 ppm)
Efficacy of Flash Glucose-Sensing Technology on the Occurrence of Cardiac Arrhythmias Associated With Hypoglycemia

Hypoglycemia, frequently asymptomatic, may lead to cardiac arrythmias and induce an increased risk of cardiovascular morbidity and mortality in patients with type 2 diabetes (T2D). The study hypothesize is that the hypoglycemia reduction, achieved with the FREESTYLE LIBRE device, a Glucose Continuous Monitoring system, may decrease cardiac arrythmias associated with hypoglycemia. So the main objective is to evaluate the efficacy of the FREESTYLE LIBRE system, associated with a specific therapeutic education on the cardiac arrythmias reduction, compared to a capillary ASG system with standard therapeutic education, in patient with T2D with high risk of hypoglycemia.

This is a open, multicenter, controlled, randomized study in parallel group.


Eligibility Criteria:
Inclusion criteria:

* Type 2 diabetes (diagnosis based on the World Health Organization criteria)
* Treatment with insulin therapy (continuous subcutaneous insulin Infusion or more than 1 daily injection)
* Resting heart beat ≥ 60bpm
* High risk of hypoglycemia defined as :

  * Estimated glomerular filtration rate 15-59 ml/min/1.73 m² (according to CKD-EPI formula)
  * Or history of stable proliferative diabetic retinopathy
  * Or body mass index ≤ 30 kg/m²
  * Or history of severe hypoglycemia in the previous 6 months
  * Or history of non-severe ≤70mg/dL hypoglycemia in the previous 4 weeks

Exclusion criteria:

* Type 1 diabetes mellitus or diabetes due to other cause
* History of atrial fibrillation
* Pacemaker
* Estimated glomerular filtration rate \<15 ml/min/1.73 m² (according to CKD-EPI formula)
* Currently using a flash continuous Glucose Monitoring device
* In the investigator's opinion, acute or chronic medical condition considered as unsuitable for inclusion in the study .
Treatment Response in Dialysis Anaemia

Anaemia in dialysis patients requires treatment with frequent dose adjustments. There are two current possible treatments for anaemia which are iron and erythropoietin stimulating agents (ESA). Dosages of these medications are currently guided by a patient's ferritin levels and haemoglobin, but these markers are known to be inaccurate. The current clinical protocol therefore tends towards overuse of both agents which can be associated with toxicity, and the reliance on these markers prevents retrospective assessment of treatment responsiveness. This study is designed to investigate the factors which predict which agent would produce a better response. Patients with a fall in haemoglobin will be given treatment with either iron or an increased dose of ESA as they are currently, but allocated at random rather than by poorly performing biochemical markers. The iron treated and ESA treated groups can then be analysed for factors which predict response in o


Eligibility Criteria:
Inclusion Criteria:

* All prevalent haemodialysis patients of the Imperial Renal and Transplant Centre will be eligible for inclusion if they have been on dialysis for more than 3 months

Exclusion Criteria:

* Patients with a bone marrow disorder, active infection or active malignancy will be excluded as these are non-renal causes of anaemia. Patients unable to give informed consent will also not be included within the study.
Evaluation of the Efficacy of Platelet-rich Plasma (PRP) on Advanced Endoscopic Resection Techniques

To avoid complications secondary to advanced endoscopic resection techniques (Endoscopic Mucosal Resection -EMR- or Endoscopic Submucosal Disection -ESD-) the endoscopists have to avoid deep thermal damage and increase mucosal healing. Platelet-rich plasma (PRP) has demonstrated efficacy in preclinical endoscopic resection models.

Background:To avoid complications secondary to advanced endoscopic resection techniques (Endoscopic Mucosal Resection -EMR- or Endoscopic Submucosal Disection -ESD-) the endoscopists have to avoid deep thermal damage and increase mucosal healing. Platelet-rich plasma (PRP) has demonstrated efficacy in preclinical endoscopic resection models.

Aim: Evaluate the efficacy of PRP on participants submitted to advanced endoscopic resection techniques: EMR or ESD.

Material and Methods: The investigators have evaluated a prospective clinical study. The investigators have included 12 participants submitted to EMR or ESD. Patients were informed and accepted to participate with a written consent. Prior to endoscopy PRP was obtained from autologous blood with a comercial kit. Submucosal injection with PRP were performed prior to resection. Resection was performed with standard technique. Participants were followed-up after the procedure.

Eligibility Criteria:
Inclusion Criteria:

* Endoscopic lesion higher than 40mm in diameter submitted to endoscopic resection (EMR or eSD)

Exclusion Criteria:

* Ineligibility to endoscopic resection
Telomere Length and Other Parameters of Telomere Dysfunction in PSC and Colitis

PSC is a chronic cholestatic disorder. The investigators intend to study some telomere parameters and telomere length in order to predict a premalignant state.

Primary sclerosing cholangitis (PSC) and colitis are chronic inflammatory disorders with malignant potential. Telomerase is an enzyme complex that lengthens telomeres and has enhanced expression in numerous malignancies. In this study, we evaluated the telomerase gene copy number, telomere length, cells in senescence, aneuploidy and additional parameters of telomere dysfunction from peripheral blood lymphocytes of patients.

Eligibility Criteria:
Inclusion Criteria:

* informed consent
* documented PSC and inflammatory bowel disease

Exclusion Criteria:

* under 18 years, above 80 y
* known active malignancy
* decompensated cirrhosis
* patients who cannot sign informed consent
Urdu Version of Core Outcome Measure Index - Neck Scale: Reliability and Validity Study

The Purpose of this study is to culturally adapt and translate Core outcome measure index-Neck Scale into Urdu language as well as to investigate the reliability and validity in Pakistani population. Also check its correlation with Neck Disability-Index, Neck-pain and the disability-scale and Functional-Rating-Index.

The English version of the Core outcome measure index-Neck Scale will be translated and culturally adapted Urdu Language. In Patients who suffer from Chronic-Neck Pain, Core outcome measure index-Neck Scale will be distributed among one hundred and twenty participants choose a convenience sampling technique based on pre-defined inclusion and exclusion criteria. To test intra and inter observation reliabilities for the final Core outcome measure index-Neck Scale, Neck-pain and the Disability Scale, Functional-Rating-Index and Neck-Disability-Index questionnaire will be filled on the same day, by two observers, and for the inter-observer's assessment, with an interval of 30 minute between the first and the second application. Third assessment will be carried out after 7 days by for intra-observer assessment. Data will be entered and analyzed using Statistical Package of Social Sciences Software Version 24. Internal consistency will be analyzed by using Cronbach-alpha-value. Test-retesting reliabilities will assesses using the intraclass correlation coefficient. Core outcome measure index-Neck Scale will be evaluated for content validities, construct validities, and responsiveness.

Eligibility Criteria:
Inclusion Criteria:

* Individuals, including both Male and females (age ≥18).
* Participants with Chronic-Neck Pains lasting more than Three months Duration.
* Participants with sufficient Knowledge and understanding Urdu Language.

Exclusion Criteria:

* Participants with the history of Neck-pains due to deformity, existing central or peripheral nervous disorders and cervical spinal cord fracture were excluded.
* Participants having systematic diseases (tumor or articular Diseases).
* Participants with any Pertinent comorbidities, including heart attack, Cancer, cognitive Impairment's and mental disorders were also excluded.
Valve Leaflet Motion in Sutureless Bioprosthetic Aortic Valves

A single-center prospective interventional trial. Patients implanted with a sutureless bioprosthetic aortic valve at Karolinska University Hospital in Stockholm, Sweden from 2012 will be eligible. 4-dimensional volume-rendered computed tomography (CT) of the heart will be performed. The aim of the CT is to assess valve leaflet motion. Results of the CT examination, preoperative clinical characteristics, and postoperative clinical data will be registered. Data will be collected prospectively and retrospectively. Informed consent will be obtained from patients meeting the inclusion criteria before the initiation of any study-specific procedures.


Eligibility Criteria:
Inclusion Criteria:

* Implanted with a sutureless Perceval (Sorin Group) sutureless bioprosthetic aortic valve at Karolinska University Hospital in Stockholm, Sweden between 2012 and 2016
* Provide written informed consent

Exclusion Criteria:

* Contraindication for CT with intravenous contrast injection
Phase 1 Clinical Trial of DA-5207 in Healthy Adults

The purpose of this study is to evaluate the safety, pharmacokinetics and pharmacodynamics of DA-5207 transdermal delivery system in healthy adults


Eligibility Criteria:
Inclusion Criteria:

* Health Volunteers (Age: 19\~55 years)
* Body Weight: Male≥55kg, Female≥50kg
* 18.5 ≤BMI≤ 25.0

Exclusion Criteria:

* Galactose intolerance, Lapp lactase deficiency, Glucose-galactose malabsorption
* Allergy or Drug hypersensitivity
* Clinically significant Medical History
* AST, ALT\>Upper Normal Range\*1.25, eGFR\<60mL/min/1.73m²
* Heavy caffeine intake
* Heavy alcohol intake (more than 210g/week)
* Heavy smoker (more than 10 cigarettes/day)
Dermotaxis v/s Loop Suture Technique for Closure of Fasciotomy Wounds : a Study of 50 Cases

The fasciotomy incisions lead to large, unsightly, chronic wounds after surgical intervention. The classic management was split thickness skin grafting but it leads to insensate skin with 23% of people upset by the appearance of the wound and 12% forced to changed occupation. Since no skin loss has occurred with the fasciotomy and utilizing the dermal properties of creep, stress relaxation and load cycling closure can be achieved in a better way. Our hypothesis is that using dermatotraction approximation could be done using inexpensive equipment readily available in any standard operating room.

25 cases each of fasciotomy will be closed either by dermotaxis or loop suture technique with the inclusion criteria being closed fractures, no concomitant skin loss, fracture related compartment syndrome and fasciotomy within 36 hrs. The fasciotomy incision will be either closed in a single stage by loop suture technique or gradually by dermotaxis once the edema settled between 3-5 days. The results will be graded as excellent if approximation could be achieved, good if sutures have to be applied for protective care and poor if they have to be grafted. In dermotaxis (Singhs skin traction) method two parallel kirschner wires (1.5mm) will be passed through the dermis on either side of the wound margins and interconnected by compression device consisting of threaded rod having two blocks and compression knob. Gradual compression will be applied daily at the rate of 1 turn/12hours on both sides of the wound.

The loop suture technique involves using corrugated drains and Ethilon no.1. It is an extension of the purse string suture technique where a surgical suture is passed as a running stitch in and out along the edge of a wound in such a way that when the ends of the suture are drawn tight the wound is closed. Two corrugated drains (1 \& 2) will be anchored to the skin adjacent to the fasciotomy incision using Ethilon no.1. Then the sutures will be passed from one edge of the wound through the skin and corrugated drain to the other in an alternating fashion.

Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria being closed fractures, no concomitant skin loss, fracture related compartment syndrome and fasciotomy within 36 hours.

Exclusion Criteria:

* The exclusion criteria was open fractures, skin loss, non-fracture related compartment syndrome and presentation after 36 hours