cyrilzakka/clinical-trials huggingface dataset:
YL-1 Needle Puncture vs BHC With Postoperative Exhaustive Drainage for CSDH

A prospective multicenter cohort study was designed to compare the differences in complications with YL-1 Needle Puncture versus Bulr-hole Craniotomy (BHC) with postoperative Exhaustive Drainage strategy for patients with Chronic Subdural Hematoma.

Chronic subdural haematoma (CSDH) is a common condition in neurosurgery. It is generally considered to be a closed exudate formed by blood or blood degradation products between the dura mater and the arachnoid membrane. Its local occupying effect will compress the neighbouring brain tissues, leading to varying degrees of neurological dysfunction. In severe cases, it can lead to cerebral hernia and endanger the patient's life. Currently, the most commonly used surgical method for the treatment of chronic subdural haematoma is BHC, but many studies have found that various complications may occur after BHC. With the rapid development of neurosurgical microtechnology, Twist Drill Craniotomy (TDC) was proposed. YL-1 puncture needle technique, as a modified solution of TDC, has a short surgical time and is less traumatic to patients. In the treatment of chronic subdural haematomas, investigator's team has adopted the strategy of postoperative instillation of urokinase and adequate drainage of the haematoma. Based on this, this study intends to conduct a multicentre prospective observational cohort study of the above two treatment in order to scientifically and rigorously derive the optimal clinical treatment strategy for chronic subdural haematoma.

Eligibility Criteria:
Inclusion Criteria:

1. Adults, male or female, 18 years ≤ age ≤ 90 years;
2. Preoperative neurological dysfunction, such as headache and dizziness, nausea and vomiting, limb numbness or weakness, unsteady walking, limb twitching, confusion, aphasia, slow response, memory loss, etc;
3. A definite diagnosis of chronic subdural hematoma by CT or MRI;
4. Signed informed consent.

Exclusion Criteria:

1. No symptoms before surgery and no obvious impact on oneself's normal life;
2. Lack of mass effect, less than 0.5 cm of midline structure shift, and no need surgery judged clinically by neurosurgeons;
3. Previous surgery for chronic subdural hematoma during the past 6 months;
4. Previous intracranial surgery for any neurological disorders but chronic subdural hematoma before
5. Existing poor medication condition or severe comorbidity so that surgery cannot be tolerated or follow-up cannot be completed
6. Combination of major systemic diseases that are expected to interfere with study implementation and follow-up observations;
7. Definite coagulation abnormalities with a high risk of bleeding (presence of one of the following three: prolongation of the prothrombin time PT or the activated partial thromboplastin time APTT by more than 10 seconds, an international normalized ratio INR greater than 3.0, and an absolute platelet value of less than 100 × 109/L);
8. Postoperative cooperation is suspected to be insufficient for follow-up for 6 months;
9. Reproductive-age women without verified negative pregnancy testing;
10. Participating in other research
Study to Evaluate the Treatment Effect of PT003 on Cardiovascular Hemodynamics in Subjects With Moderate to Severe COPD

This is a randomized, double-blind, placebo-controlled, single-center, chronic-dosing (7 days), two-period, two-treatment, cross-over study to evaluate the treatment effect of PT003 compared with that of Placebo MDI on Cardiovascular Hemodynamics following chronic-dosing (7 days) in subjects with moderate to severe COPD.


Eligibility Criteria:
Inclusion Criteria:

* At least 40 years of age and no older than 80 at Visit 1.
* Women of non-child bearing potential,or negative serum pregnancy test at Screening, and agrees to acceptable contraceptive methods used consistently and correctly from Screening until 14 days after final visit
* Evidence of lung hyperinflation
* Subjects with an established clinical history of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS)
* Current or former smokers with a history of at least 10 pack-years of cigarette smoking.
* Pre- and Post-bronchodilator FEV1/FVC ratio must be \<0.70
* Post-bronchodilator FEV1 must be ≥30% to \<65% predicted normal value, calculated using NHANES III reference equations.

Exclusion Criteria:

* Significant diseases or conditions other than COPD which, in the opinion of the Investigator, may put the patient at risk
* Women who are pregnant or lactating or are planning to become pregnant during the course of the study
* Subjects, who in the opinion of the Investigator, have a current diagnosis of asthma or other active pulmonary disease
* Subjects who have been hospitalized due to poorly controlled COPD within 3 months prior to Screening
* Subjects who have poorly controlled COPD, defined as acute worsening of COPD that requires treatment with oral corticosteroids or antibiotics within 6 weeks prior to Screening or during the Screening Period
* Subjects who have clinically significant uncontrolled hypertension.
* Subjects with symptomatic prostatic hypertrophy that is clinically significant and not adequately controlled with appropriate therapy, in the opinion of the Investigator.
* Subjects with bladder neck obstruction or urinary retention that is clinically significant in the opinion of the Investigator.
* Subjects with a calculated creatinine clearance ≤30 mL/minute using Chronic Kidney Disease Epidemiology Collaboration. (CKD-EPI) formula at Screening and on repeat testing prior to Visit 2.
* Subjects with abnormal liver function tests defined as AST, ALT, or total bilirubin ≥ 1.5 times upper limit of normal at Screening and on repeat testing prior to Visit 2
* Subjects who have cancer that has not been in complete remission for at least five years.
* Subjects with a diagnosis of glaucoma, who in the opinion of the Investigator, have not been adequately treated.
* Subjects with a clinically significant ECG
* Subjects who were previously enrolled in any previous PT001, PT003, or PT005 study conducted or sponsored by Pearl.
Translation and Cultural Adaptation of the Dysfunctional Attitude Scale (DAS) Into Urdu

Translate and adapt the Dysfunctional Attitude Scale (DAS) into Urdu language and establishing the psychometric properties (reliability, validity, and norms) of the translated scale

the present study aims to translate and culturally adapt the Dysfunctional Attitude Scale (DAS) into Urdu language. This study aims to increase the accessibility and accuracy of clinical assessments, ultimately improving the quality of mental health care delivery and advancing research in the field of clinical psychology within Urdu-speaking communities.

Eligibility Criteria:
Inclusion Criteria:

Individuals aged 18 to 65 years At least 5 years of education Individuals with symptoms of Depression and Anxiety

-

Exclusion Criteria:

* Substance use disorder according to DSM-5 TR criteria Significant cognitive impairment (for example, profound learning disability or dementia) Active psychosis as determined by their primary care clinician
Inflammatory Genomics in Human Carotid Artery Disease

To investigate the relationship between genetic variation in genes for inflammation and carotid artery atherosclerosis.

BACKGROUND:

Atherosclerotic vascular disease is a major source of morbidity and mortality. Inflammation plays an important role in atherosclerosis. The tools to systematically study the extent to which genetic variation determines risk of and progression of atherosclerosis are only now becoming available.

DESIGN NARRATIVE:

The study will evaluate the role of genetic variation in inflammatory pathway genes at 29 loci on the risk and progression of carotid artery atherosclerotic disease (CAAD). Genes to be evaluated include those potentially involved in plaque initiation and progression. The investigators will evaluate single nucleotide polymorphisms (SNPs) informative for the common locus haplotypes. Choice of informative polymorphisms for evaluation is based on the genes' evolutionary history. They will evaluate progression effects in subjects with CAAD followed longitudinally by noninvasive magnetic resonance (MR) techniques over 3 years. Risk will be evaluated by case-control comparisons. In additions to evaluating genetic polymorphisms, they will evaluate the intervening phenotypes of protein level for fibrinogen, C-reactive protein, serum amyloid A, and interleukin-6. Independence of genetic predictors from traditional cardiovascular risk factors will be evaluated.

The major specific aims are: Aim 1. Test for inflammatory genetic effects and protein level in CAAD progression in 550 subjects with CAAD (275 with 15-49% and 275 with 50-79% baseline CAAD stenosis) evaluated by 3-year magnetic resonance image follow-up of percent lumen stenosis; Aim 2. Determine whether the variation in the inflammatory genes or protein levels predicts 810 case vs. 810 control status with a case distribution of 335 subject with 15-49%, 275 with 50-75% and 200 with \>80% carotid artery stenosis at baseline. Age (onset of vascular disease for cases, current age for controls)-, sex-, race-, and hospital-matched controls will have less than 15% stenosis on carotid duplex ultrasound. Genes that are implicated in disease may eventually allow targeted therapy.

Eligibility Criteria:
No eligibility criteria
OatMeal and Insulin Resistance: OMA-IR

Insulin resistance is a central feature of Diabetes mellitus type 2 (Stumvoll et al. 2005). Hypo- and hyperglycemic states are associated with adverse inpatient outcomes (ADA et al. 2006 Diab Care) and with the development of microvascular complications (UKPDS 34 Lancet 1998).

A long known therapy for the acute treatment of patients with deteriorated glucose metabolism and insulin resistance are carbohydrate days. The principle of the therapy was firstly introduced in 1903 by Carl von Noorden (Noorden et al. 1903). The diabetic patients were treated for several days with a carbohydrate rich diet with fat restriction. Surprisingly, this resulted in an amelioration of glucosuria. Today it's still a valuable tool for patients with uncontrollable diabetes mellitus and severe insulin resistance (Willms B. 1989). But up to now there has been no systemic evaluation of carbohydrate days in patients with deteriorated Diabetes mellitus and insulin resistance.

The investigators conducted a pilot study with 14 patients to evaluate the efficacy of two days of oatmeal on insulin resistance and glucose metabolism in an acute clinical setting and after a four week outpatient period. Inclusion criteria were type 2 diabetes with deteriorated glucose metabolism, insulin resistance defined as an insulin dosage of more than 1 U per day and kg bodyweight. Within this pilot trial the investigators found a marked decrease of insulin requirements (\~40%) and mean daily blood glucose to a mean blood glucose of 114.7±36.7 mg/dl in the acute setting as well as after the four week outpatient period (Lammert et al. 2006).

The most important shortcomings of this study were the hypocaloric interventions in both groups (diabetes-adapted diet: 1500kcal/d vs. oatmeal 1200kcal/d) making it difficult to attribute the observed effects to oatmeal alone as well as the uncontrolled nature. These design flaws have been addressed within this new clinical trial. The investigators plan an open label, cross-over study with isocaloric interventions (oatmeal and diabetes-adapted diet: \~ 1200kcal/d). The intervention comprises two days of oatmeal (third and fourth day) within a 5 day hospital stay. The control is only treated with 5 days of diabetes adapted diet. Thereafter, the patients are followed every four weeks for an overall of 16 weeks.


Eligibility Criteria:
Inclusion Criteria:

* diabetes mellitus 2
* insulin therapy
* stable therapy modality within the last 3 months
* deteriorated glucose metabolism (Hba1c \> 7%)
* insulin resistance, defined as more than 1 unit of insulin per kg and day

Exclusion Criteria:

* acute vascular event within the last 3 months
* planed weight reducing therapy
* acute and chronic inflammatory disease
* therapy with corticosteroids
* pregnancy
Comparison of Two Different Intraocular Lenses Implanted With Yamane Technique

In case of instability or rupture of capsular bag occurs during cataract surgery, Yamane technique is one of the options to fix intracocularlens' haptics. Yamane technique uses a double-needle technique that seamlessly fixes the haptics intrascleral by creating a scleral tunnel.

Aberrations, IOL tilting or even dislocations might occur and influence the final outcome of IOL implantation.

The aim of this study is the evaluation of the postoperative tilt of Kowa PU6AS using Yamane technique. Furthermore of the corrected and uncorrected visual acuity and the anterior chamber depth are being developed.

During uncomplicated cataract surgery, an intraocular lens (IOL) is implanted into the patient's capsular bag. If increased instability or rupture of this capsular bag occurs due to aggravated intraoperative conditions or IOL dislocation, several options are available to the surgeon to correct the aphakia, all characterized by their respective advantages and disadvantages, but with no clear superiority of any one method.

The popular Yamane technique, or "flanged IOL fixation", uses a double-needle technique that seamlessly fixes the haptics intrascleral by creating a scleral tunnel using two 30-gauge needles.

Examples of lenses used for this purpose are the TECNIS ZA9003 (Johnson\&Johnson, USA) and the Kowa PU6AS (Kowa, Japan). Another approach is the Carlevale FIL-SSF IOL (Soleko, Italy), which was developed specifically for use in aphakia with lack of capsular stability.

All types of implantation are not immune to aberrations, tilting or even dislocation. Many factors influence the final outcome of IOL implantation, be it the optimal choice of intraocular lens power, the surgeon's experience regarding fixation in more challenging eyes, or individual anatomical conditions. As part of quality assurance, an evaluation of monthly and six-monthly data will now be performed. The aim of this study is the evaluation of the postoperative tilt of the Kowa PU6AS in Yamane technique, as well as the evaluation of the corrected and uncorrected visual acuity and the anterior chamber depth within the clinical quality management.

Eligibility Criteria:
Inclusion Criteria:

* Minimum age: 21 Years
* planned or performed lens implantation using the Kowa PU6AS or the Johnson \& Johnson ZA9003 using the Yamane technique
* signed patient consent form

Exclusion Criteria:

* best corrected visual acuity \>0.1 (Snellen)
* pregnancy
Impact of Total Thyroidectomy on Voice and Swallowing

Purpose of this study is to evaluate the outcome of total thyroidectomy on vocal and swallowing function.

Voice and swallowing alterations are frequently reported after thyroidectomy, even in the absence of nerve injury. These impair quality of life.

Purpose of this study is to evaluate the outcome of total thyroidectomy on vocal and swallowing function.

Patients will be assessed using the Greek- version of Voice Handicap Index (VHI) and a questionnaire developed by the authors regarding swallowing symptoms.

Furthermore they will undergo flexible laryngoscopy for evaluation of laryngeal mobility.

Eligibility Criteria:
Inclusion Criteria:

* All patients submitted to total thyroidectomy during the study period

Exclusion Criteria:

* Previous thyroid/ neck surgery
* Documented voice disorders
Diagnostic, Therapeutic and Reproductive Aspects of Patients with Mullerian Anomalies

The purpose of this study is to get a better understanding of the clinical implications (including reproductive problems and obstetric complications), appropriate diagnostic tools and correct surgical treatment of Mullerian anomalies.

Mullerian anomalies are rare, therefore they are not well known and not often considered as differential diagnosis. This causes a delay in the diagnosis with risk of long lasting symptoms and adverse effects on the reproductive function. However, the diagnosis can be made more accurately with improved diagnostic tools. Moreover, minimally invasive surgery allows for preservation and potential improvement of fertility in these women.

The purpose of this study is to get a better understanding of the clinical implications (including reproductive problems and obstetric complications), appropriate diagnostic tools and correct surgical treatment of Mullerian anomalies.

Eligibility Criteria:
Inclusion Criteria:

* women with a uterus
* presence of a mullerian variation
* Maximum age 45y

Exclusion Criteria:

* women without a uterus
* aged \>45y
Resistance Band Training Versus Nordic Hamstring Exercise on Hamstring Strength Among Football Players

The major aim of this project to compare the effects of Resistance band training and Nordic hamstring exercise on hamstring strength among football players.

Hamstring strength is important in football players and plays an important role in their sprint gait cycle. Football players should develop sprinter-like musculature in order to benefit their body strength and power hence preventing from hamstring strain injuries. Professional and recreational sports like Football, hamstring muscle strength training is commonly used to increase and balance lower body strength and power.

Eligibility Criteria:
Inclusion Criteria:

1. Male
2. Age: 18-28 years
3. Football players
4. Playing should be at least for 1 year

Exclusion Criteria:

1. To be involved in any additional strength training program i-e: Gym Activities
2. Athletes having hamstring and Quadriceps injuries
3. History of trauma at knee, hip or back
4. Recent history of any upper and lower extremity fracture
5. Any orthopedic or neurological disorder.
Augmenting Specialty Eating Disorder Clinical Treatment With a Smartphone Application

Cognitive behavioural therapy (CBT) is the most empirically supported and researched treatment for eating disorders. A central component of CBT for eating disorders is self-monitoring which involves patients keeping a paper food record of their meals and associated thoughts, feelings, and behaviours and receiving feedback from a clinician to help target dysfunctional cognitions and behaviours. Given the issues associated with paper journals such as non-compliance, feelings of shame when used in public, and delayed feedback, researchers have developed an evidence-based smartphone application (Recovery Record) for eating disorder self-monitoring that links patients with their clinicians and offers additional features designed to enhance treatment.

The current pilot randomised controlled trial (RCT) seeks to evaluate this smartphone application in a clinical setting alongside standard eating disorder outpatient treatment. Patients will be recruited from the Nova Scotia Health Authority Eating Disorder Outpatient Program and randomised to receive either standard treatment or standard treatment with the app (instead of the paper food record). The efficacy and acceptability of both treatments will be assessed and compared. Coping skill use and self-efficacy among patients will also be examined given the skill building focus of treatment and in-app capabilities to deliver real-time coping skill suggestions to patients.

This pilot study will be the first to examine the efficacy and acceptability of a smartphone application in eating disorder clinical treatment and if successful, should provide preliminary support for the use of smartphone applications over traditional paper food journals as a self-monitoring tool for augmenting specialty eating disorder clinical treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients with an eating disorder (anorexia nervosa, bulimia nervosa, or eating disorder not otherwise specified) according to DSM-V criteria (American Psychiatric Association, 2013) as determined through a standard clinical interview by either a team psychiatrist or clinical psychologist, and validated with a self-report diagnostic measure.
* Patients with an Apple or Android smartphone (a mobile phone with access to third-party applications and advanced features) with an active data plan or frequent (e.g., daily) Wi-Fi access.
* Patients 17 years or older.
* Signed consent from patient.

Exclusion Criteria:

* Patient has insufficient knowledge of English.
Producing Increasingly Complex Themes Using Right-hemisphere Engagement (PICTURE) Implemented With Telemedicine

The investigators propose a pilot crossover trial of 2 behavioral language treatments, with randomized order of treatments and blinded assessors, to determine if a therapy designed to stimulate right hemisphere functions (Producing Increasingly Complex Themes Using Right-hemisphere Engagement Implemented with Telemedicine - PICTURE IT; described below) is more effective in improving discourse than a published computer delivered lexical treatment (shown previously to improve naming) in subacute post-stroke aphasia.

The investigators will carry out a crossover study with randomized order of treatment conditions and blinded assessors, to compare changes in content and efficiency of discourse (primary outcome measures) from before treatment to immediately after treatment, to compare intervention focused on engaging the right hemisphere (PICTURE IT; see below) to a purely lexical treatment (see details below). Secondary outcome measures will be: (1) changes in discourse from pre-treatment to 2 weeks post-treatment, and (2) changes in naming of objects and actions from immediately before treatment to immediately after treatment, and (3) changes in naming of objects and actions from pre-treatment to 2 months after both treatments. The investigators will also carry out resting state functional near infrared spectroscopy (fNIRS) before and after each treatment to evaluate degree and location (e.g. intrahemispheric right versus left) of changes in connectivity associated with each treatment and with changes in each outcome measure. The investigators will also take saliva samples from participants who agree to this optional part of the study to determine the participants brain-derived neurotrophic factor status.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of aphasia secondary to stroke and presence of naming deficits (at least 20% errors on the Boston Naming Test or Hopkins Action Naming Assessment)
2. Capable of giving informed consent or indicating another to provide informed consent
3. Age 18 or older
4. The stroke must have occurred between 1 month and 4 months prior to enrollment in the study or more than 6 months prior to enrollment in the study
5. Able to understand therapy tasks (as indicated by 5 probes of each)

Exclusion Criteria:

1. Lack of English proficiency (by self/legally authorized representative report)
2. Prior history of neurologic disease affecting the brain (e.g., brain tumor, multiple sclerosis, traumatic brain injury) other than stroke
3. Prior history of severe psychiatric illness, developmental disorders or intellectual disability (e.g., PTSD, schizophrenia, obsessive-compulsive disorder, autism spectrum disorders)
4. Uncorrected severe visual loss or hearing loss by self-report and medical records
Changes of Bone Turnover Markers and Bone Mineral Density After Osteoporosis Treatment

To examine the changes of bone mineral density and bone turnover markers after Bonviva treatment in osteoporotic patients


Eligibility Criteria:
Inclusion Criteria:

* Osteoporosis

Exclusion Criteria:

* Kidney, parathyroid, congenital bone metabolic disease
Anastomotic Airway Complications After Lung Transplantation

Retrospective analysis of data concerning anastomotic airway complications after lung transplantation.


Eligibility Criteria:
Inclusion Criteria:

* Lung transplantation

Exclusion Criteria:

* heart and lung transplantation