cyrilzakka/clinical-trials huggingface dataset:
Comparison of Billroth-I and Roux-en-Y Reconstruction After Distal Subtotal Gastrectomy

The purpose of this trial is to compare the degree of reflux, operative outcomes and quality of life between Roux en Y and Billroth-I reconstructions after distal subtotal gastrectomy for gastric cancer

Most common procedure for the resection of gastric cancers located in middle or lower stomach is distal subtotal gastrectomy. However, the optimal reconstruction procedure after that has still not to be established. Although B-I reconstruction is most common method due to the safety and simplicity, the duodenal fluid may reflux into the remnant stomach which may contribute to the mucosal injury to remnant stomach and esophagus. Roux en Y reconstruction may reduce the reflux to remnant stomach due to the length of Roux en Y limb, although it is more complicated procedure.

Therefore, we plan to collect 120 patients to compare the degree of reflux between Roux en Y and Billroth-I reconstructions after distal subtotal gastrectomy for gastric cancer. In addition, we compare the surgical outcome and quality of life between two groups.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with adenocarcinoma at the endoscopic biopsy
* Patients who are possible to be performed curative resection in imaging study
* Patients with tumor which not involved in pylorus and are located in mid or distal portion of the stomach
* Patients with informed consent
* Patients with three or less American Society Anesthesiology Score 3

Exclusion Criteria:

* Patients who are or become pregnant
* Patients with uncontrolled disease
* Patient s with synchronous other malignancy
* Patients participated in other clinical trial
Escitalopram Treatment of Night Eating Syndrome

Night-Eating Syndrome (NES) is an eating disorder characterised by excessive eating at night, sleep disturbance and morning anorexia. This 12-week study examines the effect of escitalopram on symptoms of NES.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-70 years
* Presence of NES
* BMI 25-50

Exclusion Criteria:

* History of schizophrenia or other psychoses
* History of bipolar disorder, anorexia nervosa, bulimia, binge eating disorder
* Current major depressive disorder
* Suicidal ideation
* Psychotropic drugs in the past month
* Drugs or herbal remedies that significantly affect body weight, current participation in a weight loss program, currently following a specialized diet (e.g., Atkins, Zone, etc)
* Lack of benefit with SSRI treatment for NES
* Serious or unstable medical illness
* Allergy or hypersensitivity to escitalopram
* Pregnant, breast-feeding, or planning pregnancy in the next six months.
Theragun vs Dry Needling on Neck Pain, Range of Motion and Disability Among Heavy Weightlifters

The study is randomized and single-blinded. Ethical approval is taken from ethical committee of Riphah International University, Lahore. Participants who meet the inclusion criteria will be enrolled and allocated in group A \& B through sealed envelope method by Non-probability Convenient random sampling technique. Subjects in Group A will receive Theragun technique. Group B will receive Dry Needling technique.

The objective of the study is to determine the Comparative effects of theragun and dry needling on neck pain, range of motion and disability among heavy weightlifters. The study is randomized and single-blinded. Ethical approval is taken from ethical committee of Riphah International University, Lahore. Participants who meet the inclusion criteria will be enrolled and allocated in group A \& B through sealed envelope method by Non-probability Convenient random sampling technique. Subjects in Group A will receive Theragun technique. Group B will receive Dry Needling technique. Neck Disability index (NDI), Universal Goniometer, Numeric Pain Rating Scale (NPRS) will be used to assess at the baseline and after the completion of treatment at 6 weeks.

The data will be analyzed by SPSS, version 25. Statistical significance is P=0.05.

Eligibility Criteria:
Inclusion Criteria:

* •Male athlete,

  * 20 -35 years of age,
  * Weight lifting from 1 -2 years,
  * Cervical Flexion-Rotation Test positive

Exclusion Criteria:

* • Cerebrovascular diseases,

  * Migraine,
  * Cervicogenic Headache,
  * Musculoskeletal, cervical spondylosis, cervical spondylolisthesis,
  * Cervical post-operative,
  * Traumatic events in the past three months,
  * Presence of a physical or mental illness
Plasma and Urine TMAO Formation and Changes to Oxidized LDL After Ingestion of Different Amounts of Egg

Eggs contain an essential nutrient called choline and adequate levels of choline are required for good health. Studies in mice have demonstrated that high levels of choline may increase risk of heart disease through a process that involves the breakdown of choline by gut bacteria. Previous research did not show that human consumption of eggs increases risk of heart disease. This study is designed to investigate whether the number of eggs in the diet affects blood and urine markers for heart disease.

Diets low in choline have adverse health consequences, while observations in humans and experiments in mouse models suggest that a diet containing too much choline or phosphatidylcholine may activate inflammatory pathways and increase cardiovascular disease risk through bacterial conversion of choline to trimethylamine (TMA) and its subsequent oxidation to trimethylamine N-oxide (TMAO) in the liver. What is unclear is whether choline and phosphatidylcholine in eggs is a source of TMAO formation, and if so how many eggs must be eaten before enough TMAO is generated to cause increased oxidized LDL (a biomarker for atherosclerosis mechanisms). We hypothesize that TMAO will only be formed from eggs when very large quantities are ingested and that TMAO formation will vary greatly between individuals for any given dietary exposure. This variability will be determined by 1) the dose at which dietary choline or phosphatidylcholine exceeds the absorptive capacity of the volunteer's small intestine and therefore spills into large intestine where gut bacteria have access to it and 2) the bacterial populations that constitute the volunteer's microbiome.

Eligibility Criteria:
Inclusion Criteria:

* Healthy
* non-smoker
* Body mass index between 20 to 39 kg/m²

Exclusion Criteria:

* History of chronic system disease/s (e.g., hepatic, renal, cardiovascular, intestinal)
* Diabetes controlled by insulin
* Alcohol or illegal drug misuse/abuse
* Use of antibiotics or choline-containing supplements within three months of study
* Allergies to soy, eggs, wheat or other food
* Use of drugs or medications known to alter liver metabolism, cardiovascular and/or kidney function
* Abnormal physical examination or abnormal clinical laboratory values
* Pregnancy
* Unusual dietary habits
REGENERA Implant in Excised Non-Malignant Breast Lesions

The purpose of this First-in-Human pilot study is to evaluate the safety and performance of REGENERA breast implant in a selected cohort of patients with non- malignant breast lesions treated with excision or lumpectomy in whom the tissue removed is replaced by REGENERA.

This is a pre-market, single center, interventional, open label, non-comparative, pilot first-in-human study on adult female patients with localized non-malignant breast lesion. This study will include an enrollment period of 12 months and 6 months study duration per patient.

The primary objective of this study is to demonstrate the safety profile of a new breast implant (REGENERA) in excision or lumpectomy of non-malignant breast lesions.

The secondary objectives of this study are:

* To assess the safety of the implant procedure
* To assess the feasibility of the implant procedure
* To evaluate the performance of REGENERA breast implant:

  * In replacing the removed tissue
  * In potential interference with current diagnostic standard of care imaging procedures
  * On patient's quality of life and satisfaction
  * On investigator's satisfaction.

Eligibility Criteria:
Inclusion Criteria:

1. Female patients aged 20-85 years
2. Patients eligible for excision or lumpectomy, as per current surgical guidelines
3. Volume deficit compatible with an implant volume of 70 cc
4. Adequate hematopoietic functions
5. Good general health and mentally sound
6. Confirmation of non-malignant lesion (B2 and B3) with no discordance between biopsy and radiological imaging
7. Patients able and willing to give written informed consent form

Exclusion Criteria:

1. Pregnant or breastfeeding women or women who have nursed a child three months within enrolment in the study
2. Non-malignant lesions (B2 and B3) with discordance between biopsy and radiological imaging
3. Infection of the surgical site confirmed pre-operatively by clinical examination
4. Acute or chronic severe renal insufficiency (creatinine values \< 180 μmol/L)
5. History of severe asthma or allergies (including to anaesthetics or contrast media)
6. Autoimmune disease
7. Subject with actual concomitant malignancies, lobular neoplasm, metastatic breast carcinoma, sarcoma, malignant phyllodes lesions, or Paget's disease
8. Subject who are known to be carriers of BCRA mutation
9. Inability to undergo MRI or allergy to contrast media
10. Systemic infections in active phase
11. Immunocompromised patients (HIV)
12. Subjects who have participated in another study within the past 3 months
13. Patients who received immunosuppressant therapy in the last 3 months
14. Non-collaborative patients (severe physical disabilities or psychiatric disorders, as per specialist opinion).
Effectiveness of Massage of the Thoracic Region in Neck Pain

Neck pain is a common disorder in industrialized countries. Manual therapy techniques have been commonly used in the treatment of this problem. Actually, there is no research work that has evaluated the work well of treatment with soft tissue techniques (massage) applied to the dorsal paravertebral muscle in the management of neck pain. The goal of this study (clinical trial) is to compare the efficacy of a massage protocol performed on the dorsal region in subjects with mechanical neck pain.

The researchers will compare:

A group that will be treated with a local protocol of cervical manual therapy and therapeutic exercise along with the treatment(massage) of the thoracic region.

Another group that will be treated only with a local protocol of cervical manual therapy and therapeutic exercise.

It is to see if the inclusion of treatment of the thoracic region improves the local intervention in cervical region.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with neck pain.
* Pain between 4 and 7 points according to a visual anological scale.
* Neck pain lasting more than three months

Exclusion Criteria:

* Subjects who have suffered a whiplash injury.
* Subjects with neck pain and upper extremity pain.
* Subjects with a diagnosis of herniated disc.
* Subjects with fibromyalgia.
* Subjects with any cancer process.
Powered Echelon Device in VATS Surgery

This study aims to collect real world outcomes of Video-Assisted Thoracoscopic Surgery (VATS) for lung cancer (lobectomy, wedge resection) using ECHELON FLEX™ Powered ENDOPATH® Staplers 45 mm and/or 60 mm (study devices).


Eligibility Criteria:
Inclusion Criteria:

* Suspected or confirmed NSCLC (up to and including Stage II)
* Scheduled for lung resection surgery (lobectomy or wedge resection) involving only one lobe of the lung
* Performance status 0-1 (Eastern Cooperative Oncology Group classification)
* ASA score \< 3
* No prior history of VATS or open lung surgery
* Willing to give consent and comply with study-related evaluation and treatment schedule

Exclusion Criteria:

* Active bacterial infection or fungal infection;
* Systemic administration (intravenous or oral) of steroids (within 30 days prior to study procedure)
* Chemotherapy or radiation therapy for lung cancer may not be performed for 30 days prior to the procedure
* Scheduled concurrent surgical procedure other than wedge resection or lobectomy (central venous access - e.g. port placement, mediastinoscopy with lymph node sampling, and VATS lymphadenectomy are allowed)
* Pregnancy
* Physical or psychological condition which would impair study participation;
* The patient is judged unsuitable for study participation by the Investigator for any other reason; or
* Unable or unwilling to attend follow-up visits and examinations
A Long Term Study of Lanthanum Carbonate in Patients Requiring Dialysis Who Have Ived Lanthanum Carbonate in Previous Studies Defined by the Protocol.

The purpose of this study is to assess the safety of lanthanum carbonate in patients undergoing dialysis who have received lanthanum carbonate in the previous studies and wish to continue treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients who participated in LAM-IV-301, LAM-IV-303, LAM-IV-307 OR LAM-IV-308 and received lanthanum carbonate
* Patients must continue to require treatment with a phosphate binder for hyperphosphatemia
* male or non-pregnant female who agrees to use an effective contraceptive method while on study treatment and for 30 days thereafter

Exclusion Criteria:

* Patients withdrawn from LAM-IV-301, LAM-IV-303 OR LAM-IV-307 prior to randomization
* Patients withdrawn from LAM-IV-301, LAM-IV-303, LAM-IV-307 OR LAM-IV-308 due to adverse events termed "possible" or "related" to study medication
* Pregnant or lactating women
Protective Effect of Tranexamic Acid on Shedding of the Endothelial Glycocalyx in Patients Undergoing Spinal Fusion Surgery

The aim of this study was to determine whether the administration of tranexamic acid in patients undergoing lumbar spinal fusion surgery can inhibit damage in endothelial glycocalyx layer. As a prospective double blinded randomized placebo-controlled trial, the investigators detect and compare the changes in concentrations of serum syndecan-1 and heparan sulfate before and after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with between 30 and 80 years scheduled for posterior lumbar spinal fusion surgery.

Exclusion Criteria:

* emergency surgery
* patients unable to make their own decisions, illiterate, foreigners
* Allergy / hypersensitivity to Tranexamic acid
* Current or past history or thrombosis / thromboembolism
* patients who are taking oral contraceptives
* Patients with renal insufficiency (eGFR 60 ml / min / 1.73 m 2 or less)
* Patients receiving anticoagulants
* pregnant and lactating women
Evaluation of an Individualised Written Education Package for Stroke Patients

The primary aim of the randomised controlled trial was to evaluate the effectiveness of a tailored written education package ("What you need to know about stroke") on the outcomes of:

* Knowledge about stroke, self-efficacy, anxiety, depression, perceived health status, satisfaction with the content and presentation of the information received, and desire for additional information for patients following stroke and
* Knowledge about stroke, self-efficacy, anxiety, depression, satisfaction with the content and presentation of the information received, and desire for additional information for their carers.

A secondary aim was to evaluate the effect of written information on the outcomes of knowledge about stroke, self-efficacy, anxiety, depression, and perceived health status of patients following stroke and on knowledge about stroke, self-efficacy, anxiety, and depression of their carers.


Eligibility Criteria:
Inclusion Criteria:

* Had a stroke or transient ischemic attack (TIA) or was the informal carer of a person who had a stroke or TIA;
* Had a reported English-proficiency level, corrected hearing and vision, and communication status adequate to participate in an interview and complete assessment tasks;
* Did not have reported or observable dementia;
* Lived within 50km of the hospital, for ease of follow-up; and
* Was medically stable.
The Turkish Version of the Self-perceived Barriers for Physical Activity Questionnaire

The Self-perceived Barriers for Physical Activity Questionnaire (SBPAQ) is originally developed in Spanish to evaluate self-perceived barriers for physical activity participation in healthy individuals. The purpose of this study is to translate and cross-culturally adapt the SBPAQ into Turkish and investigate its psychometric properties.

The Self-perceived Barriers for Physical Activity Questionnaire (SBPAQ) is originally developed in Spanish to evaluate self-perceived barriers for physical activity participation in healthy individuals. The purpose of this study is to translate and cross-culturally adapt the SBPAQ into Turkish and investigate its psychometric properties. Approximately two hundred healthy individuals aged between 18-65 years will be included. For cross-cultural adaptation, two bi-lingual translators will use the back-translation procedure. After the questionnaire will be translated into Turkish, the reliability, validity, and internal consistency of the Turkish version of SBPAQ (SBPAQ-T) will be tested. The questionnaire will be applied twice within 7 days to evaluate the test-retest reliability and to calculate the "Intraclass Correlation Coefficient" (ICC). Pearson correlation coefficient will be used to analyze construct and convergent/divergent validity. The construct validity of SBPAQ-T will be analyzed based on its correlation with the Physical Activity Barriers Questionnaire, International Physical Activity Questionnaire-Short Form, and Short Form-12. The Cronbach's Alpha will be calculated to determine internal consistency. The level of significance is considered as 0.05. The floor and ceiling effects will be detected.

Eligibility Criteria:
Inclusion Criteria:

* Being aged between 18-65 years
* Having the ability to read and write Turkish
* Having good cooperation to complete the assessment
* Being a volunteer to participate in the study

Exclusion Criteria:

* Having any musculoskeletal disease, cardiorespiratory system problem, or movement limitation in any joint that prevents participation in physical activity
* Having undergone surgery affecting the musculoskeletal system in the last 3 months
* Being pregnant
* Having a neurological or cognitive impairment
* Having any movement disorder
* Having the vision and/or hearing problems
Right Ventricle Dysfunction in Critically Ill Patients

To assess prevalence of right ventricle dysfunction in critically ill patient. To assess impact of RV dysfunction on short term (ICU stay, hospital stay, or mortality ≤30 days) and long term outcome (\>30 days).

To assess the accuracy of different parameters of RV dysfunction.

1. Inclusion criteria:

   - Adult patients who admitted to critical care of Internal medicine department after obtaining consent during the period between august 2023 and august 2024.
2. Exclusion criteria:

   1. Children below 18 yr.
   2. Patients who could not be scanned within 48h after ICU admission.
3. Sample Size Calculation:

   200 patients 2.4.4 Study tools (in detail, e.g., lab methods, instruments, steps, chemicals, ):

   Beside history and clinical examination , The following data will be obtained:

   Demographic and historical data: the patient age, sex, history of hypertension, chronic obstructive pulmonary disease, IHD, cause of critical care unit admission and indication of mechanical ventilation( PEEP).

   Clinical examination data: pulse, blood pressure, respiratory rate, temperature , BMI, and thorough chest, cardiac examination data will be obtained.

   Volume state of the patient: CVP measurement, input and output fluid chart. APACHE IV score, Use of vasopressors, Use of sedatives. Investigation : Arterial blood gas analysis, pulse oxygen saturation, CBC, and renal function test and electrolytes, serum lactate and troponin.

   12 lead ECG for RV strain patterns.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients who admitted to critical care of Internal medicine department after obtaining consent during the period between august 2023 and august 2024.

Exclusion Criteria:

1. Children below 18 yr.
2. Patients who could not be scanned within 48h after ICU admission.
Aortic Stenosis With COmplex PCI (ASCOP) Features Retrospective Registry on Contemporary Management and Outcomes

To describe the prevalence and clinical features of patients with severe aortic stenosis undergoing TAVI and concomitant clinically indicated, complex and/or high-risk PCI

The aims of this study are:

* to describe the prevalence and clinical features of patients with severe aortic stenosis undergoing TAVI and concomitant clinically indicated, complex and/or high-risk PCI
* to depict the different possible strategies that are currently employed in this context and to retrospectively analyze outcomes
* to investigate predictors of better outcomes

Eligibility Criteria:
1. Severe, symptomatic aortic stenosis with an indication to TAVI
2. Concomitant, stable CAD with an indication to complex PCI, as anticipated by angiography, defined as follows (one or more features)

   1. Left-main (LM) CAD or proximal left anterior descending (LAD) / left circumflex (LCx) lesions requiring LM-PCI
   2. Three-vessel disease
   3. Last remaining vessel
   4. Bifurcation PCI (proximal bifurcation)
   5. Severely calcified lesions requiring calcium plaque modification (rotational/orbital atherectomy, intravascular lithotripsy, scoring or cutting balloon)
   6. Lesion length \> 30 mm
   7. Severely depressed Left ventricular function requiring mechanical circulatory support (intra-aortic balloon pump - IABP, Impella, Extracorporeal Membrane Oxygenation - ECMO
How Can we Treat Photophobia in Migraine

Photophobia, the aberrantly increased sensitivity to light, is a common symptom in migraine patients and light discomfort is frequently found as a trigger for migraine attacks. In behavioral studies, planned exposure to light was found to reduce headache in migraineurs with photophobia, potentially by increasing habituation to this migraine trigger. Here, neurophysiological mechanisms of light exposure versus light deprivation therapy in migraine patients are investigated using functional magnetic resonance imaging (fMRI).

Migraine patients and healthy controls receive light exposure therapy (Flash) and light deprivation therapy (Dark) for one hour daily on 7 consecutive days, in a crossover design with a wash-out period of three months. Study participants keep a diary including items on interictal and ictal photophobia, headache frequency and severity 7 days before, during, and 7 days after the interventions. One week before and one day after both interventions, fMRI using flickering light in a block design is applied. Functional activation is analyzed at whole-brain level and habituation of the visual cortex (V1) is modeled with the initial amplitude estimate and the corrected habituation slope.


Eligibility Criteria:
Inclusion Criteria:

Patients:

* Migraine without aura according to the criteria of the International Classification of Headache Disorders (ICHD-3 beta)
* 1-4 days with migraine per month in the preceding last 3 months
* A score between 2 and 6 on a numeric rating scale for the intensity of interictal photophobia (range from 0 to 10 (= max. intensity))
* A score \>4 for ictal photophobia

Controls

* No personal or family history of migraine
* A score \<2 for photophobia

Exclusion Criteria:

* Current or previous circadian rhythm disorders
* Current or previous major depression
* Current or previous anxiety disorders
* Current or previous medication overuse
* Besides migraine in the patient group, participants should not suffer from any other recurrent headache apart from infrequent tension-type headaches