cyrilzakka/clinical-trials huggingface dataset:
Laparoscopic Versus Open Gastrectomy With Splenic Hilum Lymph Nodes Dissection

Splenic hilum remains challenging during total gastrectomy with D2 lymphadenectomy.The application of minimally invasive surgery for advanced gastric cancer is gaining popularity. The investigators aim to compare the safety and feasibility of LTG and OTG for advanced proximal gastric cancer.

Total gastrectomy with D2 lymphadenectomy remains the standard surgical therapy for patients with advanced proximal gastric cancer. Although lymph nodes dissection along with the splenic hilum (No.10) is recommended by the Japanese Gastric Cancer Treatment Guidelines, however, complete removal of the No. 10 is technically challenging due to the tortuous splenic vessels and the high possibility of injury to the parenchyma of the spleen and pancreas. Recently, the application of minimally invasive surgery for advanced gastric cancer is gaining popularity. However, laparoscopic total gastrectomy (LTG) with standard D2 lymphadenectomy was still not widely performed, because pancreas- and spleen-preserving splenic hilum lymph node dissection were mainly challenging manipulations for laparoscopic surgeons. Therefore,the investigators aim to investigate the safety and feasibility of LTG with spleen-preserving splenic hilum lymph node dissection for proximal advanced gastric cancer and compare the early results of this procedure with open total gastrectomy (OTG).

Eligibility Criteria:
Inclusion Criteria:

1. Primary proximal gastric adenocarcinoma confirmed pathologically by endoscopic biopsy;
2. cT2-4aN0-3M0 at preoperative evaluation according to American Joint Committee On Cancer (AJCC) Cancer Staging Manual, 7th Edition.
3. Eastern Cooperative Oncology Group (ECOG): 0 or 1;
4. American Society of Anesthesiologists （ASA） score: Ⅰto Ⅲ;
5. Written informed consent.

Exclusion Criteria:

1. Pregnant or breast-feeding women;
2. Severe mental disorder;
3. Previous upper abdominal surgery (except laparoscopic cholecystectomy);
4. Previous gastrectomy, endoscopic mucosal resection, or endoscopic submucosal dissection;
5. Enlarged or bulky regional lymph node diameter larger than 3 cm based on preoperative imaging;
6. Other malignant disease within the past 5 years;
7. Previous neoadjuvant chemotherapy or radiotherapy;
8. Contraindication to general anesthesia (severe cardiac and/or pulmonary disease);
9. Emergency surgery due to a complication (bleeding, obstruction, or perforation) caused by gastric cancer.
Effect of Acupuncture and Diet Modification on amenorrheaIN FEMALE ATHLETE TRIAD

The present study will be designed to investigate the effect of acupuncture and diet modification using soy products on amenorrhea in female athlete triad.

For this purpose this study will be carried out on sixty female athletes participating gymnastics. They will be recruited from Sports Medicine specialized center in Nasr City, their ages will range from 17 to 25 years old and their BMI will be \< 20 Kg/m2 .

The subjects will be divided into three groups equal in number, matched for measured variable:

Group (A): Acupuncture only will be used in this group for 30 minutes, three times per week for twelve weeks. The acupuncture needles were inserted in points located on the abdomen.

Group (B): This group will receive only the diet modification contains soy products (phytoestrogen) as 100 milliliter soy milk and 100 grams soy beans daily in the morning as a breakfast alone to ensure its absorption, this dose had been taken for 12 weeks.

Group (C): This group will receive both acupuncture therapy for 30 minutes, three times per week for 12 weeks and diet modification contains soy products as 100 milliliter soy milk and 100 grams soy beans daily in the morning for 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* All patients suffering from athletic amenorrhea.
* Their age will be ranged from 17-25 years old.
* Their body mass index will be less than 18.5 kg/m2.
* No history of previous pregnancies.
* No history of any pathological disease causing amenorrhea.
* They are medically stable and consented to participate in the study.

Exclusion Criteria:

* Patients with gynecological diseases that may cause amenorrhea.
* Patients using contraceptive pills.
* Patients using hormonal treatment.
* Patients using induction of ovulation methods.
* Patients following any other diet modification method.
* Patients who receive any drug with side effect of amenorrhea.
Virtual Reality in Stroke Rehabilitation

The purpose of this research study is to investigate the effects of Virtual Reality (VR) as a treatment intervention to increase physical and cognitive function in stroke survivors.

In this pilot study, the objective is to determine if there is an increase in MoCA (Montreal Cognitive Assessment), MFRT (Modified Functional Reach Test), and FMA-UA (Fugl-Meyer Assessment Upper Extremity) scores of participants who receive the VR intervention in addition to traditional inpatient rehabilitation standard of care (experimental group) versus participants who receive the traditional standard of care (control group).

Eligibility Criteria:
Inclusion Criteria:

* Patients Age 18 and older admitted to inpatient rehabilitation with a projected LOS (length of stay) of 10 days or more within the open data collection period for treatment of ischemic stroke and agree to participate in the study in addition to traditional intensive rehabilitation therapy.

Exclusion Criteria:

* Individual patients who exhibit the following symptoms or medical history or are not medically cleared for participation will be excluded:
* History of, or high risk for, seizures
* Feed tube, tracheotomy, or other medical devices that would preclude the use or wear of the VR headset as it covers the face and head
* Blindness
* History of mental health issues such as schizophrenia, manic episodes, active psychosis, or other mental health issues that may be exacerbated by exposure to VR
* Open wounds that would preclude use for the VR headset
Biobased Polyester Versus Synthetic Fiberglass Casts for Treating Stable Upper Limb Fractures in Children

From Feb 2022 to Nov 2022, we undertook a single-center prospective randomized trial involving 100 children with cast-immobilized stable upper limb fractures. These patients were randomized into either biobased polyester or synthetic fiberglass groups. All patients were regularly followed up till the cast removal which occurred approximately 3-4 weeks after immobilizing. Objective clinical findings and subjective patient questionnaire were all collected and analyzed.

The clinical trial was approved by the research ethics review committee of the author's hospital and informed consent was obtained from the legal guardian of each patient. Between Feb 2022 and Nov 2022, all children (age range, 4-15 years) with radiography-diagnosed stable upper limb fractures (including radius, ulna, and distal humerus fractures such as Garland type I supracondylar fractures of the humerus) \[9\] diagnosed at the orthopedic outpatient clinic or emergency room of a tertiary trauma center hospital were eligible for recruitment.

Eligibility Criteria:
Inclusion Criteria:

* stable upper limb fractures (including radius, ulna, and distal humerus fractures such as Garland type I supracondylar fractures of the humerus) diagnosed at the orthopedic outpatient clinic or emergency room of a tertiary trauma center hospital

Exclusion Criteria:

* displaced or unstable fractures indicated for close or open reduction and fixation
* previous surgeries to the affected upper limb
* history of any chronic skin pathology (e.g., atopic dermatitis)
* known allergy to cast materials
BIO|CONCEPT.Renamic Neo Study

The BIO\|CONCEPT.Renamic.Neo study is designed as a pre-market study to provide clinical data and supporting evidence of the safety, performance and usability of the Renamic Neo programmer system.


Eligibility Criteria:
Inclusion Criteria:

* Patient is planned for de novo implantation or already has a BIOTRONIK active, implantable device.
* Patient is able to understand the nature of the study and provides written informed consent.

Exclusion Criteria:

* Patient is implanted with a Stratos pacemaker.
* Patient is planned for implant exchange or upgrade.
* Patient is pregnant or breast feeding.
* Patient is less than 18 years old.
Extended IASD Investigation: REDUCE LAP-HF IV

Multicenter, Prospective, Open Label, Single Arm, Clinical Trial.

The primary objective of this clinical trial is to further evaluate the safety and clinical efficacy of the IASD System II in symptomatic heart failure patients with an left ventricular ejection fraction (LVEF) ≥ 40%, and elevated left sided filling pressures despite standard Guideline Directed Medical Therapy (GDMT); and to compare the safety and efficacy results to those from the treatment arm of the REDUCE LAP-HF Randomized Trial II (Corvia protocol 1601).

Participants are screened against non-invasive eligibility criteria and scheduled for a hemodynamic evaluation. Following right heart catheterization at rest and during supine bicycle exercise, patients will undergo a brief intracardiac echocardiography (ICE) or transesophageal echocardiography (TEE) exam for septal suitability.

Eligible patients continue with, fluoroscopically and echo guided transseptal puncture and IASD System II implant procedure. If a previously unknown protocol exclusion is discovered during the index procedure, and device is not implanted, participant is followed for 30 days, and then exits the study.

Participants return for follow-up exams 30 days after the implant procedure and annually for 5 years after the implant procedure. In-person visits will take place for the first 2 years. Telephone follow-up and medical chart review will be conducted for years 3-5.

Eligibility Criteria:
Select Inclusion Criteria:

* Chronic symptomatic heart failure with preserved or mid-range left ventricular ejection fraction (HFpEF or HFrEF)
* Participant is willing to comply with clinical investigation procedures and agrees to return for all required follow-up visits, tests, and exams

Select Exclusion Criteria:

* Myocardial infarction and/or percutaneous cardiac intervention within past 3 months; Coronary artery bypass surgery in past 3 months, or current indication for coronary revascularization; AVR (surgical AVR or TAVR) within the past 12 months
* Advanced heart failure
* History of stroke, transient ischemic attack (TIA), deep vein thrombosis (DVT), or pulmonary emboli within the past 6 months
* Significant heart valve disease
* Chronic pulmonary disease
* Women of childbearing potential
* Severe obstructive sleep apnea not treated with CPAP or other measures
Effect of Tai Chi on Functional Fitness of Elderly Patients With Degenerative Arthritis

Degenerative arthritis is a common disease in the elderly , in recent years, there are young trends, the symptoms often cause great pain in the elderly, associated with lower physical exercise caused by decreased muscle mass, functional fitness performance Is also poor, affecting the ability of elderly people to live independently. Therefore, this study mainly explores whether the intervention of tai chi can improve the functional fitness of the elderly and reduce the pain index of the elderly. The study was designed to take the sample, which was divided into experimental group and control group. It was expected to receive 100 people. The subjects were asked to use the basic information, Karnofsky scale, The functional fitness test, the exercise conscious scale and the WOMAC pain scale were used as the research tools. The SPSS system was used to analyze whether the functional fitness index and the pain index were significantly different before and after exercise intervention. Whether the exercise intervention has an effect on the elderly.

Degenerative arthritis is a common disease in the elderly , in recent years, there are young trends, the symptoms often cause great pain in the elderly, associated with lower physical exercise caused by decreased muscle mass, functional fitness performance Is also poor, affecting the ability of elderly people to live independently. Therefore, this study mainly explores whether the intervention of tai chi can improve the functional fitness of the elderly and reduce the pain index of the elderly. The study was designed to take the sample, which was divided into experimental group and control group. It was expected to receive 100 people. The subjects were asked to use the basic information, Karnofsky scale, The functional fitness test, the exercise conscious scale and the WOMAC pain scale were used as the research tools. The SPSS system was used to analyze whether the functional fitness index and the pain index were significantly different before and after exercise intervention. Whether the exercise intervention has an effect on the elderly.

Eligibility Criteria:
Inclusion Criteria:

1. Elderly persons aged 65 or above who actively participate in community activities
2. awareness MMSE score ≧ 25 and can use the Chinese, Taiwanese fluent communication
3. can stand for more than 60 minutes and the Kirsley scale for the second to zero level.

Exclusion Criteria:

1. medical advice for those who can not exercise
2. suffering from significant cardiovascular and heart disease
3. suffering from high blood pressure, asthma, diabetes
4. those suffering from skeletal muscle disease
Effects of Cognitive Intervention on Cognition, Mobility and Brain Electrocortical Activity

Within this project the investigators tested the effectiveness of 2-month of computerized cognitive training (CCT) on CogniFit online platform on 77 older adults, which were randomly divided into intervention and control group. The investigators tested close (battery of cognitive functions) and far transfer (postural and mobility control, EEG, blood samples) of the CCT. Additionally, the investigators were interested into seeing a long-lasting effect, therefore participants were brought back to the laboratory 1 year post CCT.


Eligibility Criteria:
Inclusion Criteria:

* active and healthy older adults with no major health issues
* members of the Center for Daily Activity Koper (Slovenia)
* had normal or corrected-to-normal vision;
* reported no history of cardiovascular, neurological, or psychiatric conditions

Exclusion Criteria:

* younger than 60
* smoking; regular alcohol consumption;
* acute or chronic skeletal, neuromuscular, metabolic and cardiovascular disease condition;
Effect of Ranolazine on Myocardial Perfusion Assessed by Serial Quantitative Exercise SPECT Imaging

This study enrolled participants with documented exercise-induced myocardial ischemia in order to evaluate whether ranolazine, when taken prior to exercise, can improve blood flow to the heart (myocardial perfusion), as assessed by exercise-induced myocardial perfusion defect size (PDS) and total perfusion deficit (TPD), using gated single photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI).

This was a 2-period crossover study. The last dose of each period must have been taken 3-4 hours prior to conduct of the exercise SPECT MPI. After the research exercise SPECT MPI was performed at the end of Period 1, participants discontinued the treatment they were randomized to for that period and began the other treatment in Period 2.


Eligibility Criteria:
Key Inclusion Criteria:

* Exercise SPECT MPI study (stress and rest) showing at least 10% reversible myocardial ischemia (as confirmed by the core nuclear laboratory using Corridor4DM imaging software) performed not more than 12 weeks prior to screening, OR
* Exercise SPECT MPI study (stress and rest) conducted during screening (after consultation with the Medical Monitor and after informed consent was obtained) showing at least 10% reversible myocardial ischemia (as confirmed by the core nuclear laboratory)
* Stable antianginal medical therapy (excluding short-acting nitroglycerin)

Key Exclusion Criteria:

* Left bundle branch block
* Automated implantable defibrillator and/or pacemaker (selected subjects with permanent pacemakers who had an intact sinus mechanism may have been included following consultation with the Medical Monitor)
* Intervening coronary revascularization between the time of qualifying exercise SPECT MPI study and randomization
* Acute myocardial infarction (MI) within 60 days prior to screening or at any time after the qualifying exercise SPECT MPI study, or MI undergoing staged intervention during a subject's participation in the trial
* Unstable angina within 30 days prior to screening, or at any time after the qualifying exercise SPECT MPI study
* Coronary artery bypass graft surgery within 60 days prior to screening or at any time after the qualifying exercise SPECT MPI study, or percutaneous coronary intervention within 30 days prior to screening or at any time after the qualifying exercise SPECT MPI study
* Anticipated coronary revascularization during the trial period
* Cerebrovascular attack or transient ischemic attack within 90 days prior to screening
* History of serious arrhythmias
* Current atrial fibrillation or atrial flutter
* QTc interval \> 500 milliseconds
* Diagnosed as having New York Heart Association Class III or IV heart failure
* Inability to exercise or exercise limitation due to other comorbidities that may have interfered with ability to perform required exercise SPECT MPI study
* Body mass index greater than or equal to 38 kg/m\^2 (may have been up to 40 kg/m\^2 after consultation with the Medical Monitor)
* Any absolute contraindications to exercise stress testing
Preoperative Oral Carbohydrate Treatment Minimizes Insulin Resistance

Insulin resistance is a positive protective reaction against surgery .this resistance has some negative consequences for patient health. It is associated with infectious complications. At the same time, Postoperative insulin resistance has been shown to correlate with the length of postoperative stay in hospital. Recently several clinical studies have shown that a carbohydrate-rich drink given 2 h before surgery diminishes postoperative insulin resistance in patient. The aim of our study is to investigate the influence on insulin resistance in patient with diabetes.

Insulin resistance is a positive protective reaction against surgery . As a response to surgery, activation of neuroendocrine and inflammation systems occurs as a protective reaction. However, this resistance has some negative consequences for patient health. It is associated with infectious complications. At the same time, Postoperative insulin resistance has been shown to correlate with the length of postoperative stay in hospital. Recently several clinical studies have shown that a carbohydrate-rich drink given 2 h before surgery diminishes postoperative insulin resistance in patient. The aim of our study is to investigate the influence on insulin resistance in patient with diabetes.

Eligibility Criteria:
Inclusion Criteria:

* patients underwent elective open colorectal resection for colorectal carcinoma and electric orthopedic surgery

Exclusion Criteria:

* Weight loss greater than 10 per cent during the previous 6 months
* Renal insufficiency (creatinine, \> 3 mg/dl; hemodialysis)
* Hepatic insufficiency (Child-Pugh class, ≥ B)
* Gastro-oesophageal reflux disease
* Gastrointestinal obstruction or conditions (including pharmacological treatment) known to affect gastric emptying rate
ORganoid GeneratioN Study for Cancer

ORIGINS - a multi-site sample collection study to establish patient-derived pre-clinical models for cancers

People who develop cancer can often be cured if they are suitable for surgery or radiotherapy. However, a proportion of these cancers return, at which point the available treatment options are often not very effective. Our understanding of the biology of many cancers is limited, and we don't understand why some cancers are cured by surgery or radiotherapy and some are not. A better understanding of the biology of cancers could help develop new treatments, or improvements to current treatments, and this might increase the number of patients who can be cured of their disease.

One way to improve the understanding we have of the biology is to look in detail at cancer samples taken from the from patients. The problem with this is that often samples are small, and the tumour tissue sample itself already dead once removed from where it was growing, which can limit the analyses that are possible. A potential solution for this is to take cancer tissue from patients and try to directly grow the cells in the laboratory. Keeping the cancer cells alive in the laboratory can be difficult but has been shown to be possible in a number of different types of cancer. This kind of model is sometimes known as an "organoid". If successfully established, it means more tests can be done to find out how the cancer is working.

This study is looking at collecting samples of a person's cancer to see if we can develop these models from patients being treated for different cancers. We will ask people who are having surgery for cancer whether we can take samples from their tumour to try and achieve this. Some additional blood tests will be taken alongside the usual blood tests before and after surgery, without an additional blood draw, and before and again after any adjuvant therapy is completed. A collection of saliva will also be requested at these times and we will ask people whether they are happy for us to collect any previous tissue samples, or nay that are subsequently collected when they are being followed up, to allow comparison with the samples collected as part of this study.

The main goal of this study is to see if organoids can be established in our laboratories. If these models are successfully established, we will compare them to the original tumour to check they are a good match biologically. After this we can use them to understand how the cancer works and try out new treatments.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Patients with histologically proven or suspected cancer undergoing an interventional procedure, such as surgery or biopsy
* Ability to give informed consent for biological sample collection

Exclusion Criteria:

* Unable to undergo sample collection
* Pregnancy
Mass Vaccine and Drug Administration, Bangladesh

This is an open i.e. not blinded, cluster-randomised, controlled intervention study. The study will use a factorial design to estimate the protective effectiveness of mass drug administrations, mass vaccinations, combined mass vaccinations and drug administrations versus the current standard of care.

Trial Activities: The investigators are most interested in the combined effect of mass administration of vaccines and drugs on malaria transmission. Can MVDA reduce the parasite prevalence in intervention villages compared to control villages which did not receive the intervention? The entire village population will be enrolled at study start and followed for two years after D0, the first day of the interventions in the intervention villages. The village population is a dynamic cohort with new members entering the cohort by birth or immigration and other members leaving the cohort due to emigration or death. Newcomers entering villages will receive MVDA as soon as feasible and as appropriate (dependent on age). Secondly, the investigators want to know how effective the individual components of the intervention, mass vaccinations and mass drug administrations are in relation to MVDA?

Eligibility Criteria:
Inclusion Criteria:

* Current residence in a study village irrespective of permanence
* Age 6 months and above (no upper age limit)
* Written informed consent provided by participants (or a parent/guardian in case the participant is under 18 years old)

Exclusion Criteria:

* Pregnancy, plan to get pregnant, or breastfeeding.
* Acute illness requiring intervention
* A history of an adverse reaction to study drugs/vaccine and prior receipt of any other malaria vaccine or enrolment in another intervention trial.