cyrilzakka/clinical-trials huggingface dataset:
Transanal Versus Laparoscopic Total Mesorectal Excision: a Cohort

The purpose of this study was to compare the long-term oncology outcomes and specimen quality of taTME and laTME in the treatment of middle and low rectal cancer by a large sample cohort. At the same time, the local recurrence following a primary rectal cancer resection was analyzed to respond to the concerns about the event of the national suspension for TaTME due to the high local recurrence rate in Norway.

Laparoscopic surgery is considered to have better visualization for more accurate separation and further injury reduction than open surgery. However, the oncology outcomes are still controversial. Especially in the challenging patients who have narrow and deep pelvic, the disadvantage that it is difficult to obtain high-quality resected specimens during laparoscopic TME (laTME) surgery is considered to be magnified. It is considered transanal total mesorectal excision (taTME) is an alternative method to solve this "old problem". However, as a new technology that has been around for only 10 years, the applicability of taTME worldwide needs to be further proved in long-term oncology. This prospective cohort study aimed to compare taTME surgery to laTME surgery for mid and low-rectal cancer on long-term oncology outcomes from a single, experienced Chinese center that was an early adopter of taTME.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 and 80 years old
2. Confirmed rectal adenocarcinoma cancer pathologically
3. Tumor location ≦ 12 cm from the anal margin
4. Willing and able to provide written informed consent for participation in this study

Exclusion Criteria:

1. Distant metastasis before surgery
2. More than one colorectal tumor at diagnosis
3. Familial adenomatous polyposis
4. Recurrent rectal cancer
5. Undergo transanal minimally invasive surgery
6. Undergo palliative treatment
7. Undergo emergency surgery
Do Patients Who Received Tranexamic Acid in Vaginal Hysterectomy Loose Les Blood, Comparing to Patients Who Did Not?

This is a randomized control, double-blind study in which women who are about to go an elective vaginal hysterectomy are offered to participate.

Patients will be randomly assigned to one of two groups: the tranexamic acid group, in which 1 gram of tranexamic acid (Hexakapron) is administered intravenously before surgery, and the control group, in which patients will receive 10 ml of normal saline 0.9% intravenously.

This is a randomized control, double-blind study in which women who are about to go for an elective vaginal hysterectomy are offered to participate.

Patients will be randomly assigned to one of two groups: the tranexamic acid group, in which 1 gram of tranexamic acid (Hexakapron) is administered intravenously before surgery, and the control group, in which patients will receive 10 ml of normal saline 0.9% intravenously.

A nurse will prepare the solution according to the randomization and will handle it to the anesthesiologist.

Eligibility Criteria:
Inclusion Criteria:

\*Women in general good health (defined as American Society of Anesthesiologists grade 1-2) who are about to undergo elective vaginal hysterectomy indicated by pelvic organ prolapse (POP).

Exclusion Criteria:

* allergy to TXA
* familial or personal history of hypercoagulability disorder or thromboembolic events
* impaired renal function or hematuria
* patients receiving antithrombotic therapy
* additional concurrent abdominal/ laparoscopic procedures
* malignancy
* Post-assignment exclusion will be executed in cases of conversion to laparotomy/ laparoscopy.
Study Comparing Urinary Diversion (Transurethral/Suprapubic) After Radical Prostatectomy

The study aims to show the technical feasibility of the suprapubic urinary diversion after endoscopic extraperitoneal radical prostatectomy (EERPE) and has a greater comfort for the patients with at least the same catheter complication rate in comparison to the urethral urinary diversion.

Patients are randomized 1:1 in the different arms Recording of QoL measured by visual analogue ( pain )scale,EORTC QlQ -C 30 and QLQ - PR 25 questionnaires, incontinence rate, complication rate regarding insufficiency and strictures of vesicourethral anastomoses and urinary tract infection; demand of re-catheterization due to urinary retention and demand of antispasmodics

Eligibility Criteria:
Inclusion Criteria:

* Adenocarcinoma of the prostate,
* Subjects treated by conventional or robotic assisted laparoscopic prostatectomy
* Be willing/able to adhere to follow up visits

Exclusion Criteria:

* Subjects treated by retropubic or perineal prostatectomy Subjects with known bladder cancer
* Contraindications for anticholinergic drugs
* Waist measurement \> 100 cm
* No written informed consent
* Age \< 18 years
* Subjects with known narrow-angle glaucoma
New Indices for Prediction of Human Fatigue During Training Based on Non-invasive Methods

Sometimes, during strenuous aerobic activity, activity ceases only when the discomfort that follows lack of oxygen would be intolerable. Reaching this fatigue condition can cause organ damage, muscular damage and / or in different tissues of the body. In this study, investigators aim at developing new indexes, based on hemodynamics measurements from the peripheral micro - circulation system, for the benefit of early detection of fatigue during accelerated physical activity.

14 healthy volunteers, 7 males and 7 females, aged 18-30 will participate in this study.The study includes 2 stages: In the first stage, aerobic capacity of the subjects will be measured by measuring maximum oxygen consumption (VO2max test). This phase will be conducted to determine physical measurements that could indicate different stages in muscle fatigue (anaerobic threshold, maximum oxygen consumption, heart rate and breathing indices).

In the second phase, the subjects will perform the same physical effort protocol that carried out at the first stage. Non- invasive measurements of leg muscles activity during aerobic exercise and at rest (before and after activity), will be carried out using a wireless EMG. Additionally, hemodynamic measurements of oxygen levels in the skin and skin perfusion monitoring before and after strenuous activity will be performed using two optic sensors.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18-30 years.
* Healthy civilian volunteers.
* Without known medical illness or medication use that might endanger the participants.

Exclusion Criteria:

* The existence or suspicion of existing cardiac or respiratory disease.
* Any metabolic disorder.
* Any muscles or skeleton condition.
* Any neurological condition.
* the physician decision.
Android Artificial Pancreas System (Android APS) Versus Control-IQ

The aim of the investigator's study is to compare two different closed loop hybrid systems - certified Control-IQ and noncertified AndroidAPS in adult patients with Type 1 Diabetes (T1D), who had been using AndroidAPS previously from their own decision, during 12 weeks of follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes diagnosed \>2 years
* ≥ 18 years old
* written informed consent prior to starting study related activity
* previous user of AndroidAPS at least for 3 months

Exclusion Criteria:

* severe noncompliance
* lactation, pregnancy, intending to become pregnant during study
* use of medication with effects on carbohydrate metabolism
The INSPiRe Programme: Developing an Intensive Suicide Prevention Therapy for Suicidal Prisoners

This study aims to assess the acceptability and feasibility of a short-term, intensive Cognitive Behavioural Therapy (CBT) delivered to male prisoners who have thoughts of ending their lives.

10 hours of an adapted CBT therapy for suicide will be delivered across 2 weeks in 5 2 hour sessions to male prisoners. They will initially be assessed on several measures of mood, social support and suicidality. They will then undergo therapy. Following this they will be asked to re-completed the initial measures and a post-therapy interview to ascertain their thoughts on their experience of the therapy.

Eligibility Criteria:
Inclusion Criteria:

* Aged over 21 years old.
* Has been managed under the Assessment, Care in Custody, and Teamwork (ACCT) system within the last 1 month (including current ACCT review).
* Sufficient English language proficiency, as judged by the researcher, in order to complete psychometric questionnaires (i.e. adequate reading comprehension) and engage in intensive CBT programme (i.e. adequate verbal communication).
* Adult is able to provide informed consent as established during baseline clinical interview (BPS, 2006; MCA, 2005).
* Currently residing in HM Prison (and expected to remain there for at least six weeks; determined through staff and prisoner report).

Exclusion Criteria:

* A primary organic disorder (indicated by prison medical staff report or records).
* Any current risk behaviour which would compromise the safety of others, as identified by prison staff.
Articulatory Adaptation Following Oral Cancer Treatment

The goal of this longitudinal study is to learn more about the articulatory consequences of surgical oral cancer treatment. The main aims are to study the coordination and development of speech articulation of patients who will undergo surgical treatment for oral cancer longitudinally and whether individual differences in the reliance on auditory or tactile information can predict the success of speech compensatory strategies.

Participants will perform multiple speech tasks while motion tracking sensors track the articulatory gestures.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with T1 or T2 tumor in the oral cavity
2. At least 18 years old and able to provide informed consent
3. Native speaker of Dutch
4. Has nog been treated for oral cancer before

Exclusion Criteria:

1a. Recurrence of disease (for patients)

1b. Treated for oral cancer (for healthy controls) 2. Speech problems (e.g., stuttering) 3. Problems with sight or hearing that impede reading or understanding instructions. When glasses or a hearing aid resolve these problems, then participants are not excluded.

4. Neurological or psychological disorders (e.g., stroke) 5. Non-removable metal in, on or around the head (piercings, braces, pacemaker, electrodes) 6. Self-reported signs of depression
Can Conventional ECG Technology Capture Fetal Cardiac Activity?

This is a feasibility study for a new application for capturing fetal cardiac activity. The objective of this study is to determine if it is feasible to capture a fetal ECG signal using a Holter ECG device. As comparison we will use a standard Doppler Fetal Heart Rate (FHR) device.

The objective of this study is to determine if it is feasible to capture a fetal ECG signal using a Holter ECG device. As comparison we will use a standard Doppler Fetal Heart Rate (FHR) device. To obtain the raw FHR data from this standard device we will use the currently approved "fetal EEG" monitor. The important distinction is that "fetal EEG" monitor will not be connected to fetal scalp electrode, but, rather, get the data from the regular, more routinely used and non-invasive Doppler FHR monitor. We expect that we will be able to validate our algorithm with our maternal and fetal ECG channels to derive the FHR.

We will attach a Holter ECG device (4 electrodes) and a standard Doppler FHR device to a pregnant woman who is between 32 weeks gestation and full term. ECG leads will be placed in four corners of the abdomen. The targeted length of the recording will be 30 minutes. The subject will remain supine and resting while the device is recording. Additionally, the recently approved fetal EEG monitor will be connected to the Doppler FHR device to allow us to obtain a "digital copy" of the standard FHR recording. We will do that in order to have the comparison during the offline processing of the abdominal ECG with regard to the location of the fetal R peaks. This procedure will be done after the subject's routine antepartum testing. No women in active labor will be recruited.

Eligibility Criteria:
Inclusion Criteria:

* Singleton or twin pregnant women at 32 weeks gestation to full term after routine antepartum testing.

Exclusion Criteria:

* None.
Oral Ibrexafungerp (SCY-078) vs Standard-of-Care Following IV Echinocandin in the Treatment of Invasive Candidiasis

The purpose of this study is to compare the safety, pharmacokinetics, and efficacy of oral SCY-078 vs. standard-of-care following initial intravenous echinocandin therapy in the treatment of invasive candidiasis.

Patients will receive initial intravenous (IV) echinocandin therapy. Patients who are eligible for randomization will receive SCY-078 500-mg orally, SCY-078 750-mg orally, or standard-of-care.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of invasive candidiasis defined as a positive culture of blood or from another normally sterile site for Candida.
* Not of reproductive potential or if of reproductive potential, agrees to remain abstinent or use 2 methods of contraception.

Exclusion Criteria:

* Patient with Candida endocarditis, osteomyelitis, meningitis, or chronic disseminated candidiasis or evidence of endophthalmitis.
* Patient has failed treatment with an echinocandin for this episode of invasive candidiasis.
* Infection limited to the oropharynx, esophagus, urogenital system, or skin, or sputum/bronchoalveolar lavage culture.
* Participation in a clinical study with other investigational drug(s) within 30 days prior to study entry or during this study.
Penn State TXT2STAYQUIT Study- a Texting Study to Help Hospitalized Smokers Stay Quit

This study aims to pilot a method of collecting the post-discharge follow-up data required by the Joint Commission Tobacco Measure Set, using text messages sent to and received from patients' cellular-telephones. It also aims to assess whether specially designed relapse prevention text messages designed to encourage abstinence from smoking, can increase the proportion of smokers who remain abstinent during the first month after discharge from hospital.

Participants will be those who are hospitalized at Hershey Medical Center and are interested in help to stay quit when they leave the hospital.

Eligibility Criteria:
Inclusion Criteria:

* Total length of hospital stay at least 24 hours
* Free of cognitive impairment
* Read and speak English
* Smoked at least 20 cigarettes in 30 days prior to entering the hospital
* Willing to give up all forms of tobacco
* Has a cell phone capable of receiving text messages (cell phone is powered on and charged)

Exclusion Criteria:

* Patient has been admitted for a transplant
* Patient has Intensive Care status
Redo Repair in Disrupted Hypospadias

Redo hypospadias repair is a challenging situation and its success depends on many factors. Several procedures could be used in such situations with variable outcomes. The investigator in this study aimed at comparing the results of these procedures

Purpose: Our study compared the outcome of the tubularized incised plate urethroplasty procedure and other procedures in the case of redo hypospadias repair. Methods: The participants were categorized into those who were treated by the tubularized incised plate procedure (Group A) and those who were treated by other procedures (Group B) and the collected data were compared between the two groups. The patients were examined regularly during the postoperative period for urethral-cutaneous fistula, meatal stenosis, penile curvature, penile skin coverage, and re-disruption.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients with disrupted hypospadias repair

Exclusion Criteria:

* Fresh cases of hypospadias
Huangqi Guizhi Wuwu Decoction in CKD Stage 2-4 Diabetic Nephropathy

This is a prospective, open, multicenter clinical trial.The objective of this study is to evaluate the efficacy and safety of Huangqi Guizhi Wuwu Decoction in patients with CKD stage 2-4 diabetic nephropathy.

The incidence rate of chronic kidney disease is 10.8% in China. The incidence rate of diabetic nephropathy has increased year by year, and now it has become the first cause of uremia. Therefore, the treatment of diabetic nephropathy can delay the progression of renal function and is of great value and significance in reducing uremia. Huangqi Guizhi Wuwu decoction is a traditional Chinese medicine decoction. Previous studies have shown that it is effective in the treatment of diabetic nephropathy. In this study, there were 2 hospitals participating in. We planned to enroll 100 participants, who will be divided into the Huangqi Guizhi Wuwu decoction group (experimental group) and the Dapagliflozin group (control group). All participants will take medication for 12 weeks, and investigators will follow up participates at weeks 0, 2,4, 6, 8,12.

Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed as diabetic nephropathy
2. TCM syndrome differentiation is Qi deficiency and blood stasis type
3. Male or female, 18≤age≤75 4.25mL/（min.1.73m2）≤ eGFR\<90mL/（min.1.73m2） 5.24-hour urine protein ration ≤3.5g/24h

6.The participants must be capable of understanding and comply with the protocol and sign a written informed consent document

Exclusion Criteria:

1. Exposure to immunosuppressors, glucocorticoid，without a one weeks washout period
2. Urinary tract infection (leukocytes in urinary sediment \> 5 / HP)
3. Serum potassium \> 5.5 mmol/L
4. Serum albumin \< 30g/L
5. Pregnant or lactating women, and participants (including males) who were unable or unwilling to take adequate contraception during the study period
6. Having comorbidities that affect the progression of diabetic nephropathy (including but not limited to Malignant tumors, Systemic autoimmune diseases, Liver cirrhosis)
7. Participating in another clinical trial
8. Investigators do not think it suitable for a participant to join this study
The Influence of Probiotic Supplementation on Depressive Symptoms, Inflammation and Oxidative Stress Parameters and Faecal Microbiota in Patients With Depression Depending on Metabolic Syndrome Comorbidity

The trial will be a four-arm, parallel group, prospective, randomized, double-blind, controlled design that will include 200 participants and will last 20 weeks. The probiotic preparation will contain Lactobacillus helveticus Rosell®-52, Bifidobacterium longum Rosell®-175. We will assess the level of depression, anxiety and stress, quality of life, blood pressure, body mass index and waist circumference, white blood cells count, serum levels of C-reactive protein, HDL cholesterol, triglicerides, fasting glucose, faecal microbiota composition and the level of some faecal microbiota metabolites, as well as inflammation markers and oxidative stress parameters in serum.

The trial may establish a safe and easy-to-use treatment option as an adjunct in a subpopulation of depressive patients only partially responsive to pharmacologic treatment.


Eligibility Criteria:
Inclusion Criteria:

Depressive disorders diagnosed according to ICD Age between 18 and 70 years MADRS score \>=13 Antidepressant and antianxiety medications or psychotherapy not changed 3 weeks prior to the beginning of the study DMS study groups: MetS diagnosed according to International Diabetes Federation (IDF)

Exclusion Criteria:

Pregnancy; An infection and/or treatment with antibiotics in the previous 4 weeks; Supplementation with pro- or prebiotics in the previous 4 weeks; Having a diagnosis of autoimmune, serious immunocompromised, inflammatory bowel diseases, cancer, IgE-dependent allergy, severe kidney failure or unstable thyroid dysfunction in the previous 4 weeks; Psychiatric comorbidities (except for specific personality disorder, additional specific anxiety disorder and caffeine or nicotine addiction); Regular treatment (more than 3 days a week) with proton-pump inhibitors (PPIs), metformin, laxatives, systemic steroids or nonsteroidal anti-inflammatory drugs (NSAIDs) in the previous 4 weeks; Following a specific diet or a significant change in dietary pattern in the previous 4 weeks; Significant change in daily physical activity or an extreme sport activity in the previous 4 weeks; Significant change in dietary supplementation in the previous 4 weeks; Significant change in smoking pattern in the previous 4 weeks; A major neurological disorder or any medical disability that may interfere with a subject's ability to complete study procedures; High risk of suicide according to Tool of Assessment of Suicide Risk (TASR); Is participating in, or has recently participated in, another research study involving an intervention which may alter outcomes of interest to this study; Any other condition or situation which, in the view of investigators, would affect the compliance or safety of the individual taking part; D study groups: MetS diagnosed according to International Diabetes Federation (IDF).
The Effect Of Training On Nursing Qualıty

The aim of this study, in a randomized controlled design with pretest, posttest and control groups, is to determine the effect of on-the-job (toolbox) training given to nurses on nursing-sensitive quality indicators (pain management, pressure sores, patient falls, Peripheral Venous Catheter complications and adverse event reporting). it aims to answer are:

- Does toolbox training have an effect on nursing-sensitive quality indicators? After the training, participants are expected to adapt to quality practices.

This study consists of experimental and control groups. Experimental and control groups were determined by drawing lots with the help of an external expert. Nurses who met the inclusion criteria were included in the lottery.

Inclusion criteria for the experimental and control groups were determined as follows:

* Working in one of the hospital's internal medicine or surgical services
* Having been working in the current service for at least 6 months, apart from past work experience
* Having completed the orientation process to the hospital and taking responsibility for patient care
* Voluntarily agree to participate in the study

This study was carried out to determine the effect of toolbox training on nursing-sensitive quality indicators (pain management, pressure sores, patient falls, peripheral venous catheter complications and adverse event reporting) in a randomized controlled, pre-test, post-test, experimental and control group design.

The population of the study consisted of nurses working in the inpatient services (except the intensive care units) of a training and research hospital in Hatay. A total of 77 nurses working in the experimental and control group services determined by randomization constituted the sample of the research (experimental group: 38 nurses, control group: 39 nurses).

Eligibility Criteria:
Inclusion Criteria:

* Working in one of the hospital's internal medicine or surgical services
* Being working in the current service for at least 6 months apart from past work experience
* Having completed the orientation process to the hospital and taking responsibility for patient care
* To voluntarily agree to participate in the study

Exclusion Criteria:

* Participants who did not meet the inclusion criteria were excluded.