cyrilzakka/clinical-trials huggingface dataset:
TRAUMEEL for Pain After Total Knee/Hip Arthroplasty

We hypothesize that Traumeel S is more effective than placebo in reducing 48-hour mean cumulative morphine consumption following Total Knee or Hip Arthroplasty.

224 patients, meeting all inclusion and none of exclusion criteria, will be enrolled in the trial. Patients will be randomized to receive either intraoperative injection and post operative oral Traumeel S Tablets or placebo injection (normal saline) and indistinguishable oral placebo tablets. Baseline measurements of relevant outcome measures will taken preoperatively.

In the recovery room, the patient will begin to receive IV Dipyrone (Optalgin) 1000mg, for a total of 4 doses during the first 24 hours postoperatively (1000 mg every 6 hours). Once back in the ward, the patient will be connected to an IV Patient-Controlled Analgesia (PCA) device, enabling the self-administration of morphine at a set dose of 1mg every 8 minutes, should the patient require it. The PCA memory registers the time and dose, and the data will be used later to evaluate post-operative pain.


Eligibility Criteria:
Inclusion Criteria:

* Patients of either sex undergoing unilateral THAP or TKAP.
* Age over 18 years.
* Signature upon informed consent form

Exclusion Criteria:

* Participation in another clinical trial within 4 weeks prior to enrollment.
* Refused to give verbal consent to the telephone interviews
* Impossibility to be reached during the 14-17 days post operative
* Inability to comply with the study protocol for any other reason
* Previous major surgical procedure on ipsilateral leg.
* Current use of analgesics for any other reason.
* A history of chronic pain syndrome.
* Abused legal or illicit drug use.
* Hypersensitivity to botanicals of the Compositae family
* Known sensitivity to paracetamol, codeine or tramadol.
Current Status of Islet Alpha Cell Function in Patients with Type 2 Diabetes

By detecting the fasting and postprandial 120-minute glucose, insulin (Insulin, INS), C-peptide (C-peptide, Cp), glucagon (GCG) levels in newly diagnosed type 2 diabetes patients, or the 0-minute, 30-minute, 120-minute glucose, INS, Cp, GCG levels during the Oral Glucose Tolerance Test (OGTT), and examining the glucose, INS, Cp, GCG levels during hypoglycemia, the current status of islet alpha cell function in diabetic patients is observed. Type 2 diabetes patients willing to participate are treated with GLP-1RA for 3 months, and then retested for fasting and postprandial 120-minute glucose, INS, Cp, GCG, or the 0-minute, 30-minute, 120-minute glucose, INS, Cp, GCG during OGTT, as well as the counter-regulatory hormone levels during hypoglycemia, to assess the improvement of islet alpha cell function by GLP-1RA.


Eligibility Criteria:
Inclusion Criteria:

* Willing to participate voluntarily and able to sign the Informed Consent Form before the trial;
* Newly diagnosed patients with type 2 diabetes, aged 18 years or older, meeting the WHO 1999 diagnostic criteria;
* Subjects who are capable and willing to maintain a regular diet and exercise regimen.

Exclusion Criteria:

* Patients who are allergic to GLP-1RA or have a BMI less than 24 kg/m\^2;
* History of using blood sugar-lowering medications;
* Estimated glomerular filtration rate (eGFR) less than 30 ml/(min\*1.73 m\^2);
* History of drug abuse or alcohol dependence within the past 5 years;
* Patients with poor compliance and irregular diet and exercise;
* History of diagnosed pancreatitis, pancreatic tumor, medullary thyroid carcinoma, or diabetic retinopathy stage IV or higher;
* Patients who have used systemic glucocorticoid therapy within the past 3 months;
* Presence of infection or stress within the past four weeks;
* Any other significant condition or comorbidity judged by the researcher, such as severe cardiopulmonary disease, endocrine disorders, neurological disorders, tumors, other pancreatic diseases, mental illness, history of alcohol or drug abuse.
Bivalirudin Versus Enoxaparin in Critically Ill COVID-19 Patients

Coronavirus Disease (COVID-19) is characterized by a hypercoagulable state, sometimes difficult to be managed with heparin. Bivalirudin, a member of the direct thrombin inhibitor drug class, offers potential advantages compared to heparin, including to its ability to exert its effect by directly attaching to and inhibiting freely circulating and fibrin-bound thrombin.

Investigators have therefore designed this pilot open-label randomized controlled trial to assess if a off-label infusion of bivalirudin may reduce thrombosis, mortality, Intensive Care Unit (ICU) length of stay and increase ventilator free days of patients admitted in ICU for acute respiratory failure due to COVID-19, as compared to first-line treatment with heparin.


Eligibility Criteria:
Inclusion Criteria:

* ratio between arterial partial pressure to inspired fraction of oxygen (PaO2/FiO2) \< 200 mmHg
* age equal or greater of 18 years/old
* detection of coronavirus 2019 at the nasal swab;
* need for endotracheal intubation and invasive mechanical ventilation

Exclusion Criteria:

* known allergies to one of the two investigated drugs
* presence of hematological diseases
* pregnancy
* recent (10 days) surgery
* presence of active bleeding
Effect of Acupressure Applied Before CAG on Pain, Anxiety and Vital Signs

This randomized controlled experimental study aimed to determine the effects of acupressure applied before the procedure on pain, anxiety and vital signs in patients who applied to Kocaeli City Hospital Angiography Unit and were to undergo planned radial artery coronary angiography.

This randomized controlled experimental study was conducted at the Kocaeli City Hospital Angiography Unit to determine the effects of acupressure applied before coronary angiography on pain, anxiety and vital signs of the patients scheduled to undergo coronary angiography. It was conducted at the Kocaeli City Hospital Angiography Unit. The study used a stratified block randomization method and 93 patients who met the inclusion criteria were assigned to two different intervention groups, one of which received acupressure and the other a sham intervention before coronary angiography, and a control group receiving standard care. Data were collected using the 'Personal Information Form', 'State Anxiety Inventory (STAI)', 'Visual Analog Scale (VAS)' and 'Patient Follow-up Form'.

Eligibility Criteria:
Inclusion criteria for the study

* Over 18 years of age,
* Able to understand and speak Turkish,
* Open to communication,
* First time undergoing radial artery coronary angiography,
* Elective patients undergoing planned (non-urgent) coronary angiography,
* Patients who did not undergo stent/balloon intervention during angiography,
* Awake and conscious during coronary intervention (not having taken sedatives (dormicum/fentanyl))
* No deformities or lesions in the areas where acupressure will be applied (hematoma, ecchymosis, etc.)
* Having not taken sedatives or painkillers 5 hours before the angiography,
* No experience with acupressure,
* No history of attending training courses and yoga classes to control stress and anxiety in the last six months
* No diagnosis of anxiety disorder and not receiving medical treatment
* No diagnosis of depression and not receiving medical treatment
* Flat on the back (patients without respiratory distress, etc.),
* Hemodynamically stable (no chest pain or arrhythmia),
* Patients who volunteer to participate in the study,

Exclusion criteria for the study

* Diagnosed with any psychiatric disease
* Previously undergone coronary angiography from the radial or femoral artery
* Chronic pain
* Used opioid medication
* CAG procedure to be performed from the femoral artery
A Study of Subcutaneously-administered Guselkumab Delivered by 3 Different Devices in Healthy Participants

The purpose of this study is to evaluate the serum concentration of guselkumab after administration using three different devices in healthy participants.


Eligibility Criteria:
Inclusion Criteria:

* Have a weight in the range of 50.0 kilogram (kg) to 90.0 kg, inclusive
* Be healthy on the basis of physical examination, medical history, vital signs, and 12 lead electrocardiogram (ECG) performed at screening and Day -1. Any abnormalities must be considered not clinically significant and this determination must be recorded in the participant's source documents and initialed by the investigator
* A female participant must have a negative pregnancy test result at screening and baseline (Day -1) and while enrolled in this study
* Contraceptive (birth control) use by men should be consistent with local regulations (if any) regarding the acceptable methods of contraception for those participating in clinical studies
* A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for a period of 12 weeks after study intervention

Exclusion Criteria:

* History of any clinically significant medical illness or medical disorders the investigator considers should exclude the participant, including (but not limited to), neuromuscular, hematological disease, immune deficiency state, respiratory disease, hepatic or gastrointestinal (GI) disease, neurologic or psychiatric disease, ophthalmological disorders, neoplastic disease, renal or urinary tract diseases, or dermatological disease
* History of malignancy before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, which is considered cured with minimal risk of recurrence
* Has a current chronic infection, prior history of recurrent infection, or an active infection
* Has previously received guselkumab
* Has a positive urine drug and alcohol screen during screening or at admission (Day -1)
Simvatstatin Used to Treat Pulmonary Hypertension

we try to use simvastatin in the treatment of advanced pulmoary hypertension secondary to congenital heart disease or chronic pulmonary embolism before and after the operation.

advanced pulmonary hypertension is refractory to the medication in use nowaday, especially pulmonary hypertension secondary to congenital heart disease or chronic pulmonary embolism.It is revealed that statins may intefere the pathogenisis of the pulmonary hypertension in many key poing, such as improving apotosis or inhiting the proliferation of pulmonary vascular smooth muscle cell. so we try to use simvastatin in the treatment of advanced pulmoary hypertension secondary to congenital heart disease or chronic pulmonary embolism before and after the operation.

Eligibility Criteria:
Inclusion Criteria:

* pasp\>50mmHg

Exclusion Criteria:

* pasp\<50mmhg
Comparison of NOSES and Conventional Laparoscopic Surgery in Colorectal Cancer

Radical surgery for rectal cancer has evolved from the initial concept of total mesorctal excision (TME) to the wide application of laparoscopic surgery in the radical treatment of rectal cancer. After 30 years' rapid development, nowdays laparoscopic TME surgery for rectal cancer has become the first choice for those patients with rectal cancer. However, the auxiliary incision of the abdominal wall which is used to remove tumor specimens is contrary to the current concept of minimally invasive surgery. Avoiding abdominal wall incisions has become a common appeal of gastrointestinal surgeons and patients with rectal cancer. Natural orififice specimen extraction surgery (NOSES) can solve the problem of abdominal wall auxiliary incision, which complete rectal cancer radical resection and gastrointestinal reconstruction under the full laparoscopic. The specimens are taken out through the natural orifice (rectum or vagina) without an auxiliary incision, which is more in line with minimally invasive practice and easier to operate. Researching on the progress of laparoscopic radical resection of rectal cancer in NOSES aims to provide a certain reference for this operation.


Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria were as follows: (1) patients aged between 18 and 80 years; (2) histopathology confirmed as colorectal adenocarcinoma; (3) preoperative imaging (CT and MR) assessments showed that colorectal cancer did not penetrate the serosa (≤T3); (4) tumor circumference \<5 cm; (5) enhanced chest and abdominal pelvic CT scans before operation excluded liver metastasis, lung metastasis, and other distant organ metastases.

Exclusion Criteria:

* The preoperative exclusion criteria were as follows: (1) tumors could be resected by endoscopic submucosal dissection (ESD) and endoscopic mucosal resection (EMR); (2) body mass index (BMI) \> 30 kg/m2; (3) patients with severe perforation, bleeding, or obstruction requiring emergency surgery; (4) recurrent cases; (5) patients undergoing neoadjuvant therapy or preoperative radiotherapy; (6) Anesthesiologists (ASA) score ≥ IV; (7) active period of infection; (8) blood neutrophils \<3 × 109/L.
Improving Person Centered Care for Post Abortion Patients in Kenya

The purpose of this study is to understand the effect of a phone based post-abortion intervention on the experience of post-abortion care.

This study evaluates whether personalized text messages and phone calls to post abortion women can improve post abortion person-centered care, perceived social support, post-abortion family planning, and reduce perceptions of social stigma and stress. Women were randomized to one of three study arms: personalized communication with a peer counselor or nurse who received person-centered care (PCC) training, or a control arm where participants received the standard of care.

Eligibility Criteria:
Inclusion Criteria:

* Women of reproductive age
* Had an Safe Abortion (SA)/Post Abortion Care (PAC) procedure at one of six private clinics that day
* Has her own cellphone that is WhatsApp compatible and will have access to this phone for the next four weeks
* Willing to receive receive short message service (SMS) messages and phone calls from an Marie Stopes Kenya (MSK) or Innovation for Poverty Action (IPA) professional
* Able to communicate in English and/or Swahili
* Willing and able to comprehend and give informed consent
* Willing to participate in a baseline survey immediately after providing consent
* Willing to be followed up by phone at two weeks and four weeks post procedure for a 15-minute survey at each time-point
* Has not already participated in this study

Exclusion Criteria:

* Is not a women of reproductive age
* Did not have an SA/PAC procedure at one of six private clinics that day
* Does not have her own cellphone that is WhatsApp compatible and will have access to this phone for the next four weeks
* Is not willing to SMS messages and phone calls from an MSK/IPA professional
* Is not able to communicate in English and/or Swahili
* Is not willing or is not able to comprehend and give informed consent
* Is not willing to participate in a baseline survey immediately after providing consent
* Is not willing to be followed up by phone at two weeks and four weeks post procedure for a 15-minute survey at each time-point
* Has already participated in this study
Self-help Lifestyle Medicine for Generalized Anxiety Symptoms

This study will examine the effects of smartphone-based lifestyle medicine for alleviating generalised anxiety symptoms in Chinese population. Since a range of lifestyle factors are involved in the pathogenesis and progression of generalised anxiety disorder ( Cox \& Olatunji, 2016; Dale et al., 2014; Vøllestad et al., 2012), modifying different lifestyle factors simultaneously, for examples, diet, exercise, stress and sleep, may be effective to reduce generalised anxiety symptoms. Recent studies indicate that service users are showing an increasing interest in self-help interventions for common mental disorders because of their accessibility and low cost (Marshall et al., 2021; Weisel et al., 2019). Nonetheless, to date, only limited self-help interventions that target lifestyle medicine for generalised anxiety symptoms are available.

This study will be a randomised controlled trial on the effects of a self-help smartphone-based lifestyle medicine intervention for reducing generalised anxiety symptoms in Chinese population. Prior to all study procedures, eligible participants will be required to complete an online informed consent (with telephone support). Around 50 eligible participants will be randomly assigned to either smartphone-based lifestyle medicine (LM group) or the waitlist control group (WL group) in a ratio of 1:1. The randomization will be performed by an independent assessor using a computer-generated list of numbers. Participants in the LM group will receive the multicomponent lifestyle medicine intervention via the app for 8 weeks, whilst the WL control group will receive the intervention after trial completion. The primary outcomes will be the level of generalised anxiety symptoms at immediate and 3-month post-intervention assessments; while the secondary outcomes will be the level of depressive symptoms, insomnia symptoms, physical activity, health-related quality of life, functional impairment, health-promoting behaviours, and intervention acceptability at immediate and 3-month post-intervention assessments.


Eligibility Criteria:
Inclusion Criteria:

* Hong Kong residents
* Aged ≥ 18 years
* Have a Generalized Anxiety Disorder-7 (GAD-7) score ≥ 8
* Able to read Chinese and type in Chinese or English
* Have an Internet-enabled mobile device (iOS or Android operating system)
* Willing to provide informed consent and comply with the trial protocol

Exclusion Criteria:

* Current involvement in psychotherapy or recent changes in medication for anxiety
* A Patient Health Questionnaire-9 (PHQ-9) item 9 score \> 2, indicating a serious level of suicidal risk (referral information to professional mental health services will be provided)
* Self-disclosure of having unsafe health conditions for which physical activity or a change in diet was contraindicated by physicians
* Self-disclosure of a diagnosis of any major psychiatric, medical or neurocognitive disorders that make participation unsuitable or that may interfere with the adherence to the lifestyle modifications
A Study to Assess the Efficacy and Safety of 20, 40, and 80mg of Sildenafil Three Times a Day in the Treatment of Pulmonary Arterial Hypertension

To evaluate the effect of three doses of oral sildenafil (20, 40 and 80 mg three times a day \[TID\]) on exercise capacity, as measured by the 6-Minute Walk test, as well as the safety and tolerability, after 12 weeks of treatment in subjects with pulmonary arterial hypertension who are aged 18 years and over. To investigate the plasma concentration-effect relationship and to determine the population pharmacokinetic (PK) parameters.


Eligibility Criteria:
Inclusion Criteria:

Included patients had primary pulmonary arterial hypertension, pulmonary hypertension secondary to connective tissue disease, or pulmonary hypertension with surgical repair at least 5 years previously; a mean pulmonary artery pressure greater than or equal to 25 mmHg and a pulmonary artery wedge pressure of less than or equal to 15 mmHg at rest, via right heart catheterisation within 21 days prior to randomisation; and a baseline 6-Minute Walk test distance of 100 m to 450 m.

Exclusion Criteria:

Subjects with congenital heart disease, pulmonary hypertension due to thromboembolism, HIV, chronic obstructive airway disease, congestive heart failure or schistosomiasis; subjects with significant (ie \> 2+) valvular disease other than tricuspid regurgitation or pulmonary regurgitation; and acutely decompensated heart failure within the previous 30 days; subjects with pulmonary hypertension secondary to any other etiology other than those specified in the inclusion criteria.
The Efficacy of Chlorella Supplementation on Health and Performance Following a 12-week Training Programme

Algae are an emerging functional food source that are gaining traction and popularity in biopharmaceutical, nutraceutical, and biotechnology industries. They are a diverse and complex species that comprise an abundant breadth of micronutrients (multiple vitamins, minerals, fatty acids, and amino acids) that can possibly promote human health. One such popular algae is chlorella, a unicellular dark green organism, which can be readily bought in health stores worldwide. Although there is some promising data to suggest chlorella supplementation can alleviate cardiovascular risk factors and improve VO2max from supplementation alone, an area which has particularly limited existing literature is the possible ergogenic and health influence of chlorella supplementation combined with a controlled training programme in sedentary and overweight populations. Given that such populations are susceptible to increased risk of developing associated diseases (cardiovascular disease, diabetes, hypertension) and possess poor diets, there is a need to investigate the possible synergistic effect of a training programme and supplementation of algae further. Furthermore, there is growing evidence to suggest that supplementation with algae may have a beneficial effect on cognitive function, primarily owed to antioxidant and anti-inflammatory mechanisms. Therefore, the purpose of this study aims to assess the efficacy of chlorella supplementation on VO2max, blood lipid profiles, cognitive function and body composition following a 12-week training programme. Briefly, in a double blind, randomised, placebo-controlled trial, participants will be randomly allocated into 1 of 4 groups (A. Exercise + Chlorella, B. Exercise + Placebo, C. Control + Chlorella, D. Control + Placebo).


Eligibility Criteria:
Inclusion Criteria:

* Aged 18-50
* Classified a sedentary (\<30 minutes of moderate intensity exercise for \<3 days per week for 3 months) and/or overweight (BMI = 25 +)
* Be willing to complete a 12-week training programme

Exclusion Criteria:

* Individuals taking blood thinners.
* Known allergies to algae/mould and iodine.
* Taking immunosuppressant medication
* Regularly ingesting algae
* Smokers
Covid-19, Acute Myocardial Infarctions and Strokes in France

The COVID-19 pandemic has had dramatic effects on health systems and on non-COVID health care.

Using French inpatient claims data and retrospectively collected clinical data, the investigators will assess the changes in hospital admissions for acute cardiovascular and neurovascular conditions in France during and after the national lockdown.


Eligibility Criteria:
Inclusion criteria:

- Adults admitted in 2018, 2019 or 2020 in a French hospital for acute coronary syndrom or stroke

Exclusion criteria:

- None
Magnification Endoscopy and Electronic Chromoendoscopy in Patients With Inflammatory Bowel Disease

In this study the investigators aim to evaluate the ability of i-scan OE together with magnification endoscopy to detect and assess microscopic inflammation in patients with inflammator bowel diseases (IBD).

In this study the investigators aim to evaluate the ability of i-scan OE together with magnification endoscopy to detect and assess microscopic inflammation in patients with inflammator bowel diseases. For this purpose, IBD patients will be prospectively enrolled and inflammatory changes will be assessed using optical magnification endoscopy in conjunction with optical chromoendoscopy. Endoscopic scoring of inflammatory changes in IBD patients will be done on a newly developed magnification score resulting as a consensus from experts in optical diagnosis and endoscopy in IBD patients. Results will be correlated against histopathology.

Eligibility Criteria:
Inclusion Criteria:

* Patients with established diagnosis of Inflammatory Bowel Diseases
* Ability to provide written informed consent
* Age 18 years and older

Exclusion Criteria:

* poor bowel preparation
* inability to provide written informed consent
* minors