cyrilzakka/clinical-trials huggingface dataset:
"Vibwife One" a New Medical Device to Support Delivering Women in Their Mobilization

"Vibwife One" was developed to support the mobilization of the delivering women during the labor process. It consists of a mattress that fits on existing delivery beds. Different movements, adjustable in pace and intensity can be chosen to mobilize women in labor.

Although existing evidence is rare, some literature and historical reports have shown a positive impact of active mobilization during labor.

At time of rising epidural anesthesia rate, "Vibwife One" could be an interesting way to active mobilize those women to support the physiological birth process.

So far, the device has not yet been applied in delivering women. The investigators carry out a first safety study to assess the safety, to evaluate the comfort and the practicability for delivering women and medical staff of this new medical device.

The medical device will be used according to its market authorization. Because it will be used for the first time in pregnant women, the following three step application procedure has been determined:

* First five pregnant women use the device for 10 minutes. Each of them in a position and module proposed by the midwife with the agreement of the woman.
* Next 10 pregnant women use the device for 20 minutes. Again, position and module according to the decision of the midwife with the agreement of the woman.
* All the remaining pregnant women (35) use the device for 30 minutes. Position and module according to the decision of the midwife with the agreement of the woman.

During the intervention period, position and module might be changed once if required.

After the inclusion of all the 50 participants, each position and module has to be tested.

There will be a safety review board consisting of one physician, one midwife and a clinical expert midwife meeting after each group of pregnant women having used the device, evaluating the safety criteria according to predefined Adverse Device Effects and Adverse Events.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent documented by signature
* German or English speaking
* Singleton healthy pregnancy
* Cephalic presentation
* ≥37th weeks of gestation
* 4cm - 9cm of dilatation
* Regular contractions
* Physiological cardiotocograph (CTG) 30 min pre-intervention
* Physiological blood pressure (111/66 - 139/89)

Exclusion Criteria:

* Multiple pregnancies
* Breech position
* Small for gestational age (\<10. Percentile)
* Fetal congenital abnormalities
* Placenta praevia
* Fetal distress
* Heavy vaginal bleeding during birth
* Maternal weight ≥ 135 kg
* Preeclampsia or HELLP
* Diabetes I and II / Gestational diabetes insulin dependent
* Spinal and back disorder (herniated disk / scoliosis)
* Hypertension (≥140/90 mmHg)
* Hypotension (Basic blood pressure in the third trimester -20%, if not available: ≤ 110/65 mmHg)
* No signed informed consent
Cardiovascular And Metabolic Risk After Arthroplasty

Osteoarthritis is a chronic joint disease that lacks curative therapy. Epidemiological studies show increase in the burden of disease. Total joint arthroplasty is one of the best treatment options for end-stage osteoarthritis. However, the specific effects of total joint arthroplasty on cardiovascular risk and metabolic profile are largely unknown. The aim of this project is to elucidate how hip and knee total joint arthroplasty impacts cardiovascular risk and metabolomic profile in comparison with general population. We hypothesize that arthroplasty decreases pain, systemic inflammation levels and increases functional status that all lead to decreased metabolic and cardiovascular risk.


Eligibility Criteria:
Inclusion Criteria for the arthroplasty group:

primary hip and knee OA (according to the American College of Rheumatology criteria) eligible for total joint arthroplasty

Exclusion Criteria for the arthroplasty group:

posttraumatic OA, infectious and endocrine related arthropathy, any acute or chronic inflammatory disease, malignancy, renal insufficiency (estimated glomerular filtration rate (eGFR) \< 60ml/min/1.73m2), cardiac arrhythmia, clinically significant heart failure, valvular disease, diabetes.

Exclusion criteria for the control group:

any concomitant acute or chronic inflammatory disease, a visit to family practitioner due to hip or knee joint complaints, any persistent knee or hip joint pain, diabetes, symptomatic coronary artery disease, cardiac arrhythmia, cerebrovascular or peripheral artery disease, malignancies and renal insufficiency.
Rehabilitation Training Participated by Caregivers in Ischemic Stroke: a Randomized Controlled Trial to Test the Effect of Home-based Rehabilitation Intervention on Physical Function.

The goal of this clinical randomized control trial is to test the effect of home-based motor rehabilitation training participated by caregivers on physical function in patients with ischemic stroke \].

The main question\[s\] it aims to answer are:

* Dose this kind of intervention method can improve the function of ischemic cerebral apoplexy patients is physical activity?
* Does this intervention reduce the caregiver-related burden of patients with ischemic stroke? Participants will be randomly assigned to: (1) home-based motor rehabilitation training participated by caregivers (intervention group or (2) routine self-care group (control group). Both groups will receive assessment and health guidance on the day of discharge, with the intervention group receiving an additional home-based training program and supervision. The two groups will be followed up every week after discharge.

Researchers will compare two groups to see if has great effects on physical function.


Eligibility Criteria:
Inclusion Criteria:

* Patient inclusion criteria: (1) According to the international classification of diseases (ICD) definition of ischemic cerebral apoplexy, conform to the guidelines of diagnosis and treatment of acute ischemic stroke in China 2018 "diagnostic criteria, and confirmed by craniocerebral CT or MRI in the diagnosis of ischemic cerebral apoplexy patients. (2) on the day of discharge NIHSS score 15 points or less; (3) The patient's vital signs are stable and have clear consciousness.; (4) patients and their families for research cooperation and positive cooperation attitude.
* Caregiver inclusion criteria:1）who is an adult (18 years old or older); 2) physically healthy, with normal cognitive ability, living ability, language communication ability and learning ability;3) be the primary caregiver

Exclusion Criteria:

* Patients' exclusion criteria: 1) Patients with unstable vital signs or unclear consciousness; 2) Patients who are unable to express language correctly due to aphasia or dysarthria; 3) The NIHSS score of the patient was more than 15 on the day of discharge; 4) Patients with other serious chronic or malignant diseases.
* Caregiver' exclusion criteria: 1) who with tumor, history of major surgery and history of severe trauma; 2) with mental illness
The MS-LINK™ Outcomes Study

The Multiple Sclerosis (MS) Leadership and Innovation Network (MS-LINK™) is comprised of networks working cooperatively to advance Multiple Sclerosis (MS) science and improve MS participant outcomes. In this study participants will be followed from the time of consent through the lifetime of the study (currently 3 years), unless the participant chooses to withdraw from the study. Collection of participant's medical history, including MS and treatment history, will be automated through extraction from the participant's electronic medical record (EMR) and other health information systems (for example, radiology). Participants will complete patient-reported outcomes (PROs) and other health-related information digitally. Participating participants will have access to their own data in an ongoing manner via a web-based Participant Portal.


Eligibility Criteria:
Inclusion Criteria:

* Participants willing and able to provide written informed consent
* Participants willing to be contacted while participating in the study for recruitment into sub-studies that may be relevant to them
* Participants willing and able to complete PROs on a monthly basis and document events of interest as they occur
* Participants willing to participate in additional follow up at the site for at least three years

Exclusion Criteria:

* Unable to complete questionnaires in English
* Unable to consistently access the Internet
* Participants participating in interventional clinical drug trials at baseline
Emergency Medical Staff Workload Analysis

The aim of this study is to identify trauma determinants and leverage this understanding to develop solutions applicable to the prevention and treatment of PTSD among emergency medical personnel. By categorizing stimuli associated with traumatic professional experiences, the study aims to enhance existing therapeutic protocols through exposure therapy. The specific objectives are as follows:

1. Analysis and characterization of occupational workloads among doctors and emergency medical personnel, focusing on the scale of burdens associated with PTSD symptoms.
2. Development of categories for aggravating and potentially traumatizing stimuli within the medical staff of rescue teams.
3. Examination of the feasibility of incorporating the obtained results into cognitive-behavioral therapy protocols.
4. Assessment of the potential for implementing the results in solutions utilizing virtual reality technology.
5. Formation of an interdisciplinary international research team.

Background: Data on the impact of workloads indicate that emergency medical personnel exposed to sudden threats to health or life are particularly vulnerable to the consequences of occupational stress. Symptoms of Post-Traumatic Stress Disorder (PTSD) within this professional group significantly surpass the rates found in the general population. Traumatic experiences encountered by medical staff may lead to a substantial decline in their mental health, as well as in their social and professional functioning.

Participants: Several hundred medical doctors and emergency medical personnel from Poland, Ukraine, Portugal and Spain.

Research Methodology: Analysis of data collected through focused interviews, psychological scales, and questionnaires pertaining to burnout, stress, and mental health conditions.

Eligibility Criteria:
Inclusion Criteria:

* completed medical studies or emergency medical course
* assistance in life-threatening conditions

Exclusion Criteria:

* Intellectual disability
* Inability to self-complete the research questionnaires
Ultrasound Guided QLB III Versus Intrathecal Morphine for Analgesia After Cesarean Section

Subarachnoid morphine (SAM) is the gold standard for treating postoperative pain after cesarean delivery (CD) but it has undesirable side effects, that's why the aim of our study is to identify whether ultrasound-guided Quadratus lumborum block type 3, a new regional anesthetic technique that blocks the abdominal wall neural afferents, can provide at the same time better postoperative analgesia after CD with less side effects

In this prospective double blinded randomized study,120 parturients undergoing cesarian delivery via a Pfannenstiel incision and who agreed to spinal anesthesia were randomly scheduled to receive either a SAM (group SAM, n=60) or a Quadratus lumborum block type 3 (group QLB, n=60).Spinal anesthesia was initiated with hyperbaric Bupivacaïne 0.5% 10 mg, 0,005 mg SUFENTANIL MEDIS and 0.1 mg morphine in the SAM group and with Bupivacaïne 0.5% 10 mg, 0,005 mg SUFENTANIL MEDIS and 1 ml normal saline in group QLB.

After surgery, bilateral QLB block type 3 was performed with the patient in lateral position using bupivacaine 0.25% , 20 mL on each side in group QLB and 20 ml normal saline in group SAM.

Postoperative analgesia for the first 24 hours consisted of a patient controlled analgesia with IV morphine only. If necessary breakthrough pain was treated by 01 g paracetamol intravenously by the same doctor in charge of taking the values of the visual analogue scale.

Patients were assessed postoperatively in the postanesthesia care unit (time 0 hours) and at 2, 4, 6, 12 and 24 hours.

Visual analogue scale (VAS) for pain at rest and during the palpation of the uterine globe was noted.

The primary outcome measure was the total dose of morphine over 24 hours delivered by a patient-controlled analgesia system at predetermined intervals.

Secondary outcomes were visual analogue scale (VAS) for pain at rest and on the palpation of the uterine globe ,heart rate, blood pressure, itching, nausea, pruritus, vomiting and sedation.

Eligibility Criteria:
Inclusion Criteria:

* ASA I/II.
* Normal singleton pregnancy with a gestation of at least 37 weeks.

Exclusion Criteria:

* Heart disease
* Coagulopathy
* pre-eclampsia
* BMI\> 40
* Patient refusal to undergo the Quadratus lumborum block.
* Allergy to local anesthetics
Evaluation of the Efficacy and Safety of Two Ibuprofen Combination Products for the Treatment of the Common Cold and Flu in Latin America

This is a multicenter, prospective, randomized, double-blind, triple-dummy, parallel group, comparative, study designed to evaluate the efficacy of Ibuprofen (IBU) 200 mg/ Phenylephrine (PE) 10 mg and IBU 200 mg/ PE 10 mg/ Chlorpheniramine (CHLOR) 4 mg on the relief of symptoms of the common cold and flu. The reference product that the active treatments will be compared to is paracetamol (PARA) 500 mg.


Eligibility Criteria:
Inclusion Criteria:

Male and female subjects who are 18 years old or older at the time of screening.

Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Subjects must present with a score of 5 of higher for at least 2 of the following 6 symptoms: runny nose, plugged nose, sneezing, sore throat, scratchy throat, or head congestion on the WURSS-21 assessment, within 36 hours of onset of symptoms.

Exclusion Criteria:

Anyone with a history of chronic allergic rhinitis or asthma at the time of the screening visit, or with history of chronic recurrent airway disease, infections, or frequent complications of colds (otitis media, sinusitis, or bronchitis)

Subjects taking any prescription or non-prescription drug, within the last 7 days prior to the screening, with which the administration of IBU, PE, CHLOR, or APAP is contraindicated, may increase the risk associated with study participation, or may interfere with the interpretation of study results, in the judgment of the Investigator.

Subjects currently taking a monoamine oxidase (MAO) inhibitor, or has taken an MAO inhibitor within 2 months of screening.

Subjects currently taking a serotonin-selective reuptake inhibitor (SSRI), tricyclic antidepressant (TCA), barbiturate, or any other neuroleptic, or has taken an SSRI, TCA, barbiturate, or any other neuroleptic within 14 days of screening.

Subjects with a hypersensitivity to IBU, PE, or CHLOR or APAP.
SUTURE-CLOSURE OMENTOPEXY VERSUS OMENTOPEXY ALONE IN REPAIR OF PERFORATED PEPTIC ULCER

The present study will be conducted to assess whether there is a direct benefit associated with modified-Graham's omentopexy (MGO), above and beyond the benefit associated with Graham's omentopexy (GO) in the treatment of perforated duodenal ulcers. We attempted to answer the question whether primary closure of the perforation in MGO will affect the outcome of surgery. Complication rates will be compared for the two alternative surgical procedures.


Eligibility Criteria:
Inclusion Criteria:

- All adult patients of both sexes with a clinical diagnosis of perforated peptic ulcer (gastric or duodenal) that are fit to undergo surgery.

Exclusion Criteria:

- 1. Patients with associated bleeding ulcer (additional steps are needed to control bleeding).

2. Patients with associated pathology other than perforated peptic ulcer that needs surgical intervention.
Peritoneal Lavage on the Incidence of Pancreatic Fistula and Related Complications After Pancreatoduodenectomy

As one of the possible strategies to prevent pancreatic fistula, peritoneal lavage is still widely used in clinical practice, but it lacks more evidence of evidence-based medicine and recommendations of guidelines. Some clinicians believe that routine flushing after pancreatoduodenectomy wastes medical resources and has a negative impact on patients' comfort.

In this study, the investigators designed a multicenter prospective controlled trial to compare the effects of peritoneal lavage and natural drainage on the incidence of pancreatic fistula and related complications after pancreatoduodenectomy. To study the indications of peritoneal lavage.


Eligibility Criteria:
Inclusion Criteria:

1. Preoperative diagnosis was pancreatic head, lower common bile duct, ampulla and duodenum tumors;
2. Patients with resectable tumors evaluated by imaging examination, and patients who plan to undergo pancreatoduodenectomy;
3. Subjects informed consent, understood and were willing to cooperate with the trial protocol, and signed relevant documents.

Exclusion Criteria:

1. Complicated with severe liver, kidney, heart, brain, lung and other organ complications;
2. Intraoperative changes in surgical methods, such as patients with tumor dissemination and only abdominal opening and closing; Or it needs to be resected in combination with other organs;
3. Patients and their families do not understand the treatment implementation plan of this study;
4. Failure to complete follow-up;
Body Composition Study in Critically Ill Patients-Extended to COVID-19

Muscle loss (ultrasound quadricep muscle) and muscle strength (handgrip and knee extension strength) will be compared between COVID-19 and non COVID-19 critically ill patients.

Given the heightened inflammatory status among COVID-19 critically ill patients, we hypothesized that the rate of skeletal muscle loss is accelerated in this population, and this loss is even more pronounce than the general critically ill patients. We further hypothesized that the increased muscle loss will lead to worse functional outcome (lower muscle strength) in COVID-19 critically ill patients compared with age- and sex-matched non-COVID-19 critically ill patients, as it has been shown that quadriceps thickness is strongly correlated with functional status at ICU discharge. Furthermore, a recent systematic review and meta-analysis in survivors of coronavirus (severe acute respiratory syndrome, SARS or Middle-east respiratory syndrome, MERS, or COVID-19) also demonstrated reduced exercise capacity and quality of life at 6 months after hospitalization or ICU admission

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years old
* Admitted into the ICU due to COVID-19

Exclusion Criteria:

* Likely to transfer out from the ICU in 24 hours from screening
* Likely to die in the next 7 days
* Bedbound prior to hospital admission or bedbound in the hospital for \>10 days
Design and Verification of Individualized Smart Assistive Devices for Stroke Rehabilitation

This study aims to design and verify a multi-mode smart assistive device system for Stroke Rehabilitation by using EEG, fMRI, IMU and questioners


Eligibility Criteria:
Inclusion Criteria:

* the first time hemiparetic stroke;
* diagnosis confirmed by a physician on the basis of the findings of neurological examinations and brain imaging (magnetic resonance imaging or computed tomography scan);
* aged between 20 and 85 years;
* Brunnstrom's stage II to V over the proximal and distal part of the upper extremity on the affected side;
* no cognitive dysfunction, measured by the Mini-Mental State Exam (≧24; suggested by 36 with respect to age and educational level)
* willing/able to participate and having signed an informed consent form.

Exclusion Criteria:

* unstable vital sign
* irreversible contracture over any of the joints of the affected upper extremity
* history of surgery, fracture, arthritis, pain, or any other complications that might influence the recovery of upper extremity function like aphasia, apraxia and neglect;
* having spasticity, as measured using the Modified Ashworth scale (score \> 2);
* poststroke seizure;
* heart attack within 3 months poststroke; cortical lesions in any of the five core motor areas of interest, including the bilateral M1, the bilateral PM, and the SMA.
Efficacy of Vakum Technology in Patients With Chronic Hypersecretion

Mechanical devices to increase the individual's bronchial hygiene are commonly used to assist patients with chronic retention of secretions. VAKÜM technology has been recently developed with the aim to improve the respiratory condition in hypersecretive patients suffering from chronic respiratory diseases.

The aim of this study is to assess the clinical efficacy of VAKÜM technology in patients with hypersecretion, and chronic respiratory diseases a clinical trial has been designed.

Patients with chronic respiratory diseases, hypersecretion (sputum production \>30 mL/die), and reduced cough efficiency (Peak Cough Expiratory Flow \> 150 and \< 300 L\*min-1) referred to standard pulmonary rehabilitation (PR) will be included. Study design is a single-blind multicentre randomized trial with consecutive recruitment. Following a preliminary run-in period, group comparison will be made between Intervention group using VAKÜM system (Free Aspire, MPR, Legnano-I) added to the conventional manual ELTGOL technique, and Control group using manual ELTGOL alone over 10 daily sessions.

Spirometric lung volumes, respiratory muscle strength, arterial blood gases, and quality of life will be recorded in both groups pre-to-post PR. Perceived dyspnea (by VAS scale), sputum volume and characteristics (on a semi-quantitative 3-point scale) and peak expiratory air flows (PEF and PCEF) will be registered on a daily basis over the study period. Primary outcome is the change in perceived dyspnea; in order to ensure 80% power to detect a 5 point (SD 5) group difference change in the primary outcome at the end of the study period as significant at the 0.05 level, at least 42 patients per group are needed. The minimum target sample size will be then fixed at 50 patients per group.

An higher and faster significant reduction of the perceived dyspnea is supposed in the Intervention group. Additional benefits among the secondary outcomes are also hypothesised in the same group.


Eligibility Criteria:
Inclusion Criteria:

* patients with chronic respiratory diseases
* hypersecretion condition(sputum production \>30 mL/die)
* reduced cough efficiency (Peak Cough Expiratory Flow \> 150 and \< 300 L\*min- 1)
* patients admitted to standard pulmonary rehabilitation

Exclusion Criteria:

* not able to use the device
* concomitant cardiovascular or neoplastic diseases
* utilization of Non Invasive Ventilation
Pilot Study for the NorCAPITAL Trial

The aim of this pilot study for the NorCAPITAL trial is to investigate the feasibility and safety of the drug clonidine in adolescent chronic fatigue syndrome (CFS). Specifically, the investigators wanted to assess appropriate dosage in relation to a) plasma concentration levels of clonidine, b) orthostatic cardiovascular responses (the pulse and blood pressure responses when rising up), and c) reports of possible adverse effects.

A possible beneficial effect of clonidine in adolescent CFS will be investigated in NorCAPITAL, which is a randomized, placebo-controlled, double blind trial.


Eligibility Criteria:
Inclusion Criteria:

* Persisting or constantly relapsing fatigue lasting 3 months or more
* Functional disability resulting from fatigue to a degree that prevent normal school attendance
* Age between 12 and 19 years

Exclusion Criteria:

* Another disease process or current demanding life event that might explain the fatigue
* Another chronic disease
* Permanent use of drugs
* Permanently bed-ridden
* Positive pregnancy test
* Supine systolic blood pressure (SBP) \< 85 mm Hg
* Fall in SPB upon standing \> 30 mm Hg
* Supine HR \< 50 beats/min
* Abnormal ECG