cyrilzakka/clinical-trials huggingface dataset:
Stage-based Exercise Promotion Study

The purpose of this study is to increase regular physical activity among students by fostering self-management competencies. The intervention was implemented as paper-pencil intervention. The aim of this research project is to evaluate a motivational and volitional intervention in comparison to a control intervention.

Study participants will be recruited in lectures at Freie Universitaet Berlin and followed up twice (two and ten weeks after baseline).

The motivational intervention is expected to increase unmotivated participants' intention to be physically active. The volitional intervention is expected to promote physical activity among motivated but inactive participants. Both interventions are hypothesized to improve self-management competencies over time.

An experimental study is planned over a time period of ten weeks. In the physical activity study, participants will randomly be allocated to either one of two intervention groups (IG) or to an active control group (ACG), receiving a quiz on physical activity and sports. Intervention group 1 receives a paper-pencil intervention which focuses on positive outcome expectancies (motivational intervention). Intervention group 2 receives a paper-pencil intervention which promotes the formulation of action plans for physical activity (volitional intervention).

Furthermore, all participants will receive two emails as intervention boosters until the end of the study.

Study participants will be invited to take part in the study during lectures of the Freie Universitaet Berlin. The students will be followed up twice: two weeks after T1 (paper-pencil), T2 will take place (paper-pencil). Eight weeks after T2 the T3 assessment will be conducted online.

The hypotheses are:

Participants of the motivational intervention report a larger increase in motivation to adopt physical activity from T1 to T2 and T3, as compared to the participants of the volitional or the control intervention. Effects will be larger in unmotivated participants than in already motivated participants.

Participants of the volitional intervention report a larger increase in physical activity from T1 to T2 and T3, as compared to the participants of the motivational or the control intervention. Effects will be larger in motivated participants than in unmotivated participants.

Eligibility Criteria:
Inclusion Criteria:

* to be capable of exercising on their own at a minimum level
* able to fill out a questionnaire (no illiteracy)
* adequate German language ability

Exclusion Criteria:

* no internet access
* no email address
Clinical Trial Comparing Carnoy's and GEWF Solutions for Lymph Node Clearing Technique in Colorectal Cancer

Regional lymph node metastasis is a major determinant of local recurrence and overall survival rates in patients with colorectal cancer. Because of the poor prognosis associated with the presence of lymph node metastasis, stage III colorectal cancer patients should receive adjuvant treatment with chemo and / or radiation therapy according to the site of tumor. Several authors have investigated the use of revealing solutions for lymph node clearance in colorectal cancer. Most studies comparing conventional histopathological specimen examination to any lymph node clearing technique showed that the use of revealing solutions increases the mean number of lymph nodes harvested, usually in a statistically significant manner. It is still controversial the impact of the use of revealing solutions for upstaging of lymph node status and consequently for the indication for adjuvant therapy. Therefore will be conducted a randomized clinical trial to compares the performance of GEWF and Carnoy solutions for the histopathological examination of patients with colorectal cancer. The aim of this study is to determine the lymph node revealing solution with the best performance (increase in the mean number of lymph node harvested and lymph node upstaging) in patients with colorectal cancer.

Patients with histologically proven colorectal adenocarcinoma submitted to curative resection and conventional histopathological examination of the surgical specimen are randomized to undergo further investigation by lymph node clearing technique with Carnoy or GEWF solution.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven colorectal adenocarcinoma
* Voluntary agreement of the patient to participate in research
* Voluntary agreement of the surgeon to participate in research

Exclusion Criteria:

* Absence of accurate histopathological data
Impact of Lung Recruitment Maneuvers on Driving Pressure in Cardiac Surgery

In anesthesia the incidence of postoperative pulmonary complications is frequent, especially in cardiac surgery where the incidence can reach 10%. Respiratory morbidity in cardiac surgery is favored by multiple factors and is higher compared to anesthesia in "general" surgery. The prevention of these complications is a major challenge in the management of patients.

Influence of driving pressure level on respiratory morbidity was first demonstrated in management of acute respiratory distress syndrome (ARDS) in resuscitation.

More recently, this notion has been introduced in anesthesia, with a correlation between increase driving pressure level and increase of post-operative respiratory complications.

A method should reduce these levels of driving pressure: performing lung recruitment maneuvers. This technique has been successfully tested in abdominal surgery in particular in a study published by Futier et al.. They systematized and standardized lung recruitment maneuvers and showed a decrease of postoperative pulmonary complications in abdominal surgery.

Thus, the realization of lung recruitment maneuvers, already used at the discretion of the practitioner, is now recommended by several teams of experts. The investigators propose in this "before-after" trial to evaluate variation in driving pressure due to systematic use of lung recruitment maneuvers, observed in patients operated in elective or urgent surgery. The secondary objective is to evaluate their impact on postoperative pulmonary complications.

This is a retrospective, before / after, monocentric trial.

Eligibility Criteria:
Inclusion Criteria:

* Patients receiving elective or urgent cardiac surgery with cardiopulmonary bypass

Exclusion Criteria:

* Emergency or salvage surgery
* Patient under guardianship
* Pregnancy
Multicenter Study of the Protector Laryngeal Mask

The study was designed to evaluate the success rate, time of insertion, sealing efficacy and security of the Protector Laryngeal Mask, a new second generation disposable supraglottic airway device, in patients undergoing elective surgery.

Laryngeal masks (LM) and supraglottic devices (SGD), in all their different forms, have become an authentic innovation in airway management especially in day surgery.

LMA Protector (Teleflex Medical, Athlone, Ireland) is a new disposable SGD currently available for anaesthetic practice. It is made of silicone (with no latex in its composition) and shares some of the characteristics of the second generation SGDs (as the presence of a gastric access channel); however, it has an additional drainage channel, both channels terminate distally in a camera behind the mask cuff. The presence of two drainage channels ("male" and "female") increases the patient safety against regurgitation, both of distal gastric content and secretions located in the oropharyngeal region. The gastric access channel called "female" also allows the insertion of a nasogastric tube if required. These drainage channels are useful for diagnosing the correct position of the mask, since the observation of leaks or gas through it can help diagnose a displacement the mask.

LMA Protector is designed with a preformed anatomic curve, and the airway conduct has an elliptical cross section, which ends distally in the mask. This design follows the anatomy of the human airway, which facilitates the insertion of the device. The softness of the mask material allows easy insertion.

Doubts regarding the transmission of infectious diseases with reusable devices makes disposable devices such as LMA Protector, one of the most interesting devices for use in anaesthetic procedures that are usually performed with SGD.

Its characteristics in the design, composition by a smooth and atraumatic material, the presence of two gastric drainage accesses, with potential improved patient safety and its characteristic of being disposable suggests a significant expansion of its use in the coming years .

In contrast to other SGDs that have been evaluated extensively, to date there are no large clinical studies showing its suitably and performance in a daily clinical scenario.

Eligibility Criteria:
Inclusion Criteria:

* Surgery procedures usually performed with supraglottic devices.
* ASA physical status I-III patients
* Age 18-75
* Signed inform consent

Exclusion Criteria:

* Patients with known difficult airway
* Patients with predicted difficult airway
* Patients with increased risk of aspiration
* Patient refusal to participate in the study.
Pr-conceptional Progesterone for Unexplained Recurrent Miscarriage

In women with unexplained recurrent miscarriages, progesterone (400 mg pessaries, twice daily), started soon as possible at luteal phase and after a positive pregnancy test and continued to 28 weeks of gestation, compared to placebo, ).

Progesterone improves secondary outcomes such as gestation at delivery, on-going pregnancy at 12 weeks, survival at 28 days of neonatal life.

. Progesterone, compared to placebo, does not incur substantial adverse effects to the mother or the neonate.

Explore differential or subgroup effects of progesterone in prognostic subgroups.

. Perform an economic evaluation for cost-effectiveness.

Eligibility Criteria:
Inclusion Criteria:

1. Women with unexplained recurrent miscarriages (2 or more consecutive first trimester miscarriages).
2. Age 18-39 years at randomisation (likelihood of miscarriages due to chromosomal aberrations is higher in older women; such miscarriages are unlikely to be prevented by progesterone therapy).
3. Spontaneous conception (as confirmed by urinary pregnancy tests).
4. Willing and able to give informed consent.

Exclusion Criteria:

1. Age less than twenty or above forty years old.
2. Antiphospholipid syndrome (lupus anticoagulant and/or anticardiolipin antibodies \[IgG or IgM\]); other recognised thrombophilic conditions (testing according to usual clinic practice)
3. Intrauterine abnormalities (as assessed by ultrasound, hysterosonography, hysterosalpingogram, or hysteroscopy).
4. Fibroids distorting uterine cavity.
5. Abnormal parental karyotype.
6. Other identifiable causes of recurrent miscarriages (tests initiated only if clinically indicated) e.g., diabetes, thyroid disease and systemic lupus erythematosus (SLE).
Physical Activity Choices Everyday- A Pilot Study

This study aims to test two strategies for weight loss. Participants will be randomly assigned to one of the two 4-week weight loss programs: (1) a behavioral weight loss program that involves recording weekly weight, physical activity, and caloric intake plus daily exercises in which information about a healthy lifestyle is reviewed or (2) a behavioral weight loss program that involves recording weekly weight, physical activity, and caloric intake plus daily exercises in which descriptions of positive future events are reviewed. Throughout the study, participants will complete assessments that examine the effects of the interventions on delay discounting, physical activity, weight, and other important health and psychosocial outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18-70
* Body Mass Index between 30-50
* English Speaking
* Have a smartphone that can be used for study activities

Exclusion Criteria:

* Report being unable to walk 2 blocks without stopping
* Are currently participating in weight loss treatment, have a history of bariatric surgery, or lost ≥5% in the past 6-months
* Are pregnant or plan to become pregnant within 2 months
* Report a heart condition, chest pain during periods of rest or activity, or loss of consciousness on the Physical Activity Readiness Questionnaire
* Report a medical condition that could jeopardize their safety in a weight control program with diet and exercise guidelines
* History of or current traumatic brain injury, dementia or Alzheimer's disease; a history of Multiple Sclerosis, or other neurological disorders
* Report conditions that, in the judgment of the PI, would render them unlikely to follow the protocol (e.g., relocation, dementia, unable to read and write in English)
* Have no Internet access or unwilling to use personal smartphone for study.
Apnex Clinical Study of the Hypoglossal Nerve Stimulation (HGNS®) System to Treat Obstructive Sleep Apnea

The purpose of this study is to evaluate the benefits and risks of hypoglossal nerve stimulation with the Apnex Medical Hypoglossal Nerve Stimulation (HGNS) System as a potential therapeutic option for individuals with moderate to severe Obstructive Sleep Apnea (OSA) that have failed or do not tolerate positive airway pressure (PAP) therapy.


Eligibility Criteria:
Inclusion Criteria:

* Age 21 to 80 years
* Body mass index (BMI) ≤ 35 kg/m²
* Previously diagnosed with Moderate to severe OSA
* Individual has failed or does not tolerate PAP therapy
Mindfulness Psychoeducation Program for Schizophrenia

The study is the first pilot randomised controlled trial (RCT) to explore the feasibility and efficacy of Mindfulness-based psychoeducation in emotion regulation and related depressive and anxiety symptoms in people with schizophrenia.

There is increasing evidence to demonstrate the safety and effectiveness of mindfulness-based psychoeducation programme (MBPP) for Chinese people with schizophrenia. A single-blind, multi-site, pragmatic randomised controlled trial conducted in Hong Kong, mainland China, and Taiwan with 300 participants consistently demonstrated significant improvement in regard to insight of illness, functioning, mental state and the length of re-hospitalisations when compared with conventional psychoeducation and Treatment As Usual (TAU) groups (Chien, 2017).

The study hypothesises that:

1. Participants receiving MBPP will decrease their use of rumination and expressive suppression, and increase the use of cognitive reappraisal compared to a control group after completion of the intervention.
2. Participants receiving MBPP attain a reduction in depressive/anxiety symptoms compared to a control group after completion of the intervention.
3. These effects are expected to be maintained through 3-month follow up with regular self-practice.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years to 65 years old
* Diagnosis with schizophrenia-spectrum disorders according to the criteria of the Diagnostic and Statistical Manual for Mental Disorders DSM-IV-TR (and the latest DSM-V) or International Classification of Diseases (ICD-10)-Classification of Mental Disorders
* Able to communicate in written and conversational Chinese/Cantonese
* Able to understand the concepts of the study and to give informed consent

Exclusion Criteria:

* Comorbid organic brain disorders or substance abuse
* Participation in any forms of cognitive therapy
* Participation and/or practice of mindfulness (in the forms of Tai Chi, Qi Gong, etc.) more than twice a week during the previous three months
Optical Coherence Tomography (OCT) Findings and Coronary Bifurcation Lesions

To determine the clinical prevalence of vulnerable plaque using OCT in patients with coronary bifurcation lesion.

This is a prospective registry study in which patient with bifurcation lesion undergoing baseline coronary angiography, baseline OCT and percutaneous coronary intervention will be studied. OCT is used to assess the prevalence of vulnerable plaque, its location at bifurcation lesions and compare vulnerable plaque related major adverse cardiovascular events (MACE) during one-year follow-up in bifurcation lesions between patients with vulnerable plaque and those without. Relationship between endothelial shear stress and vulnerable plaque. Relationship between bifurcation angle and vulnerable plaque.

Group A: presence of vulnerable plaque at the bifurcation Group B: absence of vulnerable plaque at the bifurcation Documentation of immediate post stent OCT and 12 months follow up angiography with OCT will be performed. Immediate post stent OCT to assess successful stent implantation and after 12 months follow up to document year major adverse cardiovascular events (MACE) included myocardial infraction, cardiac death and clinically driven target lesion revascularization, stent thrombosis.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years old
* Patients with ischemic heart disease who are considered for coronary revascularization with PCI
* True coronary bifurcation lesion Medina 1.1.1, 0.1.1, 1.0.1 (stenosis\> 50% by visual estimation) treated by drug-eluting stent
* Reference vessel diameter of main vessel \>= 2.5mm and side branch \>=2.0 mm by visual estimation

Exclusion Criteria:

* Saphenous vein grafts
* In-stent restenotic lesions
* Thombus-containing lesions
* Patient who had Myocardial infarction with in less than one month
* Patent who had bifurcation lesion dilation with balloon
* Contraindication or hypersensitivity to anti-platelet agents or contrast media
* Creatinine level ≥ 2.0 mg/dL
* Severe hepatic dysfunction (3 times normal reference values)
* Hemodynamic unstable patients
* Inability of OCT devise to cross the lesion into distal vessel
* Pregnant women or women with potential childbearing
* Inability to understand or read the informed content
Injection of ex Vivo Amplified G-CSF Mobilised Autologous Peripheral Blood Stem Cell Transplantation

Hematopoietic reconstitution defined by a neutrophils number \> 500/mm3 at day 7 after injection of ex vivo amplified graft and by a platelets number \> 20000/mm3, at day 15 after the injection of ex vivo amplified graft, without transfusion.

To check that injection of autologous peripheral blood stem cell CD34(+) "amplified ex vivo in the presence of SCF, G-CSF and TPO in HP01 Maco pharma medium culture. ": Allows to obtain a hematopoietic reconstitution:

1. Rapid : 7 days or less after the injection, regarding neutrophils and 15 days or less regarding platelets
2. Complete: numbers neutrophils and platelets respectively higher than 500/mm3 and 20000/mm3 within the times mentioned
3. Stable: no secondary neutropenia or thrombocytopenia during the year following the injection, in the absence of recurence of the myeloma.

Eligibility Criteria:
Inclusion Criteria:

* Patient between 18 and 65 years of age
* Diagnosis of Multiple Myeloma, requiring a treatment, including high dose Melphalan whith autologous peripheral blood stem cell transplantation
* Performance status: \< 2 (Karnofsky \> 70%)
* Anticipated survival \> 3 month
* Collection of a minimum of 10x106 cells (CD34+)/Kg of autologous G-CSF mobilised peripheral blood stem cells in 2 to 3 pheresis.
* Signed and dated informed consent

Exclusion Criteria:

* Multiple Myeloma not requiring a treatment
* Another cancer in the 5 years preceding the diagnosis or evolutive psychiatric affection
* Positive serology for HIV, hepatitis C or hepatitis B
* Hepato cellular insufficiency
* Severe renal insufficiency defined by a creatine clearance \< 30 ml/mn
* Women pregnant or nursing, or effective absence of contraception
* Antecedent of serious cardiac disease in the last 6 months.
* Allergy known to the products derived from Escherichia Coli
The Effects of Freshwater Clam Extract on Blood Sugar, and Lipid Profile in Prediabetes Patients

The purpose of this study is to determine whether the freshwater clam extract and its combination is effective on the improvement of glucose and lipid metabolism, also evaluate its ability to postpone prediabetes patients to become diabetes.

This study aims to evaluate the effect of freshwater clam extract and its combination is effective on the improvement of glucose and lipid metabolism, as well as evaluate its ability to postpone prediabetes patients to become diabetes., 3 month and 6 month data will be collected and put into analysis to provide some suggestions on the Clam protein capsules and Clam peptide plus Chlorella capsules use in the clinical practice for prediabetes patients.

Eligibility Criteria:
Inclusion Criteria:

1. Agree to cooperate in the trial and sign the written informed consent
2. Age 25-70 years
3. Glucose AC between 100-125 mg/dL
4. HbA1c between 5.7%\~6.4%
5. Total Cholesterol≧160mg/dL or LDL-C≧100mg/dL Remark: Meet one of the (3)\~(5) conditions is acceptable

Exclusion Criteria:

1. Pregnant and lactating women
2. Poor medication compliance
3. Abnormal liver function patients (ALT and AST value\> 2 folds of normal value upper limit )
4. Abnormal renal function patients (creatinine value\>1.5 mg/dL)
5. Abnormal gastrointestinal function patients (eg. gastrostomy, enterostomy, and diarrhea)
6. Sever comorbidity in the last 6 months. (eg. Brain stroke, myocardial infarction, and major trauma and surgery)
7. Using influence blood sugar, blood pressure, and blood lipid drugs (eg sex hormones, corticosteroids, H2 blockers, diuretics and Statin )
8. Diabetes patients
9. Other sever diseases ( malignant tumor and alzheimer's disease)
10. With inflammatory diseases, infectious disease, and severe immune deficiency ( eg. tuberculosis, AIDS, active pneumonia, systemic lupus erythematosus and rheumatoid arthritis)
11. Other influence blood sugar endocrine disease (eg. Hyperthyroidism, Acromegaly, Cushing's syndrome and Pheochromocytoma)
Noninvasive Evaluation for Carotid Artery Stenosis: The Carotid Stenotic Scan

The purpose of this study is to determine the accuracy of a new non-invasive device, the Carotid Stenotic Scan (CSS), to check for stenosis of the internal carotid artery (ICA) as compared to a carotid duplex ultrasound study.

Currently, carotid duplex ultrasound is the primary diagnostic tool for the evaluation for ICA stenosis and must be performed by a trained and certified vascular technologist using advanced duplex imaging equipment and with subsequent interpretation by a trained physician. this test is not considered suitable for screening for disease. It would be of value to develop an accurate, reliable, low-cost, and easily accessible tool to screen for extra-cranial ICA disease in an office based setting. However, such a tool would require novel technology that allows for quick, accurate, reproducible, and safe evaluation.

This study will evaluate a new technology called the Carotid Stenotic Scan (CSS) developed by CVR Medical. The CSS instrument uses sensitive transducers to detect low frequency pressure fluctuations associated with flow disturbances downstream from areas of arterial narrowing.

Subjects will undergo a clinically ordered clinical carotid duplex ultrasound as part of standard of care. Subjects will have a noninvasive CSS assessment either before or after the carotid duplex ultrasound.

Eligibility Criteria:
Inclusion Criteria:

* Patients age ≥ 65 years scheduled for a diagnostic carotid artery duplex ultrasound study AND with one or more of the following:
* Hypertension
* Hyperlipidemia
* Diabetes
* Tobacco usage - Current or past
* Known CAD/PAD
* Family history of early onset of atherosclerotic disease

Exclusion Criteria:

* Unable / unwilling to provide Informed Consent
* Prior carotid endarterectomy or carotid artery stent
* Aortic stenosis
* Congestive heart failure
* BMI \> 35