cyrilzakka/clinical-trials huggingface dataset:
Functional Recovery Effects on Comprehensive Rehabilitation for Post-acute Care -Cerebrovascular Diseases

The purpose of the study is to investigate the effects and outcome predictors on functional recovery after comprehensive rehabilitation for post-acute care -cerebrovascular diseases.

The investigators will collect 165 acute stroke patients who suffer from stroke within one month and have potential of rehabilitation. The participants will be divided into mild, moderate and severe groups according to Modified Rankin Scale (MRS). The patients are admitted for 6 weeks or extend to 12 weeks if necessary after evaluation. Comprehensive rehabilitation programs including Physical Therapy (PT), Occupational Therapy (OT) or Speech Therapy (ST) will be done for two hour each every day and 5 days per week for 6-12 weeks. Initial assessment will be done within 3 days and the following assessment will be done 6 weeks or 12 weeks after rehabilitation intervention by physician and well-trained therapists. We collect basic data including sex, age, etiology of stroke, affected side, premorbid functional condition, onset time, initial function on admission, Brunnstrom stage, Charlson Comorbidity Scoring and intensity of rehabilitation. Functional assessment including: Modified Rankin Scale (MRS); Barthel Index; swallowing and feeding function, Mini Nutrition Assessment; Euro QoL-5D; Lawton-Brody IADL Scale; Berg Balance Scale (BBS); Gait speed; 6 minutes walking test; Revised Nottingham sensory assessment(RNSA); Mini-mental state examination (MMSE); Motor Activity Log(MAL); Canadian Occupational Performance Measurement(COPM); aphasia evaluation. Data analysis will be done by two-way ANOVA, paired t test, regression and multiple variant analysis.

Eligibility Criteria:
Inclusion Criteria:

* stroke patients who suffer from stroke within one month and have potential of rehabilitation
* PT, OT or ST will be done for two hour each every day and 5 days per week for 6-12 weeks.

Exclusion Criteria:

* Onset over 6 months
The Axillary Region in a High Resolution MRI

The axillary region is regularly used for brachial plexus block. The technique may be guided by nerve stimulation, ultrasound or a combination of nerve stimulation and ultrasound. Magnetic resonance imaging (MRI) has been beneficial in presenting anatomy of interest for regional anesthesia and in demonstrating spread of local anesthetic (LA). An axillary MRI-study at our department supported the suggestion of multiple rather than a single injection technique. Using a 0.5 Tesla open MR scanner in that study, the investigators were not able to distinguish terminal nerves from equally sized vessels. Therefore the investigators could not definitely answer whether the LA reached the pertinent nerves. The investigators have recently performed an axillary block study with a 3.0 Tesla scanner. Now the terminal nerves were identified and for each patient the investigators could observe if the LA reached the nerves.

The aim of this study was to demonstrate the anatomy of the brachial plexus in the axillary region at different levels. The investigators present the best pictures of the nerves with and without LA injected. The images are demonstrated in the axial and coronal plane.

For upper limb surgery, the brachial plexus can be blocked at the interscalene, supraclavicular, infraclavicular and axillary level as an alternative to general anesthesia. The axillary block requires more deposits to achieve a complete block. MRI investigations are of interest to better understand the block specific distribution of LA. With the new MRI Achieva 3.0T X-series (Philips Electronics, Eindhoven the Netherlands), with resolutions beyond 100μm using 2k imaging, we expected new information also compared with the earlier axillary MRI publication from our department. In that former study we used a single deposit technique in an open 0.5 Tesla scanner. We could not in that study recognize the terminal nerves or determine if the LA reached the axillary plexus.

MRI publications of the brachial plexus mostly study the shoulder region and few are describing the axillary region. We did not find any article describing the axillary brachial plexus using a 3.0 Tesla high resolution MRI.

Ultrasound visualizes the plexus nerves in the axilla and demonstrates dynamically the spread of LA. This usually occurs in 2-dimensional images where the initially observed LA fades after some minutes. MRI provides more easy 3 - dimensional images also in oblique planes compared with ultrasound.

This study was done in order to demonstrate the relevant anatomy in the volunteers and the spread of LA in patients. We also present the used protocols and MRI - stacks after having optimized the configuration of the 3.0 MRI scanner.

Eligibility Criteria:
Inclusion Criteria:

* ASA 1 - 2.
* Anatomic volunteers or patients scheduled for hand surgery

Exclusion Criteria:

* Nerulogic disease or sequela
Use of Electroconvulsive Therapy (ECT) in Chronic, Severe, Treatment Resistant Posttraumatic Stress Disorder

Post Traumatic Stress Disorder is a chronic debilitating illness and few treatment options have demonstrated effectiveness. The study will look at the use of electroconvulsive therapy for the treatment of Post Traumatic Stress disorder in patients who have not responded to multiple antidepressants or cognitive behavioral therapy.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of PTSD
* Treatment resistance to 4 different antidepressants from 3 different classes
* Treatment resistance to CBT
* Severe PTSD

Exclusion Criteria:

* Significant substance abuse
* Pregnancy
* History of Traumatic Brain Injury
* Unstable comorbid medical illness
* Organic brain syndrome
A Cohort Study of Patients With Intracranial Hemorrhage

As one of the most serious forms of acute stroke, the early mortality rate of intracerebral hemorrhage(ICH) can be as high as 30-40%. The incidence of intracerebral hemorrhage increases with the increase of age. Under the circumstance of the aggravation of aging in China, intracerebral hemorrhage brings a certain burden to families and society.

The results of several studies in recent years have failed to provide new therapeutic approaches for the treatment of cerebral hemorrhage. Therefore, novel therapeutic approaches is urgently needed for ICH. Primary and secondary prevention, acute inpatient care, and poststroke rehabilitation are all critical. The objective of this cohort study is to explore factors that might influence the long-term prognosis of patients with ICH and to further identify new potential targets for intervention.

The observational cohort study will be used to find the possible treatment methods and predictors of functional outcome. The medical records of patients will be collected, including age, sex, comorbid conditions, toxic habits, use of medications (antiplatelets, anticoagulants, and antihypertensives), systolic and diastolic blood pressure, Glasgow Coma Scale (GCS) score, and National Institutes of Health Stroke Scale (NIHSS) score on admission. Image data will also be collected. Follow-up information will be obtained from the medical records or telephone interviews.

Eligibility Criteria:
Inclusion Criteria:

* Primary intracerebral hemorrhage
* Over 18 year-old

Exclusion Criteria:

* Secondary intracerebral hemorrhage, such as aneurysmal, hemorrhagic transformation of ischemic stroke, cavernomas, arterio-venous malformations, central venous thrombosis, trauma-related, or tumor.
* Pregnant patients.
* Any condition which, in the judgment of the investigator, might increase the risk to the patient.
Changing Portion Size Descriptions in a Cafeteria

The goal of this this intervention is to test the degree to which a portion size labeling intervention influences consumer selection of smaller portions at two large cafés. The main question it aims to answer is: Do consumers order fewer calories when the portion size label for the smaller entree is called "standard" instead of "small"?

Participants will order lunch as usual in the two cafes (one intervention, one control) for 5.5 months, and all order items will be recorded in the check-out system. One cafe will receive the labeling intervention, while the other will not. Researchers will compare the average calories per order between the two cafes to see if there are differences.

The investigators will work with two cafés that will start offering two size options for their entrées. The cafés will go through three phases: a baseline phase where there are two portion sizes and no intervention (6 weeks), an intervention phase where the portion size labeling strategy will be implemented (7 weeks), and then a final phase where the portion size intervention is removed (7 weeks). During the baseline period, the smaller-sized entrée will not receive a label, and the larger-sized entrée will be called "Large." During the intervention period for the control café, labeling will stay the same, but in the intervention café, the smaller size will be labeled "Standard" and the larger size will be called "Large." In the post-intervention period, the smaller-sized entrée in the intervention café will have no label so that it resembles the control café.

Eligibility Criteria:
Inclusion Criteria:

* All customers who make a lunch purchase at the cafes

Exclusion Criteria:

* Purchases made outside of lunch service.
Quick Skin Sealant in Closure of Surgical Wound After Laparoscopic Surgery

The purpose of this study is to evaluate the short-term effect of sealant-assisted skin closure in prevention of surgical site infection after laparoscopic surgery.

* Study design: A prospective cohort study
* Populations: Patients who have confirmed diagnosis of gastric cancer, colorectal cancer, gastrointestinal stromal tumor (GIST), inflammatory bowel disease and diverticula decide to receive laparoscopic surgery.
* Surgical techniques: laparoscopic operations should be successfully performed with a 3-4 cm minimal incision left for sample retrieval. In all, about five trocar-associated mini incisions and a sample-retrieval incision would be left prior to skin closure.
* Skin closure: A quick skin sealant would be applied to achieve a seal, without any suture made under the skin.
* Postoperative treatment: An enhanced recovery after surgery (ERAS) bundles would be applied for enrolled subjects. As for wound management, additional wound cares are not required. Patients can take shower at postoperative day 3 (POD3).
* Primary endpoint: The primary study endpoint is freedom from surgical site infection (SSI) within 30 days. The incidence of surgical site infection with the first 30 days after surgery would be explored.

Eligibility Criteria:
Inclusion Criteria:

* The informed consent has been obtained from the patient.
* With confirmed diagnosis of gastric cancer, colorectal cancer, gastrointestinal stromal tumor, inflammatory bowel disease and diverticula.
* Endurable laparoscopic surgery without conversion.
* With moderate/good ECOG health rating (PS): 0-1 score.

Exclusion Criteria:

* Pregnant woman or lactating woman.
* With confirmed distant metastasis in liver, lung, bones, or other organs.
* Intolerable laparoscopic operation or converted to open surgery.
* With severe comorbidities, such as cardiovascular disease, chronic obstructive pulmonary disease, diabetes mellitus, and chronic renal dysfunction.
* With bad compliance or contraindication to enrollment.
Triamcinolone Assisted Anterior Vitrectomy

Injecting Triamcinolone acetenoide for visualizing and removing vitreous from the anterior chamber.

The research followed the tenets of the Declaration of Helsinki, ;informed consent were obtained from patients where all details of the procedure were explained with emphasis on the intended outcome. The research was approved by the institutional review board.

Ten eyes of 10 patients were divided into 2 groups. Group A included 6 eyes of 6 patients with accidental rupture of posterior capsule during cataract surgery (5 eyes underwent phacoemulsification technique and one underwent ECCE). Group B included four eyes of 4 patients undergoing anterior segment reconstruction (anterior vitrectomy, secondary IOL Implantation and iris repair by direct approximation using 10/0 prolene sutures). In group A the mean age was 68.1 ± 10.93 years (range 47 to 79 years), 3 were males and 3 were females. In group B the mean age was 14 ± 5.6 years (range 9 to 22 years), 3 were males and one female. Demographic data and pre-operative Information are presented in table 1 and 2.

In all patients triamcinolone acetonide was prepared by keeping the bottle vertical to allow sedimentation of crystals thus removing the vehicle. It was then injected into the anterior chamber (2 ml with concentration 20 mg/ml) just prior to anterior vitrectomy. The direction of the tip of the needle was kept away from the corneal endothelium to minimize endothelial toxicity. Triamcinolone was removed as quickly \& completely as possible after finishing anterior vitrectomy.

Postoperative regimen included topical steroids and antibiotics for about 4-6 weeks. Topical anti-glaucoma drugs were used in cases of high postoperative IOP for few days until stabilization of IOP. Follow up period ranged from 2 months up to 27 months.

Eligibility Criteria:
Inclusion Criteria:

* Patients with vitreous in the anterior chamber whether in

  * complicated cataract surgery
  * disorganized anterior segment structures

Exclusion Criteria:

* Glaucoma patients
* Intra ocular infections
* Bacterial or fungal
Improving Outcomes in PICS With Home-Based Program of Rehabilitation and Health Coaching

The purpose of this study is to gather information on the effectiveness of a home-based rehabilitation program that also includes health coaching in patients who may suffer from post-intensive care syndrome (PICS). Many patients who are admitted to a hospital ICU suffer from new or worsening symptoms related to their medical condition and ICU care. These new or worsening symptoms may persist for some time and are collectively called post-intensive care syndrome (PICS).


Eligibility Criteria:
Inclusion Criteria:

* Adults (age ≥ 18) with PICS defined as admitted to the ICU for more than 48 hours with any of the following conditions: respiratory failure of any cause requiring mechanical ventilation ≥ three days, any shock requiring vasopressors and/or inotropes, development of delirium during the ICU stay, , and cardiac arrest during the index hospital admission.
* A HABC-M-SR score \> 12 points.

Exclusion Criteria:

* Any mechanical ventilation in the last two months before the index ICU admission
* ≥ 5 days in the ICU over the previous month before the index ICU admission
* Receiving hospice or palliative care
* Severe uncontrolled psychological or psychiatric disorders, e.g., schizophrenia, bipolar disorder, struggling to cope as a result of their personality disorder, uncontrolled substance abuse (alcoholism, illegal drugs) homelessness would make them unsuitable for the intervention
* A co-morbidity so severe it would prevent the patient from engaging fully in the intervention/ control, e.g., progressive cancer, anoxic brain injury, severe rheumatoid arthritis or osteoarthritis, multiple sclerosis, chronic widespread pain syndrome, previous cerebral vascular event that the patient would not be able to participate in PR
* Patients with moderate/severe cognitive impairment per medical records screening
* Inability to obtain informed consent.
Metabolic Impact of Intermittent Fasting in Early Type 2 Diabetes

One known cause of type 2 diabetes (T2DM) is beta-cell dysfunction, which refers to the inability of the beta-cells of the pancreas to produce enough insulin for the body's needs. Unfortunately, no anti-diabetic medication or lifestyle intervention has been shown to prevent the worsening of beta-cell function over time. Interestingly, however, intermittent fasting (IF) - where no food is consumed over a period of time - has been shown to promote weight loss and improve cardio-metabolic function. In individuals with T2DM, it is also been shown to improve glycemic control (i.e. reduce the sugar levels). While no research has studied whether IF can improve pancreatic beta-cell function, the positive metabolic effects suggest that it could provide some benefit. The current study will evaluate whether IF can improve pancreatic beta-cell function in individuals with early T2DM.


Eligibility Criteria:
Inclusion Criteria:

* Men and women with type 2 diabetes mellitus diagnosed within preceding 10 years
* Age 20-70 years inclusive
* Body mass index ≥ 25 kg/m2
* Diabetes treatment consisting of lifestyle only, metformin or dipeptidyl peptidase-4 (DPP-4) inhibitor either as monotherapy or in combination
* HbA1c value of 5.5 - 9.0% inclusive

Exclusion Criteria:

* Current diabetes treatment with insulin, glucagon-like peptide-1 receptor agonists, sodium-glucose co-transporter 2 (SGLT-2) and/or sulfonylureas
* Involvements in any other clinical study on lifestyle intervention or requiring drug therapy
* Any history or eating disorder
* Renal dysfunction as evidenced by estimated glomerular filtration rate \<45 mL/min by Modification of Diet in Renal Disease (MDRD) formula
* Hepatic disease considered to be clinically significant (includes jaundice, chronic hepatitis, or previous liver transplant) or transaminases \>2.5x the upper limit of normal
* Malignant neoplasm requiring chemotherapy, surgery, radiation or palliative therapy within the previous 5 years (with the exception of basal cell skin cancer)
* Any other factor likely to limit adherence to the study, in the opinion of the investigators
Tolerance of Regular Meal Intake With Mycoprotein (TOMMY)

This study aims to assess the impact of daily intake of 11 grams of Fermotein™ on gastrointestinal complaints and several other health related biomarkers. Furthermore, consumer acceptance is investigated. The study has a randomized parallel design. Two different treatments will be evaluated e.g. a 18-day intervention with fermotein based meals and a 18-day intervention with control meals. At the start and at the end of the intervention, a blood sample will be collected. Questionnaires about gut complaints, stool consistency and frequency, wellbeing, health complaints or other adverse effects will be collected daily during intervention and up to two days after the intervention.

Fermotein™ is a mycoprotein, derived from fungi, especially produced for human consumption. It is high in protein, high in fiber, low in saturated fat and contains no cholesterol. Its functional properties and nutrient content makes them ideal to use as an ingredient for meat alternatives and other vegetarian/vegan food products. This study aims to assess the impact of frequent intake of 11 grams of Fermotein™ powder (dry) on gastrointestinal complaints and several other health related biomarkers.

The primary objective is to investigate gastro-intestinal complaints during 18 days of Fermotein™ consumption. The secondary objective is to assess blood based parameters related to general health and consumer acceptance.

The study has a randomized parallel design. Two different treatments will be evaluated e.g. a 18-day intervention with Fermotein™ based meals and a 18-day intervention with control meals. At the start and at the end of the intervention a blood sample will be collected. Questionnaires about gut complaints, stool consistency and frequency, wellbeing, health complaints or other adverse effects will be collected daily during intervention and up to two days after the intervention.

Eligibility Criteria:
Inclusion criteria:

* Apparently healthy men and women (based on questionnaire)
* Age between 18 and 70 years
* Body mass index (BMI) between 18.5 and 29.9 kg/m2

Exclusion criteria:

* Any metabolic, gastrointestinal, inflammatory or chronic disease (such as diabetes, anaemia, hepatitis, cardiovascular disease), judged by the medical doctor
* History of gastro-intestinal surgery or having (serious) gastro-intestinal complaints
* History of liver dysfunction (cirrhosis, hepatitis)
* Kidney dysfunction (self reported)
* Use of medication that may influence the study results, such as gastric acid inhibitors or laxatives
* Reported slimming or medically prescribed diet
* Current smokers
* Alcohol intake over 4 glasses of alcoholic beverages per day
* Pregnant, lactating or wishing to become pregnant in the period of the study (self-reported)
* Abuse of illicit drugs
* Having food allergies
* Participation in another clinical trial at the same time
* Being an employee of the department Consumer Science and Health group of Wageningen Food and Biobased Research
Trial of IW-1973 (A Stimulator of Soluble Guanylate Cyclase (sGC)) in Healthy Volunteers

Stage 1: To assess the safety, tolerability, pharmacokinetic (PK) profile, and pharmacodynamic (PD) effects of the IW-1973 Tablet administered orally to healthy volunteers, in fed and fasted states, in a single-dose crossover study.

Stage 2: To assess the safety, tolerability, PK profile, and PD effects of a range of doses of IW-1973 Tablet administered orally to healthy subjects in a 21-day, multiple ascending-dose study with optional up-titration of dose level within cohort.


Eligibility Criteria:
Inclusion Criteria:

* Subject is an ambulatory male or female between 18 and 55 years old at the Screening Visit
* Subject's body mass index score is \> 18.5 and \< 30.0 kg/m2 at the Screening Visit
* Women of childbearing potential must have a negative pregnancy test and must agree to use double-barrier contraception
* Subject is in good health and has no clinically significant findings on a physical examination
* Other inclusion criteria per protocol

Exclusion Criteria:

* History of any clinically significant medical condition
* Other exclusion criteria per protocol
EUS Guided Coil Embolization for Primary Prophylaxis of Gastric Varices

The standard treatment of bleeding gastric varices is obliteration with placement of coil and glue. Our study will evaluate the efficacy of EUS guided coil as primary prophylaxis for high-risk gastric varices. All procedures will be performed with patient under deep sedation or general anaesthesia under the supervision of an anaesthesiologist.

In this study Principal investigator recruiting patients with high-risk gastric varices for primary prophylaxis. Gastric varices are dilated submucosal veins in the lining of the stomach, found in patients with portal hypertension or elevated pressure in the portal venous system. The standard treatment of bleeding gastric varices is obliteration with placement of coil and glue. Our study will evaluate the efficacy of EUS guided coil as primary prophylaxis for high-risk gastric varices. All procedures will be performed with patient under deep sedation or general anaesthesia under the supervision of an anaesthesiologist. After the procedure patients will be discharged to home unless there is any indication for admission, such as significant abdominal pain, bleeding or chest pain. For enrolment into the study, patient has to sign an informed consent form which is provided at the end. First, we will do baseline evaluation of the patient which includes detailed clinical examination, routine laboratory tests, Upper GI Endoscopy, triphasic CT abdomen. The duration of study is 6 months. Only the routine tests necessary for the management of disease will be charged.

Eligibility Criteria:
Inclusion criteria: -

Each patient must meet all the following criteria to be enrolled in this study:

1. Gastric fundal varices larger than 2.0 cm in total diameter
2. High risk GV (GOV 2/IGV 1)
3. Primary prophylaxis
4. Patients with known fundal varices
5. Ability to give a signed informed consent

Exclusion criteria: -

The exclusion criteria for these volunteers will be:

1. Patients with a history of TIPS or any other portosystemic shunt procedure
2. Oesophageal stricture
3. Patient not fit for general anaesthesia
4. Secondary prophylaxis
5. Pediatric Patients (\<18 years)
6. Pregnant or lactating mother
7. Not willing to participate