cyrilzakka/clinical-trials huggingface dataset:
SG Healthcare and Assistive Robotics Programme (SHARP) - Proof of Concept Study

Robots are commonly used in many settings to help with transportation needs, reduce human injuries, and assisting clinicians during surgeries. These applications could provide direct benefits to patients in the clinical rehabilitation field.

In this study, the feasibility of 2 CARE robot prototypes in facilitating dependent transfers and assisting patient mobility in their daily living activities will be studied.

An exploratory proof of concept study involving the development and usability of 2 CARE robot prototypes will be validated in a hospital environment, in a broad range of patients.

The findings from this study will then be used to further refine and develop the robot prototypes for future deployment in other hospitals, nursing homes and homes.

Eligibility Criteria:
Inclusion Criteria:

* Aged 21-85 years
* Primary reason for admission is in /outpatient rehabilitation.
* Admission (within 72 hours) Functional Independence Measure (FIM)(transfer/walk) score of 1-5 or Modified Barthel Index Score (transfer/walk) of 0, 5 or 10.
* Activity tolerance for ambulant patients of \>30 minutes.
* Patient able to sign own consent and understand simple instructions.

Exclusion Criteria:

* Pregnancy or lactation.
* Medical instability, uncontrolled sepsis, orthostatic hypotension, contraindications to verticalization. (unstable spinal fractures, severe pain) weight-bearing on either limb), abdominal aneurysms
* Patients with behavioural problems (agitation, untreated depression, psychiatric problems)
* Skin conditions which could be worsen by the abdominal, trunk, knee and calf cuffs of straps of the CARE robots.
* Patients who are unable to sign own consent or understand simple instructions.
Comparing Thoracolumbar Interfascial Plane Block With Erector Spinae Plane Block

Major spinal surgery causes greater pain in the postoperative 24 hours. Patients with severe pain may have prolonged hospital stays and delay in mobilization. In addition, chronic pain may be seen in these patients due to ineffectively managed acute postoperative pain. Therefore, optimizing acute postoperative analgesia is a priority in patients undergoing major spinal surgery.

Recently, ultrasound-guided interfascial plane blocks such as thoracolumbar interfascial plane block (TLIPB)and the erector spinae plane block (ESPB) have been described in spinal surgery. Both blocks clinically seem to be safe and easily performed. The aims of this study are to compare the quality of recovery scores, overall morbidity and postoperative analgesia after major spinal surgery in patients receiving either TLIPB or ESPB.

Thoracolumbar interfascial plane block (TLIPB)and erector spinae plane block (ESPB) and have been shown to provide effective analgesia after spinal surgery. ESPB targets ventral and dorsal rami of the spinal nerve and also spreads over the paravertebral and epidural space. However, TLIPB targets only dorsal rami of the spinal nerve and spare ventral rami which may provide early ambulation. In addition, depositing local anesthetic in the fascial planes may prevent intraoperative washout. It may translate to an increase in the quality of analgesia. On the other hand, pain is an incomplete measure of postoperative recovery. No study to date has compared these two blocks in terms of the quality of recovery after major spinal surgery. This study will test the hypothesis that patients receiving TLIPB have higher QoR-40 scores in comparison with patients receiving ESPB.

Eligibility Criteria:
Inclusion Criteria:

-≥ 18 years old,

* Undergoing posterior lumbar spinal one to three levels fusion surgery
* Having signed a written informed consent form,
* ASAI-III

Exclusion Criteria:

* Contraindication for regional anesthesia (allergy to local anesthetics, neuropathic disease, infection at the puncture site, coagulation disorder, refusal of the technique,...)
* Contraindication to nonsteroidal anti-inflammatory drugs,
* Patient who has already had a spinal surgery,
* Patient with chronic pain syndrome (use \> 3 months of morphine, opioid analgesics of class 3, pregabalin or gabapentin) or fibromyalgia,
* A mental or linguistic inability to understand the study,
* Pregnant or or breastfeeding women,
* Patient who can not communicate in Turkish
Manual Physical Therapy During Pregnancy on Post Partum Perineal Trauma and Pain

The purpose of this study is to explore the impact of pelvic floor physical therapy during pregnancy on delivery and the impact on the woman's body and function. Currently there have not been any studies to our knowledge that have examined this relationship and the outcomes for the pregnant patient. The current research that is available is on pelvic floor training and perineal massage during pregnancy with positive outcomes. The questions we are looking to answer include:

1. Does pelvic floor physical therapy during pregnancy decrease the severity of perineal trauma during delivery?
2. Does pelvic floor physical therapy during pregnancy decrease the length of the second stage of labor (pushing)?
3. Does pelvic floor physical therapy during pregnancy decrease the occurrence of emergency C-section?

The purpose of this study is to explore the impact of pelvic floor manual physical therapy techniques during pregnancy on delivery and the impact on the woman's body and function. Currently there have not been any studies to our knowledge that have examined this relationship and the outcomes for the pregnant patient. The current research that is available is on pelvic floor training and perineal massage during pregnancy with positive outcomes. Perineal massage is a stretching technique utilized to relax the tissue of the perineum (the area between the vaginal opening and anus), and is considered routine physical therapy standard of care for pregnant women. Myofascial release of the pelvic floor is a specific manual therapy technique to relax the muscles of the pelvic floor which can include the superficial perineal area. Pelvic myofascial release is a technique used for both pregnant women, and women with chronic pelvic pain. In fact, each component of assessment and treatment are routine and standard PT practices (evaluation, manual therapy, exercise, education), however this specific manual therapy treatment protocol has not been studied during pregnancy to assess the benefits on delivery/recovery. The questions we are looking to answer include:

1. Does pelvic floor PT (physical therapy) during pregnancy decrease the severity of perineal trauma during delivery?
2. Does pelvic floor PT during pregnancy decrease the length of the second stage of labor (pushing)?
3. Does pelvic floor PT during pregnancy decrease the occurrence of emergency C-section?
4. Does pelvic floor PT during pregnancy decrease the likelihood and/or severity of postpartum pelvic pain and pelvic dysfunction? By obtaining these findings, it will allow for program design and treatment recommendations within the pregnancy period to minimize delivery trauma and risk for the mother.

Eligibility Criteria:
Inclusion Criteria:

1. Pregnant women (any pregnancy, first or subsequent) planning for a vaginal delivery
2. 28-34 weeks gestation at the start of treatment

Exclusion Criteria:

1. Planned c-section
2. \< 18 years old
3. \>34 weeks gestation
4. Women on pelvic rest
Hemodynamic Alterations in Liver Cirrhosis Validated by Non-invasive MR Compared to Invasive Assessment

Liver cirrhosis is a chronic disease characterized by a progressive accumulation of fibrosis, loss of liver function and portal hypertension leading to several hemodynamic changes.The exact pathophysiological mechanisms causing the hyperdynamic alterations in cirrhosis are not fully elucidated.

Aim:

The aim of the study is to assess hemodynamic alterations in liver cirrhosis by non-invasive MRI and echocardiography compared to portal hypertension measured with liver vein catheterization (HVPG, hepatic vein pressure gradient). Furthermore, the aim is to explore hemodynamic differences between cirrhotic patients and healthy subjects.

Study design and cohort:

The study has a cross-sectional design and a cohort with 99 patients with liver cirrhosis - with and without complications and 27 healthy volunteers. The patients are recruited at the Gastrounit Hvidovre University Hospital.

The day before the first visit patients are hospitalized and fasting overnight. At first visit liver vein catheterization (LVC) and echocardiography are performed. Second visit must be performed within 4 weeks after first visit. At the second visit patients are fasting minimum 6 hours before having MR-flow scanning, cardiac-MR and MR-Elastography (MR-E).

The healthy volunteers are only offered MR-flow scanning, cardiac MR and MR-E as well as urine- and blood tests

Follow-up for liver-related clinical outcome and mortality in medical records

MR elastography, cardiac scan, phase contrast MRI of blood flow compared to LVC

Eligibility Criteria:
Inclusion Criteria:

Patients with liver cirrhosis or portal hypertension Patient of more than 18 and less than 82 years of age

Exclusion Criteria:

Patients who are unable to give informed consent Patients with absolute contraindication for MRI Pregnant women Patient with severe hemodynamic comorbidity
Effects of Dynamic Splinting on Knee Flexion Angle After Total Knee Arthroplasty: A Randomized Controlled Trial

To evaluate the effects of a knee flexion Dynasplint orthosis on knee flexion angle after a total knee arthroplasty. Sixty participants, who underwent a total knee arthroplasty, were randomly assigned in two groups: control group and Dynasplint group.

Post-surgical rehabilitation interventions following total knee arthroplasty consist mainly of stretching exercises to improve flexibility and prevent soft tissue fibroses around the joint, thus, avoiding contractures and providing increases in the range of motion at the knee joint. Although knee manipulation and open arthrolysis may improve range of motion after total knee arthroplasty , the results have been variable and additional procedures are frequently necessary. Studies demonstrated the effectiveness of dynamic orthoses in reducing joint contractures after orthopedic surgeries in various joints that require a long rehabilitation period. Therefore, the purpose of the present study was to evaluate the effects of the knee flexion Dynasplint orthosis (KFD) on the length of rehabilitation and range of knee flexion angle after total knee arthroplasty.

Eligibility Criteria:
Inclusion Criteria:

Patients enrolled will have been schedule to receive first prosthesis of the knee:

Arthritis of the knee, dominated with pain Painful, deformed, and/or unstable knees secondary to degenerative or inflammatory conditions

Exclusion Criteria:

Fractures Knee sepsis Osteomyelitis or any orthopedic infection Psoriasis Knee joint neuropathy Previous Stroke or Brain Injury Significant pathology acquired secondary to the surgery
Evaluation of Protein Intake and Micronutrient Supplementation After Bariatric Surgery

Obesity is a chronic disease in which accumulation of excess body fat can result in impaired health. In cases of severe obesity, weight loss surgery can be necessary as a treatment. There are different forms of surgery but the common basic principle is to restrict food intake and decrease the absorption of food in the stomach and intestines. As a consequence, there is a higher risk of developing nutrient deficiency after surgery and supplementation of protein, vitamins, and minerals can be necessary. This study evaluates intakes of protein, vitamins, and minerals in patients with weight loss surgery and compares them to recommended intakes. Further, this study looks at the role of age, sex, and socioeconomic status in this context.

Obesity is defined by the World Health Organization as abnormal or excessive fat accumulation that may impair health. These days, bariatric surgery is considered the most effective treatment of morbid obesity. In the last decade, the number of bariatric surgeries performed worldwide constantly increased. Common bariatric surgery procedures include gastric bypass, sleeve gastrectomy, adjustable gastric band, and biliopancreatic diversion with duodenal switch. After surgery, weight loss is induced by a reduced food volume the stomach can hold, malabsorption of nutrients, or by a combination of both mechanisms. In consequence, patients with bariatric surgery have an increased risk of developing nutrient deficiency. Therefore, guidelines recommend supplementation of critical nutrients, i.e. protein, vitamins, and minerals, after bariatric surgery. This study assesses intake of these nutrients in patients with bariatric surgery based on the recommendations provided by the German S3 Guideline Group on the Surgical Treatment of Obesity and Metabolic Diseases. In particular, this study assesses the association of therapy adherence with age, sex, and socioeconomic status.

Eligibility Criteria:
Inclusion Criteria:

* Sleeve gastrectomy (postoperative)
* Roux-en-Y gastric Bypass (postoperative)
* Postoperative period \> 6 month

Exclusion Criteria:

* Missing consent
* Pregnancy
* Malignant tumor
* Implanted pacemaker
* Any other serious primary disease
The Use of Prostaglandin E1 in Head and Neck Microsurgery

Prostaglandin E1 (PGE1 )has been shown to have vasodilatation and anti-thrombosis effects, so it is used by some surgeons after microsurgery to keep the patency of the anastomosed small vessels. However, PGE 1 may also causes some complications, like pleural effusion or deep vein thrombosis. Therefore, it remains uncertain whether a routine use of PGE 1 after head and neck microsurgery is justified. We aim to test the hypothesis that PGE 1 increases postoperative vessel patency rate in patients undergoing head and neck microsurgery, with a comparable complication rate as the control group.

Despite meticulous microsurgical techniques, free flap failure due to postoperative vessel thrombosis cannot be completely eliminated. Postoperative pharmacological augmentation of the established blood flow is considered as a feasible solution to this problem. Prostaglandin E1 (PGE1 )has been shown to have vasodilatation and anti-thrombosis effects, so it is used by some surgeons after microsurgery to keep the patency of the anastomosed small vessels. However, PGE 1 may also causes some complications, like pleural effusion or deep vein thrombosis. Therefore, it remains uncertain whether a routine use of PGE 1 in every patient after head and neck microsurgery is justified. We aim to test the hypothesis that PGE 1 increases postoperative vessel patency rate in patients undergoing head and neck microsurgery, and yielded a comparable complication rate as the control group.

Eligibility Criteria:
Inclusion Criteria:

* Patients requiring microvascular reconstruction after head and neck cancer resection

Exclusion Criteria:

* Patients with coagulation dysfunction
Acupuncture and Nausea/Vomiting in Pediatric Patients

The purpose of this study is to investigate the effects of intraoperative P6 acupuncture plus standard therapy on postoperative nausea and vomiting in pediatric patients undergoing tonsillectomy with or without adenoidectomy. 200 children will be randomly assigned to either the treatment or the control group.

1. Treatment Group: Standard anti-emetic therapy plus bilateral P6 acupuncture after the induction of anesthesia
2. Control Group: Standard anti-emetic therapy only

This study will monitor nausea, retching, and vomiting events both directly after the surgery as well as the next day via a follow-up phone call to the parents of the study participant.


Eligibility Criteria:
Inclusion Criteria:

* ASA 1 to 3 physical status
* Undergoing Tonsillectomy and/or adenoidectomy
* Consent obtained from Parent/Guardian

Exclusion Criteria:

* Taking preoperative steroids, including inhalers
* Taking baseline anti-emetics
* History of motion sickness
* BMI \> 35 (morbid obesity)
* Severe OSA (Apnea/hypopnea Index \> 10)
* Have genetic abnormalities
Combination of ETV, TQ-A3334 and TQ-B2450 for CHB (Neptune Study)

This study is a single-center, randomized, prospective, open-label Phase 2 Clinical trial to evaluate efficacy and safety of ETV and TQ-A3334 combinated with/without inhibitor of TQ-B2450 versus ETV alone in chronic hepatitis B patients. Patients were randomized to one of 3 different antiviral treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female patients from 18 to 65 years of age;
2. Chronic hepatitis B infection
3. Negative urine or serum pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of test drug;
4. Agree to participate in the study and sign the patient informed consent.

Exclusion Criteria:

1. Patients who had NAs resistance;
2. Other antiviral, anti-neoplastic or immunomodulatory treatment;
3. Women with ongoing pregnancy or breast-feeding;
4. Co-infection with active hepatitis A, hepatitis C, hepatitis D(Those hospitals which have the ability to do the test will do) and/or human immunodeficiency virus (HIV);
5. ALT \>10 ULN;
6. LSM \>9kPa ;
7. History or other evidence of a medical condition associated with chronic liver disease other than viral hepatitis (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures, thalassemia);
8. Signs or symptoms of hepatocellular carcinoma;
9. Neutrophil count \< 1500 cells/mm3 or platelet count \<90,000 cells/mm3 at screening;
10. Hemoglobin \< 11.5 g/dL for females and \<12.5 g/dL for men;
11. Serum creatinine level \> 1.5 ULN in screening period.
12. Phosphorus \< 0.65 mmol/L;
13. ANA \> 1:100;
14. History of severe psychiatric disease;
15. History of a severe seizure disorder or current anticonvulsant use;
16. History of immunologically mediated disease, (e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, rheumatoid arthritis etc.);
17. History of chronic pulmonary disease associated with functional limitation;
18. Diseases that IFN and Nucleotides or nucleosides are not suitable.
Anti-Nephropathic Effects of Chronic Intermittent Intravenous Insulin Therapy (CIIIT)

Investigators with the goal of optimizing glycemic and blood pressure control saw type 1 diabetic patients weekly. A control group received 3-4 subcutaneous insulin injections per day; an intravenous insulin pulsed infusion group received, in addition, three one hour infusions in a pulsatile fashion over one eight hour period each week. Patients were followed for 12 months with periodic testing of renal function by repeated blood and urinary analyses; diabetes control by blood testing and diabetes impact measurement score; cardiac and autonomic function by echocardiography, 24 hour electrocardiographic testing; and visual changes with repeated fundus photography. The study hypothesis was that correction of respiratory quotient would correct the defect leading to microvascular complications of diabetes (Type 1).


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetics with proteinuria willing to be seen weekly for the evaluation of renal function

Exclusion Criteria:

* Associated active medical diseases that would not permit evaluation of stable renal disease over 18 months
Histopathology Following CCH Injection

To evaluate the histopathology of subcutaneous tissue isolated after single or multiple Collagenase Clostridium Histolyticum (CCH) injection techniques in adult female participants undergoing abdominoplasty.


Eligibility Criteria:
Inclusion Criteria:

1. Be adequately informed and understand the nature and risks of the study and be able to provide consent.
2. Be undergoing planned elective abdominoplasty.
3. Be willing to have their tissue donated for evaluation.
4. Be judged to be in good health.
5. Have a negative pregnancy test.
6. Be willing and able to cooperate with the requirements of the study.

Exclusion Criteria:

1. Is from a vulnerable population, as defined by the US Code of Federal Regulations (CFR) Title 45, Part 46, Section 46.111(b) and other local and national regulations, including but not limited to, employees (temporary, part-time, full time, etc) or a family member of the research staff conducting the study, or of the sponsor, or of the contract research organization, or of the Institutional Review Board (IRB)/Independent Ethics Committee (IEC).
2. Has systemic conditions (coagulation disorders, malignancy, keloidal scar, abnormal wound healing) that restricts study participation.
3. Has local (in the areas to be treated) conditions (thrombosis, vascular disorder, active infection/inflammation, active cutaneous alteration, tattoo/mole) that restricts study participation.
4. Required use of anticoagulant or antiplatelet medication (except ≤ 150 mg aspirin daily) before or during participation in the trial.
5. Past history of any abdominal surgery, including but not limited to: liposuction, caesarean section, appendectomy, cholecystectomy, or umbilical hernia repair.
6. Has used or intends to use any local applications/therapies/injections/procedures that restricts study participation.
7. Is presently nursing or providing breast milk in any manner.
8. Intends to become pregnant during the study.
9. Intends to initiate an intensive sport or exercise program regimen during the study.
10. Intends to use any tanning spray or tanning booths during the study.
11. Has received any investigational drug or treatment within 30 days prior to first injection of study drug.
12. Has a known systemic allergy to collagenase or any other excipient of study drug.
13. Has received any collagenase treatment at any time prior to treatment in this study.
14. Any other condition(s) that, in the investigator's opinion, might indicate the subject to be unsuitable for the study.