cyrilzakka/clinical-trials huggingface dataset:
Effect of Active-Passive Trainer Cycling on Multiple Sclerosis

This randomised controlled trial aims to explore the effectiveness of a four week programme of exercise using lower limb Active Passive trainer (APT) (MOTOmed trainer) in terms of spasticity in people with moderate to severe Multiple Sclerosis.

Exercise is beneficial for people with Multiple Sclerosis (pwMS). However, exercise options for those with moderate to high levels of disability are limited. Cycling, delivered with an Active Passive Trainer (APT) is one exercise option often offered within rehabilitation/exercise settings and many pwMS buy APTs for home use. Anecdotally, pwMS report they feel better and their spasticity reduces after APT cycling, however there is a lack of evidence to support this.

30 pwMS will be recruited from the Physical Disability Rehabilitation Unit at the Queen Elizabeth University Hospital, Glasgow, and randomised to APT + usual care or usual care only. Those in the APT group will receive 30 minutes of APT (2 mins passive warm up, 26 mins active cycling and 2 mins passive cool down), five days per week for 4 weeks. Outcome measures will be cardiovascular fitness measured using the oxygen uptake efficiency slope (OUES), spasticity assessed by Modified Ashworth Scale (MAS) and the Multiple Sclerosis Spasticity Scale (MSSS-88), function assessed by the Functional Independence Measure (FIM) and the Timed 25 foot walk test (T25FW), Quality of Life measured by MSQOL-54. Outcome measures will be assessed in both groups before and after the 4 week intervention period. Symmetry, distance cycled and power will be recorded following each cycling session in the intervention group.

Eligibility Criteria:
Inclusion Criteria:

* have a confirmed diagnosis of progressive MS
* are aged over 18 years
* have an Expanded Disability Status Scale (EDSS) of between 6.5 (requires two walking aids - pair of canes, crutches, etc - to walk about 20m without resting) and 8.5 (essentially restricted to bed much of day); has some effective use of arms (retains some self care functions) and spasticity in their lower limbs (self reported)

Exclusion Criteria:

* cognitive impairment (cannot understand instructions)
* other co-morbidities which would preclude them taking part in exercise
* visual impairment (such that they cannot see the screen on the APT)
Efficacy and Safety of Danoprevir/r + PR 12-week Triple Therapy in Treatment-Naive, Non-Cirrhotic, G1 CHC China II

The purpose of this study is to evaluate the Efficacy, Safety and Pharmacokinetics of Ritonavir-boosted Danoprevir (ASC08) in Combination with Peg-IFN and RBV in Treatment-Naive Non-Cirrhotic Patients Who Have Chronic Hepatitis Genotype 1.


Eligibility Criteria:
Inclusion Criteria:

* Willing and able to provide written informed consent
* Chronic HCV infection (≥ 6 months) ;
* Positive HCV antibody
* Serum HCV RNA of ≥ 1 × 104 IU/mL
* Hepatitis C virus GT1
* Never received prior-treatment for HCV with interferon, RBV, or other direct-acting or host-targeting antivirals for HCV
* The liver biopsy methods in the protocol (non-cirrhosis is defined as: Metavir score ˂ 4), or as determined by Fibroscan defined as: ˂ 14.6 kPa. Patients who have not obtained a liver biopsy or Fibroscan in the last 1 years will have a study related Fibroscan performed in order to confirm the diagnosis
* Others as specified in the detailed protocol

Exclusion Criteria:

* Patients with Fibroscan detection value \> 12.9 kPa, or histologic examination for liver cirrhosis patients
* Presence or history of non-hepatitis C chronic liver disease, including but not limited to, autoimmune hepatitis, α-1-antitrypsin deficiency, C282Y homozygous hemochromatosis, Wilson's disease, drug- or toxin-induced liver disease, alcohol-related liver disease, primary biliary cirrhosis, sclerosing cholangitis, and porphyria cutanea tarda causing liver pathology or requiring phlebotomy
* Patients with a history of liver cell cancer, screening before or screening suspected hepatocellular carcinoma (HCC) patients, or imaging studies found suspicious nodules, or AFP \> 50 ng/mL
* Positive hepatitis A antibody，positive hepatitis B surface antigen，syphilis antibody or HIV antibody at screening
* Others as specified in the detailed protocol
Evaluating Household Food Behavior With a Smartphone App

The purpose of this study is to test the use of a smartphone app as a way to measure food waste.

Investigators propose to improve the accuracy and convenience of household food waste measurement so that consumer food waste program evaluations yield more power, less bias, less measurement error, and greater representation of targeted populations.

Investigators will improve measurement via the development of the FoodImage smartphone app, a technology leveraging the investigators' expertise in creating and deploying apps to measure food intake and deliver nutritional interventions in free-living household conditions. Investigators will validate the app against weighed waste in a controlled laboratory setting.

The study will yield an app ready for future study deployment while analyses of the data will inform rapidly evolving policy discussions concerning optimal approaches to reduce food waste. These outcomes align with program priorities to understand the economics of food waste and to use behavioral economics to address consumption behavior.

Specific objectives include:

1. Development of FoodImage, a smartphone app that measures household food waste and food-waste-related behaviors,
2. Assess differences in the accuracy and time burden of measurements taken with the FoodImage app versus two current household food waste measurement approaches (a pen-and-paper diary, and a pen-and-paper diary with a scale).
3. Use the FoodImage app in a pilot randomized controlled trial designed to evaluate the effectiveness of reducing household food waste through behavioral nudges in the form of personalized feedback about food waste levels and household-specific reduction goals.

Eligibility Criteria:
Inclusion Criteria:

* age 18-65 years
* body mass index 18.5 - 50 kg/m2, based on self-reported height and weight
* Shops for groceries
* Conducts some of the food shopping and food preparation for their household
* Be willing to do food shopping for the study (if necessary)
* Have an iPhone and an operable Apple ID, password, and email address and is willing to use these to collect data during the study, acknowledging that data usage, and associated charges, are a result of study participation
* Be willing to complete all study procedures corresponding to their randomization group

Exclusion Criteria:

In addition to those who do not meet inclusion criteria, subjects who meet any of the following criteria will be excluded from enrollment:

* Persons who are severely immune compromised
* Persons who are pregnant, as assessed by self-report
* Pennington employee
Assess Safety & Efficacy of WC3055 in Men With Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia

The purpose of this study is to evaluate the safety and efficacy of various fixed daily doses of WC3055 compared with placebo for the treatment of subjects with LUTS secondary to BPH.


Eligibility Criteria:
Inclusion Criteria:

* History of LUTS for ≥6 months secondary to BPH
* Total IPSS (International Prostate Symptom Score) ≥ 13 at Screening

Exclusion Criteria:

-
Fecal Microbiota Transplantation for Patients With Chronic Widespread Pain

This study aims to explore the effect of Fecal Microbiota Transplantation (FMT) on the clinical symptomatology in Chronic Widespread Pain (CWP), to assess the acceptability, tolerability, and safety of FMT in patients with CWP, as well as explore the effect of FMT on the gut microbiome diversity in CWP. The investigators hypothesize that fecal microbiota transplantation will reduce pain intensity in patients with CWP, is acceptable, safe, and tolerable in patients with CWP, and will achieve change of gut microbiome diversity after FMT treatment.

In this proposed proof-of-concept pilot study, the investigators capitalize an establish chronic pain cohort to explore the effect of FMT in improving the pain symptomology in patients with CWP. This will be a 12-week single-arm prospective interventional study, all study subjects will receive 3 FMT infusions (N =20).

Eligibility Criteria:
Inclusion Criteria:

• Participants aged ≥ 18 with diagnosis CWP; A modified version of the London Fibromyalgia Epidemiology Study Screening Questionnaire (LFESSQ) will be used to screen for the presence of CWP.

Exclusion Criteria:

* Patients with fibromyalgia, a subgroup with complex neurobiological, behavioural and psychological factors on its pathogenesis, will be excluded.\[8\] This will be based on The American College of Rheumatology 2010 when subjects with CWP but with a widespread pain index (WPI) of ≥ 7 and a symptom severity scale (SSS) score of ≥ 5 or a WPI between 3 and 6 and an SSS score of ≥ 9.
* Patients have a history of inflammatory bowel disease or gastrointestinal malignancy
* Patients have previous abdominal surgery (other than cholecystectomy or appendectomy)
* Patients have depression defined by having a Patient Health Questionnaire-9 (PHQ-9) score \> 15
* Patients have anxiety defined by having a Generalized Anxiety Disorder 7 (GAD7) score \> 10
* Patients have active infection at the time of inclusion
* Patients have used antibiotic therapy or anti-inflammatory drugs within the past 7 days
* Patients have any other organic causes that can explain the symptoms of CWP
* Current pregnancy
* Confirmed current active malignancy or cancers
* Pregnancy test negative for all female patients of child-bearing potential (except postmenopausal patients and sterilized patients).
The Effect of Omega 3 Supplements Comparison With Warm Compression in Patients With Dry Eye Disease

dry eye disease is a common condition characterized by tear film instability and ocular surface inflammation. Omega 3 fatty acid and hot compression are two common tratement for dry eye diseases

to investigate the cost effective and efficient treatment for dry eye diseases, During regular visit of patient assessment will be carried out to diagnose disease ,ocular findings and cause of visit .

Eligibility Criteria:
Inclusion Criteria:

* Young adults (20-39) years diagnosed with dry eyes and willingness to participate with no ocular surgery and infection from last 2 weeks Children

Exclusion Criteria:

* People having supplements
* Patients having diet with omega 3 for 1 month
* Patients who has undergone glaucoma treatment
* Already receiving treatment of dry eyes
* Patients with any ocular surgery
Effects of Intravenous (IV) Omadacycline on Gut Microbiome

Given the clinical need to improve upon current antibiotic regimens for the treatment of C. difficile infection with a particular focus on the impact of therapies on gut microbiome, this study proposes to characterize the impact of Intravenous (IV) omadacycline on gut microbiome of healthy volunteers.

The plan to enroll eight healthy volunteers between the ages of 18 and 40 years and without history of cardiovascular, gastrointestinal, hepatic, or renal disease to receive 5 days of intravenous omadacycline followed by 5 days of oral omadacycline. Stool and saliva samples will be collected at pre-specified times and analyzed to characterize the impact of IV omadacycline on gut microbiome.

Eligibility Criteria:
Inclusion Criteria:

* 18-40 years of age
* Willing and able to comply with all study procedures
* Considered healthy without history of cardiovascular, gastrointestinal, hepatic, or renal disease
* males or females - females of child bearing potential must agree to use a highly effective contraception during the study and for at least 7 days after the last dose of omadacycline

Exclusion Criteria:

* Consumed probiotics within 30 days before enrollment
* Consumed antibiotics within 90 days prior to enrollment
* Known hypersensitivity to omadacycline or tetracycline-class antibiotics
* pregnant or breastfeeding
* in the opinion of the investigator is experiencing signs or symptoms of acute illness that increase the risk of adverse effects from participating in the study
* previously participated in the study
Study of BGB-A333 Alone and in Combination With Tislelizumab in Advanced Solid Tumors

BGB-A333 is a humanized IgG1-variant monoclonal antibody against programmed cell death 1-ligand 1 (PD-L1), the ligand of an immune check point- receptor, programmed cell death-1 (PD-1). BGB-A317 is a humanized, IgG4-variant monoclonal antibody against PD-1. This study tested the safety and anti-tumor effect of BGB-A333 alone and in combination with BGB-A317 in participants with advanced solid tumors.


Eligibility Criteria:
Key Inclusion Criteria:

1. Histologically or cytologically confirmed advanced or metastatic disease (unresectable) that is resistant to standard therapy or for which treatment is not available, not tolerated or refused
2. Has Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1
3. Has adequate organ function

Key Exclusion Criteria:

1. Active brain or leptomeningeal metastasis.
2. Active autoimmune diseases or history of autoimmune diseases that may relapse.
3. With severe chronic or active infections requiring systemic antibacterial, antifungal or antiviral therapy, including tuberculosis infection, etc. (antiviral therapy is permitted for participants with hepatocellular carcinoma)
4. Concurrent participation in another therapeutic clinical trial.
5. Received prior therapies targeting PD-1 or PD-L1.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Transnasal Induction of Normothermia in Febrile Stroke Patients

The objective of this study is to evaluate safety and performance of the COOLSTAT® Transnasal Thermal Regulating Device in reducing temperature in a population of febrile subjects who meet the inclusion/exclusion criteria.


Eligibility Criteria:
Inclusion Criteria:

1. Admitted to the Neurosciences Critical Care Unit (NCCU).
2. Patient has ischemic or hemorrhagic stroke, seizure, or metabolic encephalopathy.
3. Patient is orally intubated or has tracheostomy tube and is mechanically ventilated.
4. Planned stay in NCCU \> 24 hours.
5. Must have informed consent from the patient or the legally authorized representative (LAR)

Exclusion Criteria:

1. Age \< 18 years old or \> 95 years.
2. Intubation is contraindicated.
3. With a coagulopathy. INR above 1.5 or PTT above 45 seconds.
4. Hemodynamic instability, including elevated SPB for \>5 minutes despite standard of care interventions (SPB ≥ 160 mmHg for intracerebral hemorrhagic stroke; SPB ≥ 220 mmHg for subarachnoid hemorrhagic stroke or ischemic stroke).
5. History of cryoglobulinemia.
6. History of sickle cell disease.
7. History of serum cold agglutinin disease.
8. Active/ongoing of nose bleeds.
9. Known or suspected pregnancy.
10. Participation in another ongoing investigational study.
11. Prisoners and/or patients for whom no LAR is available.
12. Patient is in airborne/droplet disease isolation protocol.
13. Patient is or suspected to be immunocompromised;
14. Low platelet count defined as \< 100k (thrombocytopenia).
15. Nasal septal deviations (per CT scan; any degree).
16. Chronic rhinosinusitis.
17. Prior skull-based surgery
18. Penetrating cranial trauma.
19. Recent nasal trauma or anterior base skull fracture.
20. Presence of cardiac arrhythmias including: sustained tachycardia defined as heart rate above 120 beats per minute, or sustained bradycardia defined as heart rate below 60 beats per minute.
21. Refractory hypoxemia defined as partial pressure of oxygen in arterial blood (paO2) below 60 torr or oxyhemoglobin saturation below 90% despite endotracheal intubation, mechanical ventilation, and provision of supplemental oxygen of up to 0.60.
22. Refractory hypercarbia defined as partial pressure of carbon dioxide in arterial blood (paCO2) above 50 torr despite endotracheal intubation and conventional mechanical ventilation.
23. History of cardiac arrhythmia as listed above.
24. BMI of ≤ 15 kg/m2 or ≥ 40kg/m2
The Effect of Mindfulness Meditation and Virtual Reality on Laparoscopic Cholecystectomy Patients

This study aims to compare the effects of the Theory of Human Caring based short-term mindfulness meditation and virtual reality on patients scheduled for laparoscopic cholecystectomy.

Anxiety, fear and sleep disorders are frequently encountered conditions in preoperative patient evaluation. Common postoperative problems include pain, sleep disturbances, nausea and vomiting. When these problems are not dealt with effectively, patient comfort and satisfaction are adversely affected, recovery time after surgery and total hospital stay are prolonged, and the time allocated to nursing care increases. Today, it has gained great importance to try to manage these problems with pharmacological and non-pharmacological evidence-based approaches. In particular, nurses need to identify possible problems in both preoperative patient evaluation and postoperative patient follow-up and produce solutions for them. Although it is stated in studies that using easy, effective and safe non-invasive methods such as meditation and virtual reality can reduce the possibility of complications, increase the comfort level of patients, improve the quality of post-surgical recovery, and thus make the surgical process successful, there is no evidence to defend its effectiveness more clearly. more based studies are needed.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old and over,
* To undergo laparoscopic cholecystectomy operation,
* No orientation problem,
* Volunteering to participate in the study.

Exclusion Criteria:

* Conversion from laparoscopic approach to open cholecystectomy in the operating room,
* Complications that may affect participation in the study,
* Taking the patient to the intensive care unit after surgery,
* Refusal to participate in the study.
Healing Touch and Relaxation Therapies in Cervical Cancer Patients

The purpose of this study is to evaluate the effects of healing touch and relaxation therapy on cervical cancer patients undergoing chemotherapy and radiation treatment.

The side effects of chemotherapy and radiation treatment are often severe and can have devastating effects on the mental and physical well-being of cancer patients. This study will determine whether healing touch and relaxation therapy are effective in minimizing the side effects of chemotherapy and radiation treatment in cervical cancer patients.

Participants in this study will receive weekly chemotherapy and daily radiation treatments for 6 weeks. Participants will be randomly assigned to receive either standard care (SC), SC plus relaxation therapy, or SC plus healing touch therapy. The relaxation therapy consists of progressive muscle relaxation and guided imagery. The healing touch therapy involves an energy-based modality in which health care practitioners stimulate the energy fields surrounding the patient. A physician-completed assessment and measures of immune function will be used to assess the well-being and overall quality of life of participants.

Eligibility Criteria:
Inclusion Criteria:

* Stage Ib1-IVa cervical cancer
* Treatment with concurrent chemotherapy and radiation at the University of Iowa Hospitals and Clinics

Exclusion Criteria:

* Immunosuppressive disorders
* Use of immunosuppressive medications
* Transplant recipient
* Metastatic or recurrent cervical cancer
* History of any other type of cancer
Embrace and Quality of Life

A prospective, open, randomized, pilot clinical trial which aims the assessment of quality of life (QOL) in epilepsy outpatients equipped with a wrist-worn biosensor that provides measures of electrodermal activity and accelerometry. These measures are used to automatically detect epileptic seizures that are transmitted to a mobile phone-based system for alerts and recording.


Eligibility Criteria:
Inclusion Criteria:

* male or female aged \>18 years old
* clearcut diagnosis of epilepsy without evidence of non epileptic psychogenic seizure
* primary tonic clonic seizures or focal seizures evolving to generalized tonic clonic convulsion
* seizure frequency \> 1 seizure/month during the last three months
* signed the informed consent form
* own a mobile phone device compatible with the embrace apps
* able to use the device without help from caregivers

Exclusion Criteria:

* patients aged less than 18 years old
* epilepsy diagnosis remains uncertain
* evidence of psychogenic non epileptic seizures
* seizure frequency below 1/month during any of the three previous months
* past-history of nickel allergy and contact dermatitis
* did not sign the informed consent form
* does not own mobile phone device compatible with the embrace apps
* cognitive or behavioral impairment preventing compliance or correct use of the device and app.
Hatha Yoga for Patients With Colorectal Cancer

Hatha Yoga is a traditional practice that encompasses aerobic exercise, breathing techniques, and meditation. It is used in India since centuries to improve well-being and cope with diseases and is gaining more and more interest in Europe and the US. While studies have demonstrated benefits of Hatha Yoga for patients with breast cancer, no studies on patients with colorectal cancer are available yet. The purpose of this study is to investigate the effect of Hatha Yoga in patients with colorectal cancer.


Eligibility Criteria:
Inclusion Criteria:

* Colorectal cancer
* UICC stage I-III
* between 2 and 48 months post-surgery
* age at least 18 years
* physical and cognitive ability to follow the yoga intervention

Exclusion Criteria:

* UICC stage IV
* further active oncological diseases
* diagnosed and pharmacologically treated psychiatric disorder except for cancer-related depression or adjustment disorder
* pregnancy or breastfeeding
The Effect of the Abdominal Corset on Colonoscopy

In patients with central obesity, the effect of the abdominal corset on colonoscopy completeness, cecum and ileum intubation time will be investigated.


Eligibility Criteria:
Inclusion Criteria:

* Above 18 years, Meeting the central obesity criteria Cases where colonoscopy is performed under elective conditions

Exclusion Criteria:

* In case of emergency, The process is terminated due to bad bowel preparation, Inflammatory bowel disease, Serious arrhythmia, Chronic obstructive pulmonary disease Coronary artery disease The previous abdominal surgery
Evaluation of Postoperative Pain After Tension-free Obturator Tape Operation (TVT-O) With or Without Local Anesthetic

BACKGROUND:

Compare the pain intensity after TVT-O procedure in the inner part of the thigh where the anesthetic substance will be injected versus the inner part of of the thigh without anesthetic injection in the same woman.

The advantage of this work is that this method of testing neutralizes the effect of pain thresholds of different women.

If an advantage will be found in injecting anesthetic as a reduction in postoperative pain, it could be recommended for all women who undergo surgery of this kind.

METHODS:

Preoperative women will be offered the opportunity to participate in the study after a detailed explanation of the study and determine a date for an elective TVT-O procedure. After signing the Informed Consent Form, they will undergo a TVT-O procedure with injection of anesthetic into one of the obturators membranes. In a random order, Marcaine 5-ml will be injected into a left or right obturator membrane.

One side with Marcaine (Bupivacaine HCL) 0.5% 5 mg / mL Injection,opposite side without injection of any anesthetic.

Before and after surgery, patients will receive Visual Analogue Scale (VAS) instruction and will be polled at the following time points: 1,6,12,24 hours after surgery per inner part of the thigh separately. Each patient will rate the intensity of the pain she feels on the pain questionnaire at each of the time points mentioned before.


Eligibility Criteria:
Inclusion Criteria:

• Women undergoing TVT-O

Exclusion Criteria:

• Repeat surgery