cyrilzakka/clinical-trials huggingface dataset:
Development and Clinical Validation of Ketogen-based Therapeutic Diet for Pancreaticobiliary Cancer Patients

Decreased bowel function and loss of appetite in patients who underwent pancreaticobiliary surgery contribute impaired nutritional status in postoperative period. It can also affect perioperative and oncologic outcomes negatively. Therefore it is important to improve nutritional status in postoperative period by supply tailor-made optimal diets. The investigators have developed customized postoperative diets for pancreaticobiliary cancer patients. The investigators expect that customized diets for pancreaticobiliary patients will increase the food intake rate and contribute a improvement of perioperative outcomes and even oncologic outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Adult (age more than 19)
* Pancreaticobiliary cancer patient who is scheduled pancreaticoduodenectomy or distal pancreatectomy
* Pancreatic cancer / Duodenal cancer / Distal bile duct cancer / Ampulla of Vater cancer

Exclusion Criteria:

* Patient who denied clinical trial
* Diabetes Mellitus(DM) patient with DM complication
* Hyperlipidemia patient with vascular co-morbidity
* Impaired renal function or renal failure (GFP\<90%)
An Observational Cohort Study Evaluating Fatty Liver Disease and Liver Fibrosis in Moderate to Severe Psoriasis

• Main objectives and outcome measures.

1. Establish prevalence of and factors contributing to fatty liver disease and liver fibrosis in patients with psoriasis.

   Fatty liver disease diagnosed via ultrasound. Liver fibrosis diagnosed by liver biopsy or non-invasive tests of fibrosis including transient elastography, ultrasound, serum markers of fibrosis including procollagen-3-N-terminal peptide (P3NP).
2. Evaluate non-invasive markers of liver fibrosis in the psoriasis population. Namely transient elastography, standard liver function tests and P3NP.
3. Evaluate the impact of psoriasis disease severity and comorbidities including metabolic syndrome on response to treatment in patients with psoriasis.

Data on co-morbid disease collected through questionnaires and review of medical records. Response to treatment assessed using psoriasis area and severity index (PASI) physician global assessment (PGA) and dermatology life quality index (DLQI).

* Study population: 380 patients with moderate to severe psoriasis will be prospectively recruited to the study.
* Chief investigator: Professor Jonathan Barker. Co-investigator: Professor Catherine Smith
* Sponsor/funding organization: Pfizer and Biomedical Research Centre (BRC) at Guys and St Thomas Hospitals Trust


Eligibility Criteria:
Inclusion Criteria:

* Patients who have given written informed consent
* Psoriasis patients - chronic plaque-type psoriasis; PASI of 10 or above currently or in past.
* 18 yrs. of age

Exclusion Criteria:

* Patients who have not given written informed consent
* Patients under 18 yrs. of age
* Patients with a PASI less than 10.
* Pregnant women
Comparison Between Effect of Acetazolamide and NaHco3 in Prevention of Contrast Nephropathy

The purpose of this study is whether Acetazolamide is effective in prevention of contrast nephropathy

Contrast induced nephropathy is one of common causes of acute renal failure many preventive protocol existed . 240 patient that underwent coronary angiography randomly divided in three groups.Group 1,2,3 will receive Bicarbonate ,Acetazolamide+Normal salin and Normal salin respectively.We compare prevalence of contrast nephropathy in each group.

Eligibility Criteria:
Inclusion Criteria:

* patient that underwent coronary angiography

Exclusion Criteria:

* serum Cr. more than 3 mg/dl
* electrolyte and acid-base imbalance
* pulmonary edema
* allergy to Acetazolamide
Information and Communication Technology (ICT)- Based Centralized Monitoring System of Asthma Control

The aims of this study is to evaluation of the clinical efficacy and stability of Information and Communication Technology (ICT)- based centralized monitoring system of asthma control monitoring in asthma patients. We planed to enroll 100 asthma patients (50 subjects using ICT systems, 50 controls). We will monitor the asthma control status, lung function, exacerbation rate and stability of ICT systems.

This study is based upon work supported by the Ministry of Trade, Industry \& Energy (MOTIE, Korea) under industrial Technology Innovation Program (No. 10059066, 'Establishment of ICT Clinical Trial System and Foundation for Industrialization').

This study has a multi- center, open- label, prospective and randomized clinical trial design. One hundred asthma patients who fill out the informed consent form are registered and randomized 1:1 into the ICT-based centralized clinical trial monitoring group (n=50) or the ambulatory follow-up group (n=50). The planned follow-up duration is 6 months. he ICT-based centralized clinical trial monitoring group is given home based spirometry and connecting system (gateway) equipped with personal identification system. Fingerprint registration is required in advance, so that it would be used for authentication before each use of spirometry. Symptom score and lung functions (FEV1, PEFR) obtained from gateway is saved, monitored, and sent out via a home-monitoring system. In the ICT-based centralized clinical trial monitoring group, feedback is sent to both patients and medical staff in the form of texts if there is a worsening of symptoms score and/or lung function.

Subjects are to make office visits after randomization at 4, (8), 12, (16, 20), and 24 weeks. (ICT group will not visit at the schedules in the brackets) Each visit requires measurement of Questionnaire (ACQ) lung functions.

Eligibility Criteria:
Inclusion Criteria:

* asthma patients diagnosed by doctors
* Current treatment with Inhaled corticosteroid or leukotriene receptor antagonist
* able to give written informed consent prior to participation in the study

Exclusion Criteria:

* Subjects with plan of administration or operation within study periods
* Unstable heart disease and psychical disorder
* refuse the monitoring
Whole Body Vibration for Hemiparetic Cerebral Palsy

This study is to investigate the effect of whole body vibration in children with hemiparetic cerebral palsy on range of motion of shoulder, elbow and wrist and muscle strength of shoulder abductors and flexors, elbow flexors and extensors, wrist extensors and flexors.

Studies show efficacy of whole body vibration in reducing spasticity, improving strength, balance, ankle dorsiflexion angle and gait parameters in post stroke and spinal cord injury patients improving posture and balance in patients with Parkinson's disease and multiple sclerosis. Although research suggests a positive influence of vibration on motor performance in individuals with neurological disorders, there are very limited numbers of studies in children with cerebral palsy.

Few Studies Have Shown improvement in children with cerebral palsy: spasticity decrease as measured by isokinetic dynamometer. Strength of muscles increase as measured by hand held dynamometer. Motor function increase as measured by Gross Motor Function Measure and Gross Motor Function Classification Scale. Increase of the activation and the co- activation of biceps and triceps. Vibrations increase bone mass and muscle strength in upper limbs.

Vibration therapy decreases spasticity and improve motor performance in children with cerebral palsy. Reduce flexors spasticity and improve functions in the rehabilitation of upper limb spasticity. Focal muscle vibration on triceps brachii muscle can reduce the spasticity for both elbow and wrist joint muscles.

So in this study, the investigators are trying to implement an additional rehabilitation method for upper limbs in hemiparetic children to improve their upper limb range of motion and strength which will reflect an improvement in their upper limb functions and activities of daily living.

Eligibility Criteria:
Inclusion criteria:

Children will be included if they have the following:

1. Children diagnosed as hemiparetic cerebral palsy.
2. Children of both sexes in the age group ranging from 3 to 6 years.
3. Spasticity will be grade 1 and 1+ according to modified Ashworth scale.
4. They will be selected with Level I and II according to Gross Motor Function Classification (GMFCS).
5. Children could understand and follow commands given by the therapist.

Exclusion criteria:

Children will be excluded if they have any of the following:

1. History of convulsions and epilepsy.
2. Children with impaired cognitive function.
3. Any surgical procedure for correction of deformity or soft tissue release in the past one year.
nSTRIDE APS Versus Hyaluronic Acid for Knee Osteoarthritis

This is a two-phase multicenter, double-blind, randomized, prospective evaluation of intra-articular injection(s) comparing APS to intra-articular HA injection(s). The maximum study duration for each subject will be 50 months; 48 months from treatment to last follow-up, and two additional months if the maximum visit window is realized. A total of 246 patients will be enrolled. These patients will meet specific inclusion and exclusion criteria, but can be generally characterized as patients with painful unilateral knee OA who have been unable to achieve satisfactory pain relief with previous conservative OA treatment.


Eligibility Criteria:
Inclusion Criteria:

* Male or female at least 18 years of age at time of screening.
* Willingness and ability to comply with study procedures and visit schedules and able to follow oral and written instructions.
* A standing knee radiograph showing a K-L grade of 2 to 4
* Body mass index ≤ 40 kg/m2
* A qualifying WOMAC LK 3.1 pain subscale total score
* Signed an ethics committee-reviewed and approved informed consent form.

Exclusion Criteria:

* Presence of clinically observed active infection in the index knee
* Presence of symptomatic OA in the non-study knee at screening
* Diagnosed with rheumatoid arthritis, Reiter's syndrome, psoriatic arthritis, gout, ankylosing spondylitis, or arthritis secondary to other inflammatory diseases; HIV, viral hepatitis; chondrocalcinosis, Paget's disease, or villonodular synovitis
* Diagnosed with leukemia, known presence of metastatic malignant cells, or ongoing or planned chemotherapeutic treatment
* Presence of venous or lymphatic stasis in the index leg
* A history of local anesthetic allergy
* Previously documented failed treatment with nSTRIDE APS or Synvisc One
Sorafenib Monotherapy vs. TACE-sorafenib Sequential Therapy for HCC With Metastasis

Sorafenib is the standard therapy for hepatocellular carcinoma (HCC) with extrahepatic metastasis (EHM). However, addition of transarterial chemoembolization (TACE) may be beneficial for controlling intrahepatic tumour. The investigators aimed to compare the efficacy between the sorafenib monotherapy and TACE-sorafenib sequential therapy in HCC patients with EHM.

Sorafenib is the standard therapy for hepatocellular carcinoma (HCC) with extrahepatic metastasis (EHM). However, transarterial chemoembolization (TACE) which is a standard therapy for intermediate stage may be beneficial for controlling intrahepatic tumour, thereby providing chance of improving survival in HCC patients with EHM.

The investigators aimed to compare the efficacy between the sorafenib monotherapy and TACE-sorafenib sequential therapy in HCC patients with EHM.

This study is a prospective randomized controlled study being conducted at 6 tertiary hospitals in South Korea. HCC patients with EHM are being enrolled and randomized into sorafenib monotherapy or TACE-sorafenib sequential therapy group. Patients with main portal vein invasion, Child-Pugh class B or C, and history of TACE or previous systemic therapy are being excluded. The sorafenib monotherapy group receives sorafenib immediately after randomization while the TACE-sorafenib group receives 2\~4 times of TACE before starting sorafenib. Response evaluation are performed every 2 months, and time to progression (TTP), progression free survival (PFS), median survival time (MST), and overall survival (OS) which is the primary outcome measure will be compared.

Eligibility Criteria:
Inclusion Criteria:

* Patients with hepatocellular carcinoma by the European Association for the Study of the Liver (EASL) criteria or pathology
* One or more extrahepatic metastatic lesion by proven radiologically or histologically
* No serious coagulation abnormalities
* Performance status 0 or 1 by Eastern Cooperative Oncology Group(ECOG) criteria
* Child-Pugh score 5 or 6
* Serum creatinine \<1.5mg/dL
* Age between 18 \~ 75 years old
* No other life-threatening medical illness

Exclusion Criteria:

* Patients with main portal vein invasion
* Child-Pugh class B or C
* History of TACE or previous systemic chemotherapy including sorafenib
* Age \>75 years old
* Cardiovascular diseases
* History of gastrointestinal bleeding within 2 weeks
Implementation of a Multicomponent Intervention to Prevent Physical Restraints in Nursing Home Residents (IMPRINT)

Background: Physical restraints as bedrails and belts are still regularly applied in German nursing homes despite clear evidence showing their lack of effectiveness and safety. In a cluster-randomized controlled trial, the efficacy of a guideline-based multicomponent intervention has been shown with a significant reduction in physical restraints use without adverse events. The present study aims to apply different versions of the original intervention in nursing home residents in four different regions throughout Germany in order to evaluate the effectiveness of the programme.

Methods/Design: Pragmatic cluster-randomized controlled trial comparing two intervention groups ((1) updated original programme and (2) brief version of the updated programme) with a control group (3) receiving printed study materials (optimized usual care). Intervention (1) consists of an information programme for all nurses, additional training and structured support for nominated key nurses, and provision of printed study material and other supportive material. For intervention (2) nurses' training is only optional carried out facultatively by key nurses who have received an additional train-the-trainer module. The control group (3) receives printed study material only. Overall, 120 nursing homes including approximately 10800 residents will be recruited, randomized to one of the three groups and followed up for 12 months. The primary outcome is defined as proportion of residents with at least one physical restraint at 12 months. Physical restraint use will be assessed by direct observation. Secondary outcomes are residents' quality of life as well as safety parameters as i.g. falls and fall-related fractures. Process and cost measures will also be assessed.


Eligibility Criteria:
Cluster level

Inclusion Criteria:

* randomly selected nursing homes in each region; no specific inclusion criteria will be applied

Exclusion Criteria:

* no specific exclusion criteria will be applied

Individual level

Inclusion Criteria:

* all residents within the cluster present on the day of data collection
* all residents newly admitted to clusters during follow-up and present on the day of follow-up data collection

Exclusion Criteria:

* no specific exclusion criteria will be applied
Individual Patient Esmethadone (REL-1017) Expanded Access Program

To provide expanded access of esmethadone (REL-1017) to patients with a serious or immediately life-threatening disease or condition that may potentially benefit from esmethadone (REL-1017) who do not have access to other effective therapy and are not eligible for other clinical trials with esmethadone (REL-1017).

The Expanded Access Program (EAP) is intended to provide pre-approval access to esmethadone (REL-1017) for eligible patients who suffer from a serious or immediately life-threatening disease or condition that may potentially benefit from esmethadone (REL-1017) as determined by the treating physician and have no satisfactory treatment options. This program is open in the United States and operates under the Individual Patient (also referred to as Single Patient) IND expanded access route in which the patient's treating physician serves as the sponsor. Expanded access requests must be from the patient's treating physicians and submitted according to the Relmada EAP policy at https://www.relmada.com/our-portfolio/eap.

Eligibility Criteria:
Inclusion Criteria:

* Patients who may potentially benefit from treatment with esmethadone (REL-1017) as determined by the treating physician.
* Have undergone appropriate standard treatments without success and in the opinion of the treating physician no comparable or satisfactory alternative treatment is available to treat the disease or condition.
* Are ineligible or unable to participate in any ongoing clinical study of the investigational product.
* Condition for which, in the opinion of the treating physician, there is sufficient evidence of a potential benefit from the use of the investigational product, and that potential benefit outweighs the known or anticipated risks.

Exclusion Criteria:

* History or presence of clinically significant health conditions which in the opinion of the Investigator would negatively impact the safety of the participant.
* History of QTc prolongation.
* History of allergy or hypersensitivity to methadone or related drugs.
* Pregnant or planning to become pregnant.
* Breast-feeding or planning to breast-feed.
Study of Ranexa in Patients With Coronary Artery Disease and Painful Polyneuropathy

This study was to determine whether ranolazine was effective in the treatment of neuropathic pain in patients with coronary artery disease.

Eligibility required neurological examination by the study doctor and assessment of the patient's pain. Eligible participants were randomized to receive blinded study medication for a total of 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Males or females aged ≥ 18 years
* Coronary artery disease with a clinically diagnosed peripheral neuropathy
* Willing and able to provide signed informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization
* Willing and able to comply with the requirements of the protocol and follow directions from the clinic staff

Exclusion Criteria:

* History of allergy or intolerance to ranolazine
* Any condition or concomitant medication that would have precluded the safe use of ranolazine as outlined in the prescribing information sheet (see Appendix E)
* In the judgment of the investigator, any clinically-significant ongoing medical condition that might jeopardize the patient's safety or interfere with the absorption, distribution, metabolism or excretion of the study drug
* In the judgment of the investigator, clinically-significant abnormal physical findings during screening (excluding the patient's peripheral neuropathy condition)
* Use of any experimental or investigational drug or device within 30 days prior to screening
* Pregnant or breast feeding, or (if premenopausal), not practicing an acceptable method of birth control (as detailed in Inclusion Criterion 4)
* Had received prior treatment with, or investigational exposure to, ranolazine within 7 days prior to randomization
* Clinically significant hepatic impairment
* Had end-stage renal disease requiring dialysis
* Psychological or addictive disorders (not limited to, but including drug and/or alcohol dependency) that may have precluded patient consent or compliance, or that may have confounded study interpretation
* Positive pregnancy test at Baseline (pre-randomization, Day 0)
Evaluation of Evening Versus Morning Levothyroxine Intake in Elderly

A study designed to compare evening versus morning levothyroxine intake in the elderly.

This is a randomized crossover trial of two dosing strategies for pharmacological treatment of hypothyroidism in a sample of individuals aged 60 years or older, performed at an outpatient healthcare in a tertiary center.

Eligibility Criteria:
Inclusion Criteria:

* Individuals aged 60 years or older who consult at the Geriatrics, Endocrinology and Internal Medicine Clinic at Hospital Clinicas de Porto Alegre
* Patients diagnosed with Primary Hypothyroidism
* Patients on levothyroxine for at least 6 months
* Patients with the same dose of levothyroxine for at least 3 months

Exclusion Criteria:

* Severe Dementia
* Severe Congestive Heart Failure (NYHA IV or / and three or more hospitalizations for heart failure within 1-year interval)
* Diagnosis of Advanced Stage Neoplasia
* Diagnosis of Thyroid Cancer
A Study of Dayingpian Treating Bipolar Disorder

The main purpose of this cohort study is to evaluate the efficiency and safety of Dayingpian to provide evidence-based medical evidence for the subsequent drug development.

Dayingpian is a kind of formula in traditional Chinese medicine with the effect of promoting blood circulation and reducing blood stasis. It has been prescribed as an add-on in the treatment of mental disorders such as bipolar disorder. However, there is not yet much high-quality evidence of the clinical effectiveness of Dayingpian treatment. In this study, we conduct a prospective, real-world longitudinal cohort study at Shanghai Mental Health Center in China to investigate the efficacy and safety of Dayingpian for bipolar disorder patients. The observation period is 12 weeks and all participants are evaluated every 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Meets the International Classification of Diseases-10(ICD-10) criteria for Bipolar Disorder.
2. Outpatients or inpatients in Shanghai Mental Health Center.
3. Male or female subjects aged 14-65 years.
4. education of Junior high school or above.
5. The patient fully understands and signs the informed consent form.

Exclusion Criteria:

1. Apparent violent aggression/suicide within the last two weeks.
2. Other patients that the investigator believes should not be included in the study.