cyrilzakka/clinical-trials huggingface dataset:
Converting From Ropinirole Immediate Release (IR) To Ropinirole Controlled-Release for RLS (Restless Legs Syndrome)

This is a multi-center, Phase III study to evaluate the safety and tolerability of proposed dose conversion recommendations for RLS subjects converting from ropinirole immediate release to ropinirole controlled-release for RLS.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of RLS using IRLS Study Group (IRLSSG) diagnostic criteria.
* Subjects currently being treated for RLS with a stable dose (for at least 2 weeks) of ropinirole IR given once daily.
* Subjects with RLS symptoms during both the evening and night or night time only.
* Subjects who have given written informed consent to participate.

Exclusion Criteria:

* Subjects who require treatment of daytime RLS symptoms.
* Signs of secondary RLS, serum ferritin level less than 10 mcg/L.
* Movement Disorders, Clinically significant or unstable medical conditions.
* Abnormal labs, electrocardiogram (ECG) or physical findings.
* Receiving prohibited medications.
* Sleeping habits incompatible with study design.
* Intolerance to ropinirole or other dopamine agonist.
* Pregnant or lactating.
* Women of child-bearing potential who are not practicing an acceptable method of birth control.
Methods Project 4: Clinical Trial - Amended

Cigarette smokers will be randomized to E-cigarette, Nicotine Gum or Lozenge, or Control Group. Participants will enter a 1 week sampling phase. Smokers interested in continuing with the study after the sampling phase will undergo a 2 week baseline assessment phase and will then enter an 8 week intervention. Tobacco use patterns, subjective responses to product, and nicotine and toxicant exposure will be assessed.

Sampling period (1 week): Subjects will be randomized to an alternative nicotine product (E-cigarette, Nicotine Gum or Lozenge) or assigned to continue smoking their usual brand cigarettes. Subjects will complete screening assessments, asked to sample the assigned product and start recording their cigarette or other tobacco intake on a daily basis using an interactive voice response system (IVR). Smokers assigned to the control condition (smoking usual brand cigarettes) will be asked to choose the product that they would like to sample.

Baseline smoking period: After sampling, subjects who meet specific criteria will continue with the experimental intervention phase. These subjects will be required to attend 2 baseline clinic visits where baseline assessments will be captured. Records of their cigarette or other tobacco intake on a daily basis will continue using the interactive voice response system (IVR).

Experimental Period: After the baseline assessment, subjects will be instructed to either partially or completely substitute their cigarette smoking with their assigned product. They will assigned to one of six experimental conditions:

1. smoking usual brand cigarette controls, who after 8-weeks will be offered any of the other nicotine products to use as they choose for 8 weeks;
2. complete substitution (i.e., no smoking) with an E-cigarette;
3. partial substitution with an E-cigarette;
4. complete substitution (i.e., no smoking) with nicotine gum or nicotine lozenge.

The assigned product, E-cigarette, Nic Gum or Lozenge, but not usual brand cigarettes, will be provided to subjects at the clinic visits. Subjects will attend clinic visits over the next 8 weeks where tobacco use patterns and biomarker data will be collected.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects who are at least 18 years of age;
* Daily smoker;
* Generally good health;
* Subject has provided written informed consent to participate in the study (adolescents under the age of 18 will be excluded because this project involves continued use of tobacco products and new tobacco products);

Exclusion Criteria:

* Unstable health;
* Pregnant or breastfeeding (due to toxic effects from tobacco products);
* Unable to read for comprehension or completion of study documents.
The Impact of IC-Guided Feeding Protocol on Clinical Outcomes in Critically Ill Patients (The IC-Study)

Adequate nutritional support is an essential element for achieving favourable outcomes in critically ill patients. Therefore, an accurate determination of patients' energy needs is required to optimize nutritional support and reduce the harmful effects of under- and over-feeding. Currently, indirect calorimetry is considered as a gold standard for measuring energy expenditure during critical illness.

This randomized study aims to investigate the impact of indirect calorimetry guided nutrition therapy on clinical outcomes such as ICU. Mortality, hospital mortality, duration of mechanical ventilation, length of I.C.U./hospital stay and mascle wasting. The investigators hypothesis that nutrition therapy guided by IC will improve clinical outcomes in severely ill patients

This is a single-blind randomized control study. Eligible participants are randomly assigned within 24 hrs of ICU. admission in two groups

* Intervention group: The calorie needs will be determined by indirect calorimetry.
* Control group: a routine standard weight-based equation (20-25kcal/kg ideal body weight/day) will be used to estimate the energy requirements of critically ill patients.

Daily energy and protein data will be recorded for a maximum of 12 evaluable days (nutritional days) or until death or discharge from ICU.while outcome data will be collected for a maximum of 28 days.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients aged over 18 years old
* Critically ill patients with me ical ventilation
* Expected to have an ICU. stay of more than (3) days

Exclusion Criteria:

* Requirement for inspired oxygen content (FiO2) greater than 0.6
* Patients on high-frequency ventilation
* Patients with chest tubes that leak air/ Bronchopleural fistula
* Patients with incompetent tracheal cuff
* Patients inhaled nitric oxide therapy
* Patients receiving continuous renal replacement therapy (CRRT) during IC measurement
* Patients with pregnancy
* Patients with burn injury
* Patients infected with human immunodeficiency virus (HIV)
* Patients with severe liver disease (Child-Pugh score C)
* seizure activity
* patients suffering from significant head trauma (GCS \<8)
* Patients with paraplegia and quadriplegia
PTeye in Parathyroid Adenoma

Identifying the parathyroids is compulsory for success of parathyroidectomy for parathyroid adenoma. Near-infrared autofluorescence devices have been proposed as useful intraoperative tools for the identification of parathyroid glands. The aim of the present study is to evaluate the correlation of PTeye autofluorescence device with biochemical data of parathyroid adenoma patients.

Identifying the parathyroids is compulsory for success of parathyroidectomy for parathyroid adenoma. Near-infrared autofluorescence devices have been proposed as useful intraoperative tools for the identification of parathyroid glands. Two approaches are available to surgeons to perform near-infrared autofluorescence: (i) Camera-based systems (CBS) and (ii) Probe-based systems such as PTeye™ (Medtronic, Minneapolis, MN).The aim of the present study is to evaluate the correlation of PTeye autofluorescence device with biochemical data of parathyroid adenoma patients.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years old
* primary hyperparathyroidism caused by adenoma
* patient's informed consent acquired

Exclusion Criteria:

* Secondary and tertiary hyperparathyroidism
* Re-operation for adenoma
* Previous neck surgery
* Patient enrolled in another study that may affect the results of this study
Determining the Optimal Examined Lymph Node for Accurate Staging and Long-term Survival in Rectal Cancer

A multi-institutional registry of collected data on patients with rectal cancer who underwent surgical resection between January 2009 and December 2018 at the departments of colorectal surgery of five medical institutions in China

A multi-institutional registry of collected data on patients with rectal cancer who underwent surgical resection between January 2009 and December 2018 at the departments of colorectal surgery of five medical institutions in China (National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College; Changhai Hospital, Naval Medical University; The Second Affiliated Hospital of Harbin Medical University; The Affiliated Tumor Hospital of Harbin Medical University; The Affiliated Tumor Hospital of Guangxi Medical University)

Eligibility Criteria:
Inclusion Criteria:

* Rectal cancer patients in stage I-III who underwent surgical resection for first primary rectal cancer with at least one lymph node were eligible

Exclusion Criteria:

* Patients with missing values on lymph node count and clinical features were excluded
Evaluation of AIT Study

Specialized treatment of personality disorders (PD) in youth has been neglected for a long time, because these disorders were not diagnosed before the age of 18. Since 2013 the age threshold has been dropped in the Diagnostic and Statistical Manual (DSM)-5, and such change is also announced for the International Classification of Diseases (ICD)-11. There is broad consensus from both scientific evidence and clinical experience that specialized early interventions in adolescents with PD are urgently needed.

In the last decades a number of specialized psychotherapeutic treatment programs have been developed. Despite their conceptual differences, many of the treatment models have shown significant effects in the treatment of PD in adults. However, the treatment of adolescents with PD remains difficult and further enhancement and development of treatments is needed.

Given the different therapeutic approaches available, the present project aims to go beyond the comparison of integral therapeutic models in the classical outcome study design. While outcome research is important to build on the evidence of the effectiveness of an intervention, it contributes little to its understanding and refinement. The aim of the present multi-center project is to compare two therapeutic methods used in routine care:

* Adolescent Identity Treatment (AIT)
* Dialectic Behavioral Treatment for Adolescents (DBT-A)

Treatments will be performed at different study centers and compared using the same measures of outcome. The main outcome will be psychosocial functioning.

Additionally, the psychotherapy process will be investigated to explore specific and unspecific mechanisms of the therapeutic process, its outcome and mediators.


Eligibility Criteria:
Inclusion Criteria:

* Identity Diffusion (AIDA T-score \> 60)
* borderline Criteria (SKID-II)

Exclusion Criteria:

* intelligence quotient (IQ) \< 80
* psychotic disorder
* pervasive developmental disorders
* heavy and persistent substance abuse
* major somatic or neurological disease
* hospital treatment
Fluorescent-labeled IgG for Liver Tumor Detection

This study is to evaluate whether intraoperative fluorescence imaging using fluorescent-labeled IgG probe (FluoAB) can help distinguish the tumor and the liver cirrhosis (or the liver parenchyma).

The main purposes of this study include:

* To validate the safety and effectiveness of using FluoAB in hepatic surgery.
* To raise the surgical precision with guidance by FluoAB fluorescence imaging.


Eligibility Criteria:
Inclusion Criteria:

1. Patients who have been diagnosed with liver tumor.
2. Planned to receive hepatectomy.
3. Liver function Child-Pugh A/B.
4. The expected lifetime is longer than 6 months.
5. Approved to sign the informed consent.

Exclusion Criteria:

1. Enrolled in other trials in the past 3 months.
2. Metastatic lesions were found.
3. Undesirable function of heart, lung, kidney, or any other organs.
4. Unable to tolerate a hepatectomy.
5. The researchers considered inappropriate to be included.
Lonsurf® (Trifluridine/Tipiracil) Plus Chemotherapy in Metastatic Colorectal Cancer Prospective Study in Taiwan

Primary Endpoint : To evaluate the Disease control rate (DCR)

Secondary Endpoints:

To evaluate the Progression-free survival (PFS), Overall survival(OS) and Safety profile

70 Per-protocol patients Plan to recruit 70 evaluable patients (With expected dropout rate of 22%, the sample size would be 90 subjects.) Simon's two-stage design (Simon, 1989) will be used. The null hypothesis that the true response rate is 0.45 will be tested against a one-sided alternative. In the first stage, 42 patients will be accrued. If there are 19 or fewer responses in these 42 patients, the study will be stopped. Otherwise, 28 additional patients will be accrued for a total of 70. The null hypothesis will be rejected if 39 or more responses are observed in 70 patients. This design yields a type I error rate of 0.05 and power of 0.8 when the true response rate is 0.6.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically or cytologically confirmed adenocarcinoma of the metastatic colorectal cancer;
2. Previously treated with fluorouracil-, oxaliplatin-, and irinotecan-based chemotherapy, and anti-vascular endothelial growth factor (anti-VEGF) biological therapy;
3. The RAS wild-type patients need to receive anti-EGFR therapy;
4. Presence of at least one measurable tumor lesion which is defined as lesion that can be measured in at least one dimension (longest diameter) with a minimum size of : 10mm by CT scan, MRI and PET-CT(no less than double the slice thickness and a minimum of 10mm)(according to RECIST guideline version 1.1);
5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2;
6. Investigators prescribe Lonsurf® for metastatic colorectal cancer patients who had prior treatment with Anti-VEGF and Anti-EGFR agent on routine basis. Depending on RAS status, patients with RAS mutant receive Lonsurf® as 3rd line treatment, those with RAS wild type receive Lonsurf® as 3rd/4th line treatment;
7. Patients received either oxaliplatin or irinotecan.

Exclusion Criteria:

1. Patients previously received Lonsurf® (Trifluridine／Tipiracil) or regorafenib;
2. With active central nervous system (CNS) metastasis (indicated by clinical symptoms, cerebral edema, steroid requirement, or progressive growth);
3. With clinically significant gastrointestinal hemorrhage;
4. Previous or current systemic malignancy with the exception of curatively treated non-melanoma skin cancer or cervical carcinoma in situ, unless there has been a disease-free interval of at least 5 years;
5. The patient at high risk from treatment complications including but not limited to symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia, uncontrolled diabetes, liver or renal failure and psychiatric illness or social situation that would preclude study compliance;
6. Active infection.
A Study to Assess the Cognitive Effects of Fesoterodine in Elderly Subjects

The study is designed to evaluate elements of cognitive function in subjects receiving either fesoterodine or alprazolam.

Evaluation of cognitive function

Eligibility Criteria:
Inclusion Criteria:

* Adult healthy volunteers 65 years and over with minimum MMSE of 26

Exclusion Criteria:

* Prohibited concomitant medications
* Confounding medical conditions
* Clinically significant comorbid diseases
* Hypersensitivity or contraindications to fesoterodine or active control
LEAP-CT for Treatment of COVID-19 Patients (Master Protocol)

This master protocol serves as a common reference for the inpatient and outpatient clinical studies that share common elements.

There are currently two addenda to this master protocol:

Addendum 1, Study LDOS-21-001-01, is a Phase 2, randomized, single-blind, placebo-controlled study to evaluate the safety and efficacy of the combination of famotidine and celecoxib as a treatment in moderate-to-severe patients hospitalized for COVID-19.

Addendum 2, Study LDOS-21-001-02, is a Phase 2 randomized, placebo-controlled, double-blind study to evaluate the safety and efficacy of the combination of famotidine and celecoxib as a post-exposure prophylaxis (PEP) for newly infected COVID-19 patients.

Eligibility Criteria:
* For eligibility criteria specific to the protocol, see:
* Addendum #1 (LDOS-21-001-01) or
* Addendum #2 (LDOS-21-001-02)
Ligilactobacillus Salivarius MP101 for Elderly in a Nursing Home

The objective of this work was to investigate the effect of Ligilactobacillus salivarius MP101 on the functional (Barthel index), cognitive (GDS/FAST) and nutritional (MNA) status, and on the nasal and fecal inflammatory profiles of elderly living in a nursing home highly affected by COVID-19.


Eligibility Criteria:
Inclusion Criteria:

* Living in the nursing home
* Informed consent obtained

Exclusion Criteria:

* Absence of informed consent
* Parenteral nutrition (exclusively)
* Allergy to cow's milk protein
Treatment of Chronic Pain With Cannabidiol (CBD) and Delta-9-tetrahydrocannabinol (THC)

This is a study comparing the effects of Delta-9-Tetrahydrocannabinol (THC) versus Cannabidiol (CBD) versus a placebo on chronic non-cancer pain.

The overall aim of this study is to examine the effects of Delta-9-tetrahydrocannabinol (THC) and Cannabidiol (CBD) on chronic pain symptoms, specifically we will examine the effects of different doses of THC/CBD on symptoms of chronic pain and life functioning. Participants will include individuals with chronic pain, who will be randomized into one of three intervention conditions: high THC/low CBD, low THC/high CBD, or placebo. In addition to receiving THC/CBD/placebo, participants also will complete symptom assessments of chronic pain data (intensity, quality, interference/disability) throughout the study. These measures will be gathered prior to and following the fifth doses (dosing will occur once per day for five days) of CBD/THC or placebo. A secondary objective will be to examine the association between clinical and neurocognitive variables and use of CBD/THC, including the potential side effects of THC/CBD. Other secondary objectives include the use of magnetic resonance imaging (MRI) and magnetic resonance spectroscopy (MRS), acquired before and after final administration with CBD/THC or placebo to examine differences in brain metabolism, brain connectivity, and brain structure. Imaging analyses will focus on regional brain changes before and after administration of THC/CBD/placebo.

Eligibility Criteria:
Inclusion criteria:

1. Age between 18-50 yrs.
2. History of cannabis use.
3. Chronic musculoskeletal and joint pain for at least 3 months or longer.
4. Participants must live within a 60 mile radius of Salt Lake City, Utah to be eligible.

Exclusion criteria:

1. Current or past neurological illness.
2. Substance abuse or dependence within the prior 60 days.
3. Contraindication to brain MRI.
4. Type I and type II diabetes.
5. Unstable medical conditions.
6. Consumption of more than 2 drinks of alcohol per night.
7. Current pregnancy or planning to become pregnant or breastfeeding
8. History of seizures or head trauma
9. Active or history of major mental illness
10. LFT results 3 times greater than the upper limit of normal at screening.
11. Participants may be excluded if the PI feels they do not meet safety criteria.
Health, Functioning, Work, and Experiences of Social and Health Services of Persons With Stroke

The purpose of the Health, functioning, work, and experiences of social and health services of persons with stroke study (FinPostStroke) is to identify factors related to self-reported health, functioning, work, inclusion, and accessibility of social and health services, and how such factors are interconnected in Finnish adults one or more years after stroke. Participants will be targeted from two tertiary hospitals' registries and recruited via mail.

This cross-sectional explorative observational study is based on register data and postal survey. The survey questionnaire includes several valid patient-reported outcome measures. The study will add knowledge to be utilized in developing health care and rehabilitation services for people with stroke, as well as provide information for various parties involved.

The purpose of the Health, functioning, work, and experiences of social and health services of persons with stroke (FinPostStroke) study is to identify factors related to self-reported health, functioning, work, inclusion, and accessibility of social and health services, and how such factors are interconnected in Finnish adults one or more years after stroke. The International Classification of Functioning, Disability and Health (ICF) is used as a structured framework.

Adults with cerebral infarction, subarachnoid hemorrhage, or intracerebral hemorrhage will be targeted from Kuopio and HUS Helsinki University Hospitals' patient registries. The survey data is planned to be collected with postal questionnaire by May 2025. The questionnaire includes several valid patient-reported outcome measures to assess health and functioning, work and income, inclusion, and social and health services. Participants will be recruited via mail with an invitation letter and study information attached to the questionnaire. All participants are expected to give written informed consent prior to the study.

This study will add knowledge to be utilized in developing health care and rehabilitation services for people with stroke, as well as provide information for various parties involved. We plan to publish at least four peer-reviewed articles along with common articles and texts concerning self-reported health, functioning, work, inclusion, and accessibility of social and health services among Finnish adults with stroke.

Eligibility Criteria:
Inclusion Criteria:

* treated for a stroke (ICD-10 codes I60-61, I63-64) in HUS Helsinki University Hospital or in Kuopio University Hospital between January 2018 and December 2022
* stroke is primary diagnose for the treatment
* 18 years or older at the time of survey

Exclusion Criteria:

* stroke is secondary diagnose for the treatment
* treated for a stroke only as outpatient in other than emergency room
* lives abroad
* missing address