cyrilzakka/clinical-trials huggingface dataset:
Determinants of Muscle Strength in Chronic Kidney Disease

Aim of this study is to determine in chronic kidney disease patients:

* the involvement of malnutrition inflammation and atherogenesis syndrome (increase in C reactive protein and decrease in serum albumin) on voluntary muscle strength impairment
* the relationship between voluntary muscle strength and muscle mass
* the relationship between voluntary muscle strength and lean body mass
* the correlation between voluntary muscle strength and physical activity

Aim of this study is to determine in chronic kidney disease patients:

* the involvement of malnutrition inflammation and atherogenesis syndrome (increase in C reactive protein and decrease in serum albumin) on voluntary muscle strength impairment (estimated by handheld dynamometer)
* the relationship between voluntary muscle strength and muscle mass (estimated by creatinine index)
* the relationship between voluntary muscle strength and lean body mass (estimated by bioelectrical impedance analysis)
* the correlation between voluntary muscle strength and physical activity (the physical activity being estimated by the "Voorrips" score questionnaire)

Eligibility Criteria:
Inclusion Criteria:

* chronic kidney disease patient with extrarenal replacement therapy by hemodialysis for at least 3 months
* stable clinical condition (absence of infection, stroke or acute decompensation)

Exclusion Criteria:

* chronic kidney disease without extrarenal replacement therapy
* history of renal transplantation
Drug-drug Interaction Study (Telmisartan, Amlodipine, Chlorthalidone)

To evaluate Drug-drug interaction

The purpose of this study is to evaluate the Drug-Drug(telmisartan, amlodipine and/ or chlorthalidone) interaction and safety in healthy adult volunteers.

Eligibility Criteria:
Inclusion Criteria:

1. Participant who has a body weight that is ≥55kg(male) or ≥50kg(female) with ideal body weight of 80-120% (ideal body weight)
2. Who has not suffered from clinically significant disease
3. Provision of signed written informed consent

Exclusion Criteria:

1. History of and clinically significant disease psychiatric, or malignancy.
2. A history of drug abuse or the presence of positive reactions to drugs that have abuse potential in urine screenings for drugs.
3. Administration of other investigational products within 3 months prior to the first dosing.
4. Administration of herbal medicine within 2 weeks or administration of ethical drugs within 2 weeks or administration of over-the-counter (OTC) drugs within 1 week prior to the first dosing of the investigational product (if the investigator (study doctor) determines that the person meets other criteria appropriately, the relevant person may participate in the study).
5. Volunteers considered not eligible for the clinical trial by the investigator (study doctor) due to reasons including laboratory test results, ECGs, or vital signs.
Cognitive Function and Electrocardiogram (ECG) During Hypoglycemia and Blockade of the Renin-angiotensin System

Hypothesis: Treating patients with type 1 diabetes with a certain antihypertensive drug preserve cerebral function during hypoglycaemia.

Background: Studies have found that certain genetic variations leaves a subject with type 1 diabetes more prone to hypoglycaemia. It it thought to be a decline in cognition during hypoglycaemia that leaves them at risk of severe hypoglycaemia. The idea is tha when you suppress the genetic phenotype with a well known antihypertensive drug an improvement in cognition will occur and this will remove the patients tendency to severe hypoglycaemia.

Methods: The investigators want to explore whether the cerebral function is improved during hypoglycaemia in subjects with type 1 diabetes and the above mentioned genetic variation when treated with the antihypertensive drug Candesartan.

We will include 25 type 1 diabetic patients from our outpatient clinic. They are already genotyped from another trial.

Each patient goes through two cycles with hyperinsulinemic glucose clamp induced hypoglycemia. The study is double blinded, randomised and placebocontrolled so the patients receive both Candesartan and placebo but in different cycles.

In each cycle patients will receive either Candesartan or placebo for 7 days. After 8 days patients undergo a hypoglycaemic clamp during which primary and secondary endpoints will be measured.

In the hyperinsulinemic hypoglycaemic clamp the patients will undergo an adjustment period towards euglycaemia. A period of approximately 1 hour of euglycemia, an hour of hypoglycemia and a period of recovery towards euglycemia. In each of these glycemic states primary and secondary outcomes will be measured.

Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes
* Danish spoken and written
* RAS activity score\>7 - diabetes duration \> 5 years
* not pregnant and safe anticonception
* Signed informed consent.

Exclusion Criteria:

* Treatment with an ACE blocker
* An ARB og a renin blocker
* Treatment with other antihypertensive drugs
* Severe diabetic late complications
* Renal impairment
* Pregnancy and breastfeeding
* Previous reactions to study medication
* Heart insufficiency (NYHA 3-4)\\
* Known ischaemic heart disease
* Epilepsy
* Alcohol and drug abuse
* Suspicion of non-compliance,
* Plasma potassium \< 3.5 mmol/l or \>5.0 mmol/l.
Self-reported Outcomes of Patients in ERAS Nursing

We aimed to evaluate the effect of ERAS nursing program on self-reported outcomes of patients undergoing minimally invasive lung cancer surgery, and compared the differences in length of hospital stay, complications, and readmission rate between ERAS and non-ERAS nursing programs


Eligibility Criteria:
Inclusion Criteria:

* ≥18years,Minimally invasive elective surgery,cooperate

Exclusion Criteria:

* Pneumonectomy was performed and converted to open surgery

Surgery intensive care, unable to cooperate (language

Speech disorders, psychopathology)
App-delivered Sleep ThERapy for Older Individuals With Insomnia

This randomised, open, parallel controlled trial aims to compare the efficacy of a digital brief behavioural therapy for insomnia (dBBTi) against online sleep health education on insomnia symptom severity in older adults aged 60 years and over. The trial will be totally online with participants recruited from the community across Australia.

Insomnia is a highly prevalent sleep disorder affecting up to 10% of the adult population and reports of over 40% in the older population. Current insomnia treatments focus heavily on symptom management with cognitive behavioural therapy for insomnia (CBTi), in both digital and face-to-face form as the recommended first-line treatment. Despite the strong evidence for digital CBTi, there are a lack of data related to older people and whether digital brief behavioural therapy is efficacious in this population.

The investigators will conduct a fully online study comparing 6-weeks of digital brief behavioural therapy for insomnia (dBBTi) against online sleep health education. Participants will be recruited, screened and determined eligibility and consent will be conducted online. Thereafter, participants will be randomly allocated to either dBBTi delivered via a mobile application called SleepFix or wait-listed control. The SleepFix app delivers sleep restriction therapy using a 4 stage approach to improve sleep efficiency. The control will consist of 3 online sleep health education modules provided bi-weekly with information about sleep and sleep hygiene without any specific insomnia therapy. Participants will be recruited using social media and directed to a website to determine eligibility and then provided access to either the dBBTi (SleepFix) or the control with a link to the first online module.

At baseline, all participants will complete self-reported measures of insomnia, sleep, fatigue, sleepiness , anxiety, depression, quality of life, cognition and digital health literacy. These will be repeated at follow-up at weeks 8, 16 and 26.

Eligibility Criteria:
Inclusion Criteria:

1. Older adults aged ≥ 60 years
2. Able to give informed online consent
3. Insomnia Severity Index ≥ 10, including a score of 3 in at least one of the first three items (nocturnal symptoms).
4. English fluency
5. Access to a smartphone and willingness/proficiency to use a mobile app

Exclusion Criteria:

1. Shift-workers
2. Travel to a destination with \>2 hours time-difference (within 30-days)
3. Serious medical and/or psychiatric illnesses/disorders or self-harm risk (Patient Health Questionnaire-9, item 9, 1+ score of risk of suicidal ideation)
4. Diagnosed sleep disorders other than insomnia
5. Regular sleep medications or sleep devices (\>2 times a week over last 6 months)
6. Currently receiving or previously received (within the last 12 months) psychotherapy for insomnia including Cognitive Behavioural Therapy (CBT).
7. Drive for work/operate heavy machinery
Botulinum Toxin A for Treatment of Catocholamine Induced Finger Necrosis

Patients in the intensive care unit (ICU) often require blood pressure support of vasoactive drugs such as amines. Finger necrosis (so called "blue toe syndrome") is a well documented phenomena with incidence reaching as high as 60% in patients receiving vasopressin. Botulinum toxin is a known muscle relaxant used for a variety of medical application. Recently, several reports have demonstrated its effect in vasospastic disorders. It has also been in mice that when administered locally it has a local vasodilatory effect. The goal of this experiment is to compare the effect of Botulinum Toxin administered locally on amine induced finger necrosis.


Eligibility Criteria:
Inclusion Criteria:

* Patients treated with vasoactive drugs (amines) and have finger/toe necrosis

Exclusion Criteria:

* Sensitivity to drug (Botox) ingredients.
* Active local limb infection
* ICU admission due to botulism
* Chronic muscular weakness disease, e.g., Myasthenia gravis, ALS
* Age lower than 18
Nedaplatin Combined With Gemcitabine in the Treatment of Recurrent and/or Metastatic Nasopharyngeal Carcinoma : a Single Arm and Phase Ⅱ Clinical Trail

The purpose of this single arm,phase Ⅱ clinical trail is to determine the safety and efficacy of nedaplatin combined with gemcitabine in the treatment of recurrent and metastatic nasopharyngeal carcinoma


Eligibility Criteria:
Inclusion Criteria:

* biopsy proved nasopharyngeal carcinoma; stage IVc according to Union for International Cancer Control (UICC) edition VII,or recurrent disease after chemotherapy and/or radiotherapy; 18 years or older; without other malignancy; proper functioning of the major organs.

Exclusion Criteria:

* allergic to nedaplatin and/or gemcitabine; female within gestation period or lactation; patients received drug of other clinical trail within 3 months.
The Effect of Natural Molecules on HPV Infection

The purpose of the study is to evaluate the effect of the administration of natural molecules in the treatment of HPV infection.


Eligibility Criteria:
Inclusion Criteria:

* HPV DNA test positivity
* over 18 years

Exclusion Criteria:

* pregnancy
* breastfeeding
* assumption of other products containing EGCG or green tea
* primary immunodepression or pharmacological induced one
VIC Regimen Versus Bevacizumab Plus Chemotherapy as First-Line Treatment for BRAF V600E-Mutated Advanced Colorectal Cancer

In this study, we compared first-line VIC regimen with chemotherapy plus bevacizumab in Chinese patients with initially unresectable BRAF V600E-mutated mCRC. The principal goal was to evaluate the safety of VIC regimen, and to investigate the tumor response, the radical resectability, and the patient survival.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 and ≤80 years old
* Histologically confirmed colorectal adenocarcinoma
* Histologically confirmed BRAFV600E mutated and RAS wild-type
* Initially unresectable metastatic or local CRC
* ECOG performance status of 0-1 and life expectancy ≥3 months
* adequate hepatic, renal, and hematologic function

Exclusion Criteria:

* Previously taken any targeted therapy, chemotherapy, intervention therapy, or radiotherapy for CRC within 6 months
* Other cancers (with the exception of cervical cancer in situ and squamous cell carcinoma of the skin) within the previous 5 years.
Patient's Feelings After Receiving a Diagnosis of Age-related Macular Degeneration

Age-related macular degeneration (AMD) is the leading cause of blindness in the elderly population of the industrialized world. AMD is a progressive degenerative disease affecting the central area of the retina, responsible for distinct vision. Vision loss arises from aberrant new vessel growth which causes the accumulation of blood or fluid within the retina's thickness and eventually leads to permanent scarring. The two major forms of AMD are exudative, or neovascular or "wet", and non-exudative, or "dry".

Vascular endothelial growth factor (VEGF) represents the key modulator of the angiogenetic process and is involved in the pathophysiology of AMD. Anti VEGF therapies are used to treat wet-AMD.

After diagnosis and explanations of the practionner, the patients and their close relatives have still frequently many questions about the intravitreal injections, the prognosis, the risk of visual impairment, etc. Few teams have studied the modalities of diagnosis announcement and the understanding of the patients on the disease course.

The aim of this study is to evaluate the feelings after the AMD diagnosis announcement as well as the understanding of the possibilities of treatment and the clinical surveillance.


Eligibility Criteria:
Inclusion Criteria:

* patient up to 55 years old
* wet AMD
* diagnostic questionnaire group: patient being announced with AMD for less than 1 month
* disease course questionnaire group: patients treated by anti-VEGF from 6 to 12 months

Exclusion Criteria:

* dry AMD
* patient under 55 years old
* patient who doesn't speak French
* patient carrying an ophtalmologic genetic disorder
Dose-Finding and Safety Study for Oral Single-Agent to Treat Advanced Malignancies

The purpose of this study is to determine the maximum tolerated dose of RX-3117 in subjects with advanced or metastatic solid tumors (Phase 1). The purpose of the Phase 2 portion is to estimate anti-tumor activity in subjects with advanced malignancies (relapsed or refractory pancreatic or advanced bladder cancer).

This is a dose-finding, open-label, single agent study of RX-3117. Once the maximum tolerated dose is identified additional subjects will be treated in a dose expansion followed by a 2-stage Phase 2 study. Subjects will be treated for up to 8 cycles of therapy. A cycle will be 4 weeks. RX-3117 dosing will be 3 times each week for 3 weeks follow by 1 week off treatment. All subjects will be followed for at least 30 days after the last dose of RX-3117.

Eligibility Criteria:
Inclusion Criteria:

* Males or females who are 18 years or older
* Able to swallow capsules
* Histological or cytological evidence of confirmed metastatic pancreatic or advanced bladder cancer
* Able to discontinue all anticancer therapies 2 weeks prior to study start
* Measurable or evaluable disease using Response Evaluation Criteria in Solid Tumors
* Life expectancy of at least 3 months
* ECOG performance status of 0 or 1
* Provide written informed consent

Exclusion Criteria:

* Primary brain tumors or clinical evidence of active brain metastasis
* Systemic corticosteroid use within 7 days before planned start of study therapy
* Active infection requiring parenteral or oral antibiotics within 2 weeks before planned start of study therapy
* Uncontrolled diabetes as assessed by the investigator
* Prior or current history of hepatitis B, hepatitis C or human immunodeficiency virus
* History of bone marrow of solid organ transplantation
* History of congestive heart failure, arrhythmias, acute coronary syndrome or torsades de pointes
* Any other medical, psychiatric, or social condition, which in the opinion of the investigator, would preclude participation in the study, pose an undue medical hazard, interfere with the conduct of the study, or interfere with interpretation of the study results
* Known hypersensitivity to gemcitabine, azacytidine or cytosine arabinoside
* Pregnant, planning a pregnancy or breast feeding during the study
* Concurrent participation in another therapeutic clinical trial
A Micro/Nano Device for Exhaled Breath Analysis

Use of a microfabricated silicon device to concentrate ultra trace volatile organic compounds (VOCs) in human exhaled breath for quantitative analysis of VOCs.

Will use Fourier Transform Mass Spectrometry (FT-MS) and Gas Chromatography-Mass Spectrometry (GC-MS) to analyze concentrated VOCs. The purpose of this study is to search for disease-related markers in the breath in subjects with known or suspected lung or other cancer, or pulmonary disease.

Eligibility Criteria:
Inclusion Criteria:

* For controlled (healthy) subjects - we are seeking persons who do not have a known history of cancer or pulmonary disease.
* Both smokers and nonsmokers are invited to participate as control subjects.
* For experimental subjects, we are seeking persons with pulmonary disease but no known history of cancer, as identified by the investigators during routine clinic or office visits.
* Additionally for experimental subjects, we are seeking persons with known or suspected lung or other cancers, as identified by the investigators during routine clinic or office visits.

Exclusion Criteria:
BAY 77-1931 Long-term Extension From Phase II Study

A long-term study of BAY77-1931 (lanthanum carbonate) for hyperphosphatemia in patients undergoing hemodialysis


Eligibility Criteria:
Inclusion Criteria:

* Undergoing hemodialysis 3 times per week for chronic renal failure for the previous 3 consecutive months at least

Exclusion Criteria:

* Pre-dialysis serum phosphate levels of 10.0mg/dL during the washout period
BiliCam Clinical Validation Study

The goal of this study is to assess the accuracy of BiliCam, a non-invasive technology based on analysis of digital images obtained with an app installed on a commercial smartphone, in estimating total serum bilirubin levels in newborns. BiliCam estimated bilirubin levels will be compared to total serum bilirubin levels in up to 225 newborns.

Jaundice, a yellowing of the skin and eyes caused by a build up of bilirubin in the blood, is a common problem in newborn infants. Measurement of total serum bilirubin (TSB) levels is used for clinical decision making. BiliCam is a non-invasive technology used to estimate TSB levels in newborns. With BiliCam, the user obtains digital images of a small portion of a newborn's skin using the BiliCam app installed on a commercial smartphone in a standardized manner. A color calibration card is placed on the baby's sternum to account for varying light conditions. Data on color levels in the photos are used to estimate a bilirubin level.

For the study, paired BiliCam estimated bilirubin (BCB) and TSB levels will be compared on a racially and ethnically diverse sample of newborns. Recruitment will continue until 225 newborns have completed the study.

Eligibility Criteria:
Inclusion Criteria:

* Newborn born at ≥ 35 weeks gestation
* Parent speaks and reads English
* Parent provides written informed consent

Exclusion Criteria:

* previous or ongoing treatment with phototherapy for hyperbilirubinemia
* Medical or other complications that preclude completion of the study
the Efficacy and Safety of HRS9531 Injection in Subjects With Type 2 Diabetes， Inadequately Controlled With Diet and Exercise Alone

The primary objective of this study is to evaluate the effectiveness of HRS9531 compared to placebo in controlling blood glucose levels after 24 weeks of treatment


Eligibility Criteria:
Inclusion Criteria:

1. Males and females, Age ≥18 years at the time of signing informed consent.
2. Diagnosed with type 2 diabetes mellitus (T2DM) for at least 90 days prior to day of screening.
3. Treatment with Diet and Exercise alone at least 90 days prior to day of screening.
4. 7.5% ≤ HbA1c ≤10.0% at screening.

Exclusion Criteria:

1. Uncontrollable hypertension(with or without antihypertensive treatment) : systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg at screening.
2. Diagnosed or suspected with type 1 diabetes mellitus, special types of diabetes or secondary diabetes.
3. History of significant hematological disorders (e.g., sickle cell disease, hemolytic anemia, myelodysplastic syndrome, etc.) or other conditions causing hemolysis or instability of red blood cells (e.g., malaria, hypersplenism, etc.).
4. Presence of an endocrine disorder or history that may significantly affect bady weight(e.g., Cushing's syndrome, hypothyroidism or hyperthyroidism, except hypothyroidism if thyroid hormone replacement dose has been stable for at least 6 months) ；
5. Severe infection, severe trauma, or moderate-to-major surgery within 1 month before screening.
6. Participated in clinical trials of any drug or medical device within 3 months prior to screening, and participation in clinical trials is defined as signing informed consent and using investigational drugs (including placebo) or investigational medical devices; Or is still in the trial drug within 5 half-lives (whichever is Longer).
Study of CAD-1883 for Spinocerebellar Ataxia

This is a randomized, double-blind, placebo-controlled Phase 2 study evaluating oral administration of CAD-1883 in the treatment of adults with a genotypic diagnosis of Spinocerebellar Ataxia (SCA). This study offers the opportunity to understand the safety, tolerability, and efficacy of CAD-1883 in the SCA patient population.

This is a randomized, double-blind, placebo-controlled Phase 2 study evaluating oral administration of CAD-1883 in the treatment of adults with a genotypic diagnosis of SCA using multiple dose levels. The study will include multiple cohorts of 16 patients each where 12 patients will be randomized to CAD-1883 and 4 to matching placebo.

Potential subjects will undergo a screening period (14 to 28 days), a baseline (Day 1) visit, and a 12-week treatment period. A follow-up visit will occur 4 weeks after the end of the treatment period. The total duration of individual subject participation may be up to 20 weeks, depending on the duration of the screening period.

The study will assess safety by adverse events, vital signs, laboratory parameters (including chemistry, hematology and urinalysis); pharmacokinetics of CAD-1883; and efficacy measures by Scale for the Assessment and Rating of Ataxia (SARA), clinician/patient rating of ataxia and symptoms, patient quality of life measures and wearable sensors to capture falls and gait measurements.

For planning purposes, the anticipated study completion date assumes evaluation of 3 cohorts.

Eligibility Criteria:
Key Inclusion Criteria:

* Prior Spinocerebellar Ataxia (SCA) diagnosis of the following SCA genotypes: SCA1, 2, 3, 6, 7, 8, 10, 17, or Autosomal Recessive Cerebellar Ataxia Type 1 (ARCA1).
* Scale for the Assessment and Rating of Ataxia (SARA) Total score ≥8 and \<30 at Screening
* SARA item #1 (gait) score of ≥2 at Screening
* Ability to ambulate 8 meters at Screening without assistance from another person

Key Exclusion Criteria:

* Neurological condition other than SCA that could predominantly explain or contribute significantly to the subjects' symptoms of ataxia or that could confound the assessment of ataxia symptoms (e.g., chronic alcoholism, vitamin deficiencies, multiple sclerosis, Parkinson's disease, Friedreich's ataxia, vascular disease, tumors, paraneoplastic disease, head injury, idiopathic late onset ataxia, multisystem atrophy, stroke, arthritis, cerebral palsy, spasticity of unknown origin).
* Moderate or severe scores on the following Inventory of Non-Ataxia Signs (INAS) items at Screening: Dystonia: at least 3 of 5 items; Spasticity: at least 2 of 3 items; Rigidity: at least 2 of 3 items