cyrilzakka/clinical-trials huggingface dataset:
Clinical Feasibility and Efficacy of Intermittent Use of a Fasting Mimicking Diet in the Treatment of Type 2 Diabetes

In this randomized, controlled, assessor blinded and prospective intervention study the investigators will evaluate the clinical feasibility and effectiveness of intermittent use of a fasting mimicking diet in patients with type 2 diabetes mellitus compared to usual care.

100 individuals (men or women, ethnicity not specified) with type 2 diabetes and a BMI≥ 27, who are treated with diet only and have a HbA1c \> 48, or who are treated with diet and a dose of metformin can participate in the study. Participants will use a fasting-mimicking diet for 5 consecutive days per month. For the other days, there are no regulations. During follow-up of one year, several study parameters will be measured including HbA1c and antidiabetic medication dosage.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of type 2 diabetes
* Age \> 17 years and \<75 years
* Treatment with diet only and have a HbA1c \> 48, or treatment with diet and metformin
* BMI ≥ 27

Exclusion Criteria:

* Recent myocardial infarction (\< 6 months)
* Creatinine clearance \< 30 ml/min/1,73m2 (MDRD)
* Pregnancy
* Contraindications for MRI
* Allergy for nuts, sesame, soya or another ingredient of the diet
* History of syncope with calorie restriction in the past
* Any significant other disease (at the discretion of the investigator)
Laryngeal Nerve Block for Chronic Cough

The purpose of this study is to study the potential benefit of treating chronic neurogenic cough by blocking the nerve responsible for the disease with an injection of local anesthetic/steroid mixture versus a placebo.

This study will be performed by asking participants to fill out multiple questionnaires on the symptoms of their cough, and undergo cough testing by inhaling an airway irritant and monitoring the number of coughs after inhalation of the irritant. Subjects would then undergo the treatment and have an injection of either local anesthetic/steroid mixture or a placebo (normal saline) around the nerve that gives feeling to the portion of the voice box responsible for chronic neurogenic cough. After the injection you will be asked to repeat the cough testing and questionnaires 30 minutes, 1 weeks, and at 6 weeks post injection. After the initial six weeks, patients will cross over and repeat the same process with the opposite treatment (either local anesthetic/steroid mixture or placebo) from their previous injection. The total time of participation is about 12 weeks and we hope to recruit 40 subjects.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* Previously or Newly Diagnosed Chronic Neurogenic Cough

Exclusion Criteria:

* History of Laryngeal Surgery or External Beam Radiation
* Current Smokers
* Known Allergy or Sensitivity to Local Anesthetics
* Uncontrolled Pulmonary, SinoNasal, or GastroIntestinal Pathology leading to Refractory Chronic Cough
Adjuvant Radiotherapy for Patients With Esophageal Squamous Cell Carcinoma After R0 Resection

This retrospective study is exploring the treatment effect and toxicity of adjuvant radiotherapy in patients diagnosed with esophageal squamous cell carcinoma after R0 resection.

Surgery is one of the most important curative approaches for esophageal cancer. In real-world clinical practice, over 50% of the patients receiving surgical resection as primary management. For patients treated with surgical resection without adjuvant therapy, the probability of local-regional recurrence ranged from 23.0% to 56.5%, accounting for 55.6%-84.5% of the disease recurrence. Once encountering disease recurrence, the subsequent prognosis could be dismal. The median survival time after postoperative disease recurrence ranged from 3 to 8 months. Postoperative radiotherapy (PORT) was one of the potential topical treatment approaches prolonging local-regional recurrence time or moreover, attaining superior disease-free survival (DFS) or overall survival (OS) in selected patients. It is essential to identify patients potentially benefit from PORT. Besides, there were few studies evaluating the impact of postoperative radiation dose to survival outcomes in patients receiving PORT. Whether the PORT-related local-regional recurrence free survival (LRFS) enhancement could convert to OS or DFS improvement is still vague. The current study aimed at evaluating the value of PORT in patients diagnosed with esophageal squamous cell carcinoma after R0 resection.

Eligibility Criteria:
Inclusion Criteria:

* KPS≥70
* Pathologically diagnosis of esophageal cancer
* Complete resection (R0 resection)

Exclusion Criteria:

* Diagnosed with other malignancy within 5 years before surgery
* Encountered recurrence or port-site implantation receiving palliative-intended radiotherapy
* Diagnosed with adenosquamous carcinoma or basal cell-like carcinoma
* Treated with PORT with uncertain radiation dose
* Treated with PORT with radiation dose \> 60Gy
Transcranial Direct/ Alternating Current Stimulation for Parkinson's Disease Treatment

To investigate the difference in the treatment efficacy between transcranial direct current stimulation and transcranial alternating current stimulation on Parkinson's disease, including the improvements in the motor, cognitive, and underlying neural mechanisms behind differences in efficacy by electroencephalography (EEG).

All patients underwent a medical evaluation that include physical examinations and routine laboratory studies before and after stimulation sessions. Patients were randomly allocated to tACS, tDCS, and sham groups. There are about 20 patients in each group. Allocation was by computer generating random numbers. The decision to enroll a patient was always made prior to randomization. Patients were studied using a double-blind design. Study participants, clinical raters, and all personnel responsible for the clinical care of the patient remained masked to allocated conditions and allocation parameters. Only stimulation administrators had access to the randomization list; they had minimal contact with the patients, and no role in assessing the UPDRS(Unified Parkinson´s Disease Rating Scale), Hoehn \& Yahr, and MoCA(Montreal Cognitive Assessment). Each patient would be treated for 20 minutes of transcranial electrical stimulation.

Before the stimulation session, UPDRS, Hoehn \& Yahr, and MoCA were obtained by a trained investigator to assess the baseline severity of symptoms. The patients received electroencephalography (EEG) recorded during resting state for 5 minutes.

During the stimulation session, patients were asked to perform simple reaction tasks at the same time.

After the stimulation session, UPDRS, Hoehn \& Yahr, and MoCA were obtained, as well as the Global Index of Safety（tES side effects） to assess adverse events of the treatment. The patients also received a measure of electroencephalography (EEG) recorded during the resting state.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of idiopathic PD according to the movement disorder society criteria
* right-handed
* no clinically known hearing or vision impairment
* no history of epilepsy, dementia, other brain disorders apart from PD, severe internal organs disease, age-related frailty, etc.

Exclusion Criteria:

* parkinsonism due to drugs, Cerebrovascular disease, encephalitis, poisoning, traumatic brain injury, etc.
* Metal implants in the head (i.e., deep brain stimulator or aneurysm clips)
* severe somatic or psychiatric disorders that require medication or routinely monitoring
* participated in other interventional studies within the past 3 months
Digital Cognitive-behavioral Therapy for Insomnia for Patients With Multiple Sclerosis

The goal of this clinical trialis to compare a digital Cognitive-behavioral intervention for insomnia to digital administered applied relaxation in participants with Multiple Sclerosis.

The treatments will be compared in following outcomes:

* Sleep diary: total sleep time (TST), sleep onset latency (SOL), wake after sleep onset (WASO), and early morning awakening (EMA).
* Insomnia symptoms
* Depressive symptoms
* Client satisfaction
* Negative effects
* Worry
* Fatigue
* Quality of life
* MS symptoms/function

In order to start evaluate the digital treatment format, this study will use a Randomized Controlled Trial design (RCT). Participants with MS and insomnia from a Neurology clinic in Sweden will be randomized to either Cognitive-behavioral intervention for insomnia (iCBT) or Applied relaxation (AR). The treatments will consits of six sessions and will be administered digitally. Psychologists will have contact with the participants via a secure video call platform.Follow-up data will be gathered at six and 12 months after the treatments.

The treatments will be compared in following outcomes:

* Sleep diary: total sleep time (TST), sleep onset latency (SOL), wake after sleep onset (WASO), and early morning awakening (EMA).
* Insomnia symptoms
* Depressive symptoms
* Worry
* Fatigue
* Quality of life
* MS symptoms/function
* Client satisfaction
* Negative effects

Eligibility Criteria:
Inclusion Criteria:

* be medically assessed
* meet criteria for MS and insomnia disorder
* have access to the internet and a smart phone with internet access
* have good reading ability, and
* be over 18 years of age

Exclusion Criteria:

* have a planned treatment that may prevent participation
* were involved in ongoing medical research that may prevent participation,
* do not have a command of the Swedish language
* have a more serious acute psychiatric and/or somatic condition which prevented participation; or benefit from the treatment
* have an increased risk of suicide to the extent that participation in study was considered inappropriate,
* suffers from other primary sleep disorders such as sleep apnea, restless legs syndrome, periodic limb movement disorder, circadian rhythm disorder, or parasomnia
* have insomnia due to environmental factors such as shift work.
Patients' Knowledge and Understanding of Cancer Clinical Trials - a Study of Audio Recorded Information

The purpose of this study is to test if cancer patients who are informed about, and offered participation in a cancer clinical trial, are more knowledgeable about cancer clinical trials if they have access to an audio recording of their information visit.


Eligibility Criteria:
Inclusion Criteria:

* Informed in Swedish about a phase II or III clinical trial
* Signed a consent form
Comparison of Non-mydriatic Camera Systems in a Female Health Hospital

1. To compare quality and usability of images taken by two different camera-systems without dilating the pupil.
2. To compare the retinal vessel diameters based on the images of to different camera-systems.
3. To detect changes in retinal vessel diameters while pregnancy and after delivery.

1. To compare quality and usability of images taken by two different camera-systems without dilating the pupil.

   Quality means in this content that images cover the planned region of interest and images should be sharp and good illuminated to see details for medical reading of retinal findings.
2. To compare the retinal vessel diameters based on the images of to different camera-systems.

   The diameters of arteries and veins are planned to be measured with an automated software algorithm. Are there differences in the calculated results between the two used camera devices?
3. To detect changes in retinal vessel diameters while pregnancy and after delivery.

Are there detectable changes of the retinal findings between the images taken before and after delivery (e.g. bleeding, edema, vessel tortuosity)

Eligibility Criteria:
Inclusion Criteria:

* written informed consent
* age \>18 years
* pregnancy (only group 2)

Exclusion Criteria:

* limited ability for agreement
* heavy tremble
* reduced general condition
* known epilepsy
Pre-labor Ultrasound as a Visual Biofeedback Device for Maternal Pushing Education

The study will observe the effect of antenatal biofeedback with transperineal and abdominal ultrasound applied by a pelvic floor physical therapist. The training will focus on pelvic floor training and maternal-coached pushing with ultrasound-based visual biofeedback. The investigators aim to assess maternal and neonatal obstetrical outcomes, urinary and fecal incontinence, and maternal psychological effects.

Childbirth is a challenging process both emotionally and physically. The anxiety and anticipation accompanying pregnancy, labor, and delivery were reported to be relieved by pre-labor education, providing knowledge regarding the physiological process of labor to future parents.

Ultrasound examination enables the laboring women the opportunity to see fetal head movements in response to maternal pushing, and previous studies have revealed the physiological and psychological advantages of ultrasound-mediated intrapartum biofeedback during the second stage of labor.

Pre-labor sonographic maternal coaching has the advantage of a clean setting, avoiding the stressful, frequently hectic nature of labor and delivery wards, and may enable a more comprehensive implementation of the method, a structured training program, and better physical and psychological outcomes. All available literature regarding the application of intrapartum and pre-labor ultrasound refers to the examination performed by obstetricians.

The study will observe the effect of antenatal biofeedback with transperineal and abdominal ultrasound applied by a pelvic floor physical therapist. The training will focus on two aspects: pelvic floor training and maternal coached pushing - both with ultrasound-based visual biofeedback. The investigators aim to assess maternal and neonatal obstetrical outcomes, urinary and fecal incontinence, and maternal psychological outcomes.

Eligibility Criteria:
Inclusion Criteria:

* pregnant nullipara women with a low-risk pregnancy who are planned for vaginal delivery. The biofeedback will occur at 36-42 gestational weeks.

Exclusion Criteria:

* an inability to fill questionaries due to communication issues or cesarean section performed due to major obstetrical events.
Engagement 2.0 Forms of Consent for Data (re-)Use

The objective of this qualitative study is to create a better understanding of patients' mental model of health data engagement interfaces and tools (such as Dynamic Consent). The researchers will focus especially on those people who - plausibly - require adjusted communication particularities and interaction modalities due to a cognitive impairment stemming from a neurodegenerative disease. Taking into account the specific characteristics of patients with dementia, the goal of this study is to investigate how to communicate according to patients' personal skills and capabilities and identify both the proper support mechanisms for engagement 2.0 consent as well as feedback mechanisms (return of research results). Through a focus group \& interview setup, this study will discern design requirements and propose design recommendations for the (future) development of health data engagement interfaces.

While unprecedented amounts of multimodal health data become increasingly available and their secondary use in clinical and (bio)medical research holds great promise, people's agency over this data is in contention. In the context of biobank research, patient-centered initiatives such as 'dynamic consent' have been proposed as a way to provide people with ownership over their health data by allowing for granular expression of their consent preferences using a digital interface. Although such interfaces have been positively assessed within their original biobank context, more heterogeneous audiences will need to be considered if such a socio-technical tool is to be adopted widely and provide people ownership over their electronic medical records. One subset of people that will require adjusted functionalities and interaction modalities in this regard are those with a cognitive impairing condition like dementia, given the illness' consequences on decision making capacity. This study qualitatively explores the user \& social requirements of a tool like dynamic consent if it is to be used in a meaningful way also by people with dementia and their (informal) carers. We report findings from interviews and an expert focus group with people with dementia, their caretakers, and experts to depict their views and requirements on a tool like dynamic consent.

Eligibility Criteria:
Inclusion Criteria:

* no diagnosed cognitive impairment but first-degree relative with AD
* mild cognitive impairment due to AD (diagnosed according to the NIA/AA diagnostic criteria)
* mild dementia due to AD (diagnosed according to the NIA/AA diagnostic criteria)

Exclusion Criteria:

* Patients with moderate to severe dementia due to AD, defined as MMSE total score 20/30 or lower
TRANSFORM-HF Ancillary Mechanistic Study

Patients with heart failure are frequently treated with diuretics, including furosemide and torsemide, but it is not known if one is better than the other. The TRANSFORM-HF trial is studying if torsemide is superior than furosemide for reducing the endpoint of death or hospitalization, but is not designed to study why. This ancillary study seeks to measure proteins in the blood and urine to help explain the underlying mechanism for why patients who take one of these diuretics may have better outcomes than patients who take the other.

Patients who are enrolling in the TRANSFORM-HF study or being prescribed Torsemide or Furosemide at hospital discharge will provide blood and urine at the time of study enrollment (within 72 hours of hospital discharge) and at 90 days (+/- one week) after hospital discharge.

Eligibility Criteria:
Inclusion Criteria:

* Participation in the TRANSFORM-HF trial or prescription of Torsemide or Furosemide
* Willing to provide blood and urine sample at enrollment and follow-up

Exclusion Criteria:

* Inability or unwillingness to comply with the study requirements
Study to Assess Pharmacodynamics of RM-131 in Patients With Diabetic Gastroparesis

The purpose of this study is to evaluate the pharmacodynamic (PD) and pharmacokinetic (PK) profile and the safety and tolerability of RM-131 in patients with diabetes mellitus and delayed gastric emptying.


Eligibility Criteria:
Key Inclusion Criteria:

* Able to provide written informed consent prior to any study procedures.
* Diagnosis of Type 1 or 2 diabetic gastroparesis.
* Controlled Type 1 or 2 diabetes mellitus (HbA1c \<10.1%).
* Stable concomitant medications defined as no changes in regimen for at least 2 weeks prior to Period 1 (daily adjustments of insulin doses are permitted).
* Body mass index of 18-40 kg/m².

Key Exclusion Criteria:

* Unable or unwilling to provide informed consent or to comply with study procedures.
* History of gastric surgery such as fundoplication, gastrectomy, gastric pacemaker placement, vagotomy, bariatric procedure. (Note: history of diagnostic endoscopy is not exclusionary).
* Acute or chronic illness or history of illness, which in the opinion of the Investigator, could pose a threat or harm to the patient or obscure interpretation of laboratory test results or interpretation of study data such as frequent angina, Class III or IV congestive heart failure, poor renal or hepatic function, etc.
* Any clinically significant abnormalities on screening laboratories as determined by the Investigator.
* Abnormal 12-lead electrocardiogram (ECG), including evidence of acute myocardial or subendocardial ischemia and clinically significant arrhythmias or conduction abnormalities or blood pressure at screening except minor deviations deemed to be of no clinical significance by the Investigator.
* Poor venous access or inability to tolerate venipuncture.
* Acute GI illness within 48 hours of Period 1.
* Positive pregnancy test.
* Participation in a clinical study within the 30 days prior to dosing in the present study.
* Any other reason, which in the opinion of the Investigator, would confound proper interpretation of the study.
The Effects of Using Different Anesthetics on the Prognosis of Primary Lung Tumors and Its Mechanism of Action

This is a two-arm, parallel-group randomized clinical trial. Routine perioperative care would be performed in volunteers with primary early lung cancer. The study will enroll approximately 300 volunteers to compare the progression-free or overall survival in patients undergoing video-assisted thoracoscopic surgery (VATS) for primary lung tumors between propofol and sevoflurane for the maintenance of anesthesia.

Before the scheduled procedure, the patients are randomly assigned into peopofol group or groups (1:1) according to the randomization generated by the computer. Both groups were induced with propofol 1\~2.5 mg/kg propofol. The propofol group was maintained at an effect-site concentration of 2.0-4.0 mcg/mL by a target-controlled infusion system. The sevoflurane group was maintained via sevoflurane vaporizer between 1% and 3% (target minimum alveolar concentration of 0.7-1.3 MAC). During the operation, the dose of anesthetic drugs (propofol/fentanyl /remifentanil and sevoflurane/cisatracurium/rocuronium) are adjusted to maintain the mean arterial pressure and heartbeat fluctuations within 20% of the baseline value and Entropy (or BIS) value at 40-60in both groups. The following patient data were recorded, the type of anesthesia, sex, age at the time of surgery, preoperative Karnofsky performance status score and functional capacity, the postoperative complications within 30 days (according Clavien-Dindo classification), American Society of Anesthesiologists physical status scores, tumor size, intraoperative blood loss/transfusion, duration of surgery, duration of anesthesia, total opioid (remifentanil/fentanyl/ propofol) use, postoperative radiation therapy, postoperative chemotherapy, postoperative concurrent chemoradiotherapy, the presence of disease progression, and 6-month, 1-year, and 3-year overall survival and Karnofsky performance status score were recorded.

Eligibility Criteria:
Inclusion Criteria:

* eighteen to eighty-year-old
* ASA class I-III patients
* Received elective thoracic surgery for primary lung tumors under general anesthesia

Exclusion Criteria:

* mental disorder
* poor liver function
* pregnant or lactating women
* morbidly obese
* allergy to any of the drugs used in this study
* recurrent tumor or repeat surgery
* biopsy cases
* incomplete outcome-data
* palliative treatment after surgery
* simultaneous treatment of other malignancies
* emergency surgery
* presence of other malignant tumors
* combined propofol and inhalation anesthesia or other anesthetics, such as ketamine or dexmedetomidine
* diagnosed as benign lung tumor, or other metastatic lung tumor