cyrilzakka/clinical-trials huggingface dataset:
Multidimensional Assessment of Fatigue in Multiple Sclerosis- Observational Study - Ticino

Fatigue is a common symptom in patients with multiple sclerosis, however, its nature is not completely understood. Fatigue overlaps often with other symptoms such as somnolence, depression and cognitive disorders, from which it is not always readily distinguished. The evaluation of fatigue and the three most frequently associated symptoms using a multidimensional approach might allow to understand, which methodology is the best indicated to estimate the prevalence of fatigue with greatest accuracy, leading to a better differentiation of the symptoms in the diagnostic setting.

Objectives: 1- to provide a detailed characterization of fatigue in a cohort of selected MS patients, including a definition of the boundaries and the overlaps between fatigue, somnolence, mood disorders and attention dysfunction; 2- to see how the prevalence and the overlaps between fatigue, somnolence, depression and attention dysfunction are influenced by the method of assessment. 3-To better characterize the sleep structure in MS patients with fatigue under both the macro- and microstructural point of view.

Eligibility Criteria:
Inclusion Criteria:

* Definite diagnosis of MS (14,15) or CIS (16);according to the most recent standard criteria
* Expanded Disability Status Scale (EDSS) score \< 7.0 (17);
* Last magnetic resonance imaging (MRI) within the previous 12 months;
* Male or female;
* \>18 years old;
* Willing to perform the study procedures;
* Signed Informed consent.

Exclusion Criteria:

* Mini Mental Status Examination (MMSE) score \< 24;
* Relapse within the last 3 months;
* Radiologically isolated syndrome (RIS);
* History of drug and/or alcohol abuse;
* Any serious general medical condition like decompensated cardiopulmonary disease, cancer or decompensated renal failure, as well as any neurological condition (other than MS) that can interfere with the correct execution of the study design.
Prospective, Multicenter da Vinci® SP™ Surgical System TORS Study

A prospective, multicenter investigation of the da Vinci® SP™ Surgical System in Transoral Robotic Surgery (TORS) procedures for malignant oropharyngeal tumors.

A prospective, multicenter investigation to evaluate the safety and clinical performance of the da Vinci SP Surgical System, instruments, and accessories in TORS procedures for malignant oropharyngeal tumors classified as T1 and T2.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* T1 or T2 malignant oropharyngeal tumor
* Tumor amenable to transoral resection
* No previous treatment for the index tumor
* Willing and able to provide written informed consent
* Willing and able to comply with the study protocol requirements

Exclusion Criteria:

* T3 or T4 stage tumor
* Previous radiation treatment to the head and neck, with or without chemotherapy
* Evidence of other primary cancers or distant metastasis or subject with synchronous primary tumor excluding skin cancers
* Pre-operative expectation of needing microvascular soft-tissue reconstruction
* Tumor that invades and/or abuts the internal and/or external carotid artery
* Retropharyngeal carotid artery coincident with a tonsillar cancer or posterior pharyngeal wall cancer
* Evidence of mandibular invasion of tumor
* Eastern Cooperative Oncology Group Performance Status score greater than or equal to 2
* On a medication that interferes with clotting that cannot be stopped prior to surgery
* Contraindication for general anesthesia or surgery
* Mentally handicapped or has psychological disorder or severe systemic illness that would preclude compliance with study requirements or ability to provide informed consent
* Pregnant or suspected to be pregnant
The Acute Effect of Vaping on Food Intake

This study assesses the acute effects of a standardized 20-minute vaping episode compared to a non-vaping control condition on ad libitum food intake during a 30-minute buffet meal, occurring approximately 45 minutes after the vaping episode

Weight control is a common motive for cigarette smoking and nicotine has been shown to suppress appetite and increase resting metabolic rate, and also serves as a behavioral alternative to eating or a distraction from hunger or food craving. Data on the acute effect of e-cigarette use ('vaping') on ad libitum food intake are non-existent. Given that many e-cigarette users report vaping for weight control and that certain e-cigarettes are being actively marketed for weight management and/or suppression of food cravings, addressing this research gap is of the utmost importance.

Eligibility Criteria:
Inclusion Criteria:

* 18 - 65 years of age (ID card verified)
* Reports either everyday e-cigarette use with liquid containing at least 0.3% (\~3 mg/ml) nicotine or some day e-cigarette use ( at least 3 days a week) with liquid containing at least 3% (\~30 mg/ml) nicotine for the past 30 days.

Exclusion Criteria:

* being unwilling to consume the foods provided due to: a) dietary limitations or preferences or b) allergies to the foods provided.
* being unwilling to take 20 puffs from a JUUL device containing a 5% nicotine pod
* self-reported current, diagnosed medical condition(s) will be excluded automatically: heart-related conditions (e.g., recent heart attack/stroke, coronary heart disease), severe immune system disorders (e.g., HIV/AIDS, multiple sclerosis), respiratory disorders (e.g., COPD, asthma), kidney diseases, liver diseases (e.g., cirrhosis), or seizures
* observed high blood pressure at screening (systolic \>140; diastolic \>90)
* other self-reported current, diagnosed medical conditions (e.g., specific food allergies, diabetes, thyroid disease, lyme disease) will be considered for exclusion after consultation with the PI and medical monitor
* self-reported current, diagnosed psychiatric conditions or who report current psychiatric treatment or psychotropic medication use
* past month use of cocaine, opioids, benzodiazepines, methamphetamine, or other (non-cannabis) illicit drugs
* self-report of \>25 days out of the past 30 for alcohol use or \>20 days out of the past 30 for cannabis use.
* women who are breast-feeding or test positive for pregnancy (by urinalysis at screening)
* women using progestin-IUDS for birth control
* women using birth control injections (e.g., Depo-Provera)
* women who received a hysterectomy and still have ovaries present
* self-report intending to quit tobacco/nicotine products in the next 30 days
A Clinical Trial of Oral Ganaxolone in Women With Postpartum Depression

A clinical study to evaluate safety, tolerability and efficacy of oral administration of ganaxolone in women with postpartum depression


Eligibility Criteria:
Inclusion Criteria:

* Experiencing a major depressive episode, which started between the start of the third trimester and 4 weeks following delivery. The major depressive episode must be diagnosed according to Mini International Neuropsychiatric Interview (MINI) 7.0 interview
* Given birth in the last 6 months
* HAMD17 score of ≥ 20 at screening but \< 26
* Must agree to stop breastfeeding from start of study treatment or must agree to temporarily cease giving breast milk to her infant(s)

Exclusion Criteria:

* Current history of any psychotic illness, including major depressive episode with psychotic features
* History of suicide attempt within the past 3 years
* History of bipolar I disorder
* History of seizure discorder
Comparison of Non-invasive to Invasive Assessment of Jugular Venous Pressure

Assessment of the jugular venous pressure (JVP) is an important clinical sign and correlates with right atrial (RA) pressure. A patient with heart failure (HF) typically has an elevated JVP, but in cases of dehydration JVP may be low. Assessment of the JVP is key to the management of patients with fluid overload or needing diuretics. Currently the assessment of JVP is made by the physician by direct visualization of the neck veins. However this is inaccurate, may vary between investigators and depends largely on the patient's habitus. The JVP and RA pressures may also be directly measured by catheterization (a routine during right heart catheterization), but this is an invasive procedure that is seldom performed.

A thermal movie of the external jugular vein at a specific neck position may help to measure the JVP. In this study different modalities of JVP assessment (clinical assessment, thermal image and invasive measurement) are to be compared

Patients scheduled for right heart catheterization at the Shaare Zedek Medical Center for non-study related medical indications will be approached.

Non-invasive estimates of JVP will be performed independently prior to the right heart catheterization, during the waiting period (within 2 hours) prior to catheterization. These will include up to 2min of thermal camera recording (to be analysed offline) and a physician's JVP evaluation. The angle of the patient's upper body will be 30-60°, the rotation of the neck will be optimal for filming, and the neck area may be cooled to enhance the images. Blinding to the results will be confirmed by performance with separate investigators and separate data registration. Right heart catheterization will then be performed and RA pressure will be recorded, as well as pulmonary and wedge pressures. JVP measured by physician and thermal image will be matched with invasive catheterization (the gold standard) using Bland Altman plots and Spearmann correlation and comparison between methods will be performed.


Eligibility Criteria:
Inclusion Criteria:

1. Patients already scheduled for right heart catheterization for clinical indication
2. Age 18-90

Exclusion Criteria:

1. Local scar wound or bruise in the right side of the neck.
2. Current upper torso central venous catheterization such as a PICC line or dialysis catheter.
Assessment of the Aromatherapy to Alleviate Peri Operative Anxiety in Ambulatory Elective Upper Limb Surgery Under Loco-regional Anesthesia

AROMA study is a randomised controlled parallel-group single-site study. Patients randomized in the experimental group benefit from the aromatherapy at their arrival in the operating theatre in the recovery room. 2 drops of essential oils are applied on a compress placed next to the head of the patient. This compress is kept until the patient is leaving the operating theatre. Patients randomized in the control group don't benefit from the aromatherapy. The anxiety evolution is measured in both groups with the Amsterdam Preoperative Anxiety and Information Scale (APAIS). The hypothesis is that aromatherapy alleviate peri operative anxiety during an ambulatory elective upper limb surgery under loco-regional anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* Patient admitted in Hospital Centre for an ambulatory elective upper limb " fast track " surgery
* Patient with loco-regional anesthesia
* Patient categorized 3 or less according to the American Society of Anesthesiologists (ASA) score
* The patient must have given his written consent to participate in the study
* Patient - insured under the French social security system
* Patient prepared to comply with all the terms of the study and its length

Exclusion Criteria:

* Epileptic patients
* Asthmatic patients
* Patients with cognitive disorders ( Mini Mental Status below 15)
* Psychiatric disorders : current depression or bipolar disease or anxiety disorders or psychotic disorders according to DSM-V classification
* American Society of Anesthesiologists score strictly superior to 3
* Preoperative chronic pain : neuropathic pain, fibromyalgia, polyarthritis
* Pregnant or breastfeeding woman
* Patient unable to receive an informed consent and to comply with all the terms of the study
* Patient without any social insurance
* Refusal to sign the consent
* Patient under legal protection
* Patient in emergency (unstable clinical state)
* Patient unable to read or write french
* Patient enrolled in an other clinical trial
Analgesic Effect of Ultrasound-guided Bilateral Modified-thoracoabdominal Nerves Block Through a Perichondrial Approach

This study will define the postoperative analgesic effect of ultrasound-guided bilateral modified-thoracoabdominal nerves block through perichondrial approach (M-TAPA) and compare the control group in patients undergoing laparoscopic cholecystectomy.

Laparoscopic cholecystectomy is the most common laparoscopic procedure and causes moderate to severe postoperative pain. The M-TAPA block was described by Tulgar et al. for postoperative analgesia of abdominal surgeries. However, studies showing the analgesic efficacy of this block are lacking. In this prospective interventional trial, the investigators aim to define the efficacy of M-TAPA block for laparoscopic cholecystectomy surgeries under general anesthesia.

This study will be conducted as a single-center, prospective, randomized, double-blinded trial in a university hospital. Patients scheduled for elective laparoscopic cholecystectomy will be screened for enrollment in the study. After randomization, the patients in the Group M-TAPA will receive bilateral M-TAPA block at the beginning of the operation defined by Tulgar et al or no intervention (Group N). An anesthesiologist who performed M-TAPA block will not involve in the data collection. Other health care workers who will involve in the evaluation of postoperative pain scores, vital parameters, nausea and vomiting, anti-emetic and opioid consumption will be blinded to group assignment.

Eligibility Criteria:
Inclusion Criteria:

* Patients' age between 18 and 70 years with American Society of Anesthesiology (ASA) physical status I-II, who will be scheduled for an elective laparoscopic cholecystectomy surgery included in the study

Exclusion Criteria:

* presence of coagulation disorder
* refuse to participate
* infection at the injection site of the block
* known allergy to local anesthetics
* advanced hepatic or renal failure
* can not communicate in Turkish
* history of abdominal surgery or trauma
* conversion of laparoscopic to open surgery
* consumption of any pain killers within the 24 h before the operation
* chronic opioid consumption
* pregnancy
* alcohol or drug abuse
* body mass index (BMI) ≥ 35 kg m-2.
Placenta Accreta&Its Complications in Placenta Previa Cases

Cases of previous cesarean with placenta previa anterior underwent cesarean section. Placenta accreta is diagnosed during cesarean section \&confirmed by pathology. All complications are monitored in cases with placenta accreta and without.

100 cases of gestational age 30 weeks or more with placenta previa anterior with previous one or more cesarean section will be enrolled. History,examination \&routine investigations will be taken. Colour doppler will be done to diagnose cases with suspected placenta accreta. Pre \& postoperative Hb concentration will be taken. Cases with nonseparation of the placenta will be diagnosed as accreta \& confirmed by pathology. Operative time \& complications like bladder or intestinal injury will be noted. All data will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* all pregnant women more than 30 weeks with previous one or more cesarean section with placenta previa anterior

Exclusion Criteria:

* pregnant with unscarred uterus
* scars other than cesarean section
Multi-component Exercise Program and Nutritional Supplementation in Frail Older Adults

The objective of this study is to evaluate the effects of a multi-modal group-based exercise program and nutritional supplementation on physical performance in frail institutionalized older adults.

Participants will be randomly allocated to the intervention groups; exercise (EG) or exercise plus nutritional supplementation (SG), or to the control group (CG). During 6 months, participants in the intervention groups will be performing the exercise routine based on the Otago exercise programme. Additionally, participants in the SG will receive a daily oral nutritional supplement.

Objectives: Evaluate the effects of a multi-modal group-based exercise program and nutritional supplementation on physical performance and the capacity to perform daily tasks in frail institutionalized older adults.

Design: Randomized controlled trial, with a 6-month intervention period. Participants: 122 frail institutionalized older adults aged 65 and older with no cognitive impairment.

Intervention: After a baseline assessment, the participants will be randomly assigned to the control group or one of two intervention groups; multi-modal exercise program (EG) or exercise plus nutritional supplementation (SG). During 6 months, participants in the intervention groups will be performing the exercise routine based on the Otago exercise programme. Additionally, participants in the SG will receive a daily oral nutritional supplement.

Measurements: The primary outcome measure will be mobility measured with the timed up and go test. Secondary outcomes will be the functional balance, hand-grip strength, lower limb functional capacity, gait speed and distance covered during the 6-minute walk test.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 65 years;
* Frail institutionalized.

Exclusion Criteria:

* Cognitive impairment;
* Fracture;
* Neurological disorder;
* Unable to follow verbal instructions;
* Score lower than 60 in the Barthel Index.
A Clinical Trial of Decitabine in Relapsed or Refractory T-lymphoblastic Lymphoma

To explore the safety, tolerability, and clinical effects of decitabine combined with Second-line chemotherapy regimens for patients with relapsed or refractory T-lymphoblastic lymphoma.

This is a prospective, open，investigator initial clinical trial with a single arm, aimed to evaluate the safety, tolerability, and efficacy of decitabine combined with Second-line chemotherapy regimens (CODOX-M/IVAC) in relapsed or refractory T-lymphoblastic lymphoma. A total of 40 patients are planned to be enrolled into the study. Patients with diagnosis of relapsed or refractory T-lymphoblastic lymphoma will be treated with decitabine plus CODOX-M/IVAC. The primary end point is responder rate (RR) and time to progression (TTP), and the secondary end points include overall survival (OS) and the median survival time (MST).

Eligibility Criteria:
Inclusion Criteria:

* age: 14\~60 years; ECOG rate ≤ 2; expected survival \> 3 months;
* patients with T-lymphoblastic lymphoma diagnosed by histopathology detection;
* patients ever received chemotherapy and/or radiotherapy;and can not be transplanted hematopoietic stem cells;
* patients with no chemotherapy contraindications: hemoglobin ≥ 90 g/L, absolute neutrophil count ≥1.5 x 109/L, blood platelet ≥100 x 109/L, ALT and AST ≤ 2-fold upper normal limit, serum bilirubin ≤ 1.5-fold upper normal limit, serum creatinine ≤ 1.5-fold upper normal limit, serum albumin ≥ 30 g/L, normal serofibrinogen;
* at least one measurable nidus;
* no other severe diseases conflict with this project, cardiopulmonary function is basically normal;
* the urine or blood pregnancy test of women in childbearing age must be negative in 7 days before follow-up visit;
* applicable for follow-up visit;
* no other antitumor adjoint therapy (including antitumor Chinese medicine, immunotherapy and biotherapy), but double phosphate anti-bone transfer therapy and other symptomatic treatment are acceptable;
* understanding this study and assigning informed consent.

Exclusion Criteria:

* rejecting providing blood preparation;
* allergic to drug in this study and with metabolic block;
* rejecting adopting reliable contraceptive method in pregnancy or lactation period;
* uncontrolled internal medicine disease (including uncontrolled diabetes, severe incompetence cardiac, lung, liver and pancreas);
* with severe infection;
* with primary or secondary central nervous system tumor invasion;
* with immunotherapy or radiotherapy contraindication;
* ever suffered with malignant tumor;
* having peripheral nervous system disorder or dysphrenia;
* with no legal capacity, medical or ethical reasons affecting research proceeding;
* participating other clinical trials simultaneously;
* adopting other anti-tumor medicine excluding this research;
* the researchers considering it inappropriate to participate in the study.
Study of the Role of Hemostasis in Perioperative Anaphylaxis

Anaphylaxis is a severe and life-threatening complication during the perioperative period. Perioperative anaphylaxis is still associated with a significant mortality despite quick and efficient management using epinephrine, the mainstay of acute treatment. Experimental data and few case reports are suggesting that hemostasis, and more precisely platelets, could play a role in anaphylaxis. Our main hypothesis is that activation of the hemostatic system contributes to the severity of the reaction


Eligibility Criteria:
Inclusion Criteria:

* Patient, male or female, adult
* In the perioperative period
* In whom the diagnosis of anaphylactic shock is suggested
* Patient is giving his consent to participate in the study

Exclusion Criteria:

* Subject under legal protection
* Subject under guardianship or guardianship
* Anemia less than 7 g /dl at the time of inclusion
Transfer Effects of Combined Attentional Filter Exercise and Transcranial Direct Current Stimulation

Investigation of how a single session of an attentional filter exercise of distractor inhibition combined with tDCS modulates cognitive functions like working memory, decision making and attentional control.

The study is designed as a between subject design with two groups defined by real or sham tDCS. The distractor inhibition exercise is conducted under either sham or real tDCS. Cognitive performance is assessed pre and post tDCS application, complemented by a short-termed follow-up on a consecutive day. Interindividual working memory capacity at baseline is taken into consideration.

Eligibility Criteria:
Inclusion Criteria:

* right-handed
* aged between 18 and 30 years
* normal or corrected to normal vision
* German-speaking

Exclusion Criteria:

* dyschromatopsia
* neurological or neuropsychiatric diseases
* low seizure threshold
* neurological medication
* metal implants in the head