cyrilzakka/clinical-trials huggingface dataset:
Food Reward in Cachexia Induced by Acute or Chronic Disease

To study activity in the reward-circuitry of the brain in patients suffering from cachexia induced by cancer or chronic disease.

The activity in the food reward-circuitry of the brain in patients suffering from cachexia induced by cancer (lung cancer or pancreatic cancer) or chronic disease (chronic obstructive pulmonary disease) will be analysed by using functional magnetic resonance imaging. In addition, the role of the peripheral satiety hormones will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* For cachectic patients: weight loss exceeds 5% of total body weight over the past 6 months, or \>2% when body mass index is \<20 kg/m2
* For non-cachectic patients: no weight loss of ≥5% during the last 6 months
* Non-small cell lung cancer or gastro-intestinal cancer, pathology proven or diagnosis of COPD consistent with the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria

Exclusion Criteria:

* Contra-indications for fMRI examination (operation to your head or brain in the past; implanted electronic devices, for instance a pacemaker, neurostimulator, cochlear or hearing implant; insulin pump under your skin; Pregnant subjects, claustrophobia; pregnancy; metal parts in your body (except from teeth filling and connectors): implants; brain vessel clamps, prostheses, intra-uterine device, metal splinter in the eye, metal braces or other metal objects, permanent eye make-up)
* Psychiatric or other disorders likely to impact on informed consent
* Presence of brain metastasis (screening is not mandatory)
* Medical history of cerebrovascular accident, brain tumour, brain metastasis
* Previous radiotherapy to brain, both stereotactic and whole brain radiotherapy
* Memory problems
* Current use of tube feeding or parental nutrition
* Patients with an active second malignancy
* Patients unable to lie still for 2 hours
* Unable to complete the cognitive task
* Pre-existing swallowing difficulties
* Allergy to gluten-, milk- or wheat products
* Self-reported hyperthyroidism
* Self-reported diabetes mellitus
* Current use of appetite stimulant medications
Quantitative Margin Assessment Using High-resolution Positron Emission Tomography - Computed Tomograhy

The primary endpoint is the assessment of the clinical value of a novel high-resolution mobile PET-CT scanner for intraoperative margin assessment in oral squamous cell carcinoma, soft tissue sarcoma and osteosarcoma surgery. The predicted margin status will be correlated with the margin status determined with histopathology.

The ideal outcome in oncological surgery is resection of all tumor tissue with a margin of healthy tissue. However, positive surgical margins (PSMs) occur in up to 35% of the cases, depending on tumor type. The final margin status is only available five to seven days after surgery so that in case of a PSM, intensive adjuvant radiotherapy or chemotherapy is necessary. Despite adjuvant treatment, patients still have a significantly reduced overall survival. Therefore, the intraoperative identification of PSMs is paramount to enable surgical corrections and obtain a complete resection.

The investigators propose a dedicated intraoperative high-resolution PET-CT (positron emission tomography - computed tomography) imaging system for margin assessment of the excised specimen. The proposed specimen imaging system would combine the proven functional imaging capabilities of PET with the anatomical imaging info of CT, providing multi-modal information to determine whether tumor cells are present at the excision edges of the specimen. The tomographic images obtained can precisely demonstrate tumor extension along the x, y, and z axis, and the PET signal is not distorted by bone tissue. PET is the most sensitive medical imaging modality capable of detecting the picomolar concentrations of radiotracer, allowing to assess the presence of tumor cells within the specimen margins with high precision. Current standard PET-CT scanners have a spatial resolution between 3mm and 6mm, which is insufficient to accurately assess the excision margins of tumors. A specimen imaging system ideally should have a sub-millimeter resolution. The specimen PET system which will be used in this study is capable of this. The potential of intraoperative PET-CT has been shown in several tumor types, enabling the intraoperative identification of PSMs in prostatectomy and lumpectomy specimens.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years.
* Patient is confirmed with oral squamous cell carcinoma, soft tissue sarcoma or osteosarcoma.
* Patient is indicated to undergo curative surgery of the primary tumor.
* Patient is estimated compliant for study participation by the investigator.
* Written informed consent.

Exclusion Criteria:

* Medical or psychiatric conditions that compromise the patient's ability to give informed consent;
* Patient has previously received radiotherapy of the primary tumor region;
* Patient has participated in other clinical studies with radiation exposure of more than 1 mSv in the past 12 months;
* A blood glucose level over 200 mg/dL on the day of surgery.
* Pregnancy or lactation.
Evaluation of a Smartphone-delivered Peer-led Physical Activity Counselling Program for Manual Wheelchair Users

Despite physical activity (PA) being a valuable modality for promoting health, the evidence for effective PA intervention strategies for manual wheelchair (MWC) users is underdeveloped. Community-based programs and telephone-counselling interventions to increase PA among MWC users have had some success, but the uptake and adherence to these interventions remains low within this population. Community-based programs may not reach MWC users who live in rural areas and have issues with transportation, while health professionals may not optimally relate with MWC when providing telephone counselling. Although the PA needs of MWCs are not fully understood, there is reason to believe that including peers into intervention delivery may have benefits.

A feasibility trial is critical and prudent prior to moving forwards with a large and expensive multi-site randomized controlled trial (RCT) to ensure that: the intervention meets the needs of the target population; the right outcomes are measured; and that the intervention is feasible to administer.

The objective of this study is to evaluate the feasibility of a Smartphone-delivered Peer-led Physical Activity Counselling (SPPAC) program for MWC users.


Eligibility Criteria:
Inclusion Criteria:

* live in the community
* have used a manual wheelchair for ≥ 1 year
* able to self-propel a manual wheelchair for at least 10m
* able to communicate in English or French
* have physical activity or mobility goals
* cognitively able to set goals (Mini-mental State Exam Score ≥ 25)

Exclusion Criteria:

* anticipate a health condition or procedure that contraindicates training (e.g., surgery scheduled which would impair physical activity)
* have a degenerative condition that is expected to progress quickly (e.g., Amyotrophic Lateral Sclerosis
* are concurrently or planning to receive manual wheelchair mobility training over the period of the study
Comparison of Blood Flow in the Arteriae Uterinae in Ovarian Stimulation Cycles

This study will measure the blood flow in the aa. uterinae in women, undergoing firstly ovarian stimulation for In-Vitro Fertilization (IVF) / Intracytoplasmic sperm injection (ICSI), in Hormonal Replacement cycles (HRT) and Natural cycles (NC) for Frozen Embryo Transfer (FET)

To evaluate the influence of ovarian stimulation on the blood flow in the arteriae uterinae as well as whether there is an influence of the type of endometrial preparation for FET with either hormonal replacement therapy or natural cycle on the blood flow of the arteria uterina left / right

Eligibility Criteria:
Inclusion Criteria:

* Patients who undergo ovarian stimulation in a Gonadotropin-Releasing-Hormone (GnRH)-antagonist protocol for IVF / ICSI
* Patients who have vitrified embryo(s)
* Preparation for FET either in HRT or NC cycle

Exclusion Criteria:

* Poor responder according to Bologna criteria (Ferraretti et al.) as follows:
* At least two of the following three features must be present:
* (i) Advanced maternal age (≥40 years) or any other risk factor for poor ovarian reserve (POR);
* (ii) A previous POR (≤3 oocytes with a conventional stimulation protocol);
* (iii) An abnormal ovarian reserve test (i.e. antral follicle count (AFC) 5-7 follicles or anti-mullerian hormone (AMH) 0.5 -1.1 ng/ml).
* Uterine surgery for removal of fibroids (hysteroscopic, laparoscopic) or removal of uterine septum
* Endometriosis
* Asherman-Syndrome
* Previous cytotoxic treatment
* Previous radiation of the uterus / adnexal region
* Known hypertension
* Intake of Aspirin or similar medication which might influence the blood flow
* Status after tubal ligation
* Status after surgery in the adnexal region on 1 side
Comparison of Efficacy Between Piracetam and Dimenhydrinate in Patients With Peripheral Vertigo

This study aims to investigate efficacy of two different intravenous drugs (dimenhydrinate and piracetam) in the symptomatic management of peripheral vertigo.

The patients will be randomized in two groups according to symptomatic treatment modalities: Dimenhydrinate (100 mg) and piracetam (2 g) will be given in 100 cc normal saline in 30 minutes. Each patient will be asked if her/his vertigo symptoms resolved or not, according to a numeric rating scale (0=no vertigo, 10=worst possible vertigo). The patient will be rate the intensity of symptoms in the following times:

* Numeric rating scale (1 to 10): Admission
* Numeric rating scale (1 to 10): After the study drug (No ambulation)\*
* Numeric rating scale (1 to 10): After the study drug (Ambulation)\*

  * Ambulation refers to head movements or walking in the room, if applicable.


Eligibility Criteria:
Inclusion Criteria:

* Presenting to emergency department with vertigo symptoms
* Adult patients (over 18)
* Agree to participate to study (understanding the study protocol and signing the informed consent form)

Exclusion Criteria:

* Patients under 18 years
* Patients diagnosed with ischemic/hemorrhagic stroke after neuroimaging
* Patient diagnosed with transient ischemic attack
* Pregnants
* Patients taking any analgesics or antihistaminic drugs last 24 hours
* Documented or declared allergy to dimenhydrinate, piracetam or benzodiazepines
* Patients who do not agree to participate to the study
A Study to Evaluate Rofecoxib Versus Placebo and Diclofenac in Patients With Acute Painful Rotator Cuff Syndrome

Comparing the short-term efficacy of rofecoxib versus placebo. Patients receive rofecoxib or placebo or diclofenac and fill out a patient diary on daytime pain severity during daily activities, night pain severity, and acetaminophen/paracetamol intake.


Eligibility Criteria:
Inclusion Criteria:

* Males or females between the ages of 18 and 59 with acute painful rotator cuff syndrome.
Crenobalneotherapy in the Treatment of Chronic Venous Insufficiency

At 3 months, crenobalneotherapy session is superior to waiting list for patients with chronic venous insufficiency.


Eligibility Criteria:
Inclusion Criteria:

* patients aged 18 to 80 years with chronic venous insufficiency regardless of etiology stages 3 or 4 according to the CEAP classification (Clinical severity, Etiology or cause, Anatomy, Pathophysiology)
* Patients available to participate in a 3 weeks session in the spa center and to be followed for 6 months

Exclusion Criteria:

* pregnant women,
* contra-indication for the spa treatment (chronic infectious diseases, cancer, heart failure, serious liver or kidney disease, open leg ulcer, psychiatric disorders, immune deficiency, phlebitis, erysipelas or history of erysipelas);
* surgery in the next three months,
* spa treatment in the previous 6 months,
* professional involvement with a spa resort
TACE With Lenvatinib Versus Lenvatinib Alone in in First-line Treatment of Advanced HCC

This trial is is an open label, multicenter, randomized controlled phase 3 clinical trial. The purpose is to compare the efficacy and safety of lenvatinib plus TACE with lenvatinib alone for advanced HCC patients.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-75 years old;
2. Patients with primary advanced HCC (in accordance with AASLD2018 guidelines for the diagnosis of HCC), without any previous treatment;
3. There is at least one measurable lesion in the liver according to mRECIST criteria, single tumor ≤ 10.0 cm or multiple tumors and tumor burden ≤50% , with portal vein tumor embolus or with extrahepatic metastasis;
4. ECOG score 0-1;
5. Child-Pugh class A;
6. Expected survival time ≥ 3 months;
7. Blood, liver and kidney function meet the following conditions: Neutrophil count ≥ 1.5 × 10 9 /L; Platelet count ≥ 60 × 10 9 /L; Hemoglobin ≥ 90 g/L; Serum albumin ≥ 30 g/L; Bilirubin ≤ 50 umol/L; AST, ALT ≤ 5 times the upper limit of normal, ALP ≤ 4 times the upper limit of normal; Prolongation of prothrombin time not to exceed the upper limit of normal by 6 seconds; Creatinine ≤ 1.5 times the upper limit of normal

Exclusion Criteria:

1. Preoperative imaging examination revealed diffuse intrahepatic lesions or invasion, inferior vena cava or primary branch bile duct;
2. Previous history of hepatic encephalopathy, refractory ascites or gastric esophageal varices;
3. There are contraindications to TACE treatment, such as portosystemic shunt, liver flow ablation, significant atherosclerosis;
4. Brain metastases;
5. Hypersensitivity to intravenous contrast agents;
6. Pregnant or lactating women or subjects with family planning within two years;
7. With HIV, syphilis infection;
8. Accompanied by other malignant tumors or suffering from other malignancies within 5 years before enrollment;
9. Allogeneic organ transplant recipients;
10. Severe dysfunction of heart and kidney or other organs;
11. Active severe infection \> grade 2 (NCI-CTC version 4);
12. Suffering from mental and psychological diseases may affect informed consent;
13. Unable to take oral medication;
14. Participated in other drug clinical trials within 12 months before enrollment;
Preoperative Exercise in Pancreatic Cancer

The purpose of this study is to investigate the effects of a preoperative exercise program in patients with pancreatic cancer preparing for surgery. Preoperative exercise programs have been shown to be effective in other cancer populations, but have not been investigated in patients with pancreatic cancer. The outcomes in this study will be changes in physical fitness, function, and postoperative outcomes. This investigation is a non-randomized control trial, with participants assigned to receive the preoperative exercise intervention in addition to standard care, or standard care alone if unable to commit to an exercise program for practical reasons. Possible mediators for the effects of exercise on postoperative outcomes will also be assessed, including psychological outcomes and markers of systemic inflammation. These measures will be assessed in all participants prior to program initiation, prior to surgery, and after surgery. Changes in these measures in response to exercise will be assessed, as well as the ability of the preoperative measures to predict postoperative outcomes.

This study focuses on patients prescribed neoadjuvant (preoperative chemotherapy and radiation) prior to surgery for borderline resectable pancreatic adenocarcinoma. This allows for a known, preoperative window long enough to provide an effective exercise intervention. The exercise program will be administered for at least eight weeks, but has no cap on length, as neoadjuvent treatment periods can vary between participants and a cessation of the exercise program before the end of this period could result in an undesirable loss in physical fitness and function.

The study is a non-randomized, parallel group, intervention control trial, based on pilot studies in similar patient populations. All participants meeting the inclusion criteria and able to participate in the exercise program will be assigned to the exercise group. Participants meeting the inclusion criteria, but unable to commit to the exercise program for practical reasons (transportation, location, etc), will be assigned to the standard care group.

Eligibility Criteria:
Inclusion Criteria:

* Recent (\< 4 week) first diagnosis of a borderline resectable pancreatic adenocarcinoma
* Prescription to receive neoadjuvant therapy and surgery,
* Age 21 to 80 years old,
* Physician clearance to participate in exercise program.

Exclusion Criteria:

* Any significant comorbid conditions that would interfere with or preclude participation in an exercise intervention, including orthopedic conditions such as advanced osteoarthritis, mobility-limiting amputations or chronic injuries, or mobility-limiting acute orthopedic injuries
* Advanced rheumatoid arthritis
* Widespread chronic pain conditions such as fibromyalgia
* Pulmonary conditions such as chronic obstructive pulmonary disease, emphysema, interstitial lung disease, use of supplementary oxygen
* Known cardiovascular disease or new cardiac event in last 6 months
* Diabetes
* Pregnancy
* Second cancer diagnosis at the time of enrollment
Clinical Intervention Study in the Primary Care Setting of Patients With High Plasma Fibrinogen (EFAP)

Objectives:

* To study the possible effects of an intensive lifestyle change program on, the plasma fibrinogen levels in patients with no cardiovascular disease, with a high fibrinogen and normal cholesterol levels, and moderate Cardiovascular Risk (CVR).
* To analyse whether or not the effect on fibrinogen is independent of the effect on lipids.

Methods: Controlled, randomised clinical trial in 13 Basic Health Areas (BHA) in L'Hospitalet de Llobregat (Barcelona) and Barcelona city. Of the 436 patients between 35 and 75 years with no cardiovascular disease, with a high plasma fibrinogen (\> 300 mg/dl) and a plasma cholesterol \< 250 mg/dl, 218 received a more frequent and intensive intervention, consisting of advice on lifestyle changes and treatment. The follow up frequency of the intervention group was every two months. The other 218 patients continued with their usual care in the BHAs. Fibrinogen, plasma cholesterol and other clinical biochemistry parameters were assessed.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 30 and 75 years, than in 2 analytical consecutive, separated by a minimum interval of 15 days, have fibrinogen plasma \> 300 mg/dl and plasma Total cholesterol \< 250 mg/dl.
* Acceptance through informed consent of the patient to participate in the study.

Exclusion Criteria:

* Patients receiving lipid lowering treatment (including dietary measures)
* Local or generalized, acute or chronic infection.
* Patients with a history of cardiovascular disease.
Calcium Supplementation to Prevent Preeclampsia in Sichuan Province of China

the purpose of this study is to determine whether calcium supplementation is effective to prevent preeclampsia in Sichuang Province of china and which dose is more suitable


Eligibility Criteria:
Inclusion Criteria:

* Nulliparity;age ≥35 years;Previous pre-eclampsia;Family history of pre-eclampsia;Multiple pregnancy;Time between pregnancies ≥10years;Body mass index ≥25;diastolic pressure ≥ 80 mm Hg before 20 weeks' gestation;Proteinuria ≥+ on more than one occasion or ≥ 300 mg/24 h before 20 weeks' gestation;Underlying medical conditions(Pre-existing hypertension;Pre-existing renal disease;Pre-existing diabetes;Presence of antiphospholipid antibodies;Chronic autoimmune disease);male sex partner's predecessor wife has Previous pre-eclampsia

Exclusion Criteria:

* first prenatal visit after 16 weeks' gestation;severe anemia;other Underlying medical conditions which need treatment first (such as uncontrolled hyperthyreosis )
A Facilitated Access Program to Provide Everolimus (RAD) Maintenance for Patients Completing Therapy in RAD Trials in Solid Organ Transplantation

Facilitated access to everolimus until it is commercially available and reimbursable by appropriate parties

This is a treatment protocol designed only to provide access to everolimus (RAD) for maintenance immunosuppression. The objectives are to facilitate the management of patients on maintenance immunosuppression therapy who are completing everolimus trials,

* To provide everolimus maintenance therapy through this access program and
* To collect and review safety data for up to 120 months or until the project has been discontinued whichever comes first.
* To collect and review safety data for up to 120 months or when Certican is commercially available in the given indication and reimbursed by appropriate payors or the project has been discontinued whichever comes first.

Eligibility Criteria:
Inclusion Criteria:

* Male or female recipients of solid organ transplants
* Subject is currently enrolled in an everolimus (RAD) trial sponsored by Novartis
* Currently on investigational drug everolimus (RAD) therapy

Exclusion Criteria:

* Inability or unwillingness to comply with immunosuppressive regimen.
* Pregnancy.
* History of acute organ rejection within the last 3 months.

Other protocol-defined inclusion/exclusion criteria may apply.
Comparison Between the Onlay and Inlay Techniques for Patellar Resurfacing in Posterior Cruciate Ligament-Substituting Total Knee Arthroplasty

The purpose of this study is to compare clinical outcome in posterior cruciate ligament-substituting total knee arthroplasty with onlay patellar resurfacing technique and inlay patellar resurfacing technique


Eligibility Criteria:
Inclusion Criteria:

* Primary osteoarthritis of knee who were scheduled for a primary total knee arthroplasty

Exclusion Criteria:

* Valgus deformity
* History of inflammatory arthroplathy
* Previous fracture or open surgery on the same knee
* History of patellar instability
The Application of Music Therapy in Female Amphetamine Use Disorder

The group music therapy will be used to treat female amphetamine-type stimulant (ATS) addiction

Amphetamine addicts are often accompanied by severe emotional problems and are difficult to control and regulate negative emotions by themselves.And the emotional problems are high risk factors of addicts relapse. Music therapy as the intervention is in order to improve amphetamine addicts' emotional status and the ability of emotion regulation. Self-rating Depression Scale(SDS), Self-rating Anxiety scale(SAS) will be used to investigate the emotion of participants. These methods will also be used to evaluate the efficacy of the intervention.

Eligibility Criteria:
Inclusion Criteria:

* In accordance with the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) for methamphetamine (MA) use disorder
* Junior high school degree or above
* Normal vision and hearing
* Have emotional problem

Exclusion Criteria:

* Other substance abuse or dependence in recent a years (except nicotine)
* Mental impairment, Intelligence Quotient (IQ) \< 70
* Mental disorders
* Physical disease
Effects of Bloodletting Acupuncture for Subacute and Chronic Non-specific Low Back Pain

Evaluation of a bloodletting acupuncture at the fossa poplitea in comparison to bloodletting acupuncture at the regio glutaea and a waiting list control group in patients with subacute and chronic non-specific pain low back pain.


Eligibility Criteria:
Inclusion Criteria:

* Specialist confirmed diagnosis of subacute or chronic non-specific low back pain for at least 6 weeks prior to inclusion
* Average pain intensity with at least 50 mm on the VAS from 0 to 100 mm

Exclusion criteria:

* Serious illnesses
* Poor general condition
* Coagulation disorder, therapy with anticoagulants
* Thrombophlebitis, skin inflammation in the area of the lower extremities
* Alcohol, drug or medication addiction
* Pregnancy
* Lack of willingness to cooperate, linguistically or mentally unable to understand the contents of the study
* Participation in another clinical trial during the study period
* Starting a new therapy for the treatment of low back pain in the last 2 weeks