cyrilzakka/clinical-trials huggingface dataset:
Pulsed Electromagnetic Field Treatment In Patients With Alzheimer's Disease

An open label pilot study in mild to moderate AD patients to assess the effects of treatment with ECHS AD pulsed electromagnetic treatment device on disease progression. Enrolled patients will receive active devices. They will treat themselves at home three times a day for 15 minutes over 120 days. Primary end points are the The Alzheimer's Disease Assessment Scale-Cognitive Subscale and the Mini-Mental State Exam. Participants will be followed-up for 9 months post-treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 50 years
2. Patients diagnosed with mild to moderate Alzheimer's Dementia defi
3. At least an eighth grade of educational achievement
4. If female, post-menopausal.
5. MMSE score between 16 and 26
6. Capable of providing consent or having a surrogate (e.g., spouse, family member) capable of providing consent if participant lacks consent capacity
7. Able and willing to comply with the protocol
8. If the participant is receiving a cholinesterase inhibitor and/or memantine, such medication has been prescribed for at least 3 months prior to screening and the dose is stable for at least 60 days prior to screening (that dose needs to be maintained throughout the period of this study)
9. Spouse, family member or professional caregiver agree and are capable of taking care of the participation of the patient in the study (answering questions regarding the patient's condition, assuming responsibility for medication, and applying and supervising the daily PEMF treatments)
10. Physical clearance for study participation as evaluated by the clinician

Exclusion Criteria:

1. The patient lacks capacity to consent to study participation and no surrogate is available to provide consent
2. History of epileptic seizures or epilepsy
3. Currently taking medication that lowers the seizure threshold
4. Presence of depression, bipolar disorder, a psychotic disorder, or any other neurological or psychiatric condition (whether now or in the past), which the Investigator finds as interfering with the study
5. Severe agitation that would interfere with study procedures
6. Alcoholism or substance use disorder as defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) within last 5 years (addicted more than one year and or in remission less than 3 years) or severe sleep deprivation
7. Major surgery (defined as any major abdominal, vascular or thoracic surgery requiring general anesthesia and resulting in a period of \>1 week hospitalization) within 4 weeks
8. Head anatomy that interferes with the fit of the treatment device
9. Participation in another clinical trial within the previous 30 days
10. Metal implants in the head, (i.e., cochlear implants, implanted brain stimulators and neurostimulators, aneurysm clips) with the exception of metal implants in mouth
Use of the "Game-Ready" Splint for Better Recovery in Primary Total Shoulder Arthroplasty

The aim of the study is to compare the level of postoperative pain after fitting the Game Ready splint, at 48 hours versus that observed with fitting a standard splint


Eligibility Criteria:
Inclusion Criteria:

1. First-line reverse prosthesis
2. Without prosthetic history
3. Patient who has given his consent to participate in the observational study after being informed by the surgeon
4. Patient living in France and able to answer the questionnaire alone.
5. Subject affiliated to a social security scheme or beneficiary of such a scheme
6. Lack of participation in another clinical study

Exclusion Criteria:

1. Minor patient
2. Major subject protected by law, under curatorship or tutorship
3. Anterior prosthesis
4. Infection
5. Parkinson's, degenerative neurological disease
6. Pregnant or breastfeeding woman
Chronic Thalidomide Administration in Patients Undergoing Chemoembolization for Unresectable Hepatocellular Cancer

This is a clinical trial to test the safety and efficacy of the drug thalidomide in combination with a procedure called chemoembolization in patients with inoperable liver cancer. Chemoembolization is the process by which chemotherapy is instilled directly into the blood vessels feeding the tumor, so that the blood vessels feeding the tumor may be blocked. Chemoembolization consists of two separate procedures. It will be done by infusing chemotherapy with the drug doxorubicin through the hepatic artery into the liver and then by infusing collagen to cut off the blood supply to the tumor. A catheter will be inserted at various times to allow for these infusions.

The objectives are to investigate the feasibility and potential activity of chronic administration of thalidomide in patients with unresectable hepatocellular cancer who receive chemoembolization to predominant tumor masses. The toxicity of thalidomide in these patients will be evaluated. Overall safety will also be assessed. Serum levels of angiogenic cytokines such as VEGF, bFGF, and TNF-a, that are believed to have a role in hepatocellular carcinoma, will be collected.


Eligibility Criteria:
Inclusion Criteria:

* Patients with unresectable hepatocellular carcinoma.
* MRI of liver must show discrete tumor nodules. Lesions on angiography must be hypervascular.
* Patient must have the following minimum labs: ANC\> 1200/mm3; Hemoglobin \> 8 mg/dl; platelets \> 50,000 mm3; hepatic transaminases \< 5x normal; bilirubin \< 3.0 mg/dl; and creatinine \< 1.5 mg/dl.
* ECOG performance status \> 2.
* No history of prior chemotherapy or biologic therapy for hepatocellular carcinoma.
* No other history of malignancy other than curatively resected basal cell carcinoma of the skin or carcinoma in situ of the cervix.
* Patients must not be pregnant or lactating.
* Sexually active men and women of childbearing age must use adequate contraception. All patients must understand the potential for severe birth defects with thalidomide and must be able to follow instructions to avoid conception while taking thalidomide
Prefabricated Versus 3D-Printing Myofunctional Appliances

The aim of this clinical study is to evaluate the dentoskeletal effects of Class II division 1 treatment in growing patients with a prefabricated myofunctional appliance versus a 3D-printing myofunctional appliance.

This study aims to investigate the dentoskeletal effects of Class II division 1 treatment in growing patients with a prefabricated myofunctional appliance versus a 3D-printing myofunctional appliance.

Eligibility Criteria:
Inclusion Criteria:

* Increased overjet \>4 mm
* Skeletal Class II relationship (ANB \> 4 degree)
* No previous orthodontic treatment

Exclusion Criteria:

-Craniofacial syndrome
Single-dose of Nalmefene to Modulate Neural Alcohol Cue Reactivity

The aim of this study is to use functional Magnetic Resonance Imaging (fMRI) to measure neural reactivity to alcohol-related and emotional cues in alcohol dependent subjects following a single dose of the opioid receptor modulator nalmefene. The study will be done in a cross over design with nalmefene versus placebo.

All subjects will undergo a battery of minimal risk procedures during each study visit; filling out questionnaires, performing agreed behavioral tasks, scanning procedures including two functional MRI (fMRI) scans as well as structural MRI.

The fMRI will be obtained in non-abstinent participants with breath alcohol concentrations not larger than \> 0.3 ‰ and withdrawal severity not more than 4 on the clinical institute withdrawal assessment for alcohol (CIWA-Ar) scale.

Alcohol consumption will be assessed with the Form90 interview. Severity of alcohol dependence will be examined with the Alcohol Dependence Scale (ADS). Drinking situations will be assessed with the Inventory of Drinking Situations (IDS). Trait aspects of craving for alcohol will be measured with the Obsessive Compulsive Drinking Scale (OCDS). To examine state and trait anxiety the State-Trait Anxiety Inventory (STAI) will be used. Depressive symptoms will be measured with the Beck Depression Inventory (BDI) and the State-Trait Depression Scales (STDS). Nicotine consumption will be assessed with the Fagerström Test for Nicotine Dependence.

The following scales will be administered before and after each fMRI scanning: The Alcohol Craving Questionnaire (ACQ), the Alcohol Urge Questionaire (AUQ) and visual analogue scales for craving assessment.

Participants will undergo two fMRI scanning sessions at intervals of one week: one 2 h after administration of nalmefene and one 2 h after administration of placebo, carried out in a randomized order.

MRI examinations include

* a cue-reactivity task;
* an emotional faces task;
* resting-state fMRI;
* structural MRI;
* including preparation, instructions and breaks

Eligibility Criteria:
Inclusion Criteria:

* severe alcohol use disorder according to DSM 5 and "heavy drinking": alcohol consumption \>=60g (men) and \>=40g (women) (minimum of 5 days / week)
* right-handedness
* normal or corrected to normal vision
* signed written informed consent

Exclusion Criteria:

valid at the time of MRI investigation:

* psychotropic medication within the last 14 days
* severe withdrawal symptoms (CIWA-Ar \> 4; Sullivan et al. 1989)
* intoxication (breath alcohol concentration \> 0.3 ‰)
* common exclusion criteria for MRI (e.g. metal, claustrophobia)
* positive drug screening (opioids, cannabinoids, benzodiazepines, barbiturates, cocaine, amphetamines)
* pregnancy
* contraindications to the prescription of nalmefene valid at inclusion:
* previous severe withdrawal / withdrawal complications
* previous inpatient detoxification treatment
* other Axis I psychiatric diagnoses than alcohol- or nicotine-dependence in the last 12 months
* neurological disorders, history of brain injury
Couple-Focused Intervention for Breast Cancer Patients

The goal of the proposed study is to evaluate the efficacy of 2 couple-focused interventions developed to reduce the psychological distress on women and their partners during and after the breast cancer experience. The first group, an Enhanced Couple-Focused Group (ECG), incorporates cognitive-behavioral interventions (e.g., relaxation, stress management skills) as well as basic relationship communication and support skills (e.g., expressing support needs constructively). The second group, a Couples' Support Group (SG), is a non-structured group where general topics are discussed. The investigators will evaluate the impact of each group condition on patients' psychological adaptation, social and role functioning, and cancer treatment adherence. The investigators will also evaluate whether patient and partner perceptions of relationship support, relationship intimacy, stress management skills, and intervention group support mediate the groups' effects on each other's psychological adaptation.

The investigators hypothesize that ECG will have stronger positive effects on patient general and cancer-related distress and well-being than SG.

The investigators hypothesize that group support will mediate greater improvements in patient psychological functioning in both groups but that the effects of group support will be significantly stronger in SG than ECG.


Eligibility Criteria:
Inclusion Criteria:

* patient has a primary diagnosis of Stage 0 (Ductal Carcinoma in situ), 1, 2, or 3a breast cancer
* patient has had breast cancer surgery within the last twelve months
* patient and partner married or cohabitating
* patient and partner 18 years of age or older
* patient and partner speak and read English
* patient and partner can provide meaningful informed consent
* patient and partner do not have any chronic physical or cognitive illness that would preclude participation in the group sessions
* couple lives within 2 hour commuting distance to the center from which they are recruited

Exclusion criteria:

- patient is male
Emergence Agitation in Adult Patients After Intracranial Surgery

Emergence agitation is a frequent complication that can have serious consequences during recovery from general anesthesia. However, agitation has been poorly investigated in patients after craniotomy. In this prospective multicenter cohort study, adult patients will be enrolled after craniotomy and emergence agitation will be evaluated. The incidence, risk factors and outcome will be investigated.


Eligibility Criteria:
Inclusion Criteria:

* Both supratentorial and infratentorial intradural cranial operations

Exclusion Criteria:

* Unarousable state (SAS=1) during the first 24 hours after the operation
* Interval longer than 24 hours between the end of the surgery and neurosurgical ICU admission
Sciatic Nerve Block for Ankle and Leg Fracture Manipulation in the Emergency Department

The goal of this feasibility clinical trial is to assess the acceptability of ultrasound-guided sciatic nerve block when performed at Emergency Departments for manipulation and temporary stabilization of distal leg and ankle fractures.

The trial aims to assess:

* The acceptability of sciatic nerve block
* The technical feasibility of sciatic nerve block
* The technical success of sciatic nerve block
* The analgesic efficacy of sciatic nerve block

In addition to that, this study aims to

* Describe patient-reported and physician-reported satisfaction
* Assess the Adverse Event rate at 48 hours post intervention


Eligibility Criteria:
Inclusion Criteria:

* Age \>18
* Confirmed radiological diagnosis of distal tibia fracture (Group 43 according to AO classification, all subtypes included); or malleolar fracture (Group 44 according to AO classification, all subtypes included); or distal fibula fracture (Group 4F3 according to AO classification, both the two subtypes included); or any combination of the fracture patterns described
* Fractures requiring manipulation in the ED to achieve temporary stabilization either as manual reduction and cast immobilization; or calcaneal pin traction (as per local policy or treating physician's preference)
* Capacity to understand the aim of the study, the potential benefits and harms of the proposed intervention
* Capacity to provide consent
* Capacity to provide a self-assessment of pain using the written VAS Scale

Exclusion Criteria:

* Fractures that do not require any form of manipulation in the ED according to the treating physician (e.g., fractures with minimal or no displacement of the bony fragments, that are immobilized in a posterior leg cast by the nursing stuff/physicians assistants without any painful manipulations of the bony fragments performed by the physician)
* Open fractures
* Perisynthetic or periprosthetic fractures
* Distal leg/ankle fractures with neurovascular compromise
* Clinical signs of compartment syndrome
* Skin infection at the needle entry sites
* Diabetic neuropathy or any other known form of neuropathy that causes reduced sensation in the sciatic and/or femoral nerve territory
* Charcot-Marie-Tooth disease
* Known allergy to local anaesthetics or opioids
* Hemodynamic instability
* Known diagnosis of severe cognitive impairment
* Dementia and/or delirium (defined by a 4AT score ≥ 2)
* Lack of capacity to provide consent and to understand the aim of the study
* Patient's refusal to participate in the study
* BMI\>35
* Body weight \< 40 Kg
Interstage Assessment of Remnant Liver Function in ALPPS

Post-hepatectomy liver failure is one of the most feared complications by hepatic surgeons. When size of the future liver remnant (FLR) is regarded to be not sufficient to sustain post-hepatectomy liver function, techniques as preoperative portal vein embolization or two-stage hepatectomy/associating liver partition and portal vein ligation (ALPPS) can be performed. ALPPS induces rapid and extensive hypertrophy by portal vein ligation and in situ liver splitting. To date, feasibility of the second stage of ALPPS has been assessed only on the basis of standardized future liver remnant or future liver remnant on body weight. However, decrease of liver function between stages, measured by means of laboratory parameters, has been demonstrated to be associated with higher 90-day mortality, regardless of FLR volume. In other words, this volumetric increase may not reflect the increase of liver function.

The aim of this study is to determine the predictive value of hepatobiliary scintigraphy with 99mTc-mebrofenin between stages in ALPPS, in assessing risk of postoperative liver failure and liver failure-related mortality after completion of stage 2.

Eligibility Criteria:
Inclusion Criteria:

* Hepatobiliary scintigraphy performed between stages in patients submitted to ALPPS surgery
* Aged ≥18

Exclusion Criteria:

* Known allergy to Hida derivatives
Study Evaluating the Efficacy, Safety, and Reliability of Vardenafil

Study to investigate the efficacy and safety of Vardenafil


Eligibility Criteria:
Inclusion Criteria:

* Heterosexual males
* \>/= 18 years old with ED for more than six months
* Subjects also needed a positive first-time response to a single dose of 10mg vardenafil to be eligible for randomisation

Exclusion Criteria:

* Primary hypoactive sexual desire
* History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month
* Nitrate therapy
* Other exclusion criteria apply according to the Summary of Product Characteristics
Follow-up of Elderly Patients in Ambulatory Surgery

The number of surgical procedures performed in ambulatory hospitalization for cancers of the skin or breast is increasing for medical and economic reasons. But the protocols of care and the clinical pathways are poorly adapted for elderly patients with physical or cognitive impairment.

The goal of this study is to test the impact of an oncology ambulatory surgical care in patients aged 75 years or older, with breast or skin cancer and treated in Henri Mondor hospital on the increase in the proportion of patients operated on an outpatient basis


Eligibility Criteria:
Inclusion Criteria:

* Patient ≥ 75 years old with breast cancer or skin cancer and requiring surgical excision: partial mastectomy, lumpectomy, axillary dissection, cutaneous excision, etc.
* With an indication of ambulatory care
* Patient (legal representative or trusted person or member of the family) having been informed and having given his non-oral objection to his participation in the study
* Possessing a health insurance

Exclusion Criteria:

* Patients reserved for breast reconstruction to the operative gesture of tumor resection.
* Patients do not consent to care because of deficient mental state.
* Formal surgical contraindication due to a pathology medical device does not allow anesthesia. - Participation in another interventional research or be in the exclusion period after a previous search, if applicable
The Influence of 5-HTTLPR and BDNF Polymorphisms on Anxiety and Mood After Acute Exercise

The Influence of 5-HTTLPR and BDNF Polymorphisms on Anxiety and Mood After Acute Exercise.

Introduction: The 5-HTTLPR (SLC6A4) and BDNF (Val66Met) polymorphism presents an action on the modulation of human behavior and has received great attention as a risk factor for several psychiatric disorders. In recent years, a growing number of studies have evaluated the association between these polymorphisms and personality traits related to anxiety and depression. Objectives: To determine the frequencies of 5-HTTLPR and BDNF polymorphisms in a college students population; To determine the influence of 5-HTTLPR and BDNF polymorphisms on mood states and anxiety after acute physical exercise. Material and Methods: Four hundred (400) College students will be assessed.

In the first phase of the study, the following procedures will be performed: Screening, Aerobic Fitness Assessment (Step Test), Questionnaires (PAR-Q, Habitual Physical Activity Level, Beck Anxiety and Depression Scale, State-Trait Anxiety, and Perceived Stress Scale), blood sample collection and genotyping. In the second phase of the study, two (2) groups with or without polymorphisms will be selected (for each gene). These groups will be submitted to four conditions (three experimental conditions and one control condition), carried out randomly and separated by an interval of 1 week. In the experimental Conditions the volunteers will perform treadmill exercises sessions (30 minutes) in three different intensities (light, moderate and vigorous) and will respond to the Borg Scale at 10, 20 e 30 minutes. In the control condition the volunteers will be instructed to remain seated (quiet rest), relaxed and silent for 30 minutes. In both conditions, the volunteers will complete the Profile of Mood States (POMS) and State-Anxiety (STAY), 05 (five) minutes before and, 5 (five) and 20 (twenty) minutes following the interventions.


Eligibility Criteria:
Inclusion criteria:

* 18-30 years of age;
* able to perform physical activities;

Non-inclusion criteria:

* history of cardiovascular or respiratory diseases;
* smoking;
* use of psychiatric drugs;
* psychotherapy treatment in the last six months.
Inspiratory Muscle Training in Ehlers Danlos Patients

Evaluation of the effect of inspiratory muscle training in Ehlers Danlos patients


Eligibility Criteria:
Inclusion Criteria:

* a diagnosis for Ehlers Danlos syndrome combining genetics and clinical examination
* no infectious exacerbation in the last four weeks

Exclusion Criteria:

* respiratory comorbidities
Acceptance of the CP950 Sound Processor

Acceptance of CP950 sound processor with experienced CP810/CP910/CP920 BTE sound processor users.


Eligibility Criteria:
Inclusion Criteria:

1. Eighteen years of age or older
2. At least 6 months experience with a Nucleus 24 series or later implant in at least one implanted ear
3. At least 3 months experience with the CP810,CP920 or CP910 sound processor
4. Native speaker in the language used to assess speech perception performance
5. Willingness to participate in and to comply with all requirements of the protocol
6. Able to score 30% or more at +15 SNR with CI alone

Exclusion Criteria:

1. Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the procedure and prosthetic device
2. Additional disabilities that would prevent participation in evaluations
3. Nucleus 22 Implant
Higher Enjoyment in Response to High Intensity Interval Training Versus Moderate Intensity Continuous Exercise

Previous research is equivocal concerning if high intensity interval training is viewed as more aversive versus moderate exercise. Our data in active men and women showed that interval training is viewed as more enjoyable than higher volume moderate exercise.

Twelve men and women who were habitually active initially performed ramp exercise on a cycle ergometer to assess maximal oxygen uptake (VO2max) and peak power output (PPO), which was used to determine workload for the subsequent 2 bouts. They returned at least 48 h later at the same time of day to complete high intensity interval training (HIIT consisting of repeated 1 min bouts at 85 %PPO) or moderate intensity continuous training (MICT consisting of 25 min at 40 %PPO). During exercise, heart rate, oxygen uptake, perceived exertion, pleasure:displeasure, and blood lactate concentration were continuously assessed. Ten minutes post-exercise, physical activity enjoyment was measured. Data showed that despite higher oxygen uptake, heart rate, blood lactate concentration, and perceived exertion in HIIT, enjoyment was higher in HIIT versus MICT.

Eligibility Criteria:
Inclusion Criteria:

* Habitually active, healthy, non-obese

Exclusion Criteria:

* Sedentary, unhealthy, joint pain precluding tolerance to exercise