cyrilzakka/clinical-trials huggingface dataset:
Acute Effect of Photobiomodulation in Individuals with Hypertension

This is a randomized, double-blind and sham-controlled clinical trial that aims to evaluate and compare the acute effect of full-body photobiomodulation (PBM) and modified ILIB (Intravascular laser irradiation of blood) on blood pressure, endothelial function and arterial stiffness in individuals with hypertension. Participants (n=48) will be equally, randomly and secretly allocated into one of 4 groups: Panel Group; Panel Sham Group; Modified ILIB group; and Modified ILIB Sham Group. Participants aged 40 to 60 years old, diagnosed with hypertension and using control drugs for at least 3 months will be included. Participants will be assessed at pre- and post-intervention for: BP; endothelial function; arterial stiffness; blood nitrite; and thermography. In the post-intervention period, the ambulatory blood pressure monitoring will also be carried out. Participants will receive a single application of PBM, which, depending on the group, may be full-body irradiation from an LED panel (660 nm; 25.34 J/cm²; 42.24 mW/cm²), modified ILIB (660 nm; 42,462 J/cm²; 35.385 W/cm²), or the respective sham therapies. Data homogeneity and normality will be verified by the Levene and Shapiro-Wilk tests, which will determine the choice of subsequent tests. A statistical significance of 5% will be considered.


Eligibility Criteria:
Inclusion Criteria:

* Sedentary or irregularly inactive individuals (IPAQ)
* Both sexes
* Age between 40 to 60 years old
* Clinical diagnosis of hypertension for at least 3 months with difficulty in blood pressure control
* Hypertension classification up to stage 2
* Individuals who have a prescription for hypertension control drugs and have been using these drugs for at least 3 months

Exclusion Criteria:

* Diabetes diagnosis
* Smokers
* BMI \> 30 kg/m²
* Cardiac pacemaker use
* Presence of arrhythmias or other decompensated cardiovascular diseases
* Musculoskeletal, orthopedic or neurological conditions that make it unable to participate in the procedures
* Presence of cognitive deficits that make it difficult to understand the assessments
* Presence of active neoplasia, under suspicion or after 5 years in remission period
* Presence of tattoos (covering a large body area, or the anterior wrist region)
* Photosensitive drugs use
* Pregnant women or under suspicion
* Presence of epilepsy or seizures
* Participants who present a systolic blood pressure ≥ 180 mmHg and/or diastolic blood pressure ≥ 110 mmHg on the day of the intervention
Single Arm Study Using the Symphony -- MRI Guided Focused Ultrasound System for the Treatment of Leiomyomas

Single arm, first-in human feasibility study using the Symphony - MRI guided focused ultrasound system for the treatment of leiomyomas. The study is expected to accrue over 12 months. This study will help determine the feasibility to ablate leiomyomas, as measured by MR thermometry and contrast enhanced imaging. In addition, the study will look at the efficacy and safety of the treatment, as measured by the reduction in fibroid size and reduction in symptom severity score and adverse events. This study will help develop future pivotal trials using the same device.


Eligibility Criteria:
Inclusion Criteria:

1. MR-HFU device accessibility to fibroids that at least 50% of fibroid volume can be treated
2. Fibroids selected for treatment meet the following criteria

   1. Total planned ablation volume of all fibroids should not exceed 500 ml AND
   2. Completely non-enhancing fibroids should not be treated
3. Transformed SSS score \>= 40
4. Pre- or peri-menopausal, as indicated by clinical evaluation
5. Weight \< 140 kg or 310 lbs
6. Willing and able to attend all study visits
7. Willing and able to use reliable contraception methods
8. Uterine size \< 24 weeks
9. Cervical cell assessment by PAP: normal, LOW Grade SIL, Low risk HPV or ASCUS subtypes of cervical tissue
10. Waist circumference \<110cm or 43 inches

Exclusion Criteria:

1. Other Pelvic Disease (Other mass, endometriosis, ovarian tumor, acute pelvic disease, significant adenomyosis, prolonged bleeding requiring further evaluation as determined by patient's gynecologist)
2. Positive pregnancy test
3. Extensive scarring along anterior lower - abdominal wall (\>50% of area)
4. Surgical clips in the potential path of the HIFU beam
5. Tattoos in the potential path of the HIFU beam
6. MRI contraindicated
7. MRI contrast agent contraindicated (including renal insufficiency)
8. Calcification around or throughout uterine tissue that may affect treatment
9. Communication barrier
10. Fibroids not quantifiable on MRI (e.g., multi-fibroid cases where volume measurements are not feasible)
11. Pedunculated fibroids
12. Bowel loops int he ultrasound beam path
13. Patients with inability to tolerate prolonged prone position for up to 3 hours
14. Patient with unstable medical conditions
15. Patients with coagulopathy or under current anti-coagulation therapy
King Vision Video Laryngoscope Ambu (aBlade) System for Use in Children

This is a single center trial to evaluate the performance of the King Vision video laryngoscope in pediatric patients between the ages of one month and 10 years of age. If the performance is satisfactory, this device may become a standard laryngoscope for tracheal intubation in elective and emergent tracheal intubations.


Eligibility Criteria:
Inclusion Criteria:

1. All children between the ages of 1 month to 10 years with a normal preoperative airway examination
2. Scheduled for a surgical procedure that requires tracheal intubation shall be included.

Exclusion Criteria:

1. Patients that will be excluded are those with an airway examination or previous anesthesia history that suggests difficulty with mask ventilation.
Vedic Counselling for Women Victims of Domestic Abuse

The Vedic Counselling is the whole person approach, system of total life style counselling based on 'Vedic Laws of right living, right actions, right relationship and right awareness'.Vedic Counselling was developed as trauma focused therapy for this study to treat female victims of domestic abuse.


Eligibility Criteria:
Inclusion Criteria:

* Female survivors of Domestic Abuse
* 18 years old or older
* Sign informed consent

Exclusion Criteria:

* Severe mental illness that requires specialized treatment
* Terminally ill
* Under psychiatric medication
* Chronic illnesses
MT-R Followed by Autologous Stem Cells Transplantation in Newly-diagnosed Primary Central Nervous System Lymphoma

The purpose of this study is to evaluate the efficacy and safety of chemotherapy with MT-R followed by autologous stem cells transplantation in newly-diagnosed primary central nervous system lymphoma.

It's a single center, single arm, prospective clinical trial. Patients younger than 65 years old with primary central nervous system lymphoma will received four cycles of chemotherapy with rituximab plus high-dose methotrexate and temozolomide as induction therapy, and then received consolidation therapy with autologous stem cell transplant for which the conditioning regimen is Carmustine plus thiotepa.

Eligibility Criteria:
Inclusion Criteria:

* primary central nervous system diffuse large B-cell lymphoma histologically confirmed by brain biopsy
* ECOG 0-2
* Absence of systemic disease as evaluated by chest-abdomen-pelvis CT scan
* Leucocytes\>3.500/mm3, platelets\>130.000/mm3, Bilirubin \< 2 mg, transaminases \< 2.5 N), creatinine \< 150 μM/l, creatinine clearance \> 50 ml/min/1.73m2
* Age 18-65 years
* Negative HIV test
* Signature of informed consent

Exclusion Criteria:

* prior chemotherapy for primary central nervous system lymphoma
* presence of another cancer (excepting basal cell carcinoma of the skin and cervical carcinoma in situ )
* systemic lymphoma (outside the CNS)
* Isolated ocular lymphoma
* Immunosuppressed patients (HIV , use of immunosuppressors)
* Other uncontrolled or progressive disease compromising shot-term survival
* Severe renal or hepatic disease
* Patients not legally covered by the French Social Security
* Inability to swallow the medication
Follow-up Assessment of a Trial of Open-label Placebos for Women With Premenstrual Syndrome

With the proposed study, the investigators aim to evaluate the long-term efficacy of the open-label placebo (OLP) intervention in premenstrual syndrome (PMS) and to contribute to a broader understanding of how OLPs work. It is planned to survey participants of the intervention groups (OLP+ and OLP-) regarding symptom intensity and impairment due to PMS after the conclusion of our randomized controlled trial (RCT) and intervention provision. Additionally, it will be examined if there is a difference between the OLP group with and without a treatment rationale (OPL+ vs. OLP-) across time. More precisely, it will be investigated whether participants of the intervention groups with and without treatment rationale experience any long-term improvement.


Eligibility Criteria:
Inclusion Criteria:

* Participants are willing to participate in the follow-up study
* Participants have the ability to use an electronic device with internet access to complete the online follow-up survey
* Participants give Informed consent
* Participants have a regular menstruation (i.e., no menopause; pregnancy; cycle inhibiting medication etc.)

Exclusion Criteria:

* Pregnancy or breastfeeding (currently or within the last three months)
* A severe psychological or somatic disease, affecting premenstrual complaints (e.g., cancer of the uterus or fallopian tubes)
* Commencement of the menopause, sterilization, or (part) resection of the uterus or fallopian tubes
* Changes in body mass index (i.e., under 18 or above 30)
Effect of Protein From Complementary Foods on Infant Growth, Body Composition and Gut Health

Current research shows that dairy protein accelerates infant weight gain, which is a risk factor for later on obesity and metabolic syndrome. However, dietary protein from other sources haven't been studied yet. This longitudinal study will compare two complementary feeding regimens with dietary protein mainly from 1) meat; 2) dairy on infant growth, body composition and gut microbiome from 5 to 12 months of age in formula fed infants. Healthy infants at approximately 5 months of age will be randomized to either a meat protein, or a dairy protein group with complementary protein mainly from meat or dairy. Infants will consume one of these diets for 7 months (6-12 months of age) and infant growth, body composition, growth biomarkers and gut microbiome will be measured to compare between groups and over time.

Two observational follow-up visits will be conducted at 18 and 24 months of age.

Eligibility Criteria:
Inclusion Criteria:

* 1-5 months of age
* Formula fed
* On breast milk less than 1 month
* Healthy
* Term Birth (36-42 weeks)
* Appropriate for gestational age

Exclusion Criteria:

* Congenital anomalies that impact feeding, growth, or development
* Low birth weight
* Not able to consume milk-based formula
* Known chronic diseases or allergies affecting protein consumption/digestion
Effective Postoperative Pain Treatment After Sternotomy. Comparison of the Erector Spinae Plane Block vs Conventional Opioid Treatment

Comparison of effect between Erector Spinae plane block and conventional opioid treatment after cardiac surgery

Comparison of effect between Erector Spinae plane block and conventional opioid treatment after cardiac surgery. In group "A" will be erector spinae plane block provided in the thoracic part of the body, under ultrasound control. In the group B will be analgesia provided by Pethidine. Numerical pain score will be recorded every 2 hours, also usage of analgetics will be recorded in both groups.

Eligibility Criteria:
Inclusion Criteria:

* Postoperative state after cardiac surgery, Serious pain NRS 8-10

Exclusion Criteria:

* disagreement
Measurement of Retinal Venous Pressure Under Short-term Low-oxygen Environment

The hypothesis is that the pressure in the retinal veins increases under a short-term lack of oxygen and leads to a decreased blood circulation. On the basis of measurements in the hypobaric chamber this hypothesis should be verified.

Conduct a pilot study to describe and quantify the retinal venous pressure (RVP) in healthy volunteers under conditions of controlled, reduced ambient and oxygen partial pressure in the pressure chamber of the Aeromedical Institute FAI in Dübendorf, Switzerland. Obtaining evidence of the adaptation behavior of the retinal vascular system in controlled, short-term hypoxic changes.

Eligibility Criteria:
Inclusion Criteria:

* healthy

Exclusion Criteria:

* eye diseases
* systemic diseases
* term medication (except contraceptives)
* pregnancy
* allergies to the ingredients Alcain, Tropicamide and Phenylephrine
* blood pressure levels except standard (\<60 /\> 140 mmHg)
* oxygen saturation (SO2) \<90%
Role of B2 Adrenergic Receptors in Labor Pain

The study aims to understand why labor is more painful for some women compared to others. The study will study whether a woman's baseline pain sensitivity, beta2 adrenergic receptor genotype is related to her pain in labor for the birth of a first child.

Other than parity, and infant size, the etiology of the great variability in labor pain us unknown. Previous studies have demonstrated that baseline pain sensitivity is related to postoperative pain and narcotic requirement. We hypothesize that baseline pain sensitivity is related to pain in labor. The study will determine baseline sensitivity to heat, cold and pressure as measurement of pain sensitivity. Furthermore, b2 adrenergic genotype has recently been identified as a potential determinant of pain sensitivity. The investigators will determine whether B2 receptor haplotype is an independent predictor of pain experienced in labor.

Eligibility Criteria:
Inclusion Criteria:

* nulliparous women
* Third trimester of pregnancy on enrollment

Exclusion Criteria:

* Chronic Pain
* Pain medication utilization
* Large for gestational age baby
* Small for gestational age baby
* Systemic illness
Biomarkers and Therapeutic Modelisation in Heart Failure

The telemonitoring systems for congestive HF did not yet prove their efficacy despite initial encouraging results. Decongestion is one of the main objectives in Congestive HF, but an appropriate titration of diuretics is warranted, since long-term use of diuretics was consistently found associated with adverse outcomes. The investigators showed (ROSSIGNOL et al., JACC 2011, Circulation 2012) that the aldosterone antagonist eplerenone has diuretic effects, as assessed by an estimated plasma volume depletion, in addition to potassium-sparing properties, independently from renal function variations. These three parameters were independently associated with patient outcomes and may therefore be potential monitoring/and therapeutic targets in patients with congestive HF.

Main objective :

To assess the variations of estimated plasma volume, serum potassium and estimated glomerular filtration rate after an hospitalization for decompensated HF, by using a home-based finger capillary punction for 5 consecutive days per week during the two months postdischarge, using an approved dedicated device (ABOTT iSTAT).

Secondary objectives :

1. to assess the correlations between plasma volume, serum potassium and estimated glomerular filtration rate variations (as measured by Istat, and by a weekly venous punction) and body weight, home blood pressure measurement, dyspnea self assessment variations.
2. bio banking (serum, plasma, urine) for further biomarker studies, one a weekly basis


Eligibility Criteria:
Inclusion Criteria:

* 18 years old or over
* Patients with heart failure and FE ≤ 45% hospitalized for decompensated heart failure

Exclusion Criteria:

* GFR \< 30 ml/min/1.73 m2 as estimated by the abbreviated MDRD formula
* Pregnancy and lactation
* Participation in other investigational trials
Magnetoencephalography (MEG), Attention and Conscience

The tight relationship between attention and conscious perception makes them difficult to study in isolation and has led many scientists to closely link these two processes. However, while some authors argue that conscious perception cannot occurs without attention, magnetoencephalography (MEG) and fMRI studies had shown that attention and consciousness are two distinct brain processes.

If endogenously triggered attention and consciousness are dissociated, it has been proposed that orienting of exogenous attention is a necessary, though not sufficient, antecedent of conscious perception.

In the present study we used MEG to explore the neural correlates of exogenous attention and consciousness during visual processing.


Eligibility Criteria:
Inclusion Criteria:

* Subjects aged between 18 and 40 who have signed informed consent for participation to the study and are affiliated to a social security regimen
* right-handler, without auditory or visual deficit

Exclusion Criteria:

* history of neurological or psychiatic disease
* medication
* sensory disorders
A Study to Evaluate the Effectiveness and Safety of EUS-guided Transluminal Drainage With 'Niti-S SPAXUS Stent'

The purpose of this study is to evaluate the safety and effectiveness of endoscopic ultrasound (EUS)-guided transluminal drainage with 'Niti-S SPAXUS Stent' for the treatment of pancreatic pseudocyst.

'Niti-S SPAXUS Stent' is a newly designed lumen-apposing fully covered self-expandable metal stent. It is indicated for use in patients with pancreatic pseudocyst. Consecutive subject data should be collected at discharge, stent removal (day 30 or 60), and day 20 post Niti-S SPAXUS stent removal.

Eligibility Criteria:
Inclusion Criteria:

* Pancreatic pseudocyst ≥6cm in size, with ≥70% fluid content that is eligible for transluminal drainage
* Patient willing to provide written informed consent and comply with follow-up requirements

Exclusion Criteria:

* Ineligible for endoscopic intervention
* Pancreatic pseudocyst with severe internal septation
* Platelet count \< 60,000 cells/mm3 or international normalized ratio (INR) \>1.5
* Hemodynamic instability (e.g. shock)
* Active infectious disease (e.g. endocarditis, meningitis)
* Participating in any other investigational drug or device clinical trial within past 3 months
* Female of child-bearing potential who are unable to take adequate contraceptive precautions, are known to be pregnant, or are currently breastfeeding an infant
A Phase I Study of the Safety and Immunogenicity of Rgp 120/HIV-1IIIB Vaccine in HIV-1 Seropositive Adult Volunteers

To test the safety and immunogenicity of rgp 120/HIV-1IIIB vaccine in HIV-1 seropositive adult patients.


Eligibility Criteria:
Inclusion Criteria

Patients must have the following:

* Stage 1 or 2 Walter Reed clinical staging of HIV infected individuals.
* The ability to understand and sign a written informed consent form, which must be obtained prior to study entry.
* Be available for 24 weeks so that follow up may be completed.
* Qualify for care as Department of Defense health care beneficiary.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

* Prior history of clinically significant cardiac, pulmonary, hepatic, renal, neurologic or autoimmune disease, other than HIV-1 infection, and in less than average general health as determined by a medical history, physical examination, and the required laboratory test results.

Concurrent Medication:

Excluded:

* Corticosteroids or other known immunosuppressive drugs.
* Any experimental agents.

Patients with the following are excluded:

* Prior history of clinically significant cardiac, pulmonary, hepatic, renal, neurologic or autoimmune disease, other than HIV-1 infection, and in less than average general health as determined by a medical history, physical examination, and the required laboratory test results.

Prior Medication:

Excluded within 30 days of study entry:

* Zidovudine or other anti-retroviral agents.
The Liver Health Study for Patients with NAFLD

The study will investigate whether the level of fat stored in the liver is related to the liver's ability to burn fat.

The study has two phases. In Phase I, liver samples from patients undergoing bariatric surgery or a diagnostic liver biopsy will be tested for the ability to burn fatty acids. In Phase II, patients with nonalcoholic fatty liver disease will participate in either a nine-month lifestyle treatment program or undergo standard care. The goal is to determine how weight loss and exercise improve liver health.

Inpatient comprehensive metabolic tests are performed before and after the nine-months.

Eligibility Criteria:
For Phase I: Any patient scheduled to undergo bariatric surgery or a liver biopsy to diagnose nonalcoholic fatty liver disease.

For Phase II: Only subjects who have had a diagnosis of nonalcoholic fatty liver disease and completed Phase I (and no subjects who have undergone bariatric surgery)

Inclusion Criteria:

1. Men and women (pre and post-menopausal)
2. Overweight/obese with BMI ≥ 25.9 or \< 50.0 kg/m2
3. Characteristics of the metabolic syndrome, pre-diabetes (fasting glucose 100-125 mg/dL or 2h glucose 140-200 mg/dL) or diabetes type 2, or undergoing bariatric surgery
4. 22-65 years of age
5. Sedentary, \< 60 minutes per week of structured physical activity
6. Alcohol intake\< 20 g/d

Exclusion Criteria:

1. Having undergone bariatric surgery.
2. Acute disease or advanced cardiac or renal disease, anticoagulation therapy, or any severe co-morbid condition limiting life expectancy \< 1 years
3. Other causes of hepatitis including hepatitis B \& C, autoimmune hepatitis, hemochromatosis, celiac disease, Wilson's disease, alpha-1-antitrypsin deficiency, medication-induced hepatitis, any clinical or biochemical evidence of decompensated liver disease
4. Use of steroids or other drugs that cause NAFLD
5. Pregnant or trying to become pregnant
6. Inability to exercise on a bike or treadmill