cyrilzakka/clinical-trials huggingface dataset:
The Effects of Fluoxetine And/or DHEA

(1) To determine how the Selective Serotonin Reuptake Inhibitor (SSRI), fluoxetine (Prozac), an antidepressant often used to treat depression, stimulates the participant's body's ability to defend against low blood sugar (hypoglycemia). (2) To learn how a hormone, dehydroepiandrosterone (DHEA), stimulates the participant's body's ability to defend itself from low blood sugar (hypoglycemia). DHEA is a hormone produced naturally in the human body. However, it can be manufactured and is sold as an over-the-counter dietary supplement. The dose the investigators are giving in this study is higher than the usual recommended dosage taken as a supplement for certain medical conditions. (3) To study combined effects of fluoxetine and DHEA during low blood glucose. In the present study, the investigators will measure the participant's body's responses to hypoglycemia when given fluoxetine or DHEA or fluoxetine and DHEA or a placebo (a pill with no fluoxetine or DHEA). Approximately 64 individuals with type 1 diabetes will take part in this study.


Eligibility Criteria:
Inclusion Criteria:

* 64 (32 males, 32 females) T1DM patients aged 18-50 yr.
* HbA1c \< 11.0%
* No clinically diagnosed diabetic tissue complications (i.e. history of retinopathy, neuropathy, stasis ulcers, etc)
* Body mass index \< 40kg · m-2

Exclusion Criteria:

* Pregnancy
* Subjects unable to give voluntary informed consent
* Subjects on anticoagulant drugs, anemic or with known bleeding diatheses
* Subjects taking any of the following medications will be excluded: Non-selective Beta Blockers, Sedative-Hypnotics, Anticonvulsants, Antiparkinsonian drugs, Antipsychotics, Antidepressants, Mood stabilizers, CNS Stimulants, Opioids, Hallucinogens
* Subjects with a recent medical illness or past history of severe depression, mania or psychotic disease
* Subjects that score greater than 50 on the depression scale
* Subjects unwillingness or inability to comply with approved contraception measures
* Abnormal results following screening tests and physical examination that are clinically significant
* Subjects with a history of severe uncontrolled hypertension (i.e., blood pressure greater than 160/100), heart disease, cerebrovascular incidents
* Clinically significant cardiac abnormalities (e.g. heart failure, arrhythmias, ischemic tachycardia, S-T segment deviations, etc.) from history or from cardiac stress testing in subjects ≥ 40 years old.
* Pneumonia
* Hepatic Failure/Jaundice
* Creatinine greater than 1.6 mg/dl
* Acute Cerebrovascular/ Neurological deficit
* Fever greater than 38 °C

Screening Laboratory Tests Exclusion Criteria

* Hematocrit lower than 32
* WBC lower than 3 thou/ul or greater than 14 thou/ul
* Liver Function Tests: SGOT and SGPT greater than twice upper limit of normal range (i.e. greater than 80 U/L).
* TBil greater than 2 mg/dl
* Alkaline Phosphatase greater than 150U/L
* Positive HIV, Hep B, Hep C
* Hepatic transaminase \> 2x normal
Nu-Mask Intraoral Airway Device Versus Conventional Bag Valve Mask Ventilation Crossover Trial

This study comprised a randomized cross-over trial of ventilation using the NuMask Intraoral Mask versus conventional Bag Valve Mask in a cadaver model among United States Army combat medics.

This study comprised a randomized crossover trial of adult United States Army combat medic volunteers participating in a cadaver laboratory as part of their training. The study took place in Bulverde, TX. Participants were randomized to perform cadaver ventilation first using either the novel Nu-MaskR intraoral device or conventional bag valve mask. A one handed seal technique was used to simulate single operator ventilation. Participants were responsible for mask placement while a ventilator delivered 10 breaths each with a standardized tidal volume of 750 ml. After a 5-minute washout period, they performed ventilation using the alternative device. The primary outcome measure was air leak as calculated by subtracting tidal volume received from tidal volume delivered as measured by the ventilator.

Eligibility Criteria:
Inclusion Criteria:

* United States Army Combat Medics

Exclusion Criteria:

* Injuries precluding performance of bag valve mask ventilation
Dose Responsive Study of Ringer's Lactate Solution in Prevention of Post-induction Hypotension

To assess the dose responsiveness of ringer lactate solution in prevention of post-induction hypotension predicted by Ultrasound guided Inferior Vena Cava diameter in patients receiving General anesthesia.

OBJECTIVES Primary - To find the optimum preloading dosage of Ringer Lactate to prevent post induction hypotension.

Secondary - To find the predictive incidence of Post-induction hypotension according to age, gender, type of surgery and comorbidities.

All patients, after Ultrasonographic Inferior vena cava collapsibility index calculation, will receive Lactated Ringer's solution as per body weight and as per their allocated group in the receiving area.

After induction inside the Operating Room, All patients will be monitored continuously using Electrocardiography, pulse oximetry, noninvasive Blood pressure measurement and capnography .

Heart rate, Systolic - Diastolic - Mean blood pressure, Oxygen saturation will be monitored as follows :

1. Baseline parameters - Prior to administration of intravenous Ringer's lactate solution
2. T0 (after administration of intravenous Ringer's lactate solution but prior to induction of anaesthesia),
3. T1-T10 (every minute for first 10 mins after induction of anaesthesia) Our institutional standard practice of induction of Anaesthesia with Fentanyl (2 μg/kg), Propofol (2 mg/kg) and Vecuronium (0.1mg/kg ) will be followed and intubation will be done only after first 10 mins post induction.

Amount of Mephentermine needed to correct hypotension despite RL infusion will also be calculated.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years American Society of Anesthesiologists (ASA) Physical status classification system group I and II Elective surgery under General anesthesia

Exclusion Criteria:

* Age \<18 and \> 65 American Society of Anesthesiologists (ASA) Physical status classification system group III and IV Systolic blood pressure ≥ 180 mmHg Systolic blood pressure \< 90 mmHg Pregnant women Patients with abdominal mass or ascites Emergency surgery
Brain Plasticity in Carpal Tunnel Syndrome and Its Response to Acupuncture

This study will characterize brain plasticity in Carpal Tunnel Syndrome and will determine how this central fMRI biomarker is modulated by acupuncture. This study will also investigate the behavioral consequences of maladaptive cortical plasticity in this disease population.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female adults aged 20-60.
2. History

   * Pain and/or paresthesia in median nerve distribution (i.e., numbness in some combination of digit 1, 2, 3, and the radial part of digit 4)
   * Nocturnal pain and/or paresthesia in median nerve distribution
   * Symptoms (a and b) greater than 3 months in duration
3. Physical Exam with two of the following three findings:

   * Phalen's and Durkin's sign (positive with paresthesia in at least 1 of 3 radial digits)
   * Abnormal grip strength (greater than 2 S.D. compared to uninvolved side using an isometric hand grip device)
4. Nerve conduction findings consistent with mild to severe CTS:

Mild CTS: Delayed distal latency of the sensory nerve conductions across the wrist (\> 3.7milliseconds and/or \> than 0.5 milliseconds compared to the ulnar sensory conduction) with normal motor conductions

Moderate CTS: Delayed distal latency of the sensory nerve conductions across the wrist as stated above with delayed distal latency of the motor conductions across the wrist (\> 4.2 milliseconds).

Severe CTS: Delayed distal latency of the sensory nerve conductions across the wrist as stated above with greater than 50% loss of motor amplitudes (relative to unaffected side and/or normative range).

Exclusion Criteria:

1. Contraindications to MRI examination (pregnancy, pacemaker, etc. according to guidelines set by MGH NMR-Center)
2. History of diabetes mellitus or other major cardiovascular, respiratory, or neurological illnesses.
3. History of rheumatoid arthritis.
4. History of wrist fracture with direct trauma to median nerve.
5. Current usage of prescriptive opioid pain medication.
6. Severe thenar atrophy.
7. Nerve entrapment other than median nerve.
8. Cervical radiculopathy or myelopathy.
9. Generalized peripheral neuropathy.
10. A blood dyscrasia or coagulopathy or current use of anticoagulation therapy
What is the Efficiency When Comparing Active Sentry at Low IOP vs Ozil at High IOP?

The objective is to assess the efficiency of the Active Sentry handpiece at low intraocular pressure (IOP) compared with the Ozil at high IOP.

This study is a single site, single-masked, randomized, prospective, contralateral eye study of the efficiency of the Active Sentry handpiece at low IOP compared with the Ozil at high IOP.

Eligibility Criteria:
Inclusion Criteria:

Subjects are eligible for the study if they meet the following criteria:

Note: Ocular criteria must be met in both eyes.

* Be eligible to undergo sequential bilateral uncomplicated cataract surgery.
* Undergo uneventful cataract surgery.
* Gender: Males and Females.
* Both eyes must have same grade of cataract.
* Willing and able to provide written informed consent for participation in the study.
* Willing and able to comply with scheduled visits and other study procedures.

Exclusion Criteria:

If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.

* Patient under 50 years of age.
* Unable to complete sequential bilateral cataract surgery in both eyes by the same surgeon (JS).
* Patient cataract surgery complicated by posterior capsular tear.
* Any disease state deemed by PI that increases risk of complicated cataract surgery (ie Pseudoexfoliation syndrome, zonular dehiscence, history of eye trauma, RA, prior refractive surgery, etc).

The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial.

Pregnancy has a known effect on the stability of refractions and visual acuity. As such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.
Non-interventional Observational Study of Helical Tomotherapy for Oligometastatic Colorectal Cancer

Patients with oligometastatic colorectal cancer (5 metastases or less) receive a combination of systemic treatment and often local treatment, such as surgery, radiofrequency ablation and more recently stereotactic body radiotherapy. The aim of this study is to register the results and side effects of stereotactic body radiotherapy (SBRT) by means of helical tomotherapy in the treatment of oligometastatic colorectal cancer.

The trial has two cohorts. Patients in cohort I get consolidation SBRT after best response on first line chemotherapy. Patients in cohort II get SBRT when there is progression under, or no indication for (further) chemotherapy. The primary endpoint is to evaluate the metabolic complete remission rate three months after the start of radiotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients with (residual) oligometastatic CRC: ≤ 5 mets
* Primary tumor treated with curative intention (surgery, radiotherapy, chemoradiotherapy)
* Functional liver volume \> 1000cc if livermets, lung DLCO \> 30% if lungmets.
* No Child B or C liver cirrhosis
* No contra-indications for radiation of all metastatic CRC (= no violation of constraints of organs at risk (OAR))
* No mets from another carcinoma
* Age \> 18 years
* WHO-PS ≤ 2
Comparison of Absorbability Between Calcium Tablet and Calcium Ion Water

The purpose of this study is to evaluate the absorbability of calcium tablet and calcium ion water.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal females

Exclusion Criteria:

* Taking medicines or functional food that affect serum calcium levels
* Diseases that affect bone
* Renal or hepatic dysfunction
* Heart disease
* Participation in any clinical trial within 90 days of the commencement of the trial
PEMF: an Adjunct Therapy for Anterior Uveitis

The purpose of this study is to determine if a medical device (ActiPatch) that emits a low frequency pulsed electromagnetic field (PEMF) will benefit patients with anterior uveitis. Anterior uveitis (aka iritis) is an inflammatory disease involving the front segment of the eye. This is a common cause of a painful red eye, and ActiPatch has been shown to be effective in treating tissue inflammation. The conventional treatment of iritis typically involves frequent administration of topical steroids which have their own inherent risks (development of cataracts and/or glaucoma). The purpose of this study is to determine if ActiPatch therapy can be used to shorten the length of time and/or quantity of steroids administered.

Iritis is an inflammatory disease focused in the anterior chamber of the eye. The inflammation inside the eye can lead to a number of conditions that ultimately effect vision. These can include glaucoma, posterior synechiae, cystoid macular edema, and cataract. The standard treatment for the disease is drug therapy centered around the administration of corticosteroids. These are administered in the form of eye drops, and if necessary periocular/intraocular injections, or/and by systemic oral/IV administration. Unfortunately, the treatment with corticosteroids can similarly induce severe side effects including glaucoma and cataract formation. ActiPatch is a medical device that emits a low frequency pulsed electromagnetic field. This device has been shown to reduce inflammation and pain in a number of conditions, eg blepharoplasty (eyelid surgery). ActiPatch is FDA approved for use after blepharoplasty to reduce swelling, inflammation and pain. The treatment is not invasive, does not require additional medication, and side effects from ActiPatch and other PEMF devices have not been reported. The potential benefit of treating uveitis with ActiPatch is the potential to reduce the time and/or amount of steroid administration. This would benefit patients by reducing the risk of unwanted side effects of the corticosteroid treatment.

The benefit to society would be an improved treatment for anterior uveitis.

Eligibility Criteria:
Inclusion Criteria:

* Human subjects who have been clinically diagnosed with anterior uveitis (iritis) but are in otherwise in good health will be recruited for the study. The age requirement will be a minimum of 18 yrs. We will recruit 24 patient for this study. Subjects will only be included who have been clinically diagnosed with anterior uveitis (noninfectious). Eligibility will be determined by the treating Ophthalmologist (principal investigator) for inclusion in the study.

Exclusion Criteria:

* Vulnerable subjects, as defined by the Institutional Review Board (IRB), will not be recruited for participation (This includes individuals under 18, pregnant women, prisoners, fetuses, patients mentally or physically unable to provide written informed consent).
* Other groups excluded include: patients with pacemakers and patients with ferromagnetic metal implants since these devices may be effected by the pulsed electromagnetic field.
Autofluorescence Detection of Oral Malignancies and Database and Biospecimen Collection to Identify Biomarkers of Head and Neck Tumor Progression

This research may help dentists or surgeons to better detect areas in the mouth that are either prone to cancer or are early cancers. The earlier the detection on cancer in the mouth, the better the chance that treatment or prevention can be more effective.


Eligibility Criteria:
Inclusion Criteria:

Patients with a history of suspicious lesions or currant suspicious lesions:

* No history of CIS or HNSCC
* History of clinically suspicious oral/oral pharyngeal lesions.
* Over 21 years old
* Not actively under treatment for any other type of malignancy, except Non-Melanoma Skin Cancer (NMSC)
* Must be willing to sign consent, have AFL screening with biopsies and sample collection, must be willing to complete a social and health history questionnaire

Patients with biopsy proven dysplasia, CIS or HNSCC prior to treatment:

* Patients with biopsy proven dysplasia, CIS or HNSCC without a prior history of an antineoplastic treatment, including chemo/radiation and Photodynamic Therapy
* Biopsy performed at an outside institution and referred for evaluation for treatment, or biopsied here at RPCI and proceeding for further care.
* Over 21 years of age.
* Must be willing to sign consent, have AFL screening with biopsies and sample collection, must be willing to complete a social and health history questionnaire

Patients with clinically treated CIS or HNSCC amd no evidence of disease (NED):

* Patients with prior history of HNSCC, previously treated with either surgery alone or combination of therapy, including Head and Neck radiation, with or without chemotherapy and Photodynamic Therapy including at least 3 months following completion of definitive treatment.
* Over 21 years of age
* Must be willing to sign consent, have AFL screening with biopsies and sample collection, must be willing to complete a social and health history questionnaire
L-Glutamine Therapy for Sickle Cell Anemia and Sickle ß0 Thalassemia

The purpose of this research is to evaluate the effects of L-glutamine as a therapy for sickle cell anemia and sickle ß0-thalassemia. as evaluated by the number of occurrences of sickle cell crises.

The primary purpose of this study is to evaluate the effectiveness of oral L-glutamine in the therapy of sickle cell anemia and sickle ß0-thalassemia.

The secondary purpose is to assess the effect of L-glutamine frequency of hospitalizations for sickle cell pain, frequency of emergency room visits for sickle cell pain; energy and appetite levels; narcotics usage.

Methodology:

By site, patients will be randomized to L-glutamine or placebo in a 1:1 ratio after a 4-week screening period. Patients will undergo 48 weeks of treatment with dosing BID orally, with dose calculated according to patient weight. Patient visits will occur every 4 weeks. After 48 weeks of treatment, dose will be tapered to zero within 3 weeks. A final evaluation visit will occur 2 weeks after last dose.

Eligibility Criteria:
Inclusion Criteria:

To be eligible to participate in the study, a patient must meet all of the following inclusion criteria:

* Patient is at least five years of age.
* Patient has been diagnosed with sickle cell anemia or sickle ß0-thalassemia (documented by hemoglobin electrophoresis).
* Patient has had at least two episodes of painful crises within 12 months of the screening visit.
* If the patient has been treated with an anti-sickling agent within three months of the screening visit, the therapy must have been continuous for at least three months with the intent to continue for the next 14 months.
* Patient or the patient's legally authorized representative has given written informed consent.
* If the patient is a female of child-bearing potential, she agrees to practice a recognized form of birth control during the course of the study.

Exclusion Criteria:

If the patient meets any of the following criteria, the patient must not be enrolled:

* Patient has a significant medical condition that required hospitalization (other than sickle painful crisis) within two months of the screening visit.
* Patient has diabetes mellitus with untreated fasting blood sugar \>115 mg/dL.
* Patient has prothrombin time International Normalized Ratio (INR) \> 2.0.
* Patient has serum albumin \< 3.0 g/dl.
* Patient has received any blood products within three weeks of the screening visit.
* Patient has a history of uncontrolled liver disease or renal insufficiency.
* Patient is pregnant or lactating.
* Patient has been treated with an experimental anti-sickling medication/treatment (except hydroxyurea) within 30 days of the screening visit.
* Patient has been treated with an experimental drug within 30 days of the screening visit.
* There are factors that would, in the judgment of the investigator, make it difficult for the patient to comply with the requirements of the study.
Scoliosis and Quality of Life of Adolescents

Around the scoliosis surgery, the pain (pre or post operative, physical, psychological, fantasy or real) is a major concern for adolescents and their families. She is also a key concern of caregivers, both its assessment and management is complex. this pain involved predominantly in the quality of life of these teenagers today who will become the adults of tomorrow.

To date in France, no study aims to describe and evaluate the effect of a multidisciplinary approach and its impact on the quality of life of these young people made.

The present study wish to prevent, anticipate and limit the short, medium and long-term morbidity. Focus will be on pain and its management, on preparing for surgery, hospitalization, follow-up after surgery, rehabilitation until recovery.

Help teens reclaim their bodies after the changes caused by the intervention is a major issue.

This study believe that support good quality, adapted to patient needs will limit operating and postoperative pain in the medium and long term.

Medical team developed special attention around the teenagers that are operated for scoliosis (teen groups and parent groups, interview before the operation and counseling, physiotherapy support ...).

The present study would systematize data collections in order to have a comprehensive and accurate assessment of the care.

The qualitative research will focus on the multidisciplinary care in an effort to evaluate the whole course of these teenagers, their experience and to identify efforts to put in place to optimize the current care.


Eligibility Criteria:
Inclusion Criteria:

* Patients followed for idiopathic scoliosis with indication for surgery
* Patients monitored and operated at the Children Hospital of Toulouse

Exclusion Criteria:

* Opposition to the participation
* Spine deformations other than scoliosis
* Non idiopathic scoliosis