cyrilzakka/clinical-trials huggingface dataset:
Implementing an IPTS Treatment Approach to Improve Outcomes in Suicidal Youth

The purpose of this project is to evaluate a set of interventions derived from a theory of suicide that supplements a clinical program and compare their effects on outcomes to the outcomes of the unsupplemented program. This study proposes to evaluate the effect of these interventions on reducing specific negative cognitions associated with depression and suicide ideation in an intensive outpatient program for suicidal youth (Suicide Prevention and Resilience at Children's, SPARC).

The trial will be conducted in a program where half of the clients are enrolled into either the original program (SPARC A which has a general focus on negative cognitions) or SPARC B (which will overlap significantly with SPARC A but targets in some sessions specific negative cognitions of perceived burdensomeness). The program is already structured so that each patient consistently attends either a morning or an afternoon track, with different therapists running each track. This allows for separate programs in each track. Clinically justifiable innovations are routinely introduced into the program usually in a stepwise fashion in one or another part by one set of therapists at a time. The investigators propose to take advantage of this partial introduction by assessing relative impact of SPARC A and SPARC B on depressive symptoms and suicide ideation. The investigators have no data to indicate that one program will be better than the other. The investigation will, however, allow the investigators to assess whether this innovation in fact is effective. Patients will not be randomized at the individual level, but rather their time slot (usually decided based on opening within the program) will place them into either SPARC A or SPARC B. The two programs are of identical length with numerous features in common, differing only in the specificity of the exercises and examples and their relevance to perceived burdensomeness. Routine assessments at entry and discharge from the program will not change based on study enrollment. However, suicide ideation, depressive symptoms, and negative cognitions (perceived burdensomeness and thwarted belongingness) will be more formally assessed at the one-month follow-up meeting or phone call which will add approximately 10 minutes to the contact.

Eligibility Criteria:
Inclusion Criteria:

* adolescents, ages 12 - 17
* enrolled in the SPARC program at Children's Medical Center of Dallas
* completed at least 5 SPARC group therapy sessions

Exclusion Criteria:

* adolescents who have previously received treatment in the control arm of the study
Trial of Levetiracetam in Patients With Primary Brain Tumors and Symptomatic Seizures Who Undergo Surgery

The purpose of this study is to determine the feasibility, efficacy and safety of intravenous and oral antiepileptic treatment with levetiracetam in patients with primary brain tumors and symptomatic epilepsy in the period of neurosurgical intervention.


Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years
* suspected primary brain tumor by imaging
* planned bioptical or cytoreductive surgery of the tumor
* symptomatic epilepsy
* Karnofsky performance score ≥ 70%
* women with child bearing potential must perform sufficient contraception
* sufficient haematologic, hepatic and renal function by laboratory testing

Exclusion Criteria:

* treatment with other antiepileptic drugs other than levetiracetam in the last seven days before surgery
* known allergic reaction to levetiracetam or other serious side effects
* known, not tumor-induced, epilepsy
* previous brain surgery
* dementia
* participation in another clinical trial
* addiction to drugs or alcohol
* pregnant or breast feeding women
Mechanistic Studies on Video-guided Acupuncture Imagery Treatment of Knee Pain

The aim of this study is to investigate brain response and connectivity changes evoked by video-guided acupuncture imagery treatment (VGAIT) and verum and sham acupuncture in knee osteoarthritis patients to elucidate the underlying brain mechanisms of mind-body interaction, imagery, and acupuncture.


Eligibility Criteria:
Inclusion Criteria:

* Right-handed
* Knee osteoarthritis patients
* Ages 40 to 70 years old

Exclusion Criteria:

* Any contraindications to MRI scanning (claustrophobia, metal implants)
* Current or past history of major medical, neurological, or psychiatric illness other than knee osteoarthritis (including high blood pressure, heart disorders, impaired elimination, stomach problems, major kidney or liver problems, bleeding problems, severe dehydration, history of diabetes, history of asthma or other respiratory condition)
* Pregnancy
* Non fluent English speaker
Radial Versus Femoral Arterial Access for Cardiac Catheterization: Comparison of Complications at 30 Days

Cardiac catheterization has traditionally been performed via access to the arterial circulation from the femoral artery located in the groin. As an alternative to this approach, the radial artery, located in the arm, is gaining wider use in clinical practice. Multiple studies have demonstrated that cardiac catheterization via the radial approach has a very low complication rate, in the short term. This study is intended to determine if there are any differences in the long term complication rate between radial artery cardiac catheterization as compared with femoral artery cardiac catheterization.


Eligibility Criteria:
Inclusion Criteria:

* Male or Female
* 19 years old or older
* candidate for radial or femoral cardiac catheterization
Effectiveness of the Montpellier Falls Clinic in Preventing InjuRiEs

A falls prevention clinic opened in Montpellier (France) in 2015. The objective of the project is to evaluate whether the tailored multifactorial programme delivered in this real practice setting by a geriatrician, a podiatrist, a physiotherapist, and a occupational therapist would help prevent injuries in high-risk older patients using a 6-month pre-post intervention analysis.

The Montpellier falls prevention clinic is a referral-based clinic specialized in the prevention of falls and fractures among patients aged 65+ (http://www.chu-montpellier.fr/fr/crepc/). The FPC that opened in 2015 is a member of the European Commission in its European Innovation Partnership on Active and Healthy Ageing (EIP on AHA) A2 action plan. The main mission of the clinic is to identify the underlying causes of the patients' falls, and to address modifiable risk factors in collaboration with family physicians in order to prevent injurious falls.

Based on a geriatric assessment performed by a geriatrician, a podologist, a occupational therapist, and a physiotherapist, the likely diagnoses and recommendations are notified in the medical report that is handed over to the patient or the caregiver for the patient's GP, along with the prescriptions, and sent also by mail to the GP. Recommendations remain under the GP's control with the possibility of another consultation if needed.

All patients admitted to the FPC are reassessed by phone at 3 months to register falls and injuries, and at 6 months to register falls and injuries, assess fear of falling, mobility and ability to perform activities of daily living, and satisfaction for the programme, and list proposed measures effectively applied.

Eligibility Criteria:
Inclusion Criteria:

All patients aged 65 or older with a history in the previous year of recurrent falls, or of a fall associated with a balance, gait, or muscle strength problem referred to the Montpellier falls prevention clinic

Exclusion Criteria:

* patients unable to walk 3 metres with or without an assistive device
* patients expected to live for less than 6 months based on the geriatricians' expert opinion
Acute Gastric Variceal Bleeding: Endoscopic Treatment Versus BRTO

The purpose of this study is to study the efficacy of endoscopic cyanoacrylate injection versus balloon-occluded retrograde transvenous obliteration in the management of acute gastric bleeding.


Eligibility Criteria:
Inclusion Criteria:

1. Cirrhosis
2. Active bleeding from gastric varices (GOV2 or IGV1)
3. Presence of gastrorenal shunt

Exclusion Criteria:

1. Previous pharmacologic therapy combined with endoscopic treatment to prevent rebleeding
2. Previous use of TIPS or surgical shunt
3. Non-cirrhotic portal hypertension
4. Contraindications to cyanoacrylate injection or BRTO
5. Portal cavernoma
6. Hepatorenal syndrome
7. Proven malignancy including hepatocellular carcinoma
8. End-stage renal disease under renal replacement therapy;
9. Cardiorespiratory failure
10. Pregnancy or patients not giving informed consent for endoscopic procedures
Contribution of L-Tyrosine to Recovery From Operational Strain on Return From External Operation

Operational conditions amplify soldier's constraints and stress factors, upsetting individual and collective adaptive landmarks. The soldier's resistance is strained by the high intensity of stressors, by the long duration of exposure and by their cumulative effect.

This may lead to a state of "operational strain" that refers to chronic stress and the allostatic load imposed by operational constraint.

The investigators believe that operational strain could manifest itself by a kind of accelerated aging of the organism due to the increased allostatic load without sufficient resource restoration (neurotransmitter precursors, partial and repeated sleep deprivation, etc.).

This aging mechanism would be reversible after a sufficient period of resource restoration (sleep, physical activity, adapted diet, etc.).


Eligibility Criteria:
Inclusion Criteria:

* From 18 to 65 years of age

Exclusion Criteria:

* Tyrosine intake within the previous 15 days
* History of neurological or psychiatric disorder
* History of nephrological or endocrine disorder or liver failure
* Hereditary tyrosinemia
ARISE: After 8 Hours Reperfusion in Ischemic Stroke Embolization

A prospective pilot study to evaluate the recanalization and safety of mechanical thrombectomy through a cerebral angiogram in patients with stroke symptoms last seen normal between 8 - 24 hours.

Ischemic stroke patients who are 8-24 hrs from symptom onset without prior mechanical or IV thrombolytic treatment and are screen with CT or MR perfusion imaging showing penumbra and infarction not \> 1/3rd the territory.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years last seen normal between 8 - 24 hours, without prior history of intravenous plasminogen activator (IV t-PA ) or
* mechanical thrombectomy Vessels - intracranial vertebral artery, basilar artery, intracranial ICA, ICA terminus bifurcation, MCA M1/M2, or
* ACA NIHSS ≥ 7 MRI DWI/PWI or
* CTA/P, which demonstrates an area of mismatch ≥ 2/3 rd
* Signed informed consent

Exclusion Criteria:

* creat \>= 2
* NIHSS \< 7
* Baseline mRS \>= 2
* infarct \> 1/3rd MCA territory
* competing trials
* prior IV or IA treatment
Hypnosis Mask: a New Approach to Management of Pain in Medical Imaging

The prostatic biopsies echo-guided are a painful and stressful. The purpose is to test a new medical device created recently, " Hypnos-Pro ", wich uses connected technologies. This connected device is a mask with diodes coupled with an audio headset and a touch pad. This connected mask is an another option to induce an hypnotic state for our patients. the objective is to value hypnotic mask effectiveness, to reduce the level pain and anxiety for the patients who benefit a prostatic biopsies echo-guided with local anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* Patient eligible for prostate biopsies
* Having accepted and signed the consent, for performing a prostate biopsy ultrasound examination
* No contraindication to the gesture
* Supporting the left lateral decubitus

Exclusion Criteria:

* Patient isolation contact / droplets
* Patient with hearing and / or epilepticus and / or dementia and / or having a history of stroke and / or allergic to lidocaine
* Person unable to consent, or benefiting from a system of legal protection (tutelage / curatorship).
* Patients with epileptic seizures.
* Patients with known allergies to plastics and other resins that may develop allergic contact dermatitis.
* Patients who are hypersensitive to radio frequency.
* Patients with Rocephin administration before the gesture
Effect Posterior QLB on Atelectasis

We aimed to investigate the effect of posterior quadratus lumborum block on postoperative atelectasis in inguinal hernia surgery in pediatric patients.


Eligibility Criteria:
Inclusion Criteria:

* under 2 years old,
* ASA I-II risk group
* Patients who underwent an inguinal hernia operation under general anesthesia, posterior quadratus lumborum block for postoperative analgesia or pain treatment with conventional method
* Patients whose informed consent was read and approval was obtained from him and his guardian

Exclusion Criteria:

* who do not want to participate in the study,
* ASA III-IV-V patients
Correlation Between Exhaled Propofol Concentration With Plasma Concentration in Children

Children due for elective eye surgery in propofol based anesthesia will be kept at steady state propofol infusion for maintenance, ventilation via endotracheal tube. Exhaled propofol will be measured continously by Edmon (R) (BBraun) monitor and compared with arterial plasma samples of propofol, drawn 3-5 times during the procedure.

The primary objective of the study is to determine the correlation between simultaneous concentrations of propofol in plasma and expiratory air in children during general anesthesia.

Key secondary objectives include correlating plasma and exhaled measurements of propofol with electroencephalogram (BIS) values and computer estimated propofol concentrations in plasma and brain (TCI: target control infusion) Primary endpoint: Exhaled air and plasma concentration ratios of propofol during general anesthesia in children.

Eligibility Criteria:
Inclusion Criteria:

* elective eye surgey

Exclusion Criteria:

* known propofol hypersensitivity
Prevention of GvHD in Participants With Hematological Malignancies Undergoing Hematopoietic Stem Cell Transplant (HSCT)

The purpose of this Phase 1, first in human open-label study is to assess the safety and tolerability of TRX-103 in patients with hematological malignancies undergoing HLA-mismatched related or unrelated hematopoietic stem cell transplantation (HSCT). It is anticipated that up to 36 Subjects will be enrolled during a 18-24 month enrollment period. TRX-103 will be infused one time post HSCT.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects with one of the following hematologic malignancies: Acute Lymphoblastic Leukemia (B- or T-ALL), Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS), or Chronic myelomonocytic leukemia (CMML)
2. Males and Females Age ≥ 18 years.
3. Weight of ≥ 35 Kg.
4. Karnofsky performance status ≥ 70 %.
5. Available mismatched related (haploidentical) or unrelated donors for peripheral blood stem cell (PBSC) donation.
6. Subjects must otherwise fulfill institutional criteria for eligibility to undergo allogeneic stem cell transplantation.
7. Absence of uncontrolled bacterial, viral or fungal infection at time of enrollment.
8. Have adequate organ function.
9. Subjects \> 65-year-old receiving MAC conditioning will only be eligible if they have a HSCT-comorbidity index score \< 5.
10. Subjects must be able to understand and sign informed consent and be willing and able to complete all specified procedures and visits.

Exclusion Criteria:

1. Prior allogeneic bone marrow, peripheral blood, or cord blood HSCT.
2. Any subject with a history of significant renal, hepatic, pulmonary, or cardiac dysfunction, or on treatment to support cardiac dysfunction.
3. HIV positive.
4. Positive hepatitis-B surface antigen. Subject may be included if they are HBV PCR negative.
5. Positive hepatitis-C antibody with positive Recombinant Immunoblot Assay (RIBA) or PCR unless the subject has received curative anti-viral treatment and confirmed negative viral load by PCR.
6. Received another investigational agent for treatment of disease understudy within 28 days (or 5 half-lives, whichever is shorter) of conditioning and/or have not recovered from treatment related toxicities.
7. Subjects with a previous history of Thrombotic Thrombocytopenic Purpura (TTP) or Hemolytic Uremic Syndrome (HUS) who are not good candidates for treatment with sirolimus.
8. Subjects that are pregnant, breast feeding or aim to become pregnant during the study period. (Subjects must agree to use a highly effective method of contraception).
9. Any serious illness, uncontrolled inter-current illness, psychiatric illness, active or uncontrolled infection, or other medical condition or history, including laboratory results.
Compliance of HCV Genotype 1 Infected Patients Receiving PegIntron/Rebetol and a Patient Assistance Program (Study P04671)

Enrolled patients will be recruited to two parallel groups during therapy for Hepatitis C. Patients in the first one will receive a patient assistance program, and patients in the second group will not. All patients will receive PegIntron and Rebetol according to label.

Non-Probability Sample, Commercial product used according to EU label.

Eligibility Criteria:
Inclusion Criteria:

* According to PegIntron/Rebetol label.
* Only HCV genotype 1 infected patients will be enrolled in the study.

Exclusion Criteria:

* According to PegIntron/Rebetol label.
Risk Perception of Needlestick Injury

The purpose of this study is to determine the effectiveness of needlestick injury prevention module

After being informed about the study and the potential risk, participants were given written informed consent to be filled out and signed. Agreed participants will receive a 1-week duration of educational intervention. The intervention only involved education and was less likely to cause injury or damage to the body.

Eligibility Criteria:
Inclusion Criteria:

1. All house officer in government hospitals with house officer training programme
2. House officers must be among those who join housemanship program for minimum of 1 month duration

Exclusion Criteria:

1. House officer who undergo attachment outside the training hospital
2. House officer that are not available during the data collection period or on long leave
Influence of Yoga in Patients With Neurocardiogenic Syncope

Syncope is a common problem that many clinicians may encounter in various outpatient settings. Neurocardiogenic syncope (NCS) is a benign condition characterized by a self limited episode of systemic hypotension. Patients are usually managed with education on syncope, anxiety management, and coping skills.

It has been established that practice of Yoga could relieve stress and anxiety. In a different study, they also found that Yoga positively influences cardiovascular function by decreasing the heart rate and blood pressure. The main objective of Yoga is to achieve control over the autonomic nervous system and able to control functions like heart rate, blood pressure and respiratory rate.

Based on the findings that Yoga relieves stress and reduces heart rate, the investigators propose to study if Yoga can decrease the frequency of NCS and also reduce the symptoms associated with these episodes.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of recurrent Neurocardiogenic syncope
* At least one episode of syncope or pre-syncopal event in the last 3 months prior to enrollment

Exclusion Criteria:

* Previously established diagnosis of any psychiatric illness.
* Previous history of Coronary Artery Disease, myocardial infarction, congestive heart failure, carotid sinus hypersensitivity
* Established diagnosis of tachy and/or brady arrhythmias, except cardioinhibiotry neurocardiogenic syncope.
* History of pacemaker, ICD or CRT-D implantation.
* Other conditions where Yoga should be avoided are:

  1. Pregnant women
  2. Subjects with untreated or uncontrolled high blood pressure
  3. Subjects with past history of Pnuemothorax.
  4. Subjects with severe cervical spondylitis and cervical, thoracic or lumbar disc prolapse.
  5. Subjects with carotid stenosis
  6. Subjects with history of psychosis (evidence of acute episodes with deep and prolonged meditation) or substance abuse.
  7. Subjects with the history of epilepsy ( evidence of acute episodes with deep and prolonged meditation)
  8. Subjects with glaucoma
  9. Subjects with history of Total Hip Replacement.
Airway Response to Repeat Allergen Challenge and the Effect of Ibuprofen in Mild Atopic Asthma

The study will assess airway responses in mild atopic asthmatics undergoing repeat allergen challenge testing and will investigate whether ibuprofen changes the response.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of mild asthma, currently well controlled requiring only a bronchodilator (e.g. salbutamol) as needed and infrequently
* has allergies that trigger asthma
* responds to methacholine challenge at 16mg/ml or less
* has FEV1 \> 69.5% predicted

Exclusion Criteria:

* respiratory illness within 4 weeks
* other medical condition assessed by the principal investigator that would put the participant at risk or influence the integrity of the data
* pregnant or lactating females
* hypersensitivity to ibuprofen
Evaluate the Efficacy and Safety of Insulin Compared to Glargine in Patients With Type 2 Diabetes

A study to compare Human Inhalation Powder (also known as AIR® Inhaled Insulin) (AIR® is a registered trademark of Alkermes, Inc.)with insulin glargine injections in patients with Type 2 diabetes who are currently taking oral medications and have not previously taken insulin. Change in HbA1c levels will be reviewed to determine superiority or inferiority of the AIR Inhaled Insulin regimen.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 Diabetes Mellitus
* Insulin naive
* One or more oral antihyperglycemic medications
* HbA1c greater than or equal to 8.0% and less than or equal to 10.5%
* Non-smoker

Exclusion Criteria:

* Taking a TZD dose greater than what is indicated
* Have not taken insulin within 6 months of entry into study
* Have had more than 2 episodes of sever hypoglycemia during the 6 months prior to study entry
* Have had more than 1 hospitalization or emergency room visit due to poor diabetic control during the 6 months prior to study entry
* Have had pneumonia in the 3 months prior to study entry
* Systemic glucocorticoid therapy
* Clinical signs or symptoms of liver disease, acute or chronic hepatitis
* History of renal transplantation
* Have an active or untreated malignancy
* Have a current diagnosis or past history of clinically relevant pulmonary disease
* Taking or have taken exenatide during the 6 weeks prior to study entry