cyrilzakka/clinical-trials huggingface dataset:
NIRS Monitoring During Intracranial Interventions

Near infrared spectroscopy is a valuable tool to monitor cerebral oxygenation during intracranial interventions. However, it yields artificial results when the dye indocyanine green (ICG) is applied, which is routinely done for intraoperative angiography.

The investigators examine, to what extent and which duration NIRS is disturbed following ICG application.


Eligibility Criteria:
Inclusion Criteria:

* patients scheduled for aneurysm clipping or av-malformation removal

Exclusion Criteria:

* pregnancy
Dose Finding Study in Physically Frail Elderly to Measure 25(OH) Vitamin D Levels After Supplementation With Hy.D Calcifediol 25 SD/S and Vitamin D3

The purpose of this study is to assess the dose of Hy.D Calcifediol 25 SD/S (a metabolite of vitamin D3) which will achieve the range of mean serum 25(OH)D between 75-100nmol/L in physically frail elderly people after 24 weeks of daily supplementation with different doses of Hy.D Calcifediol 25 SD/S compared to vitamin D3.


Eligibility Criteria:
Inclusion Criteria:

* 25(OH)D levels between 25 - 50 nmol/L;
* Age 65 and older;
* Physically frail, based on the criteria designed by Fried et al. \[1\]. Frailty will be defined as a clinical syndrome in which one or more of the following criteria are present: unintentional weight loss (4.5 kg in past year), selfreported exhaustion (CES-D questionnaire), weakness (grip strength), slow walking speed and low physical activity (Minnesota questionnaire). These criteria are easily assessable and have been commonly used to determine frailty;
* Men and women;
* Body mass index between 20 and 35 kg/m2 (used for stratification);
* Willingness and ability to comply with the protocol.

Exclusion Criteria:

* Medical Illness: malabsorption syndrome: known intestinal malabsorption, celiac diseases, inflammatory bowel disease; diseases that may enhance serum calcium concentration: sarcoidosis, lymphoma, kidney stone in the last 10 years, primary hyperparathyroidism; abnormal indices of calcium metabolism, uncontrolled hypocalcaemia; diagnosed renal insufficiency, diagnosed cancer, diagnosed liver failure.
* Hypercalcemia : serum calcium adjusted for albumin of \> 2.6 nmol/L.
* Medication: bisphosphonate or Parathyroid hormone (PTH) treatment, tuberculostatics, epilepsy medication, interfering with vitamin D metabolism and vitamin D supplementation.
* Use of vitamin D supplementation in the last three months (excluding multivitamin supplementation).
* Not willing to stop the use of multivitamin supplementation during the study.
* (Expected) increase in exposure to sunlight (e.g. travelling to a sunny resort).
* Patient heavily consumes alcohol containing products defined as greater than (\>) 3 drinks (beer, wine, or distilled spirits) of alcoholic beverages per day.
* Donating blood in the period of 2 months before, until 1 month after the end of the study.
* Planned surgery.
* Participation in another clinical trial.
Liposomal Anthracyclin in the Treatment of Elderly ALL

Phase II multicentric study comparing VAD regimen with continuous infusion over 96 hours of doxorubicin, vincristine and dexamethasone to a 90 minutes infusion of equivalent doses of Dox li-PEG, bolus infusion of vincristine and dexamethasone

Patients aged 55 years or over will be assessed for response to steroids from day -7 to day 0 During steroid therapy, Ph status will be determinated : patients with Ph+ ve ALL will be treated according to the another French Protocol while patients with Ph-ve ALL will be included in the "caelyx" protocol and randomly allocated to induction with VAD or with vadox-li-Peg (caelyx).

A second course of induction therapy with VAD+ cyclophosphamide of Vadox-li-peg+ cyclophosphamide(according to the initial randomization arm) will then be given to all patients.

Consolidation therapy included 2 courses of vad or of vadox-li-Peg , according to the initial random allocation, followed by two courses of cytarabine,cyclophosphamide and thioguanine.

During induction and consolidation therapy, doxorubicin and liposomal pegylated doxorubicin pharmacokinetics will be assessed in all patients.

Treatment of occult CNS invasion includes skull radiotherapy and 6 intrathecal injections(steroÏds+methotrexate) A two years maintenance course with 6 mercaptopurine and methotrexate will then be offered to all patients.

Eligibility Criteria:
Inclusion Criteria:

* 55 years of age and older
* ECOG performance \</=2 or \>/=3
* VIH negative
* Absence of previous ALL treatment
* Informed consent signed
* SGPT and Bilirubin \< 4x upper limit of normal
* Normal creatinine for age
* cardiac state compatible with anthacyclin

Exclusion Criteria:

* ALL with Philadelphia Chromosome
* ALL3
* CML blasts crisis
* Cardiac insufficiency and/ or left ventricular ejection fraction \< 50%
* Evolutive infection
* Presence of other evolutifs cancer or ongoing treatment

  * mental status incompatible with inform consent
A Pragmatic Randomized Controlled Trial of Chinese Herbal Medicine for Severe Pandemic H1N1 Influenza

The aim of this study is to evaluate the effectiveness and safety of Chinese herbal medicines for severe pandemic H1N1 influenza.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of severe pandemic H1N1 influenza patients and pandemic H1N1 influenza patients with risk factors for severe H1N1 influenza
* Rapid Diagnostic Tests:positive
* Age≥6 years
* Influenza symptoms occurred less than 48 hours and body temperature≥37.5℃ for pandemic H1N1 influenza patients with risk factors for severe H1N1 influenza

Exclusion Criteria:

* Suffering from mental illness
* Attending other clinical studies on influenza
* Critical pandemic H1N1 influenza patients
A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight for the Maintenance of Weight Loss

This was a study of tirzepatide in participants with obesity or overweight. The main purpose was to learn more about how tirzepatide maintained body weight loss. The study had two phases: a lead-in phase in which all participants took tirzepatide and a treatment phase in which participants either continued tirzepatide or switched to placebo. The study lasted about 2 years (25 visits).


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) ≥30 kilograms per square meter (kg/m²), or ≥27 kg/m² and previous diagnosis with at least one of the following comorbidities: hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease
* History of at least one unsuccessful dietary effort to lose body weight

Exclusion Criteria:

* Diabetes mellitus
* Change in body weight greater than 5 kg within 3 months prior to starting study
* Obesity induced by other endocrinologic disorders or monogenetic or syndromic forms of obesity
* History of pancreatitis
* Family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
* History of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder within the last 2 years
* Any lifetime history of a suicide attempt
The Ultrasound-guided vs Bronchoscopy-guided vs Ultrasound-bronchoscopy-guided Percutaneous Tracheostomy Trial

This trial (BRONCUS) is a randomized one designed to evaluate the overall safety of ultrasound guided compared to bronchoscopy guided compared to ultrasound-bronchoscopy guided percutaneous tracheostomy, in order to find out if universal standardization is required or customized approach can be sufficient.

Enrolled patients will be randomized in a 1:1:1 ratio to ultrasound or bronchoscopy or ultrasound-bronchoscopy arms, and then the procedure related complications and clinical outcomes will be evaluated and compared between the groups. The procedures will be performed according to standardized practices following hospital guidelines.

Eligibility Criteria:
Inclusion Criteria:

* adult patients (over 18 years old), intubated, mechanically ventilated, and with an indication for a tracheostomy

Exclusion Criteria:

Patients with contraindications for PDT:

* short neck
* tracheal deviation
* difficult anatomy
* previous neck surgery
* cervical trauma or inability to perform neck extension
* preference for surgical tracheostomy by the patient assistant team
* patients unable to provide informed consent
Aetna_Intel Medicare Home Biomonitoring Study

The hypothesis is that use of Internet-connected home biomonitoring of weight, blood pressure and other indicators, in conjunction with nurse case management, will result in improved outcome for Medicare beneficiaries with with Congestive Heart Failure; compared to case management assistance without the biomonitoring device.

Goals of the Study:

* Demonstrate synergy between the Intel® Health Guide home biomonitoring and nurse case management. Measure positive impact on member engagement and clinical outcomes for members with Heart Failure.
* Quantify the potential to avoid costly re-hospitalization based on the Intel® Health Guide - enhanced case management interaction through early alerts and early intervention.

Eligibility Criteria:
Inclusion Criteria:

* Aetna Medicare (PFFS, HMO/PPO fully insured) Individual members, plus Medicare members from any plan sponsor that has agreed it would like its members to be included
* Member meets Aetna Health Profile Database criteria for Chronic Heart Failure (Disease Management Eligibility = Y) with a disease risk stratification score of 3 - 5 (moderately severe to severe). These proprietary criteria yield a group of individuals for whom historical claims data estimates a substantial risk of hospital readmission within the coming 6 months.
* Acute inpatient admission or 2 or more emergency room visits within 6 months prior to identification
* Residence in the designated geographic areas selected for the study (The planned source population is all New Jersey, New York, Pennsylvania and North Central Aetna Individual Medicare members and North Central. If members identified from these states have not filled the study within three months, the source population may be expanded to include Aetna's North Central region members in Illinois and Ohio. These North Central members would include all Aetna Medicare Individual members in these areas, plus any Group Medicare members from Groups whose Plan Sponsors agree that the study may be offered to the members.)
* Member may be currently open/ active in case management
* Responds telephonic outreach to offer study participation, or to Interactive Voice Response outreach call, and confirms each of:

  * Their own identity {secure Health Insurance Portability Accountability Act (HIPAA) compliant acknowledgement to caller}
  * That they have been told of having a heart condition
  * Interest in hearing more and possibly participating in the study

Exclusion Criteria:

* Member had case management and this was closed within the 30 days prior to identification for the study
* End-of life, terminal cancer, end stage renal disease, hospice, late stage Alzheimer's disease, dementia, ventricular assist device, heart transplant or active in heart transplant program. Excluded diagnoses or conditions will be identified where it is evident through Aetna's Health Profile Data diagnoses in claims, or upon case management assessment.
* Chronic or ongoing intravenous heart failure medication
* Any response to Interactive Voice Response outreach call other than "Yes, I am interested"
A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment

The objective of Study M15-991 is to evaluate the efficacy and safety of risankizumab versus placebo during induction therapy in participants with moderately to severely active CD.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged \>=18 to \<= 80 years, or minimum age of adult consent according to local regulations, at the Baseline Visit. Where locally permissible, participants 16 to \< 18 years of age who meet the definition of Tanner stage 5 for development at the Baseline Visit.
* Confirmed diagnosis of CD for at least 3 months prior to Baseline.
* Crohn's disease activity index (CDAI) score 220 - 450 at Baseline.
* Confirmed diagnosis of moderate to severe CD as assessed by stool frequency (SF), abdominal pain (AP) score, and Simple Endoscopic Score for Crohn's Disease (SES-CD).
* Demonstrated intolerance or inadequate response to biologic therapy for CD.
* If female, participant must meet the contraception recommendations.

Exclusion Criteria:

* Participant with a current diagnosis of ulcerative colitis or indeterminate colitis.
* Participants with unstable doses of concomitant Crohn's disease therapy.
* Receipt of Crohn's disease approved biologic agents (infliximab, adalimumab, certolizumab, vedolizumab, natalizumab within 8 weeks prior to Baseline or ustekinumab within 12 weeks prior to Baseline), or any investigational biologic or other agent or procedure within minimally 35 days or 5 half-lives prior to Baseline, whichever is longer.
* Prior exposure to p19 inhibitors (e.g., risankizumab).
* Complications of Crohn's disease.
* Having an ostomy or ileoanal pouch.
* Known active Coronavirus Disease 2019 (COVID-19) infection.
Study of Cilostazol and Probucol to Assess Their Effects on Atherosclerosis Related Biomarker

1. To evaluate the efficacy of Cilostazol and Probucol alone and in combination on atherosclerosis related biomarker
2. To evaluate the safety of Cilostazol and Probucol alone and in combination on atherosclerosis related biomarker

Efficacy evaluation:

Primary efficacy index:

After 12 weeks of treatment, the change of arteriosclerosis related biomarker in 4 modality groups, comparing with the base line information

Secondary efficacy index:

After 8 weeks of treatment, the change of arteriosclerosis related biomarker in 4 modality groups, comparing with the base line information

Safety evaluation:

1. Adverse Event
2. Vital Sign and Physical Examination
3. 12-lead ECG
4. Laboratory Tests (including blood routine examination, routine urine analysis, blood biochemistry examination, glycosylated hemoglobin)

Eligibility Criteria:
Inclusion Criteria:

* 40\~75-year-old male or female
* Clarified diagnosis of type 2 diabetes mellitus
* Arteriosclerosis obliterans (ASO) is diagnosed (ASO diagnoses should meet at least one of the conditions as below:

  * ABI\<1.0;
  * The pulse of popliteal artery or dorsalis pedis artery is weeken significantly or is different between left and right sides
  * Intermittent claudication, diagnosed as ASO by doctor
  * Ultrasonogram showed that there was atherosclerotic plaque in lower limb within 1 year
* Informed Consent Form Signature

Exclusion Criteria:

* Has an allergic history to study drugs
* Use one of the following drugs: other antiplatelet or anticoagulation agents except Aspirin, other hypolipidemic agents except Statins
* Type 1 diabetes mellitus, specific diabetes mellitus, or gestational diabetes mellitus
* Has severe ASO above Fontaine IIb,
* Hemorrhagic tendency or hemorrhagic disease (such as gastrointestinal tract hemorrhage, etc.)
* Had a myocardial infarction, angina pectoris, or cerebral infarction within the last 3 months
* Congestive heart failure
* Is pregnant, or potentially pregnant, or breastfeeding
* Severe hepatic insufficient or severe renal insufficiency (AST or ALT is 2.5 times higher than the upper limit of the normal value range, or serum creatinine is 1.2 times higher than the upper limit of the normal value range)
* Persistent or hardly controlled hypertension (such as malignant hypertension, BP\> 160/100 mmHg)
* Severe ventricular arrhythmia (such as multiple and multifocal premature ventricular contractions)
* Has a medical history that includes a cardiac syncope or a primary syncope
* Has conditions that may prolong QT interval (such as congenital long QT syndrome, taking drugs which prolong QT interval, hypokalemia or hypomagnesemia, etc.)
* Has severe complications (such as diabetes mellitus ketoacidosis, nonketotic hyperosmolar diabetic coma, malignant tumor, severe anaemia, severe hematologic diseases, etc.)
* Other conditions that would exclude the subject from this study by doctor's judgement
Symptomatic Ascites Drainage With a Patient-controlled Vascular Catheter.

The purpose of this study is to determine whether drainage with the usage of a fine, patient-controlled vascular catheter inserted into abdominal cavity is a feasible, safe and effective method in the management of symptomatic malignant ascites. Complications' rate of the procedure and patients' quality of life, nutritional status and experience on the treatment are main endpoints.

Patients with symptomatic, refractory malignant ascites (MA) will be eligible for the study. In case a cancer treatment is not effective against ascites, or no target, systemic treatment is possible patients will be eligible for percutaneous placement of a vascular catheter into abdominal cavity followed be drainage performed in a regular basis when required, at home or ambulatory. Adult patients with every malignant disease, female and male, and coexisting symptomatic MA can be recruited.

Clinical, quality of life (QOL) and quality of the procedure data will be collected. The study is planned to be a multiinstitutional. A template is provided to collect essential clinical data concerned with a patient, malignant disease, procedure performance and complications. QOL and patients' experience on the treatment is to be evaluated with formal questionnaires - EORTC C15-PAL and FACIT-TS-G - permission to use granted from EORTC and FACIT respectively. Additionally, a nutrition monitoring will be performed (if possible and feasible) in patients with MA and drainage.

Data will be saved in a computer, secured data base for calculations. A cohort of 150 patients is planned to be collected. Duration of the study will depend on how many institutions will participate, and how fast patients will be recruited.

Eligibility Criteria:
Inclusion Criteria:

* patients with symptomatic, refractory malignant ascites,
* supportive care (professional or family members) available at patients' home,
* informed signed consent of the patient.

Exclusion Criteria:

* ascites not of malignant origin,
* asymptomatic ascites,
* suspected or clinically apparent infection especially at the site of planned drainage placement,
* significant coagulopathy,
* very poor performance status (PS4),
* patient not able to read and sign informed consent,
* mucinous ascites.
Study of HBV-001 D1 in Healthy Adults

This is a single-center, double-blind, randomized, Phase 1 study to assess the safety and tolerability of HBV-001 D1 in healthy adult subjects.

This is a single-center, double-blind, randomized, Phase 1 study to assess the safety and tolerability of HBV-001 D1 in healthy adult subjects. This will be an upward titration of two dose levels of HBV-001 D1 (10 µg and 50 µg of DEN1-80E) in 16 subjects across two cohorts. Participants in each cohort will receive HBV-001 D1 vaccine or placebo on Visits 1, 3 and 5.

Eligibility Criteria:
Inclusion Criteria:

* Males or females age 18 to 45.
* Body weight ≥ 110 pounds (50 kg).
* Satisfactory medical condition established by medical history and physical examination.
* Females must be of non-child bearing potential (i.e., surgically sterile) or, if of child-bearing potential must be abstinent or willing to employ adequate means of contraception.

Exclusion Criteria:

* Positive serum test for HIV, Hepatitis B surface antigens (HBsAg) and/or Hepatitis C antibodies.
* Abuse of drugs or alcohol within 12 months prior to screening.
* Use of corticosteroids or immunosuppressive drugs within 30 days of screening (use of topical or nasal corticosteroids is allowed).
* Any confirmed or suspected immunosuppressive or immunodeficient condition.
* Receipt of any vaccination within 30 days prior to screening.
* Receipt of blood products within 6 months of screening.
* Previous flavivirus vaccination (e.g., Japanese encephalitis or yellow fever) or flavivirus vaccination planned during the study period.
* History of flavivirus infection.
* No easy access to a fixed or mobile telephone.
* History of residing in a country endemic for dengue, Japanese encephalitis virus, or Yellow Fever virus for a period of \> 1 year.
* Donation of ≥ 450 mL of blood within the previous 12 weeks.
An Interactive Game for HIV Prevention in Early Adolescents

The purpose of this study is to evaluate, through a randomized clinical trial, the efficacy of an interactive video game the investigators are developing at reducing risk behaviors in at-risk teens.

The purpose of this study is to evaluate, through a randomized clinical trial, the efficacy of an interactive video game the investigators are developing at reducing risk behaviors in at-risk teens. The investigators are using proven components of HIV prevention interventions, social cognitive theory, self-efficacy, prospect theory, message framing, and video gaming principles to develop and evaluate this interactive HIV prevention video game. In Phase 1 of this project, the investigators have been working with Schell Games of Pittsburgh, PA, Digitalmill of Portland, ME, and the Farnam Neighborhood House in New Haven, CT to develop our interactive video game with the input from our experts and focus groups and interviews with adolescents. Phase 1 has been a developmental iterative process in which the investigators have been building the software for the game for the purposes of targeting HIV prevention in our population of interest: young minority adolescents. Following development of the video game, the investigators will move to Phase 2 in which the investigators will enroll 330 minority adolescents who are attendees at one of several after-school programs in the greater New Haven area and assign them to play either the experimental game or a control game. In the experimental game, the player will be presented with a series of "risk challenges" thereby helping them to develop sex, drug and alcohol negotiation and refusal skills.

Eligibility Criteria:
Inclusion Criteria:

1. Ages 11-14 years
2. Able to provide assent/parental/guardian consent
3. Agree to participate in a computer-based videogame (willing to sit at a computer for 75 minutes twice weekly to play the game)
4. English-speaking

Exclusion Criteria:

1. Not between the ages of 11-14 years
2. Not able to provide assent/parental/guardian consent
3. Not willing to sit at a computer for 75 minutes twice weekly to play the game
4. Non-English speaking