cyrilzakka/clinical-trials huggingface dataset:
Comparing Opioids Vs NSAIDs for Postoperative Pain Management in Unilateral Primary Open Inguinal Hernia Repair

To control post-operative pain, multiple drugs are available, and in the western countries opioids are preferred. However, they have their own side effects, and so to reduce their dependence, multiple adjuncts are used. We compared the use of opioids vs just non steroidal anti-inflammatory drugs on post-operative pain control following inguinal hernia surgery

Inguinal hernia repair is one of the most common surgeries performed by general surgeons worldwide. The preferred procedure for primary open inguinal hernias is open mesh repair (tension-free)-also called Lichtenstein repair. Opioids remain the mainstay for post-operative analgesia, however, they have a tendency for dependence along with other side effects. Non-steroidal anti-inflammatory drugs (NSIADs) have been used as adjuncts to decrease the use of opioids, however, usually NSAIDs are not used in isolation following surgery. We compared post-operative analgesia following primary open inguinal hernia repair, with patients receiving only opioids vs patients only receiving NSAIDs. 60 patients were randomized in to 2 groups. Group A patients received tramadol injection (opioid) every 8 hours, while patients in Group B received injection ketorolac (NSAID) every 8 hourly. Pain was measured using visual analogue score at 2-, 6-, 12- and 24-hours following surgery.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing elective primary unilateral open inguinal hernia repair under spinal anesthesia - Lichtenstein repair with prolene mesh
* ASA I or II
* Ages 18 - 65

Exclusion Criteria:

* Patient on chronic pain meds
* Patient receiving analgesics 24hrs prior to surgery
* Incarcerated or strangulated hernia or recurrent hernia
* BMI \&gt;40
* Allergic to medications being tested in this study
The Metabolic Effects of Breaks in Sedentary Time

The purpose of this study is to determine whether acute bouts of sedentary behaviour (with or without breaks and/or structured physical activity) result in measurable changes in metabolic health in children and youth.

North American children spend the majority of their waking hours engaging in sedentary behavior (e.g. sitting). Research in adults and animal models suggests that even short bouts of uninterrupted siting may result in acute changes increases in cardiometabolic risk, although to date no studies have investigated this relationship in children and youth. The purpose of this study is to assess the feasibility of a protocol which will expose participants aged 10-14 years to a full day of uninterrupted sitting, and to determine the impact of this protocol on markers of cardiometabolic risk (insulin, glucose, triglyceride, HDL-C and LDL-C) as well as subsequent food intake and physical activity. The impact of uninterrupted sitting will be compared to the impact of interrupted sitting, with and without the inclusion of moderate physical activity.

Eligibility Criteria:
Inclusion Criteria:

* Age 10-14
* Normal weight or obese

Exclusion Criteria:

* Overweight
* Overt diabetes or heart disease (or taking medications to treat this conditions)
* Being unambulatory or otherwise unable to perform the study protocol
tDCS to Enhance Cognitive Training in Schizophrenia

The primary aim for the study is to determine whether transcranial direct current stimulation (tDCS) enhances training gains on cognitive training (CT) tasks. Secondary aims are to determine whether tDCS combined with CT causes larger transferable improvements on non-trained tasks (i.e., generalisation effects) and whether these generalisation effects are maintained over time (i.e., maintenance effects).

Specific hypotheses are:

1. CT combined with active tDCS will produce greater training gains on CT tasks compared to a similar control group receiving CT with sham tDCS.
2. CT combined with active tDCS will produce greater generalisation effects on non-trained cognitive tasks compared to CT with sham tDCS.
3. The cognitive improvements gained by patients from both interventions will be maintained over 1 month follow-up.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects are 18 years of age or above.
2. Subjects meet criteria for a DSM -IV schizophrenia or schizoaffective disorder but with a stable mental status as demonstrated by a stable Positive and Negative Symptom Score (PANSS) score over a period of 2 weeks.
3. Subjects have had no medication changes in the 2 weeks prior to obtaining informed consent.
4. Subjects are right-handed.
5. Subjects able to give informed consent for the trial.

Exclusion Criteria:

1. Drug or alcohol abuse or dependence (preceding 3 months).
2. Concurrent anticonvulsant or long acting benzodiazepine medication, as these medications may interfere with the effects of tDCS.
3. Subject requires a rapid clinical response due to inanition, psychosis or high suicide risk.
4. Clinically defined neurological disorder or insult, including history of seizures, cerebral aneurysm or trauma, significant head trauma with loss of consciousness for ≥ 30 minutes.
5. Subject has metal in the cranium, skull defects, or skin lesions on scalp at proposed electrode sites.
6. Female subject of child bearing age, sexually active and not using reliable contraception
VL vs DL in Inexperienced Users: a Pediatric Manikin Study

This study will compare the CMAC and Glidescope videolaryngoscopes (VL) to traditional direct laryngoscopy (DL) using either a Miller or Macintosh laryngoscope by studying the performance of users. This will involve the use of an intubating pediatric manikin to assess various aspects of endotracheal intubation by experienced and inexperienced users.

The commonly used method for endotracheal intubation in children is direct laryngoscopy using a Miller or Macintosh blade. Videolaryngoscopy is a widely accepted pediatric airway management. Videolaryngoscopes (VL) provide an indirect view of glottis without the need to align the oral, pharyngeal, and glottis structures. Some types of VLs provide also direct view of glottis with indirect view. Videolaryngoscopes can be used as a teaching tool for learners as they can visualize all the anatomical structures of larynx at the same time with the performer. VLs may facilitate the learning of endotracheal intubation in inexperienced users in the pediatric population. There are limited data on the use of videolaryngoscopes by anesthesia providers and medical personnel who are inexperienced in the use of videolaryngoscopes.

Eligibility Criteria:
Inclusion Criteria:

* Faculty pediatric anesthesiologists
* CRNAs
* Trainees (SRNAs, residents, fellows, and medical students)
* Nurses from NCH

Exclusion Criteria:

* If subjects are unwilling to participate.
Intervention to Improve Engagement in Care Among Newly Diagnosed HIV-positive Men

The study involves delivering one of two interventions - either Promoting Action Towards Health (PATH) or Personalized Cognitive Counseling (PCC) - to 440 men who have sex with men (MSM) who have recently been diagnosed with HIV and assessing whether participants who received PATH achieve greater suppression of HIV viral load, demonstrate greater uptake of care and adherence to treatment, and engage in less sexual HIV transmission risk behavior than participants who received PCC.

* PATH consists of two preliminary sessions plus "booster" sessions after 1, 3, and 6 months.
* Personalized Cognitive Counseling consists of one session.

Participants will complete assessments before participating in their intervention (i.e., at "baseline") and at 3, 6, 9, and 12 month follow-up points. Participants' viral loads will be measured at approximately 6 and 12 months following baseline.

Objectives:

The investigators will conduct a randomized controlled trial to test the efficacy of Promoting Action Towards Health (PATH), a brief health-enhancement and risk reduction intervention targeting newly HIV diagnosed men who have sex with men (MSM).

Specific Aims:

The investigators will establish the efficacy of PATH. The following hypotheses will be tested: Participants in the experimental condition will (1) achieve significantly greater suppression of HIV viral load; (2) demonstrate greater uptake of care and adherence to treatment; and (3) engage in less sexual HIV transmission risk behavior across the study duration than participants in the comparison condition.

Procedures:

440 newly HIV diagnosed (within 12 months) men will be randomly assigned to either: (1) the PATH experimental condition, or (2) the PCC comparison condition and followed for one year. HIV counselors will be trained to deliver the interventions within each condition. Assessments will be conducted at baseline, 3, 6, 9 and 12 months.

Significance:

Given increases in HIV incidence among MSM, advances in HIV treatment, and the demonstrated efficacy of early treatment in preventing HIV transmission, there is a critical need for effective interventions that can increase engagement and retention of MSM in care and reduce sexual HIV transmission risk behavior. PATH can be seamlessly integrated into medical care and translated into a sustainable model of care for newly diagnosed MSM to meet the urgent need for care programs that identify, treat, and prevent HIV infections.

Eligibility Criteria:
Inclusion Criteria:

* receiving an HIV diagnosis within the previous 12 months
* entry into HIV primary care
* residence in the greater New York metropolitan area
* aged 18 or older
* provision of written informed consent

Exclusion Criteria:

-demonstrating cognitive impairment, acute psychosis, or suicidal intent or plans
Loss of Control Eating Following Weight Loss Surgery

This study will test the effectiveness of two distinct behavioral treatments for loss of control eating following bariatric surgery:

1. Behavioral Weight Loss Treatment
2. Cognitive Behavioral Therapy

These treatments will be compared to Standard-of-Care.


Eligibility Criteria:
Inclusion Criteria:

* Gastric bypass surgery or sleeve gastrectomy patients from Yale Bariatric/Gastrointestinal Surgery Program
* 5-8 months post-bariatric surgery
* Regular loss of control eating (once weekly during past month)
* Read English proficiently enough to read patient self-care materials and study assessments
* Available for duration of treatment plus follow-up period
* Agree to study procedures

Exclusion Criteria:

* Current enrollment in a formal exercise program
* Medical status judged by the surgeon as contraindication (rare instances of need for additional surgery or medical instability)
* Unable to ambulate
* Current medications that influence eating/weight
* Current substance dependence or other severe psychiatric disturbance (e.g., suicidality) that requires immediate treatment
An Exploratory Study to Investigate the Inflammatory Response During a Cold Sore Episode

This study will treat approximately 24 participants who experience cold sores. Patches will be applied to the cold sore for up to ten days, and the symptoms will be measured during daily clinic visits using non-invasive measurement techniques.


Eligibility Criteria:
Participants who are susceptible to cold sores that reactivate when exposed to ultraviolet (UV) light
Effects of Osteopathy in Autonomic Nervous System

The most important regulatory system in the body is the autonomic nervous system. There are several studies that evaluate the effect of techniques applied at the base of the skull on the autonomic nervous system. The aim of this study is to evaluate the effect of the flying buttress technique on the autonomic nervous system.

The most important homeostatic regulatory system in the body is the autonomic nervous system (ANS), as it coordinates functions of many organs and tissues, including the cardiac muscle.

ANS regulation in most visceral organs reflects a balance between sympathetic and parasympathetic modulation. In the neural control of the heart, there is a balance between sympathetic excitation and vagal inhibition of sinoatrial node activity, which contribute to fluctuations in heartbeat, known as heart rate variability (HRV).

HRV is considered a valuable non-invasive measurement tool for assessing ANS function, as it is relatively simple and quickly performed.

Previous studies provide evidence that osteopathic treatment is associated with changes in HRV that appear to be indicative of increased cardiac vagal modulation in various conditions.

The aim of this study is to evaluate the effect of the osteopathic technique flying buttress on the ANS through HRV.

Eligibility Criteria:
Inclusion Criteria:

* Volunteers between 18 and 35 years of age;
* Ability to maintain a supine position for 30 minutes;
* Healthy volunteers.

Exclusion Criteria:

* Presence of acute or chronic pain;
* Recent cranial and/or cervical injury;
* History of cranial and/or cervical surgery;
* Oncological disease;
* Brain injury;
* Cardiovascular pathology;
* Neurological pathology;
* Psychological/emotional disorder;
* Pregnancy;
* Manual therapy treatment in the last month;
* Consumption of alcohol, drugs, tobacco, chocolate, and sodas in the last 48 hours;
* Consumption of caffeine on the day of the study;
* Extreme physical exercise in the last 24 hours;
* Less than 6 hours of sleep on the night preceding the study.
A Phase 2 Study to Determine the Safety and Efficacy of BIND-014 (Docetaxel Nanoparticles for Injectable Suspension) as Second-line Therapy to Patients With Non-Small Cell Lung Cancer

The purpose of this study is to evaluate the efficacy and safety of BIND-014 in patients with advanced non-small cell lung cancer (NSCLC).


Eligibility Criteria:
Inclusion Criteria:

* Males or females at least 18 years of age
* Diagnosis of NSCLC with locally advanced or metastatic disease
* Previously treated with one platinum-based chemotherapy
* Disease status must be that of measurable and/or evaluable disease
* Performance status of 0 to 1 on the ECOG Scale
* Prior chemotherapy completed at least 3 weeks prior to study enrollment
* Prior radiation therapy allowed to \< 25% of the bone marrow
* Patient compliance and geographic proximity that allow adequate follow-up
* Adequate organ function
* Patients with reproductive potential must use contraceptive methods
* Signed informed consent from patient

Exclusion Criteria:

* Active infection
* Pregnancy or planning to become pregnant
* Breast feeding
* Serious concomitant systemic disorders
* Second primary malignancy
* Patients who are symptomatic from brain metastasis
* Presence of detectable (by physical exam) third-space fluid collections
* More than 1 prior cytotoxic chemotherapy regimen for advanced disease
* Prior treatment with docetaxel
* History of severe hypersensitivity reaction to polysorbate 80
* Peripheral neuropathy at study entry
* Patients known to be HIV positive
* Patients known to be seropositive for hepatitis C hepatitis B
* Congenital long QT syndrome, congestive heart failure, or bradyarrhythmia
A Study of Darbepoetin Alfa for the Treatment of Anemia in Subjects With Non-Myeloid Malignancy Receiving Multicycle Chemotherapy

The purpose of this study is to evaluate the efficacy of darbepoetin alfa as 500ug once every 3 weeks to show that the dose and schedule are not inferior to darbepoetin alfa administered as 2.25ug/kg once per week in the treatment of anemia in subjects with non-myeloid malignancies.


Eligibility Criteria:
Inclusion Criteria:

* Non-myeloid malignancy
* At least 12 additional weeks of cyclic cytotoxic chemotherapy anticipated regardless of schedule
* Eastern Cooperative Oncology Group performance status of 0-2
* Hemoglobin concentration of less than 11 g/dL within 24 hours before randomization
* Of legal age at the time written informed consent is obtained

Exclusion Criteria:

* Known history of seizure disorder
* Known primary hematologic disorder, which could cause anemia, other than a non-myeloid malignancy
* Unstable or uncontrolled disease/condition, related to or affecting cardiac function
* Clinically significant inflammatory disease
* Inadequate renal and/or liver function
* Known positive HIV test
* Previously suspected of or confirmed to have neutralizing antibodies to rHuEPO
* Received more than 2 red blood cell (RBC) transfusions within 4 weeks before randomization or any RBC transfusion within 14 days before randomization, or any planned RBC transfusion between randomization and study day 1
* Received any erythropoietic therapy within 4 weeks before randomization or any planned erythropoietic therapy between randomization and study day 1
* Other investigational procedures
* Subject is currently enrolled in or less than 30 days since receipt of any investigational drug or device that is not approved by the applicable regulatory authority
* Pregnant or breast feeding
* Not using adequate contraceptive precautions
* Known sensitivity to any of the products to be administered during dosing
* Previously randomized in this study
* Concerns for subject's compliance with protocol procedures
Study to Evaluate the Efficacy and Safety of Sandostatin LAR at High Dose or in Combination Either With GH-receptor Antagonist or Dopamine-agonist in Acromegalic Patients

This study will assess the efficacy of 8 months treatment of Sandostatin® LAR® High Dose monotherapy or Sandostatin® LAR® High Dose in combination either with growth hormone antagonist or dopamine agonist to control biochemical parameters (GH and insulin-like growth factor I \[IGF I\]) of acromegalic patients not achieving biochemical normalization at conventional regimen.


Eligibility Criteria:
Inclusion Criteria:

• Patient with a biochemically documented active acromegaly, not adequately controlled by somatostatin-analogues at conventional regimen as follow : mean 1-hour GH \> 2.5 ng/mL and elevated IGF-1 (adjusted for age and gender)

* Patient with reduction of either mean fasting GH at least 50% or IGF-1 at least 25% from any medical pretreatment level
* Patient currently receiving somatostatin-analogues at conventional regimen (maximum registered dose) for at least 6 months before inclusion

Exclusion Criteria:

* Newly diagnosed or previously medically untreated acromegalic patient
* Concomitant treatment with GH-receptor antagonist
* Concomitant treatment with dopamine-agonist
* Symptomatic cholelithiasis or choledocolithiasis
* Liver transaminases (ALT, AST) elevated, but \> 3 times upper normal limit (according to local laboratory)
* Previous gamma-knife radiotherapy for treatment of acromegaly
* Compression of the optic chiasm causing visual field defect
* Any medical conditions contraindicated in the Summary of Product Characteristic (SPC) of all drugs

Other protocol-defined inclusion/exclusion criteria may apply
Providing Personally Tailored Dietary Suggestions Using Individual Microbiome and Glycemic Index Response.

Provide personally tailored dietary suggestions to participants based on the Personalized Prediction Engine (patent pending) owned by DayTwo.

* Answer personal questions including such things as health information, eating habits and preferences, activity level and intensity.
* Submit a first stool sample via a self-addressed, postage-paid kit that is mailed to you.
* Attend one of the 2 hour connection meetings based on available dates.
* The study team will collect vitals: measurements of height, weight, blood pressure, pulse, waist and hip circumference.
* You will have a Blood collection for study (approximately 35 ml of blood/5 tubes)
* You will be provided a FitBit wrist band that you will wear
* You will be provided a manual blood glucose monitor you will use for pricking finger and measuring blood sugar level at least 4 times per day.
* You will have a continuous blood glucose sensor and monitor inserted by study staff.
* You will use DayTwo's mobile application where you will input food eaten, activity, measurements, medications, and sleep.
* You will be given a second stool kit and instructions for collection.
* You will be asked to eat 4 breakfasts consisting of either bagels and cream cheese or cereal. These foods will be provided for you. Other than these four breakfasts, we would like you to follow your normal eating habits during the collection week.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Comprehension of the study objectives and requirements
* Ability to download the DayTwo proprietary mobile application
* Ability to access the DayTwo website for registration and nutrition report

Exclusion Criteria:

* Under 18 years of age
* Pre-diagnosed type I or type II diabetes mellitus
* Pregnancy
* Use of antibiotics or fertility treatments within 3 months prior to participation
* Bariatric weight loss surgery
* Chronic Anemia (hemoglobin of 10g per deciliter or less
* Chronic gastrointestinal disorder (IBD, Celiac, etc.)
* Active cancer or chemotherapy or radiation within 2 years prior to participation
* Condition not allowing to follow the dietary recommendation during the study
* 4 or more alcoholic drinks per day on a regular basis or use of recreational drugs
* Chronic medical condition, treatment, or medication that may affect glucose metabolism (HIV diagnosis, use of steroids or immunosuppressive drugs, etc.)
The Young Adult and Pediatric Bipolar Study

To examine the safety and effectiveness of extended-release carbamazepine in the treatment of children and adolescents aged 10-17 years with acute manic or mixed bipolar I disorder.


Eligibility Criteria:
Inclusion Criteria:

* Key Inclusion Criteria:

  1. DSM-IV diagnosis of bipolar I disorder, most recent episode manic or mixed.
  2. A lifetime history of bipolar disorder symptoms for at least 2 months.
  3. YMRS score greater than or equal to 16.
  4. CGI-S score greater than or equal to 4.
  5. Male or female outpatient aged between 10-17 years old inclusive at the time of consent.
  6. Functioning at an age-appropriate level intellectually, as deemed by the Investigator.
  7. The subject has no co-morbid illness that could affect efficacy, safety, or tolerability or in any way interfere with the subject's participation in the study.
  8. Must have a satisfactory medical assessment with no clinically significant and relevant abnormalities.

Exclusion Criteria:

* Key Exclusion Criteria:

  1. Current controlled or uncontrolled, co-morbid psychiatric diagnosis that could interfere with clinical assessments or study conduct.
  2. A history of lack of therapeutic response or hypersensitivity to the study drug.
  3. A greater than or equal to 50% reduction in YMRS between Screening and Baseline.
  4. Acutely at risk for suicidal or violent behavior or a history of suicide attempts requiring medical intervention.
  5. A history of aplastic anemia, agranulocytosis or bone marrow depression.
  6. A history of seizure disorder, other than a single childhood febrile seizure.
  7. A history of severe, unstable asthma.
  8. Current hospitalization for psychiatric symptoms.
  9. History of alcohol or other substance abuse or dependence.
  10. Pregnant or lactating females.
  11. Body weight less than or equal to 25 kg.
Peripheral Drivers of Heart Failure Progression - the Prospective PEDAL-HF Study

PEDAL-HF is a registry-based randomized prospective multicenter study. We plan to include 1000 patients who were recently admitted with acute decompensated heart failure at five tertiary heart clinics in Germany. For the randomised part, 750 patients will be randomized to care within a heart failure network or usual care. The primary endpoint of the randomized trial is change in NT-proBNP from baseline to 6 months of follow-up.

All patients (randomized or not) will be followed for two years.

See above.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to the participating study centres with acute decompensated heart failure (ADHF), defined as clinical signs and/or symptoms of heart failure, objective structural cardiac abnormalitites according to the ESC criteria.

Exclusion Criteria:

* Age \&lt; 18 years, pregnancy, any condition interfering with the informed consent process, patients placed in an institution by official or court order