cyrilzakka/clinical-trials huggingface dataset:
Patient's Preference Between Conventional Oral Olanzapine Tablet vs Olanzapine Orodispersible Tablet

The purpose of the study is to estimate drug preference of stable schizophrenic patients who will be treated with olanzapine orodispersible tablets for 6 weeks then with olanzapine tablets for 6 weeks and vice-versa.


Eligibility Criteria:
Inclusion Criteria:

* You are an outpatient diagnosed with stable schizophrenia.
* You are a male or female in the age of 18 to 65 years old.
* You are retrospectively judged by investigators, based on clinical interview and impression, to have been stable for at least 4 weeks.
* You must be able to take olanzapine orodispersible in a single daily dose.
* You are treated with conventional oral olanzapine tablet (as monotherapy) for at least 1 month.

Exclusion Criteria:

* You have used olanzapine in the past and are no longer using it because of a bad reaction.
* You have known Human immunodeficiency virus positive (HIV+) status.
* You have known uncorrected, narrow angle glaucoma.
* You have known Leukopenia, (abnormally low white blood cell count).
* You have a serious or uncontrolled illness (for example: liver disease, history of heart disease, or inadequately controlled diabetes.)
* You have Parkinson's disease.
* You are a female patient who is either pregnant or nursing
* You are taking medications that are not allowed in the study.
Intelligence and Neurodevelopmental Disorders After Prenatal Exposure to General Anaesthesia

Every year in the European Union, thousands of babies are exposed to anaesthesia before they are born because their mothers need surgery during pregnancy. While these surgeries are necessary, there is a concern that the anaesthesia might affect the baby's brain development. However, there isn't enough research to know for sure how this exposure might impact the child's intelligence or behavior later in life.

The goal of this cohort study is to compare the intelligence and neurodevelopmental outcome of children prenatally exposed to general anaesthesia for maternal abdominal surgery with those of unexposed children.


Eligibility Criteria:
Prenatal anaesthesia exposure:

Inclusion Criteria:

* Prenatal anaesthesia exposure: Children exposed in utero to maternal general anaesthesia to allow laparoscopy or laparotomy for appendicectomy, adnexal pathology, cholecystectomy or for diagnostic procedures to rule out intra-abdominal pathology
* No prenatal anaesthesia exposure: Children not exposed to general anaesthesia for non-obstetric or obstetric (e.g. cesarean section) surgery in utero
* Children born in 2000-2023
* (Parental) informed consent

Exclusion Criteria:

* Children whose mothers underwent obstetric surgery or foetal surgery/interventions during the same pregnancy.
* No Dutch-speaking children
* Diagnosis of severe disability of genetic origin (e.g., Fragil X, Down syndrome,...), history of head trauma, major congenital birth defects
FOLFIRINOX in Metastatic High Grade Gastroenteropancreatic Neuroendocrine Carcinomas

The purpose of this study is evaluate the efficacy and safety of FOLFIRINOX in patients with gastroenteropancreatic high-grade neuroendocrine carcinomas.

This is a prospective Phase II open-label trial, stratifying gastroenteropancreatic high grade neuroendocrine carcinomas participants equally into two cohorts (first-line versus beyond first-line).


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed neuroendocrine carcinoma of the gastrointestinal (GI) tract. Potential participants with unknown origin for the neuroendocrine carcinoma in which a gastroenteropancreatic origin is suspected (per pathologist or investigator discretion) will be eligible for the study.
* Tumors must have a Ki-67 index greater than 20% and/or \>20 mitotic figures/10 high-power fields.
* Must have metastatic disease.
* Must measurable disease, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
* Any line of treatment (first line versus beyond first line).
* Age \>18 years.
* Life expectancy of greater than 12 weeks.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
* Must have adequate organ and marrow function.
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Have had chemotherapy or radiotherapy within 3 weeks prior to entering the study.
* Receiving any other investigational agents.
* Untreated brain or meningeal metastases.
* Prior treatment with 5-fluorouracil (5-FU), irinotecan or oxaliplatin.
* Pre-treatment peripheral neuropathy greater than grade 1 per the CTCAE, version 4.0.
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* A secondary primary cancer (excluding baso/squamous cell carcinoma of skin) within 1 year.
* Active viral hepatitis or autoimmune hepatitis. The work-up to confirm active hepatitis or autoimmune hepatitis will only be done if clinical suspicion based on investigator discretion.
* Potential participants with childbearing potential who are not willing to use adequate contraception precautions during the study and for 3 months after stopping study chemotherapy.
Comparison of the Results of Arthroscopic Suturing of the Medial Meniscus Using the Fast Fix and FiberStitch Systems

Clinical and comparative evaluation of the treatment results of arthroscopic reconstruction of the medial meniscus of the knee joint using the Fast Fix and FiberStitch systems.

The main goal of the project is to evaluate the results of medial meniscus traumatic injury suturing. Further (detailed) objectives are: to compare the results obtained in the study groups of suturing the medial meniscus with the use of two systems: Fast Fix (smith \& nephew) and Fiber Stitch (arthrex). The results refering to the operated limb will be compared in both groups between themselves and furthermore with the results of clinical and biomechanical studies on non-operated limbs.

Eligibility Criteria:
Inclusion Criteria:

* Isolated MM damage.
* Operation performed only in arthroscopy technique.
* No any knee intervention earlier.
* No other pathology in the anatomical area.
* Patient informed consent to participate in research

Exclusion Criteria:

* Age under 18 years old or above 35 years old.
* Any knee intervention performed earlier.
* Any other pathology in the anatomical area identified during preoperative diagnostics.
* Any damage in the area of the second knee joint.
* Failure complying the same treatment protocol rigor.
A Clinical Trial of Soluble Fiber for Asthma

Randomized controlled trial of soluble fiber (NOVELOSETM 3490). Participants will complete an ASA 24 dietary recall questionnaire to access their fiber intake. If eligible for the study, participants will be supplemented to their target fiber dosage with either soluble fiber (NOVELOSETM 3490) or placebo. Collection of blood serum, fecal samples, and nasal wash will aid in analyzing the microbes present in one's gut and how fiber and diet may impact it. Thus, allowing researchers to better understand the pathways that may connect diet and asthma and if it is possible to improve asthma by altering one's diet.

A Phase II randomized, controlled, clinical trial analyzing the impact of increasing fiber intake and the gut microbiome for children with asthma. If eligible, (determined by inclusions/exclusion criteria as well as fiber intake assess by ASA 24) participants will be put into a fiber (NOVELOSETM 3490) or placebo (Maltodextrin) group. Each participant will fil out an Asthma Control Questionnaire (ACQ), collect a nasal wash, and have their blood drawn. Their study medication will be available for them to pick up after their first visit, and they will receive counseling from the Pharmacist on how to implement it into their diet. They will also be sent home with three stool sample kits to be mailed to Northern Arizona University for microbiome analysis. The first kit will be sent within 7 days of their first visit. The second kit will be sent within 2-3 weeks of their first visit. The second study visit will occur 4-6 weeks after the first visit. All the procedures will be repeated again including taking the ASA 24 questionnaire. The participant will send their final kit within 7 days of completing their last visit. Total study time is 6 weeks. This study is minimal risk which includes risk of fecal contamination, discomfort from collecting specimens, discomfort with answering some of the survey questions, and the risks associated with receiving a blood draw. Participants are compensated for their time and receive a portion of their dietary results. There may not be a direct benefit to the participant, but by participating in this research they may help people in the future with asthma.

Eligibility Criteria:
Inclusion Criteria:

* Between ages 6-17
* Asthma diagnosis within the last 2 years
* Fractional excretion of exhaled nitric oxide (FeNO) \> 50 ppb OR a clinical history of environmental allergies as defined by a positive skin prick or positive specific immunoglobulin E (IgE) tests to aeroallergens
* No emergency department visits in the past 1 month
* Ability to consume a liquid drink of fiber or placebo
* Ability to return for a 4-6 week follow-up visit
* No special or unique diet

Exclusion Criteria:

* Cystic fibrosis
* Bronchiectasis
* Change in asthma medicines other than short acting bronchodilators planned over the next 4-6 weeks
* Baseline estimated daily fiber intake less than or equal to 16 grams as determined by the ASA 24
* Sibling of a participant already enrolled in the study
A Study to Evaluate the Real-world Usage and Effectiveness of Elocta and Alprolix in Patients With Haemophilia A or B

Elocta (rFVIIIFc) and Alprolix (rFIXFc) are recombinant extended half-life coagulation factor products. The purpose of this non-interventional study is to describe the real-world usage and effectiveness of Elocta and Alprolix in the prophylactic treatment of haemophilia A and B.


Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of haemophilia A or B and previously treated with factor Product
* Have started prophylactic Elocta/Alprolix treatment prior to enrollment visit, or at enrollment prescribed prophylactic treatment with Elocta or Alprolix regardless of participation in the study
* Signed and dated informed consent provided by the patient, or the patient's legally acceptable representative for patients under the legal age, Before any study-related activities are undertaken. Assent should be obtained from paediatric patients according to local regulations.

Exclusion Criteria:

* Participation in an investigational medicinal product trial, from four weeks prior to first injection with Elocta or Alprolix to enrollment visit.
Relapse-prevention Study With Lu AA21004 (Vortioxetine) in Patients With Generalized Anxiety Disorder

The study will evaluate the long-term maintenance of efficacy of Lu AA21004 in patients with Generalized Anxiety Disorder (GAD) who responded to acute treatment with Lu AA21004.

GAD is a common and disabling mental disorder associated with substantial medical and psychiatric comorbidity and occupational impairment. It is characterized by inappropriate or excessive anxiety and worrying that persists over time for more than six months. Common features include apprehension, with worries about future misfortune; inner tension and difficulty in concentrating; motor tension, with restlessness, tremor and headache; and autonomic anxiety symptoms, with excessive perspiration, dry mouth and epigastric discomfort. GAD is typically a chronic disorder with a high relapse rate and therefore requires effective long-term treatment. Long-term studies are necessary to demonstrate that the short-term effect is maintained.

Eligibility Criteria:
Inclusion Criteria:

The patient has GAD as the primary diagnosis according to DSM-IV-TR criteria (classification code 300.02).

* The patient has a HAM-A total score \>=20 at screening and baseline visits
* The patient has a HAM-A score \>=2 on both Item 1 (anxious mood) and Item 2 (tension) at screening and baseline visits
* The patient has a MADRS total score \<=16 at screening and baseline visits

Exclusion Criteria:

* Any current psychiatric disorder other than GAD as defined in the DSM-IV-TR (assessed with the MINI)
* Any substance disorder (except nicotine and caffeine) within the previous 6 months as defined in the DSM-IV-TR
* Women of childbearing potential not using effective contraception

Other protocol-defined inclusion and exclusion criteria may apply.
Randomized Trial of Immediate Versus Early and Selective Invasive Percutaneous Coronary Intervention in NSTEMI

In non-ST-elevation the optimal time of percutaneous coronary intervention (PCI) is unclear.

Some studies showed benefit of very early PCI, some others early PCI between 12-48 hours and others even showed a benefit of a selective invasive approach only in case of recurrence of symptoms or a positive stress test.

The optimal timing of intervention is still matter of debate as a result of a randomized clinical trial.

In this randomized, controlled, open-label clinical trial we compare a very early cardiac catheterization (\< 2,5 hours after randomization) similar to ST-elevation myocardial infarction treatment, versus an early invasive approach (within 2-48 hours after randomization) versus a selective invasive approach in patients with non-ST-elevation myocardial infarction.

All patients are treated with heparin, ASA, Clopidogrel loading dose (600 mg) with subsequent 75 mg/d and tirofiban for 24 hours.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical symptoms:

   Instable angina pectoris:
   * Angina at rest \< 24 hours
   * new onset worsening angina within the last weeks with angina at very low threshold \< 24 h
2. Troponin T:

   Troponin T-elevation ≥ 0,03 μg/l
3. Informed consent

Exclusion Criteria:

1. Age \< 18 years
2. Age \> 90 years
3. STEMI
4. Hemodynamic instability
5. Cardiogenic shock
6. Warfarin therapy
7. Contraindications for GpIIb/IIIa-inhibitors
8. life expectancy \< 6 months
9. known high bleeding risk
10. Pregnancy
11. Other reasons for Troponin-elevation: Myocarditis, secondary after hypertensive crisis, cardiac decompensation
12. No informed consent
Effect of Improving Caregiving on Early Mental Health

This study evaluates the effect on children and caregivers of providing training in warm, sensitive, responsive caregiving to caregivers in three orphanages in St. Petersburg, Russia. The study also assesses the effectiveness of having more consistent care from fewer caregivers in a family-like environment.

This project will provide experimental evidence that warm, sensitive, responsive caregiving and structural changes that promote more consistent and fewer caregivers will lead to better physical, mental, social, and emotional development of young children. Structural changes are designed to facilitate a more family-like environment and include smaller group sizes, more consistent caregiving from fewer caregivers, integration by age and disability status, and establishing two daily 60-minute Family Hours in which children and caregivers interact together. The project also attempts to demonstrate that training caregivers can be beneficial to both caregivers and children.

All caregivers and children in three orphanages for children under 4 years old in St. Petersburg, Russia will participate in this study. One orphanage will implement both training and structural changes. A second orphanage will receive training only. The third orphanage will serve as a control, receiving neither training nor structural changes. Caregivers are assessed annually for attitudes to and problems with their jobs; anxiety and depression; coping styles; traditional versus progressive attitudes toward caregiving; sensitivity to children's emotions; values; and perceptions of their own relationships. Children are assessed at 3, 6, 9, 12, 18, 24, 36, and 48 months for physical growth, chronic and acute disorders, functional abilities, and mental, motor, social, and emotional development.

Eligibility Criteria:
Inclusion Criteria

* All caregivers and children in three Baby Homes in St. Petersburg, Russia, who remain in the Baby Homes for at least 4 months.
Effects of Liraglutide on Kidney Function in Type 2 Diabetic Patients

Recent studies in rodents show that glucagon-like peptide-1 (GLP-1) analogues protect against diabetic nephropathy. We hypothesise that this is also the case in humans. This study will investigate the short-term effect of liraglutide (GLP-1 analogue) on the kidneys in type 2 diabetic patients. Impact on basic kidney physiological will be determined and kidney injury markers will be measured as surrogate parameters of kidney protection.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent obtained before any trial-related activities.
* Male gender
* T2DM, diagnosed according to international guidelines
* Age 20-60 years, both included
* Body Mass Index (BMI): 20-32 kg/m2, both included
* Metformin treatment
* Albumin/creatinine ratio \<25 mg/mmol

Exclusion Criteria:

* Known or suspected allergy to trial product or related products
* Previous participation in this trial
* Previous treatment with GLP-1 analogues or DPP-4 inhibitors
* Current treatment with any antidiabetic drug other than metformin
* Poorly regulated glycemic control (HbA1c \> 8%)
* Impaired kidney function: estimated GFR \< 70ml/min
* Impaired liver function: liver parameters exceed 2 times upper normal limit
* Subjects with active malignancy
* Severe cardiac insufficiency classified according to NYHA III-IV
* Unstable angina pectoris, acute myocardial infarction (AMI) within the last 12 months
* Severe, uncontrolled hypertension: sitting blood pressure (BP) \> 180/110 mmHg
* Antihypertensive treatment consisting of more than two different pharmaceutical products
* Symptoms related to benign prostate hyperplasia
* Claustrophobia
* Any metal body implants
* History of pancreatitis, type 1 diabetes, gastroparesis or multiple endocrine neoplasia syndrome type 2
* Personal or family history of medullary thyroid carcinoma
* Any diseases judged by the investigator that could affect the trial
* Any medication judged by the investigator that could affect the trial
Spinal Cord Stimulation for Refractory Pain in Erythromelalgia

Erythromelalgia is a rare disorder characterized by red, warm, and painful extremities, which is often precipitated by warm conditions. The pathophysiology is incompletely understood. The management of pain in erythromelalgia is challenging as no single therapy has been found to be effective. Response to pharmacotherapy varies, meaning that the physician has to take a stepwise trial and error approach with each patient. Consequently, this disorder is often associated with poorer health-related quality of life. There is currently no consensus or guideline on management of pain in erythromelalgia. Spinal cord stimulation is a widely applied therapy to treat severe chronic pain of various origin. Case reports and anecdotal evidence suggest that this therapy might alleviate refractory pain in patients with erythromelalgia.

The aim of this trial is to evaluate the efficacy of spinal cord stimulation for refractory pain in erythromelalgia.


Eligibility Criteria:
Inclusion Criteria:

1. A diagnosis of primary or idiopathic erythromelalgia
2. Patients ≥18 years who have developed chronic pain that has remained refractory to medical treatment for ≥6 months.
3. Minimum pain intensity of 5/10 on a numeric rating scale NRS at baseline.
4. Successful two-week SCS testing period with tonic stimulation (≥2 points reduction in pain NRS from baseline). This means patients will experience paresthesia during the trial period of spinal cord stimulation.

Exclusion Criteria:

1. Coexisting conditions that would increase procedural risk (e.g., sepsis, coagulopathy).
2. History of laminectomy or posterior fusion at the thoracolumbar junction, where percutaneous electrode end tips are routinely placed.
3. Abnormal pain behavior and/or unresolved psychiatric illness.
4. Unresolved issues of secondary gain or inappropriate medication use.
5. Unfit for participation for any other reason as judged by the study physician.
Evaluating Alternative Aftercare Models for Ex-offenders

This study is examining the relative effects of alternative aftercare models for ex-offenders who are recovering from substance abuse/addiction. The study is a longitudinal, randomized field trial that assigns participants to one of three conditions: Oxford House, a professionally-run residential treatment facility, or a control condition that involves usual aftercare chosen by participants (which may include no treatment at all). Oxford Houses are self-run residential recovery homes based on the premise of mutual support. These homes do not involve professional treatment staff and the expenses (e.g. rent, utilities) are paid for by the residents. The hypothesis of this study is that Oxford House participants will have as good or better outcomes in terms of substance recovery, recidivism, and health in comparison to the participants who were assigned to the residential treatment facility, and better outcomes in comparison to the control group. In addition, the cost to government/tax payers will be substantially lower given that participants pay their own way.


Eligibility Criteria:
Inclusion Criteria:

* released from prison/jail in last 24 months
* recovering from alcohol or drug dependence

Exclusion Criteria:

* convicted of violent crime such as murder, aggravated assault
* currently using alcohol or drugs
Criteria for Advanced Prosthetic Foot Prescription

The purpose of this study is to develop criteria for prosthetic foot prescription for Veterans and Service Members with transtibial limb loss. The objectives are to: 1) Determine the appropriate functional outcome tests and measures to support the prescription of a type of Energy Storing and Returning (ESR) non-articulating, articulating or active plantarflexion prosthetic ankle-foot for a Veteran or Service Member with transtibial limb loss. 2) Correlate patient goals and subjective measures with objective data to determine the appropriate prosthetic ankle-foot category that will facilitate the greatest overall function to the user. 3) Develop criteria for the appropriate prescription of non-articulating ESR, articulating ESR, and active plantar flexion ESR ankle-foot units.


Eligibility Criteria:
Inclusion Criteria:

* DEERS eligible Veteran or Service Member, or civilian with unilateral transtibial amputation
* Currently using an Energy Storing and Returning prosthetic foot with a well-fitting socket as a primary or back-up prosthesis
* Achieved a "Modified Independence" score on the Functional Independence Measure (FIM) for the locomotion mobility items
* Has a minimum clearance of 8 ¾ inches to accommodate all feet

Exclusion Criteria:

* Has active wounds/ulcers or significant musculoskeletal comorbidities on their intact limb that would impair their ability to participate in all functional outcome measures
* Has any comorbidity that results in rapid limb volume changes (i.e. end stage renal disease with dialysis),
* Weighs more than 275 pounds, the maximum product weight load
* Is unable or unwilling to comply with all research visits
* Has cognitive deficit(s) or mental health pathology limiting a subject's ability to participate fully in the study
* Women who are pregnant or plan to become pregnant during study activities. This will be determined by asking the participant if they are pregnant or if they believe that they may be pregnant. This question will only be asked at inclusion, as biomechanical changes will only be impacted if the woman is in the 2nd or 3rd trimester, and will not be impacted if the participant becomes pregnant while in the study.
* Poorly fitting socket
* Vision loss that requires use of an assistive device for gait
* Upper Limb Amputation