cyrilzakka/clinical-trials huggingface dataset:
Neurofeedback for Obsessive-Compulsive Disorder (OCD)

The aim of this study is to train patients with obsessive-compulsive disorder to control a region of their brain that has been associated with their symptoms. Patients in the experimental group will be given direct feedback regarding activity in this brain area while they are undergoing functional magnetic resonance imaging (fMRI) scanning, and will try to learn to control activity in the region during these feedback sessions. A separate group of patients will be given a control form of feedback that we do not believe can have clinical benefits. Our primary hypothesis is that the neurofeedback training will reduce OCD symptoms more than the control feedback.

Original study design recruiting controls who were matched to the experimental group was changed to a randomized design prior to enrollment of the first participant.

Eligibility Criteria:
Inclusion Criteria:

* Primary Diagnosis of Current OCD, based on Diagnostic and Statistical Manual (DSM-IV) criteria, a Y-BOCS (Yale-Brown Obsessive-Compulsive Scale) score \>=16
* Principle OCD symptoms- Primary symptoms must be either Cleaning/Contamination or Checking; other symptoms okay
* Unmedicated (or medications stable for 8 weeks).
* Research group must be able to identify a target region in the orbitofrontal cortex that is related to symptoms

Exclusion Criteria:

* Active Psychosis; Pervasive Developmental Disorder ; epilepsy or other major neurological disorder
* History of major head trauma or psychosurgery
* Active Substance Abuse within 6 months
* Seizure disorder or other significant neurological disorder
* Active Suicidality
* Pregnancy
* severe claustrophobia, ferromagnetic metal in the body, a pacemaker or defibrillator, or any other condition that would make MRI scanning unsafe or inappropriate
* any psychotropic medication other than a selective serotonin reuptake inhibitor (SSRI) antidepressant, anafranil, or a low-dose hypnotic or anxiolytic taken on an as-needed basis
* active cognitive/behavioral therapy initiated within the last 3 months (continuation of established maintenance therapy that has been going on for longer than 3 months will not be grounds for exclusion)
Immunohistochemical Study of Chordomas to Improve Their Diagnosis and Prognosis Care

Chordomas are very rare malignant tumors, chemo-resistant with high propensity for recurrence. The role of immunotherapy in these patients remains largely unexplored while PD-L1 and CD8 status in the micro-environment of chordomas is basically not known. Similarly, this tumor often poses diagnostic difficulties due to its resemblance with metastasis or chondrosarcoma, thus, it would be useful to know the expression status of factors used during the work-up of metastatic or mesenchymal tumors, like CDX2, INSM1 and FOXA1, which remains unknown for chordomas. Thus, the aim of the study is to explore PD-L1, CD8, CDX2, INSM1 and FOXA1 expression in a series of chordomas and compare it with clinico-pathological and prognostic features.

Retrospective, non-interventional study. A series of chordomas will be analyzed for detailed histologic features and for various immunohistochemical factors and results will be compared with clinical factors, like overall and disease-free survival.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with chordoma
* Sufficient histological material available
* Tumor expression of brachyury

Exclusion Criteria:

- Insufficient histological material
Preterm Donor Human Milk Supplementation of Mother's Own Milk in VLBW Infants

This prospective randomized controlled trial aims to investigate whether feeding very low birth weight (VLBW) infants with Mother's own milk (MOM) supplemented with either preterm (PDM) or term donor milk (TDM), when MOM is insufficient, has a positive impact on infants' protein intake, growth and morbidity.

Mother's own milk (MOM) is the optimal nutrition for preterm infants. When MOM is not sufficient, pasteurized donor milk (DM) is the best alternative according to current recommendations. Donor milk is primarily derived from mothers of term-born infants for the first six months of lactation. However, this term milk presents significant differences compared to preterm human milk which has higher protein concentration and more caloric energy.

The investigators hypothesized that feeding VLBW infants with preterm donor milk (PDM) in combination with MOM may positively influence the protein intake and, consequently, the infants' growth. The aim of the current study is to assess whether MOM supplementation with PDM has any beneficial effects on the nutrition, growth and morbidity in VLBW infants.

Eligibility Criteria:
Inclusion Criteria:

• VLBW infants with birth weight \<1500g born to mothers who agree to provide donor milk for the first three weeks of life (donor milk period) if their own milk quantity is insufficient

Exclusion Criteria:

* Congenital anomalies
* Chromosomal disorders
* Metabolic diseases
* Feeding with formula at any point during the first 3 weeks of life (donor milk period)
A Study in People With Depression to Test the Effects of BI 1358894 on Parts of the Brain That Are Involved in Emotions

To assess the effect of a single dose of BI 1358894 compared to placebo on BOLD responses in modulating brain processing of emotional and cognitive stimuli on the amygdala and related brain structure using fMRI in in unmedicated patients with depression.


Eligibility Criteria:
Inclusion Criteria:

* Patients having a diagnosis of a MDD according to Diagnostic and Statistical Manual of Mental Disorders-V (DSM-V) (single episode or recurrent) with a MADRS total score between ≥ 7 and \< 26 at screening.
* Male or female aged 18 to 45 years, inclusive at screening.
* Male or female patients. Women of childbearing potential (WOCBP) and men able to father a child must be ready and able to use highly effective methods of birth control.
* Patients must be, in the opinion of the Investigator, capable of and eligible for completing the fMRI and tasks.
* Patients must be right-handed.
* Patients must have acceptable weight as defined by BMI (weight \[kg\]/height \[m\]²) range of 18 to 30 kg/m², inclusive at Visit 1.
* Patients must be a non-smoker or light smoker (≤ 5 cigarettes per day).
* Patients must have signed the informed consent form prior to the first study-related procedure indicating they understand the purpose of and procedures required for the study and are willing to participate in the study.
* Further inclusion criteria apply

Exclusion Criteria:

* Meeting any diagnostic criteria for a major psychiatric disorder (other than MDD), as determined by DSM-V at screening.
* Has received a prescribed medication (including antidepressants) within 28 days prior to Visit 1 (apart from the contraceptive pill) or having received over the counter medication (including pain killers) within 10 days prior to screening. Participants who have taken prescription medication may still be entered into the study, if, in the opinion of the Investigator, the medication received will not interfere with the study procedures or compromise safety.
* Patients where it is foreseen (per investigator judgement) that a delay of initiation of standard of care therapy for the depressive disorder to 14 days after day 1 of Visit 2 is medically not justifiable.
* A history of alcohol or substance dependence or abuse within the last 12 months from Visit 1.
* Has a current or recent history of clinically significant suicidal ideation within the past 6 months, corresponding to a score of 4 or 5 for ideation on the C-SSRS, or a history of suicidal behavior within the past year, as validated by the C-SSRS at screening or treatment visit.
* Has a history of, or presents (in the opinion of the Investigator) with, significant neurological or psychiatric conditions (such as stroke, traumatic brain injury, seizures, space occupying lesions, multiple sclerosis, Parkinson's disease, vascular dementia, transient ischemic attack, schizophrenia, blackouts requiring hospitalisation).
* A planned medical treatment within the study period that might interfere with the study procedures.
* Further exclusion criteria apply
A Feasibility Study of the Nativis Voyager® System in Patients With Recurrent Glioblastoma Multiforme (GBM) in Australia

This feasibility study will assess the effects of the Nativis Voyager therapy in patients with recurrent GBM who have either failed standard of care or are intolerant to therapy. The study will enroll and treat up to eleven subjects over six months. Safety and clinical utility will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

1. Subject has histologically confirmed diagnosis of GBM.
2. Subject has failed or intolerant to radiotherapy.
3. Subjects has failed or intolerant to temozolomide therapy.
4. Subject has progressive disease with at least one measureable lesion on MRI or CT.
5. Subject is at least 18 years of age.
6. Subject has a KPS ≥ 60.
7. Subject has adequate organ and marrow function.
8. Subject has provided signed informed consent.

Exclusion Criteria:

1. Subject has life expectancy less than eight weeks
2. Subject has received other investigational therapy within the last 28 days.
3. Subject has received surgery within the last two weeks or not fully from prior surgery.
4. Subject has a clinically significant electrolyte abnormality.
5. Subject has an active implantable (e.g., neurostimulator, pacemaker) or other electromagnetic device.
6. Subject has a metal implant, including a stent, in the head or neck that is incompatible with MRI.
7. Subject is known to be HIV positive.
8. Subject is pregnant, nursing or intends to become pregnant during the study period.
9. Subject is participating in other investigational research.
10. Subject has any condition that at the discretion of the investigator would preclude participation in the study.
11. Subject is unable or unwilling to comply with the protocol-required follow-up schedule.
Aprepitant With Dexamethasone Versus Ondansetron With Dexamethasone for PONV Prophylaxis in Patients Having Craniotomy

We hypothesize that the combination of aprepitant with dexamethasone will provide significantly improved prophylaxis against Postoperative nausea and vomiting compared with the combination of ondansetron and dexamethasone, in patients undergoing craniotomy under general anesthesia.


Eligibility Criteria:
Inclusion Criteria:

A patient is eligible for inclusion in this study if all of the following criteria apply:

* Age: 18-75 years of age
* Surgery: craniotomy under general anesthesia.
* American Society of Anesthesiologists (ASA) Status: ASA: I, II, or III
* Language: Fluent in the English language
* Informed Consent: Written informed consent must be obtained.

Exclusion Criteria:

A patient will not be eligible for inclusion in this study if any one or more of the following criteria apply within thirty days of patient enrollment in this clinical trial:

* Medical: Any condition that may impair a patient's ability to complete any of the study assessments or confound interpretation of results.
* Hypersensitivity: Patient has a known immediate or delayed hypersensitivity reaction or known idiosyncrasy to any of the two study medications, ondansetron, or aprepitant.
* Other Drugs: Patients should not be taking medications with known antiemetic properties (phenothiazines, butyrophenones, antihistamines), nor should they receive metoclopramide, or other antiemetics preoperatively or 12 hours before the scheduled surgical procedure.
* Pregnant or lactating females: A pregnancy test will be performed within 24 hours of entering the study for females of childbearing potential.
* Substance Abuse: Clinically significant abuse of substances (alcohol, illicit or prescribed medications) such that the patient is unable to provide informed consent or reliably complete any of the study assessments.
* Psychiatric Disease: History of a psychiatric illness that may impair the patient's ability to provide informed consent or complete any of the study assessments.
* Nausea verbal rating score (VRS): A VRS nausea score \> 3 (scale 0-10) in the preoperative holding area before pretreatment with the study medications.
The Effectiveness of Supported Employment for People With Severe Mental Illness: an RCT in Six European Countries

The primary aim of the study was to determine the effectiveness of a form of supported employment, Individual Placement and Support (IPS) compared to existing good quality rehabilitation and vocational services for people with psychotic illnesses in terms of 'open' employment outcomes (in the competitive labour market), and to examine its relative effectiveness in the context of different European welfare systems and labour markets. The primary hypothesis was that IPS patients would be more likely to obtain open employment than control service patients. Secondary hypotheses were that they would be in open employment for longer than the control patients, and that they would not spend more time in hospital.

An RCT was conducted in six European centres: London (UK), Ulm-Guenzburg (Germany), Rimini (Italy), Zurich (Switzerland), Groningen (the Netherlands) and Sofia (Bulgaria). Patients were included if they had a diagnosis of SMI (psychotic illness including bipolar disorder), were aged 18 to retirement age, had been ill and had major role dysfunction for at least two years, were living in the community at baseline, had not been in competitive employment in the preceding year and expressed the desire to enter competitive employment. They were randomly allocated to receive either IPS or the 'Vocational Service' (control service). Given the need to consider the impact of gender and work history on vocational outcomes (20), service allocation was stratified by centre, gender and work history (more or less than a month's competitive employment in the five years prior to baseline). Randomisation was conducted centrally using MINIM Version 1.5. A researcher at each centre recruited the patients, submitted them to the statistician for randomisation and received the allocation by email. The allocation sequence was concealed until the services had been assigned, but it was not possible for patients, professionals or researchers to be blind to service allocation thereafter.

Eligibility Criteria:
Inclusion Criteria:

* pscychotic illness of at least a years duration
* unemployed for at least a year

Exclusion Criteria:

-
Improving Adherence to Postpartum Family Planning Guidance in Ghana

Evaluating a Postpartum Family Planning Package (PPFP) in a Hybrid Type II implementation study with a stepped-wedge design.

Our overarching goal is to enable providers to consistently offer and deliver highly effective postpartum family planning methods in accordance with international guidelines. Our primary objective in this research is to assess the implementation and effectiveness of the "Postpartum Family Planning Package (PFPP)," an implementation strategy that consists of the following components: 1) a provider training on contraceptive methods available in the immediate postpartum period, and techniques for their placement in the case of intrauterine devices and implants, with quarterly booster trainings, and 2) promotion of the WHO MEC/Postpartum Family Planning Compendium mobile application as a provider decision tool to aid in postpartum family planning counselling.

Eligibility Criteria:
Provider Inclusion Criteria:

* Providers who care for postpartum women on the inpatient postpartum ward, including midwives, nurses, residents, fellows, and consultant physicians.

Provider Exclusion Criteria:

* Students caring for postpartum patients on the postpartum ward.

Client Inclusion Criteria:

- Women receiving antenatal care who have the potential to be admitted to the inpatient postpartum ward following delivery, or women admitted in the postpartum ward.

Client Exclusion Criteria:

- None
Clinical Trial of Gene Therapy for Leber Congenital Amaurosis Caused by RPE65 Mutations

The purpose of this clinical trial is to examine the safety of gene therapy for Lebers Congenital Amaurosis (LCA) caused by RPE65 mutations using a recombinant adeno-associated virus serotype 2 (rAAV2) vector carrying the human RPE65 (hRPE65) gene. Recently, three independent short-term gene therapy studies in humans with LCA due to RPE65 mutations were published, suggesting that subretinal delivery of rAAV virus carrying the RPE65 gene is safe. As a secondary outcome, improvement in visual function was observed in seven of the first nine treated patients. The proposed study is a similar open label, Phase I clinical trial of uniocular subretinal rAAV2-hRPE65 administration to individuals with RPE65-associated retinal disease. Two cohorts of three subjects each and one cohort of four subjects will be included in this trial. Cohort 1 and 2 will consist of individuals 18 years of age and older and Cohorts 3 will consist of individuals 8 years of age and older. In cohort 2, a larger volume of vector will be administered. Enrollment in Cohort 3 will begin only after confirming the safety of rAAV2-hRPE65 administration in the older group of participants.


Eligibility Criteria:
Inclusion Criteria:

* Retinal disease caused by homozygous or compound heterozygote RPE65 mutations;
* Clinical diagnosis of Leber congenital amaurosis (LCA) with severely impaired visual and retinal function, and best corrected visual acuity of 20/50 or worse in the study eye;
* Ability to perform tests of visual and retinal function;
* Good general health;
* Ability to comply with research procedures;
* Specific for Cohort 1 and 2: 18 years of age and older;
* Specific for Cohort 3: Over 8 years of age;

Exclusion Criteria:

* Immune deficiency or use of immunosuppressive medications;
* Pre-existing eye conditions that would preclude the planned surgery or interfere with the interpretation of study endpoints (for example, glaucoma or ocular media opacities);
* Complicating systemic diseases;
* Impaired coagulation or use of anti-platelet agents within 7 days prior to study agent administration;
* Pregnancy or breastfeeding;
* Individuals (males and females) of childbearing potential who are unwilling to use effective contraception for 1 year following agent administration and barrier contraception for 3 months following agent administration;
* Any other condition that would prevent a subject from completing follow-up examinations during the course of the study;
* Any other condition that, in the opinion of the investigator, makes the subject unsuitable for the study;
* Current or recent participation in any other research protocol involving investigational agents or therapies, including recent (within past 6 months) receipt of an investigational biologic therapeutic agent.

Subjects will not be excluded based on their gender, race or ethnicity.
Surgery for Locally Advanced Colon Cancer: is it Worth it? A Multicenter Retrospective Analysis.

The aim of the present study is to assess the post-operative outcomes (morbidity and mortality) in relation to preoperative data and the oncological outcomes (overall and disease-free survival) in patients with a locally advanced colon cancer (LACC) with the necessity of a multivisceral resection (MVR).

All patients that meet the inclusion criteria will be registered in a retrospective database from 2014 to 2019 (5 years) Data will be reported for every patients with colon cancer to have had either a resection of another organ or structure in addition to resection of the primary tumor, or to have had a T4 (a or b) tumour on postoperative histopathology.

Data included are patient demographics, ASA score, tumor localization, preoperative imaging, neoadjuvant treatments, type of bowel resection and adjacent organs resected, tecnique (laparoscopic/laparotomic), postoperative complications and 30-day mortality, histopathology data including TNM scoring, completeness of surgical procedure (R0 to R2) and infiltration of tumor cells in resected tissues, adjuvant oncological treatments, and long term follow-up data on local and distant recurrence and survival.

Eligibility Criteria:
Inclusion criteria

* \> 18 aa
* Patients with a locally advanced colon cancer (LACC) with the necessity of a multivisceral resection (MVR).

Exclusion criteria

* Stage IV
* Rectal cancer
* Emergency surgery (\<48 hours from admission)
* ASA \> III
Preemptive Pharmacogenomics Testing Among Geriatric Patients

The primary goal of this study is to conduct pharmacogenomics testing (a type of DNA test) within an aging population and measure the impact of this test on medication selection, dosing, healthcare utilization, and costs of care.

Pharmacogenomics is the study of how a patient's unique DNA may interact with medications that the patient currently takes or may take in the future. DNA may change how a patient reacts to a medication, such as changing how well it works or the side effects. Knowing a patient's DNA profile may help healthcare professionals select the best medication treatment plan to use. This could include selecting the best medication to give or the medication strength that will work best for the patient. Currently, there is no standard that helps healthcare professionals decide to order a pharmacogenomics test that includes multiple genes. The investigators of this study think that having these DNA results in the medical record for participants who are at least 65 years old and are taking 5 or more medications will result in better health since healthcare professionals may use these results for treatment planning. Knowing if this is true will help healthcare professionals decide if ordering this test will improve patient health.

This study seeks to recruit participants for a pharmacogenomic study who visit at Geisinger 65 Forward locations. Patients who meet the study requirements and consent to be enrolled in this study will be randomly put into a group that receives this pharmacogenomics test or a group that does not receive it. There is a 50% chance of being put in the group that receives this pharmacogenomics test. The investigators will follow all patients enrolled in this study as they visit with their healthcare providers in the future. Geisinger healthcare professionals will have access to the results of this test in the medical record.

Eligibility Criteria:
Inclusion Criteria:

* Follows at a Geisinger 65 Forward clinic location
* Active prescriptions for 5 or more medications

Exclusion Criteria:

* Liver transplantation
* Allogenic hematopoetic stem cell transplantation
* Previously enrolled in the Electronic Medical Records and Genomics (eMERGE) pharmacogenomics cohort
Copeptin After Arginine Infusion in Polyuria-Polydipsia Syndrome

the purpose of the study is to investigate whether arginine infusion is a new tool to differentiate patients with diabetes insipidus, primary polydipsia and healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Age over 18 years
2. No medication except hormonal contraception

Exclusion Criteria:

1. Evidence of any acute illness
2. Subjects refusing or unable to give written informed consent
3. Pregnancy
4. Any evidence of disordered drinking habits and diuresis