cyrilzakka/clinical-trials huggingface dataset:
Group Treatment for PTSD: A Randomized Clinical Trial With Veterans

The purpose of this study is to examine whether group cognitive behavioral treatment (GCBT) is efficacious in the treatment of PTSD in a sample of male Veterans. Veterans with a primary diagnosis of chronic PTSD will be randomly assigned to either GCBT or a supportive group treatment condition. Both treatments will consist of 14, weekly sessions. Assessment of PTSD and related symptoms will be conducted at pre-treatment, mid treatment, post-treatment, and 3-, 6-, - and 12-month follow-up.

The mental health needs of Veterans within the VA Healthcare system are notable. With the substantial increase over the past 10 years in Veterans seeking Posttraumatic Stress Disorder (PTSD) treatment services, the VA system is straining to accommodate these needs, relying heavily on group-based treatments. The proposed research will take the next step in the literature on group psychotherapy for PTSD by examining a group cognitive behavioral treatment (GCBT) program with promising pilot data. This application supports a randomized controlled trial, which will compare GCBT with Supportive Group Psychotherapy (SGP). The trial will involve 196 male Veterans with combat-related PTSD who will be randomly assigned to GCBT (n= 98) or SGP (n =98) to determine efficacy within a naturalistic care environment. Outcome data will be collected pre-treatment, mid-treatment, post-treatment, and 3-, 6- and 12-month follow-up. Two aims are included, one focusing on outcome with respect to PTSD symptom severity, the second focusing on treatment generalization to comorbid emotional disorders (major depressive disorder, generalized anxiety disorder, and alcohol abuse), and distress and impairment. Data will be examined using latent growth curve modeling, with emphasis on determining efficacy and effectiveness. The information provided by the proposed project could assist in developing more effective care models for individuals with chronic PTSD from numerous traumatic experiences. Additionally, this project represents an effort to move the literature on group-based treatments for PTSD ahead, through inclusion of advanced methodological and analytic approaches.

Eligibility Criteria:
Inclusion Criteria:

* primary diagnosis of DSM-IV (American Psychiatric Association, 2000) criteria for chronic, PTSD (symptoms lasting 3 months or more)
* male, Veteran
* be free of psychosis and impaired cognitive function caused by traumatic brain injury or dementia

Exclusion Criteria:

* a current diagnosis of substance dependence or unstable bipolar disorder
* currently involved in psychosocial treatment for PTSD
A Phase 2 Study to Evaluate Biomarker Change, Efficacy, Pharmacokinetics, Safety and Tolerability of Telacebec (Q203) in Covid-19 Patients

This is a Phase 2, open-label, randomized controlled trial to determine the effects of Telacebec (Q203) on inhibition of leukotriene production, clinical change, pharmacokinetics, and safety in participants with moderate COVID-19 disease


Eligibility Criteria:
Inclusion Criteria:

1. Provide written, informed consent prior to all study-related procedures.
2. Provide written, informed consent to undergo Human Immunodeficiency Virus (HIV) testing.
3. Willingness and ability to attend scheduled visits and undergo study assessments.
4. Able and willing to measure their oxygen saturation level and temperature, record their COVID-19 symptoms and complete a patient diary.
5. Male or female aged 18 years or older.
6. Confirmed and documented SARS-CoV-2 infection, defined as RT-PCR laboratory confirmation.
7. Clinical and/or radiological findings indicative of moderate COVID-19 disease

Exclusion Criteria:

1. Severe or critical COVID-19 disease at enrollment (Day 1) (per NIH Treatment Guideline categorization) as determined by the Investigator.
2. Inability to swallow oral medication.
3. Concurrent known asthma, active tuberculosis or tuberculosis within the last 3 months, or any other condition that could compromise the well-being of the participant, or prevent, limit or confound protocol specified assessments, in the opinion of the Investigator.
4. Female Participant who is pregnant, breast-feeding, or planning to conceive a child within the anticipated period of participating in the study or within 6 months after last dose of study medication. Males planning to conceive a child during the study or within 6 months of cessation of treatment.
Effect of Citrus Flavonoids on Obesity.

The aim of this study is to evaluate whether the intake of a functional juice enriched in citrus polymethoxylated flavonoids is able to improve the glycaemic profile and insulin resistance of obese patients by reversing the associated oxidative and inflammatory stress, as well as the differential alteration of the intestinal microbiota. To achieve this, a prospective, randomised, double-blind, placebo- controlled, clinical-baseline intervention study will be conducted in obese patients (BMI=30-40 kg/m2) with type 2 diabetes (DM2) (n=40) and obese patients without alterations in carbohydrate metabolism (n=40). Each of these groups will be randomly divided into 2 subgroups (n=20), one of which will receive polymethoxyflavonoid-enriched orange juice (14%: nobiletin, sinensetin, tangeretin) (200 ml/ day) and the other group will receive the corresponding placebo juice for 8 weeks. In addition, all of them will receive a hypocaloric diet. Anthropometric parameters, body composition and nutritional status will be assessed, cardiovascular risk factors and comorbidities will be studied (HT, SAHS, dyslipidaemia, insulin resistance), oxidative stress parameters will be compared (total and mitochondrial ROS production, mitochondrial membrane potential, glutathione levels by static cytometry and mitochondrial respiration rate by Seahorse flow analyser), antioxidant enzymes (SOD, GPx) and molecular oxidation products (Carbonyl proteins and 8-oxo-dG, LDLox) and LPS by ELISA techniques, inflammatory parameters (IL6, TNFa, IL1b, adiponectin, PAI-1, IL10) by Luminex XMAP technology in serum. Metabolomic analysis will also be performed in plasma (NMR spectroscopy and PLS-DA), and the content and diversity of the gut microbiota (16S rRNA amplicons, and direct metagenomic sequencing, with Illumina MiSeq technology) will be assessed in faeces, before and after the dietary intervention. Individualised dietary follow-up and assessment of subjects' quality of life will be carried out.


Eligibility Criteria:
Inclusion Criteria:

* patients with a BMI of 30 -40 kg/m2, between 18 and 65 years of age.
* Obesity of more than five years' duration
* Patients will maintain a stable weight (±2 kg) during the 3 months prior to the study.

Exclusion Criteria:

* Patients with acute or chronic inflammatory diseases and established liver and kidney failure (based on transaminase levels ±2 SD of the mean and estimated glomerular filtration rate using the CKD-EPI formula \>60), neoplastic diseases and secondary causes of obesity (hypothyroidism, Cushing's syndrome), use of drugs that may influence inflammatory status or insulin sensitivity (NSAIDs, corticosteroids, anti-TNFα), treatment with insulin or GLP1 inhibitors, type 1 diabetes, morbid obesity (BMI\>40 kg/m2), hypertriglyceridaemia (\> 400 mg/dl), fructose intolerance.
A Study of the Use of Chartis System to Optimize Subject Selection for Endobronchial Lung Volume Reduction (ELVR)

Use of the Chartis® Assessment System prior to EBV Treatment

This is a multi-center study which will enroll up to 120 patients. Subjects will undergo a Chartis Assessment prior to EBV treatment. The Chartis assessment will determine the presence or absence of collateral ventilation, a potential determining factor in the success of EBV therapy. This study is not randomized; all subjects are eligible to receive EBV Treatment, regardless of Chartis Assessment outcome. Follow-up data will only be collected on those patients that meet the Chartis inclusion criteria.

Eligibility Criteria:
Inclusion Criteria:

* Heterogeneous emphysema
* Able to obtain a Chartis value during Assessment

Exclusion Criteria:

* Any co-existing major medical problems that would not make it possible for the subject to tolerate a bronchoscopic procedure.
Effect of a Phosphate Modified Diet on Phosphate Balance and Phosphate Metabolism in Predialysis Patients Stage 3-4

Patients with chronic kidney disease struggle to eliminate phosphate as the renal function deteriorates, which results in accumulation of phosphate in the body. This has been shown to increase the patients' risk of cardiovascular disease and death. Even with dialysis treatment the patients cannot excrete enough phosphate to reach phosphate balance. The patients are therefore recommended a very restrictive diet when they reach the dialysis stage. It is therefore important to find ways to prevent such accumulation of phosphate in the body as early in the disease process as possible, but without compromising the nutritional status. Because phosphate occurs naturally in many of our foods, such as meat, fish and dairy products, it is difficult to reduce the intake of phosphate, without also reducing the intake of energy and protein. Over the past couple of years there has been an increased focus on the use of phosphate containing additives in the food industry. A reduction in the intake of phosphorus containing additives may reduce the accumulation of phosphate in the body. This can be achieved by decreasing the intake of processed food products. Because it is also very time consuming and inconvenient for the patient to keep these strict diets, the patients have a reasonable claim to know which effects can be achieved by such diets. This will therefore seek to be further explored in the following study. The study is conducted as a randomised crossover trial in predialysis patients stage 3-4.


Eligibility Criteria:
Inclusion Criteria:

* Patients \> 18 years.
* Diagnosed with Chronic Kidney Disease stage 3-4 (GFR 15-59 ml / min)
* p-phosphate between 0.85 mmol / L (2.7 mg / dL) and 1.50 mmol / L (4.7 mg / dl)
* Read and understand Danish
* Have received oral and written information about the study
* Signed informed consent form

Exclusion Criteria:

* Diagnosed hyperphosphatemia
* Diagnosed hyperparathyroidism
* Treatment with phosphate binders
* Dysphagia
* Diagnosed with decreased absorption capacity in the intestine
* Co-morbidities in liver, pancreas or lungs
* Dementia
* Pregnancy / breastfeeding
* Embedded within the last 4 weeks
* Kidney transplant
* Terminal patients
Evaluation of Cardiovascular Risk After Preeclampsia in General Practitioners and Patients

Pre-eclampsia is a disease characterized by placental damage leading to a cascade of complications during pregnancy. It is initially manifested by high blood pressure and the presence of albumin in the urine. It can lead to emergency hospitalization in severe cases and cause major complications or even death in the mother and the fetus.

Several studies observing the outcome of patients with pre-eclampsia have shown an increased long-term cardiovascular risk in these patients, justifying regular medical follow-up with the treating physician and specialists, mainly cardiologists.

The main objective of this research is to describe the cardiovascular risk assessment actions implemented by the treating general practitioner in the year following pre-eclampsia (blood pressure measurement in the office, self-measurement of blood pressure, ABPM, cardiological consultation, biological monitoring of blood (creatininemia, LDL, fasting glycemia) or urine (albuminurie/creatininurie ratio), and screening and management of possible smoking).


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years hospitalized for preeclampsia at the Nancy regional maternity hospital

Exclusion Criteria:

* Fetal death in utero;
* Adult Person subject to a legal protection measure (guardianship, curatorship, safeguard of justice);
* Person deprived of liberty by a judicial or administrative decision;
* Person subject to psychiatric care under constraint by virtue of articles L. 3212-1 and L. 3213-1 of the Public Health Code.
B Cell Repertoires in Chronic Lymphocytic Leukemia and Aging

B-CLL is the most prevalent leukemia in the Western hemisphere, accounting for \~25% of all leukemia's (1). This disease occurs virtually exclusively in the aging population, with the median age of diagnosis ranging between the mid 60s and the early 70s. Indeed, its occurrence before the age of 50 is quite unusual. This increase in occurrence with age is not unique to B-CLL; rather, it is characteristic several B cell lymphoproliferative disorders (e.g., non-Hodgkin's lymphoma, multiple myeloma). Gender and race also influence the development of B-CLL. Thus, the ratio of men: women is \~2:1 and the prevalence is increased in Caucasians. The rate of occurrence of B-CLL among Asians is significantly lower than for Caucasians and this does not increase with immigration to the West. DNA sequence analyses performed in our laboratory and in those of others indicate that B-CLL cells from unrelated patients share Ig V gene characteristics. These include the use of selected genes, the association of these genes with certain D and JH gene segments that code for unique CDR3 motifs, and the occasional occurrence of highly similar VHDJH + VLJL pairs. In \~50% cases, these rearranged genes are mutated, whereas in the others mutations are infrequent; this difference is related to the VH gene family used by the B-CLL cell.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age Patients must be willing to be contacted in the future

Exclusion Criteria:

* Patients who are known to be anemic, with a hemoglobin \<8 PAtients who are known to be infected with HIV
Decision Aid to Facilitate Shared Decision Making During Treatment in Schizophrenia

We hypothesize that the use of a visual decision aid tool to educate patients regarding potential harm with respect to weight gain with olanzapine versus perphenazine can lead to better shared decision making by patients, increase rates of antipsychotic switches and promote weight loss in overweight patients with schizophrenia/schizoaffective disorder.

Our specific aims are the following:

1. To investigate the effects of a visual decision aid, versus care as usual, on patients' perceived difficulties in medical decision making regarding switching antipsychotics in overweight veterans with schizophrenia or schizoaffective disorder.
2. To investigate the effects of a visual decision aid and a shared decision making model on rate of medication switches (from olanzapine to perphenazine) in overweight veterans with schizophrenia or schizoaffective disorder.
3. To investigate the effects of a visual decision making aid and shared decision making model on BMI in overweight veterans who switch from olanzapine to perphenazine therapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients with diagnosis of Schizophrenia or Schizoaffective Disorder as per by their medical record diagnosis.
* Patients currently on olanzapine therapy and BMI \>29.9.
* Patients treated with olanzapine for greater than or equal to 3 months prior to enrollment.
* Patient would be required to have either attempted dietary, lifestyles modifications and/or participated in weight loss programs.
* Patients with no history of psychiatric hospitalizations in past six months and judged by treating clinician to be suitable for antipsychotic medication switch.
* Patients with adequate decisional capacity to make a choice about participating in this research study.
* Patients, who are able to comprehend and satisfactorily comply with protocol requirements and have an ability to read and write English.
* Patients, who signed the written consent given prior to entering any study procedure.

Exclusion Criteria:

* Patients with a history of treatment resistant schizophrenia or past trials with clozapine.
* Patients with a concurrent DSM-IV diagnosis of PTSD as per their medical record.
* Substance Dependence or Abuse (excluding nicotine) within one month prior to the screening visit.
* Patients with a history of non-response, intolerance or hypersensitivity ot perphenazine.
* Subjects with history of treatment of clozapine.
* Patients who based on history of mental status examination have a significant risk of committing suicide.
* Patients who are homicidal or violent and who are in the Investigator's opinion in significant imminent risk of hurting others.
* Female patients who are pregnant, planning to become pregnant, or if of childbearing potential, not using an acceptable method of birth control.
* Patient currently receiving depot neuroleptics.
* Patients with visual impairments.
Pharmacokinetic Study of Milrinone in Babies With Persistent Pulmonary Hypertension of the Newborn

The purpose of this pilot study is to determine a safe dose of milrinone to use in a larger study of babies with persistent pulmonary hypertension of the newborn (PPHN).

Persistent pulmonary hypertension of the newborn (PPHN) is a condition in which the pulmonary vasculature fails to relax after birth resulting in severe hypoxemia. This condition has a high rate of mortality and morbidity. The current standard of care is treatment with inhaled nitric oxide (iNO). However, for many babies this treatment does not provide sufficient improvement in oxygenation.

In this study, subjects already receiving nitric oxide will be randomized to one of two dosing regimens of milrinone. They will receive milrinone IV for 24 hours and will be monitored for 24 hours afterwards. During this time, milrinone assays will be performed by blood sampling. Echocardiograms will also be performed to explore the pharmacodynamics of milrinone. Safety monitoring will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Gestational age \> 34 weeks
* Post-natal age \< 10 days
* Hypoxemia defined by: Oxygenation Index (OI) \>15 (Mean Airway Pressure x Fraction of Inspired Oxygen (FiO2) x 100 /PaO2) as drawn from two post-ductal arterial blood gas samples (in-dwelling arterial catheter) taken at least 15 minutes apart. OR mechanically ventilated and with \>75% FiO2 for \>6 hours while on iNO
* Absence of congenital heart disease based on a two-dimensional echocardiogram and/or clinical assessment
* An in-dwelling arterial catheter to facilitate painless sampling
* Currently on iNO or plan to start iNO before enrollment

Exclusion Criteria:

* Lethal non-cardiac congenital anomalies including diaphragmatic hernia
* Clinically apparent bleeding; thrombocytopenia \<30,000 or other laboratory evidence of coagulopathy
* Currently on extracorporeal membrane oxygenation (ECMO)or plan to initiate ECMO within 2 hours of enrollment
Radiolabeled Gallium-68 (68Ga-PSMA) for PET/CT Imaging to Detect Prostate Cancer

The purpose of the study is to find out whether imaging of the prostate with a new molecule called 68Ga-PSMA can find prostate cancer. 68Ga-PSMA has been shown in a large number of patients to be useful to find recurring prostate cancer following initial cancer treatment. This study is performed to test 68Ga-PSMA whether it can be used to find prostate cancers that would be considered in need for treatment.

In this study, two different imaging tests are being compared: a) 68Ga-PSMA Positron Emission Tomography (PET)/Computed Tomography (CT) and b) Magnetic Resonance Imaging (MRI) of the prostate gland. Participants already have received the MRI, and the results were either suspicious of or definitive for prostate cancer. Both tests (MRI and 68Ga-PSMA PET/CT) are expected to show tumor tissue when more aggressive, but one test could be more accurate than the other test.

Another important question is whether these imaging tests will perform as good or better than prostate biopsies in finding all prostate cancer lesions in need for treatment. If imaging would be comparable or better than biopsies, then imaging may be able to replace invasive biopsies for some indications in the future.

To investigate these questions, participants are asked to undergo a 68Ga-PSMA PET/CT before a planned prostate biopsy procedure. After the biopsy procedure is performed, investigators will compare the imaging results from 68Ga-PSMA with those from the MRI and determine which test is more accurate.

Eligibility Criteria:
Inclusion Criteria:

* Recent MRI of the prostate has resulted in at least one lesion suspected to represent prostate cancer (reported by the Radiologist as PI-RADS 3, 4 or 5 lesion)
* Treating physician has already indicated a need for a prostate biopsy procedure.
* Known Gleason 6 or 7 prostate cancer OR rising PSA with either a) no prior biopsy or b) single or multiple negative prior biopsies.

Exclusion Criteria:

* Prostate biopsy within 12 weeks before enrollment
* Acute prostatitis within the last 6 months
* Current non-urologic bacterial infection requiring active treatment with antibiotics
* Active other malignancy (except basal cell or squamous cell skin cancer) within the last 2 years
* Body weight greater than 350 lbs (158 Kg)
* Inability or unwillingness to receive a prostate biopsy procedure
* Unable to lie flat, still, or tolerate a PET/CT scan
* Unable to provide own consent
* Concurrent severe and/or uncontrolled and/or unstable medical disease other than prostate cancer (e.g. poorly controlled diabetes, congestive heart failure, myocardial infarction within 6 months prior to study participation, unstable and uncontrolled hypertension, acute renal failure of any intensity, chronic renal or hepatic disease, severe pulmonary disease).