cyrilzakka/clinical-trials huggingface dataset:
Study Evaluating DVS-233 for Treatment of Outpatients With Major Depressive Disorder

To evaluate the long-term safety of desvenlafaxine sustained release (DVS-233SR) during open-label treatment of outpatients with major depressive disorder (MDD).


Eligibility Criteria:
Inclusion Criteria:

* Outpatients.
* Men and women aged 18 to 75 years.
* Women of childbearing potential must have a negative serum pregnancy test result at screening. Sexually active individuals participating in this study must use a medically acceptable form of contraception during the study and for at least 15 days after the last dose of test article.
* Subjects must have a primary diagnosis of MDD based on the criteria in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV), single or recurrent episode, without psychotic features, on study day 1. If other allowable psychiatric diagnoses are present, MDD must be the predominant psychiatric disorder present. (See Exclusion Criterion 6 for psychiatric diagnoses that are not allowable.)
* Depressive symptoms for at least 30 days before the screening visit.
* Subjects who have symptoms of depression judged by the investigator to require long-term treatment (i.e., 6 months or longer) with an antidepressant drug.

Other inclusion applies.

Exclusion Criteria:

* Treatment with DVS-233 SR at any time in the past.
* Treatment with venlafaxine (immediate release \[IR\] or extended release \[ER\]) within 90 days of study day 1.
* Known hypersensitivity to venlafaxine (IR or ER).
* Significant risk of suicide based on clinical judgment, including common suicidal thoughts, and suicide being considered as a possible solution, even without specific plans or intention.
* Women who are pregnant, breastfeeding, or planning to become pregnant during the study.
* Current (within 12 months of baseline) psychoactive substance abuse or dependence (including alcohol), manic episode, posttraumatic stress disorder, obsessive-compulsive disorder, or a lifetime diagnosis of bipolar or psychotic disorder as assessed by the modified Mini International Neuropsychiatric Interview (MINI). Current (within 12 months of baseline) generalized anxiety disorder, panic disorder, or social anxiety disorder as assessed by the modified MINI and considered by the investigator to be primary, causing a higher degree of distress or impairment than MDD. Presence (within 12 months of baseline) of a clinically important personality disorder (such as antisocial, schizotypal, histrionic, borderline, narcissistic).
* Depression associated with the presence of an organic mental disorder due to a general medical condition or a neurologic disorder.
* History of a seizure disorder other than a single childhood febrile seizure.

Other exclusion applies.
Docetaxel With a Phytochemical in Treating Patients With Hormone Independent Metastatic Prostate Cancer

RATIONALE : Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Dietary supplements, such as phytochemicals, may stop or delay the development of prostate cancer.

The purpose of this study is to assess the pathological response rate in metastatic prostate cancer patients treated by : Docetaxel with a phytochemical

Eligibility Criteria:
Inclusion Criteria:

* Age \>18
* WHO performance status 0-2
* Life expectancy ≥ 3 months
* Patients receiving androgen-suppressive therapy in the form of chirurgical castration by orchiectomy or pulpectomy,or medical by LHRH agonist or antagonist with or without anti-androgen or all treatment blocking non gonadic testosterone fraction
* Resulting to testosteronemia \<0,5 ng/ml
* Histologically confirmed adenocarcinomia of prostate cancer and documented hormone independant metastatic disease - defined by: objective progression with at least one measurable lesion and/or evaluable lesion according to RECIST criteria and /or a rise in PSA level ("rising PSA")
* Total bilirubin ≤ upper limit of normal (ULN).
* AST and ALT ≤ 1.5 times ULN. Alkaline phosphatase ≤ 2.5 times ULN.
* Serum creatinine \< 140 µmol/L or creatinine clearance \> 60 mL/ min.
* Neutrophil count \> 2.109 L-1.
* Platelet count ≥ 100,000/mm3.
* Hemoglobin ≥ 10 g/dL
* Not previous chemotherapy, except Estracyt
* No liver, kidney or heart failure link to treatment
* No malabsorption syndrome or disease significantly affecting gastrointestinal function
* Prior radiotherapies are permetted withing four weeks of the first study treatment and must be \< 25 % of the bone marrow, and all adverse events must be resolved
* Prior surgery are permitted.

Exclusion Criteria:

* Age \< 18
* History of psychiatric disorders including psychotic disorder, dementia or seizures that would prohibit the understanding, observance and giving of informed consent
* Previous or concomitant other malignancies except basal or squamous cell carcinoma of the skin or other cancer curatively treated with surgery and/or radiotherapy
* Patients should not have symptomatic brain metastasis
* Concurrent severe and/or uncontrolled co-morbid medical condition
* Malabsorption syndrome or disease significantly affecting gastro-intestinal function or major resection of the stomach, proximal small bowel or grade \> 2 dysphagia
* Patients with uncontrolled infection
* History of significant neurologic (i.e. peripheral neuropathy grade \> 2 using NCI-CTC criteria v3.0)
* Patients should not have received NSAIDs or COX2 inhibitors within the three weeks prior to starting the study
* Treatment with any investigational drug within 30 days prior to registration
* Patients should not have current regimen containing dietary phytonutrients
Bioimpedance as a Diagnostic Tool for Assessing the Need for Socket Modification in Transtibial Amputees

The purpose of the proposed study is to conduct research on individuals with lower limb amputation, evaluating if residual limb fluid volume data collected using a novel non-invasive device is beneficial towards prosthetic prescription, fit, and comfort as determined by amputee test subjects and practitioners (prosthetists). Participants' residual limb fluid volume will be monitored through bioimpedance analysis both before and after a practitioner-issued modification to the prosthesis as an observational cohort study and then as a blinded randomized control trial in which the data may or may not be shared with the practitioner before the modification is made to the prosthesis.


Eligibility Criteria:
Inclusion Criteria:

* Transtibial amputees, unilateral or bilateral
* Amputation at least 18 months prior
* Walking activity of at least 7 hours per week
* Medicare functional classification level of 2 or higher
* Residual limb length of at least 9 centimeters
* Detrimental impacts to socket fit caused by residual limb volume fluctuations
* Indication for augmented suspension, socket modification/change, sock application removal or activity modification

Exclusion Criteria:

* Incidence of skin breakdown
* Inability to ambulate continuously on a level walkway
Post Mortem Tissue Donation of Pediatric Tumor Tissues and Cells

The objective of this study is to utilize all donated pediatric tumor tissues and cells obtained from autopsy to prospectively develop novel patient derived orthotopic xenograft (PDOX) mouse models as well as in vitro cell culture model systems for pediatric cancers, and also provide tissue samples to other researchers and organizations (eg, CBTN, DIPG Registry, COG).

The objective of this study is to utilize all donated pediatric tumor tissues and cells obtained from autopsy to prospectively develop novel patient derived orthotopic xenograft (PDOX) mouse models as well as in vitro cell culture model systems for pediatric cancers, and also provide tissue samples to other researchers and organizations (eg, CBTN, DIPG Registry, COG).

This model system will then be subjected to 1) comprehensive histopathological and molecular characterizations during serial in vivo sub-transplantations; 2) cryopreserved for long term preservation of tumorigenicity; and 3) used for future biological studies and preclinical drug testing.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients with cancer and non-cancer tumor types (solid, liquid, neuro-oncology)
* Signed consent for post mortem tissue donation and autopsy

Exclusion Criteria:

* Signed consent for post mortem tissue donation and autopsy not obtained
Fovea ERM After Fovea-sparing ILM Peeling

To report cases who had received previous fovea-sparing internal limiting peeling membrane and developed secondary fovea epiretinal membrane contraction

Purpose: To report the rare complication of foveal epiretinal membrane (ERM) formation on residual internal limiting membrane (ILM) with severe contraction after previous fovea-sparing internal limiting membrane (ILM) peeling.

Study design: Retrospective case series Methods: We report patients who previously received fovea-sparing ILM peeling and complicated with foveal ERM formation and contraction.

Eligibility Criteria:
Inclusion Criteria:

* patients who developed secondary fovea epiretinal membrane after previous fovea-sparing internal limiting membrane surgery

Exclusion Criteria:

* patients who did not receive previous fovea-sparing internal limiting membrane surgery
Liposomal Cytarabine in the Treatment of Central Nervous System Resistant or Relapsed Acute Lymphoblastic Leukemia in Children

The purpose of this study is to describe the activity and toxicity of a new formulation of cytarabine called liposomal cytarabine given into the central nervous system for the treatment of central nervous system localization of acute lymphoblastic leukemia (ALL) in children and adolescents.

Liposomal cytarabine (DepoCyte) is a new formulation of the drug cytarabine, a drug commonly used in the treatment of ALL. This formulation of the drug can be given intrathecally (into the spinal fluid), and is released slowly over a longer period, about two weeks. This allows a longer exposure of the drug to the central nervous system, and requires fewer intrathecal injections for the patient.

Eligibility Criteria:
Inclusion Criteria:

* Age \< 18 years
* Diagnosis of acute lymphoblastic leukemia (ALL)
* Central nervous system involvement with malignant cells present in cerebrospinal fluid
* CNS involvement may be refractive to prior systemic therapy, a first recurrence after prior systemic and intrathecal therapy or a second recurrence
* CNS involvement may be an isolated lesion or present with other sites of disease
* ECOG performance status 0-2
* Life expectancy of at least 8 weeks
* Absence of severe organ dysfunction
* Informed consent

Exclusion Criteria:

* Eligibility for AIEOP studies of first recurrence of ALL,and receiving therapy in a center participating in the AIEOP studies
* Concurrent treatment with experimental therapies
* Severe neurologic toxicities from previous chemotherapy
* Severe coagulopathy at time of recurrence
* Sepsis
* Intrathecal therapy within 1 week of planned study therapy
* Total body or head and spine radiation within 8 weeks of enrolment
* Bone marrow transplant within 8 weeks of start of study therapy.
Validation of ClarityDX Prostate as a Reflex Test to Refine the Prediction of Clinically-significant Prostate Cancer

This study is designed to determine the accuracy of blood test ClarityDX Prostate to predict the results of prostate biopsies in men who have PSA (Prostate Specific Antigen) greater or equal to 3 ng/mL.

The main objective of this study is to validate ClarityDX Prostate as a reflex test to PSA to refine the prediction of clinically-significant prostate cancer in a prospective cohort of men to be recruited in North America when they are scheduled for a biopsy as a result of on an elevated PSA.

This prospective training and validation cohort study will consist of up to 2,800 consenting men from Alberta in addition to up to 2,500 men from external institutions, between ages 40-75 years old, without prior diagnosis of prostate cancer, who have been selected to undergo a prostate biopsy to rule out prostate cancer.

Eligibility Criteria:
Inclusion Criteria:

1. Males between 40-75 (inclusive) years of age;
2. With and without family history of prostate cancer;
3. No prior prostate cancer diagnosis and who are referred to have a prostate biopsy;
4. Total PSA results \>/= 3ng/mL collected within 6m of enrollment;
5. Willing to permit provincial agencies (e.g. Alberta Health Services, Alberta Health, Netcare, Service Alberta) to disclose health-related information to study;
6. Undergoing a diagnostic prostate biopsy; and
7. Provided informed consent to participate in the study.

Exclusion Criteria:

1. Unwilling to participate in the study;
2. Unavailable for biopsy procedure in recruitment areas;
3. Not undergoing a prostate biopsy;
4. Prior diagnosis of cancer excluding non-melanoma skin cancer; and/or
5. Under the age of 40 years of age or over the age of 75 years of age.
Evaluation of Safety of GlaxoSmithKline (GSK) Vaccines' Quadrivalent Seasonal Influenza Vaccine, Fluarix Tetra When Administered According to the Approved Prescribing Information (PI) in Korea.

The purpose of this study is to collect safety information on the use of Fluarix Tetra according to the approved PI, in Korea, over a period of 6 years from children greater than or equal to (≥)3 years of age and adults, and over a period of 4 years from children between 6 months and 35 months of age.

Adults and previously vaccinated children aged ≥6 months, a single dose of Fluarix Tetra will be administered. To previously unvaccinated children aged 6 months to less than (\<) 9 years, two doses will be administered with a second dose at least 4 weeks apart from the first one as per the local PI in Korea.

Fluarix Tetra may be administered to pregnant women/lactating women as per PI, if there is a clear need. Pregnancy outcome (whether full-term or premature, information on the status of the mother and child) in vaccinated pregnant subjects will be followed-up at 6-8 weeks after delivery, if possible.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects who were vaccinated with Fluarix Tetra or eligible to receive Fluarix Tetra according to the locally approved PI.
* Signed informed consent as Informed Consent Form (ICF)/Informed Assent Form (IAF) obtained from the subject/subject's parent(s)/Legally acceptable Representative(s) \[LAR(s)\].

Exclusion Criteria:

* Those who are not eligible for vaccination with Fluarix Tetra according to the local PI.

  * Hypersensitivity reaction to Fluarix Tetra.
  * History of hypersensitivity reaction to Influenza vaccine.
  * History of Guillain-Barre syndrome or other nervous system abnormalities to Influenza vaccine within 6 weeks post-vaccination.
* Those who are not eligible for vaccination with Fluarix Tetra according to the medical judgement of physician.
Implementation and Effectiveness of a Psychosocial Intervention Among Registered People Living With HIV(HIV Patients) at Pakistan Institute of Medical Sciences (PIMS) Islamabad Pakistan.

"Implementation and Effectiveness of a Psychosocial Intervention Among Registered PLHIV at PIMS Islamabad Pakistan." The study aims to evaluate the impact of a structured psychosocial intervention on the mental health and well-being of people living with HIV (PLHIV) registered at PIMS.

Study Highlights:

1. Participants: Registered PLHIV receiving care at PIMS.
2. Data Tools: Standardized measures (e.g., DASS-21, WHO-5 Well-Being Index).
3. Design: Randomized Control Trial (RCT) with intervention and control groups, including pre- and post-intervention assessments.
4. Ethical Approval: Approved by Pakistan Institute of Medical Sciences Pakistan Islamabad's Ethical Review Board

"Implementation and Effectiveness of a Psychosocial Intervention Among Registered PLHIV at PIMS Islamabad Pakistan" The study aims to evaluate the impact of a structured psychosocial intervention on the mental health and well-being of people living with HIV (PLHIV) registered at PIMS.

Study Highlights:

1. Participants: Registered PLHIV receiving care at PIMS.
2. Data Tools: Standardized measures (e.g., DASS-21, WHO-5 Well-Being Index).
3. Design: Randomized Control Trial (RCT) with intervention and control groups, including pre- and post-intervention assessments.
4. Ethical Approval: Approved by Pakistan Institute of Medical Sciences Pakistan Islamabad's Ethical Review Board

Eligibility Criteria:
Inclusion Criteria:•

1:PLHIV who are registered at HIV Treatment Centre at PIMS Islamabad.

* 2:PLHIV who are registered and visiting for regular follow up
* 3:Participants willing to provide written informed consent.(Acceptance or willing of participants)

Exclusion Criteria:

* 1:PLHIV who are registered, but with other co morbidities like TB, Hepatitis BC, Cardiac issues etc.
* 2:PLHIV who are registered and admitted due to severe any co morbidities.
* 3:PLHIV who are registered and are already involved in other studies
* 4:PLHIV who are registered and have history of receiving any psychosocial support or counseling before this study.
* 5:Participants not willing to provide written informed consent.(Refusal of participants).
Neurofeedback Based on Near-infrared Spectroscopy as a Therapy for Food Addiction in Obese Subjects.

The hypothesis is that the increase in dlPFC brain activity via near-infrared spectroscopy-based Neurofeedback (fNIRS-based NF) training based on near-infrared spectroscopy would allow an improvement of the eating behavior, thus promoting a long-term weight loss in obese subjects.

Patients will be trained during a month with 8 NF sessions and results based on clinical data and different questionnaires results will be compared between inclusion and 3 months later

Obesity is a disease of increasing prevalence due in part to the greater availability of fatty, sugary and/or salty foods which, when consumed chronically and in excess, can lead to food addiction.

According to the neurocognitive model of addiction, the development and maintenance of addiction is associated with deficits in cognitive control, as well as a decrease prefrontal cortex (dlPFC). Self-control in food choice situations also depends on prefrontal network with the dlPFC as a hub, strongly connected with striatal and cingulate structures.

Neurofeedback (NF) is a technique that relies on the patient's positive or negative self-regulation of brain activity. It has been shown to be effective in several pathologies, in particular attention deficit/hyperactivity disorder in young people and more recently in depression and emotion regulation.

In this study, NF will be based on near-infrared spectroscopy (fNIRS), because its use is easy mobile and inexpensive. The hypothesis is that the increase in dlPFC brain activity via fNIR-based NF training based on fNIRS would allow an improvement of the eating behavior, thus promoting a long-term weight loss in obese subjects.

Eligibility Criteria:
Inclusion Criteria:

* Eligible for obesity surgery according to the 2009 French High Authority on Health (HAS) criteria (BMI ≥40 or BMI ≥35 with comorbidities)
* Right-handed
* Presenting a food addiction determined by the YFAS 2.0 questionnaire ;
* Affiliated to a social security system;
* Having given free and informed consent in writing.

Exclusion Criteria:

* Psychotic psychiatric disorders (schizophrenic disorders and bipolar disorders);
* Psychotropic drugs, except antidepressants stabilized for at least 3 weeks and benzodiazepines
* Addiction to alcohol or other psychoactive substances (except tobacco);
* History of bariatric surgery;
* Current treatment in the nutrition unit;
* Insufficient command of French;
* Pregnant or breast-feeding woman;
* Persons of legal age under legal protection (safeguard of justice, curatorship, guardianship), persons deprived of liberty.
* Contraindications to fMRI
* Inability to perform the fNIRS procedure due to blockage or attenuation of the light at the capillary level
Pertrochanter Arthroplasty Versus Osteosynthesis

This is a single-centre, comparative, prospective randomised trial. It will include 70 patients over a period of 2 years randomized into two groups of 35 patients: one group of patients treated with osteosynthesis (plate, nail or screw) and the second group treated with total hip replacement.

The Harris and PMA functional scores will be assessed at 6 weeks, 3 months, 6 months and 1 year.

The time to recovery of weight-bearing, the subjective satisfaction score, the EQ5D quality of life questionnaire, the VAS score for pain at rest and when walking, the Parker score, the rate of complications and deaths will also be measured. Operating time, blood loss and scar size will also be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have provided written informed consent
* Patients over 18 years old
* Patients less than 70 years old
* Patient presenting with a fracture of the trochanter (type 1 to 6 according to the Ender classification, and A1 and A2 according tyo the AO classification (Association suisse pour l'étude de l'Ostéosynthèse : classification internationale)

Exclusion Criteria:

* Adult under guardianship
* Patients not covered by national health insurance
* Pregnant or breast-feeding women
* Unable to walk independently before the trauma
* Patients with dementia
Analgesic Efficacy of Ultrasound Guided Quadratus Lumborum Block During ESWL

Extracorporeal shockwave lithotripsy (ESWL) is widely used for the treatment of urinary tract calculi; however, the vast majority of patients do not tolerate the procedure without analgesia and sedation.

Lots of methods have been tried to control this pain (non-steroidal anti-inflammatory drugs, opioids, alpha 2 agonists, transversus abdominis plane block with long-acting local anesthetics, paravertebral block, local anesthetics infiltration, lidocaine/prilocaine cream).

The quadratus lumborum block was first described by Blanco. QL block is performed as one of the perioperative pain management procedures for abdominal surgery. QL block provides anesthesia and analgesia on the anterior and lateral wall of the abdomen.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologist's physiologic state I-II patients undergoing Extracorporeal Shockwave Lithotripsy

Exclusion Criteria:

* chronic pain
* bleeding disorders
* renal or hepatic insufficiency
* patients on chronic non-steroidal anti-inflammatory medications
* emergency cases
Molecular Genetics of Heterotaxy and Related Congenital Heart Defects

The goal of this study is to obtain specimens and data from individuals and their families with heterotaxy and related congenital heart defects in order to clarify the molecular genetics of this disorder. The knowledge gained from the analysis of this information will provide the basis for future genetic counseling as well as contribute to knowledge about the biology of normal and abnormal development of left-right anatomic asymmetry.

Heterotaxy syndrome is a rare birth defect that involves the heart and other organs. Many cases are genetic. Fundamental lack of information about the genetic basis of heterotaxy and related congenital heart defects in the vast majority of children has hindered management and therapy. The study outlined in this protocol is designed to obtain information about the causes of heterotaxy and related congenital heart defects. In this study, investigators will perform genetic analyses on patients with heterotaxy and related congenital heart defects, or individuals at risk for these abnormalities. The investigators will collect medical information related to symptoms and disease course. These results will provide important information on the causes, management, and prognosis of heterotaxy and related congenital heart defects.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with heterotaxy and related congenital heart defects
* Family members of subjects with heterotaxy and related congenital heart defects

Exclusion Criteria:

* Subjects without heterotaxy and related congenital heart defects
* Family members of subjects without heterotaxy and related congenital heart defects