cyrilzakka/clinical-trials huggingface dataset:
An Extension Study of a Second Course of a Digital Therapeutic for the Treatment of Experiential Negative Symptoms of Schizophrenia

The purpose of the proposed an open label extension (OLE) study is to evaluate the maintained efficacy and safety of a second consecutive course of Click Therapeutics Study App as an adjunct treatment to standard of care (SOC) in participants who were on the Study App and have recently completed the Click Therapeutics Randomized Clinical Trial NCT05838625.

Click Therapeutics Study App is an interactive, software-based intervention for experiential negative symptoms of schizophrenia.

The purpose of the proposed OLE study is to evaluate the maintained efficacy and safety of a second consecutive course of Click Therapeutics Study App as an adjunct treatment to standard of care (SOC) in participants who were on the Study App and have recently completed the Click Therapeutics Randomized Clinical Trial.

Eligibility Criteria:
Inclusion Criteria:

A participant will be eligible for entry into the study if all the following criteria are met:

* Completed participation in NCT05838625 study within 7 days of the extension study Baseline Visit (Day 1).
* Is the sole user of an iPhone with an iPhone operating system (iOS) 14 or greater or a smartphone with an Android operating system (OS) 10 or greater and is willing to download and use the specified Study App required by the protocol.
* Is willing and able to receive SMS text messages and push messages on their smartphone.
* It is the owner of, and has regular access to, an email address.
* Has regular access to the Internet via cellular data plan and/or wi-fi.
* Had stable housing during NCT05838625, with no anticipated housing changes during the duration of this study.

Exclusion Criteria:

A participant will not be eligible for study entry if any of the following criteria are met:

* Has not completed the Week 16 Visit (Day 112) in the NCT05838625 study.
* Has a positive urine drug screening or participant self-reports use of synthetic cathinones (bath salts), synthetic cannabinoids (K2, Spice), inhalants, amphetamines (including MDMA/ecstasy), phencyclidine (PCP), cocaine, opiates, benzodiazepines, barbiturates, hallucinogens, or parenteral drugs. Participants with a positive urine drug test and/or recreational use of THC will not be excluded from the study at the discretion of the investigator. Participants with a positive urine drug screen (UDS) or self-report who have a valid prescription for barbiturates, benzodiazepines, or opiates will not be excluded from the study at the discretion of the investigator.
* Has suicidal ideation or behavior, as assessed by the C-SSRS:

  1. Participants with a "yes" response to either Items 4 or 5 on the C-SSRS Suicidal Ideation Item during the NCT05838625 study.
  2. Participants with a "yes" response on the C-SSRS Suicidal Behavior Items within the last 6 months (26 weeks) prior to or at the Baseline Visit
* Participants who, in the opinion of the investigator, present a serious risk of suicide.
A First-in-human Dose-escalation and Expansion Study With the Antibody-drug Conjugate SYD1875

This is the first-in-human study with SYD1875, an antibody-drug conjugate (ADC) comprising of a humanized IgG1 monoclonal antibody directed against the 5T4 oncofetal antigen covalently conjugated to a duocarmycin-based linker-drug. This study includes a dose-escalation part (Part 1) in which the maximum tolerated dose (MTD) and recommended dose for expansion (RDE) will be determined, and an expansion part (Part 2) to evaluate efficacy and safety in specific patient cohorts.

Cancer cells can have different kinds of proteins on their cell surface; one of these is the oncofetal antigen 5T4. 5T4 plays an important role in the development of cancer. Currently no drugs are available that work via the 5T4 antigen.

The new cancer drug SYD1875 is being developed by Byondis B.V. SYD1875 is an antibody-drug conjugate and consists of two parts: an antibody and a linker-drug moiety containing a toxin. The antibody part binds to 5T4 on the surface of the cancer cell. When SYD1875 binds to this cancer cell, it will be internalized by the cell. After proteolytic cleavage of the linker, the toxin will be split off in the cell and the cancer cell will be killed. Thus, SYD1875 can be considered as a form of targeted chemotherapy.

This is the first study in which SYD1875 is administered to humans. The study consists of two parts:

Part 1 is the dose-escalation part in which a low dose of SYD1875 is given to cancer patients. If it is well tolerated, a higher dose of SYD1875 will be given to other cancer patients until the maximum tolerated dose is reached.

In Part 2 of the study, groups of patients with a specific type of cancer will receive the SYD1875 dose which has been selected for further evaluation.

All patients from both parts of the study will receive SYD1875 infusions every three weeks until progression of the cancer or unacceptable toxicity develops.

Eligibility Criteria:
Main Inclusion Criteria:

* Patient with histologically-confirmed, locally advanced or metastatic cancer who has progressed on standard therapy or for whom no standard therapy exists, with the following restriction:
* Part 1: solid tumours of any origin
* Part 2: three patient cohorts
* Tumour 5T4 membrane staining according protocol
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1;
* Adequate organ function
* For Part 2: measurable disease

Main Exclusion Criteria:

* Having been treated with:

  1. 5T4-targeting therapy at any time
  2. Trastuzumab duocarmazine (SYD985) at any time
  3. Other anticancer therapy within 4 weeks or as defined in the protocol
  4. Hormone therapy within 1 week
* History or presence of keratitis, clinically significant renal disease, lung disease, or cardiovascular disease as specified in the protocol
* Symptomatic brain metastases, brain metastases requiring steroids or treatment for brain metastases within 8 weeks
Cardiovascular Changes and Changes in Tissue Oxygenation During Early Postoperative Mobilization in Total Hip Arthroplasty (THA) Patients

The purpose of this study is to investigate the cardiovascular changes during early postoperative mobilization of hip arthroplasty patients.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Primary THA

Exclusion Criteria:

* Alcoholism
* Known orthostatic hypotension
* Daily use of anxiolytic medication
Antibody Responses to Pneumococcal Vaccines Among HIV-Infected Adults.

Streptococcus pneumoniae is the major cause of bacterial infection in HIV-infected patients. The current pneumococcal vaccine is poorly efficacious in patients with a CD4 cell count lower than 500/mm3. This study will test the efficacy and safety of a new pneumococcal vaccine strategy in patients with a CD4 cell count between 200 and 500/mm3.

Streptococcus pneumoniae (SP) is the major cause of bacterial infection in HIV-infected patients. The 23-valent pneumococcal polysaccharide (PPV) is poorly immunogenic in patients with CD4 below 500 cells/mm3. The purpose of this multicentric national study is to evaluate whether a prime with a 7-valent pneumococcal conjugate vaccine (PCV), able to induce immunological memory, would improve immunogenicity against SP polysaccharides. 212 HIV-1 infected patients, with a CD4 count between 200 and 500/mm3, will be randomly assigned to one of two vaccine groups: PCV at Week 0 followed by PPV at Week 4 or PPV alone at Week 4. Evaluation will be done at week 8. The primary endpoint is the proportion of patients who had antibody responses against 7 pneumococcal polysaccharides at Week 8. Secondary endpoints include the persistence of antibody responses at Weeks 24 and 96, vaccines safety and occurrence of pneumococcal disease over time.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with proven HIV-1 infection
* Naïve or antiretroviral experienced
* CD4 cell count between 200 and 500/mm3
* Plasma HIV RNA load lower than 4 log10 copies/mL
* Signed written informed consent

Exclusion Criteria:

* Immunotherapy
* Immunization with the PPV within the past 5 years
* Splenectomy
* Use of intravenous immunoglobulin within the past 2 months
* Chemotherapy or radiation
* Any other vaccination within the past 2 months
* Severe renal failure
* End-stage liver disease
* Pregnancy
Clinical Study to Assess the Efficacy and Safety of G238 Compared to Clotrimazole Otic Solution in the Treatment of Otomycosis

The purpose of this study is to evaluate the safety and efficacy of G238 for the treatment of otomycosis


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older.
* Clinical diagnosis of otomycosis where topical treatment is indicated.

Exclusion Criteria:

* Other ear diseases.
Based-virtual Reality Diagnosis for Neuropsychiatric Diseases and Sleep/Wake Disorders

The objective of this research is to develop original virtual reality scenarios and/or new virtual reality equipments to evaluate or diagnose pathologies, such as attention deficit disorders or neuropsychiatric pathologies, addiction, anxiety or depression or pathologies interfering with sleep/wake disorders.

Nature of the trial: without direct individual benefit study conducted in healthy volunteers, patients with attention disorders : ADHD (Attention Deficit Disorder / Hyperactivity) and cognitive aging, addictive disorders, anxiety disorders, depressive disorders or pathologies that interfere with sleep/wake cycle. The duration of the study is 8 years.

Type of trial: Comparison of two parallel groups of healthy volunteers and patients with attention disorders, addictive, anxious, depressive or interfering with sleep/wake cycle.

Study design:

* standardized clinical interview with a sleep specialist, psychiatrist, or psychologist and rating scales,
* a virtual reality task. The primary outcome is to evaluate the diagnosis accuracy and the acceptability of the virtual tool to the referent standard (clinical interview and scales).

The secondary outcomes are:

* The comparison of healthy subjects and patients performances
* Tolerance, acceptability to exposure to virtual scenarios.

Eligibility Criteria:
Inclusion Criteria:

* Being aged between 7 and 75 years
* Having signed written informed consent

Exclusion Criteria:

* Having participated to a clinical trial in the previous 3 months
Real-World Study of DLBCL With Different Genetic Subtypes

To collect and evaluate the data of real-world treatment regimen, efficacy, safety and survival information of DLBCL patients with different genetic suptypes

DLBCL is a highly common malignant tumor in Asia. The aim of the study is to observe and explore the clinical information on DLBCL patients with different genetic subtypes and to analyze the clinical characteristics and prognosis of different molecular subtypes of DLBCL. This study is a non-interventional real world, observational study and all registered data are collected from real clinical practice cases. The medical data includes patient demographic, tumor characteristics, laboratory examination, history of treatments, adverse reactions, efficacy results and possible prognostic factors. The results can guide future precision therapy for DLBCL.

Eligibility Criteria:
Inclusion Criteria:

* Histologically-confirmed diffuse large B-cell lymphoma (DLBCL)
* Genetic subtype belonging to at least one of the seven subtypes by using next generation sequencing: MCD, BN2, N1, ST2, A53, EZB (MYC+, MYC-) and others
* Fully comprehension and signature of the informed consent form (ICF) for participation

Exclusion Criteria:

* Those who refuse to use reliable methods of contraception during pregnancy, lactation or age-appropriate period
* Severe mental illness
* Patients deemed unsuitable for inclusion by the investigator
Clinical Significance of Marginal Acute Inflammation for Stage II Colon Cancer

Marginal acute inflammation would make reporting the serosal involvement of tumors controversial. We aimed to investigate the clinical significance and explore the prognostic value of MAI for stage II localized colon cancer.


Eligibility Criteria:
Inclusion Criteria:

* (1) colon cancer patients with the preoperative staging of stage I-III who lacked distant metastasis; (2) patients who underwent radical resection, with postoperative pathology confirmed as pT3-4N0M0; and (3) complete follow-up information

Exclusion Criteria:

* (1) patients who received neo-adjuvant therapy; (2) patients with multiple primary colorectal cancer; and (3) patients with a history of malignant tumors
Propranolol Administration and Prevention of Child PTSD in Child Trauma Victims

Twenty-nine pediatric injury patients (ages 10-18) at risk for PTSD were randomly assigned to receive either propranolol or placebo in a double-blind placebo controlled design. Medication was initiated within 12 hours of hospital admission. At 6-weeks, child PTSD symptoms and heart rate (HR) during trauma recall were assessed. We hypothesized that participants who received propranolol would report fewer PTSD symptoms and have lower heart rates than those who received placebo.


Eligibility Criteria:
Inclusion Criteria:

* Participants consisted of 15 male and 14 female accidental injury patients aged 10-18 recruited from the emergency department of Akron Children's Hospital. - Eligibility criteria included a Glasgow Coma Scale (GCS) score of 14 or greater (to permit informed consent) and an "at-risk" child score on the STEPP (Winston, Kassam-Adams, Garcia-Espana, Ittenbach, \& Cnaan, 2003), a screen for risk of PTSD.

Exclusion Criteria:

* Medication-specific exclusion criteria included hypersensitivity to beta-blockers
* Bradycardia
* Cardiogenic or hypovolemic shock
* Diabetes
* Preexisting heart condition; OR
* Treatment for asthma within the year prior to study entry (per Lacy, Armstrong, Goldman, \& Lance, 2002).
* Children were also excluded if they received epinephrine during emergency care or if they sustained any injuries precluding initiation of the propranolol regimen within 12 hours post-trauma.
Immersive Virtual Reality for Chronic Neuropathic Pain After Spinal Cord Injury: A Feasibility Trial

The aim of this study is to provide critical information about the efficacy of Immersive Virtual Reality (IVR) to decrease the experience of neuropathic pain in the upper and lower extremities of people with a spinal cord injury.

When a spinal cord injury occurs, the spinal somatosensory circuit is thought to generate aberrant nociceptive impulses that the brain interprets as pain. Neuropathic pain (NP) affects 40 to 70% of people with SCI and is a very disabling clinical condition. Many treatment options have been offered, but provide limited effects, leaving people with SCI with a reduced quality of life. The study team believes that Immersive Virtual Reality (IVR) neurorehabilitation has the potential to be an effective treatment for chronic neuropathic pain. For this reason, the objective of this study is to evaluate the feasibility of using a virtual reality device to decrease chronic neuropathic pain in individuals with spinal cord injury.

Eligibility Criteria:
Inclusion Criteria:

* Spinal cord injury survivors (chronic only)
* Presence of neuropathic pain at or below SCI level for at least 6 months following trauma or disease of the spinal cord
* A pain intensity of at least 2 out of 10 in the numerical pain rating scale (NPRS) test at baseline
* Stable pharmacological treatment for at least 4 weeks prior to the study and throughout the trial

Exclusion Criteria:

* Psychiatric or other neurological disorders (Participants will not be excluded for having a SCI, if they score 0-30 points on the BDI, or if they report having anxiety)
* Head injuries causing cognitive or visual impairment
* Severe vertigo
Optimal ECMO Flow in the Critical Phase of Cardiogenic Shock to Optimize Peripheral Organ Perfusion and Myocardial Stress

Veno-arterial ECMO (VA ECMO) is considered the ultimate lifesaving technique in refractory cardiogenic shock (CS). However, VA ECMO is associated with potentially serious adverse effects and complications. Many authors have demonstrated that VA ECMO increases left ventricular (LV) afterload, leading to increased LV stress, left ventricular end-diastolic pressure (LVEDP), and left atrial pressure (LAP). This pressure increase frequently results in pulmonary oedema and higher myocardial oxygen consumption. These complications are critical to patient survival and myocardial recovery and can lead to prolonged hospital stays and increased healthcare costs.

In the absence of clinical studies and strong recommendations, the optimized management of VA ECMO in clinical practice involves finding an ECMO flow that balances adequate organ perfusion with preserved ventricular ejection, while minimizing LV stress. Since the optimal flow changes with myocardial recovery, ramp tests are regularly performed to adjust ECMO flow.

To date, the optimized management of VA ECMO has been guided empirically. The aim of this study is to describe the consequences of variations in VA ECMO flow during the critical phase of cardiogenic shock on peripheral organ perfusion and LV stress. By analyzing the relationships between VA ECMO flow rate, peripheral perfusion, and myocardial stress, investigators aim to optimize flow settings-particularly by minimizing the potential complications of VA ECMO.

During the daily ramp tests, investigators plan to collect hemodynamic data (cardiac output, SvO₂, pulse pressure, EtCO₂, vasopressor and inotrope dosing), echocardiographic measurements, and organ perfusion indicators (NIRSS, CO₂ gap, respiratory quotient, lactate levels). Data will be collected on Day 1 (ECMO initiation), Day 2 (24 hours after ECMO initiation), and Day 3 (48 hours after ECMO initiation).


Eligibility Criteria:
Inclusion Criteria:

* cardiogenic shock
* treated with VA ECMO for less than 48hours

Exclusion Criteria:

* ECMO initiated for refractory cardiac arrest
* Cardiac arres prior to the cardiogenic shock with Low-Flow \> 30 min
* Noradrenaline dose \> 1μg/kg/min, vasopressin dose \> 2IU/h, dobutamine dose \> 15μg/kg/min, adrenaline dose \> 1μg/kg/min, or unstabilized vasopressors or inotropes
* Post-cardiotomy cardiogenic shock
* Septic shock
* Left ventricular unloading by Impella (CP/5) or atrioseptostomy
* Atrial septal defect
* Ventricular septal defect
* Pregnant or breast-feeding women
* Patients protected by law (under guardianship or curatorship),
* Patient participating in another research study with an exclusion period still in progress
* Opposition to participation after having been informed
* Patient not affiliated to any health care system
* Patient unable to express non-opposition without available trusted person
Study on Pre-menopausal Patients With Advanced ER and PR + BC Treated With Arimidex Plus Zoladex

The purpose of this study is to determine the efficacy and tolerance of the association of two drugs already marketed and used to treat your disease: Arimidex® 1 Mg per day per os and Zoladex® 3,6 Mg in injections under cutaneous once per month in subjects with breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent, premenopausal women 18 years or older, histologically or cytologically confirmed locally advanced or metastatic breast cancer, suitable for endocrine treatment, no curative treatment available,, one or more measurable lesions, life expectancy more than 6 months, normal biological parameters.

Exclusion Criteria:

* Presence of life-threatening metastases, previous endocrine therapy or chemotherapy for advanced or metastatic disease, any previous treatment with hormone (LH-RH) severe or uncontrolled systemic disease, pituitary adenoma, High risk of medullar compression.
Continuous Glucose Monitoring (CGM) After Surgical Variations of the Roux-en-y Gastric Bypass

This study evaluates the difference in post prandial tissue glucose levels between two variation of Roux-en-Y Gastric bypass by continuous glucose monitoring.


Eligibility Criteria:
Inclusion Criteria:

1. Patients who underwent bariatric-metabolic surgery at the Medical University of Vienna in the years 2012-2016 for the "long and narrow" pouch group
2. Patients who underwent bariatric-metabolic surgery at the Clinic of Hollabrunn in the years 2010- 2012 for the "short and wide" pouch group
3. Patients on oral medication for diabetes mellitus (for subgroup assessment)
4. Stable weight (not more than + 15kg from lowest weight postoperatively)
5. Stable BMI

Exclusion Criteria:

1. Unable to give written informed consent
2. Patients with methods other than RYGB
3. Reoperation within the observed period
4. Any intervention changing pouch size or diameter of the anastomosis after the initial operation
5. Known allergy to oral contrast agent
6. Any regular intake of medication interfering with blood glucose levels
Skin Disease in Methamphetamine Abuse

1. To detect the skin diseases in patients using methamphetamine

Methamphetamine is a stimulant drug that associated with a broad spectrum of health conditions, include addiction, mental health disorders, and overdose. The Drug Enforcement Agency (DEA) classifies it as a Schedule II drug. This means that the drug has a high potential for misuse. The drug is also called crystal meth, ice, and blue.

Methamphetamine use has increased in Egypt especially in upper Egypt. Literature on cutaneous manifestations among methamphetamine users is limited, although cellulitis, delusion of parasitosis (DOP), hyperhidrosis, formication and prurigo nodularis (PN) have been attributed to methamphetamine users. While the relationship between skin lesions and substance use in not fully defined, there is some evidence that points to the development of these itchy, red lesion also known as meth sore after meth use. Meth sores often look like small round red patches on your skin, they can often be confused with acne when they appear on the face or a rash when they appear on other parts of the body.

Meth sores form as a result of heavy meth misuse. other signs of meth abuse at the stage where sores likely to develop include:

* Weight loss
* Paranoia
* Hallucinations
* Aggressive behavior
* Being easily distracted
* Tooth and gum decay
* Changes in brain structure

Eligibility Criteria:
Inclusion Criteria:

* Patients using methamphetamine

Exclusion Criteria:

* 1. Pregnant and lactating patients. 2. Patients with chronic diseases
IMPlementation of gUideLines for the Management of Arterial hypertenSION. The IMPULSION Study

The objective of this protocol is to improve awareness, treatment, and control of arterial hypertension, within primary prevention of target organ damage, by implementing guidelines, after training of the participating physicians.

Physicians from 20 hospitals and 40 health centres (primary health care settings) were trained to implement guidelines in treating arterial hypertension.

There will be a baseline recording of patients with arterial hypertension and then physicians will have to complete a one page form (by ticking pre-specified boxes) about the baseline status of the patients and will have to report the measures they took to improve awareness, treatment, and effective control of arterial hypertension. After a six month effort, physicians will have to complete the same form at study completion. Previous training of physicians and the fact that they will have to report their success in treating hypertension will hopefully contribute to an increase in number of hypertensive patients at blood pressure target, and will minimise the target organ damage. The estimated reduction in coronary heart disease risk will be evaluated by a comparison of this risk (as evaluated by a risk engine, i.e. PROCAM) at study completion with that of baseline.

Eligibility Criteria:
Inclusion Criteria:

* Arterial hypertension as defined by the JNC 7 report

Exclusion Criteria:

* Pregnancy
* Lactation
* Malignancies with small life expectancy
* Unwillingness to participate