cyrilzakka/clinical-trials huggingface dataset:
Development of a Biomarker of Efficacy of Vedolizumab (EnTyvio®) in Patients With ulcErative ColiTis (DETECT)

The main objective of this project is to demonstrate the feasability of an endomicroscopic biomarker of efficacy of vedolizumab and adalimumab, in Ulcerative colitis (UC) by coupling vedolizumab to a fluorescent component, FITC (Fluorescein isothiocyanate) , and adalimumab to rhodamine.

This project should allow the development of a biomarker of therapeutic efficacy for vedolizumab and adalimumab that can be used in a single time-frame in vivo in humans, while respecting manufacturing standards and Good manufacturing procedures.

Patients will be recruited before initiation of vedolizumab injections. The schedule for vedolizumab infusions will corresponding to the protocol follow-up visits (Week 0, W2, W6, W14, W22), and flexible sigmoidoscopy appointments will be performed at Week 0 and 22.

For responder patients, the end of the study will occured two weeks after the last vedolizumab infusion (W24).

At week 22, nonresponder patients to vedolizumab may be treated by adalimumab in the absence of contraindication and depending on the decision of the physician responsible for the patient. Patients will be treated every two weeks during 8 weeks. The protocol follow up will end 2 weeks after the fourth adalimumab injection.

During W0 and W22, colon biopsies will be collected. Blood samples will be collected on W0, W2, W6, W14, W22 (and W30 for non responder).

Eligibility Criteria:
Inclusion Criteria:

* Patients with moderate to severe UC defined by an overall Mayo score ≥ 5 and an endoscopic sub-score ≥ 2 points and rectal bleeding score ≥ 1 point
* Extension \> 15 cm from the anal margin
* Requiring treatment with biotherapy and meeting the indications for the treatment
* Affiliated with a social security scheme

Exclusion Criteria:

* Crohn's disease or unclassified colitis
* Severe acute colitis
* Requirement for immediate surgical treatment
* Previous treatment with vedolizumab or anti-TNF-α
* Contraindication to the use of vedolizumab or an anti-TNF-α agent
* Contraindication to the use of adalimumab
* Corticosteroid therapy \> 20 mg/day
* Corticosteroid therapy started within the previous two weeks
* Conventional Immunosppressor started within the previous month
* Colonic dysplasia or known cancer
* Likelihood to refuse two rectosigmoidoscopies, performed eighteen weeks apart
* Pregnant or lactating women
Prevalence and Risk Factors Nocturnal Polyuria in Female OAB

Nocturnal polyuria may decrease the treatment efficacy of overactive bladder syndrome (OAB); and adjuvant medication, such as desmopressin, may be needed for the treatment of nocturnal polyuria. The knowledge of prevalence and risk factors of nocturnal polyuria might be important for the treatment of OAB. Thus, our aim is to describe the prevalence and risk factors of nocturnal polyuria in women with OAB.

Between July 2009 and January 2018, all women with OAB visiting a medical center for evaluation were reviewed. The classification of OAB-wet or OAB-dry is based on the record of the three-day bladder diary of each patient. The diagnosis of OAB in each patient was based on the presence of at least one episode of urgency in her three-day bladder diary and with the absence of stress urinary incontinence. The presence of at least one episode of urgency associated incontinence was defined to be OAB-wet, otherwise, OAB-dry.

Nocturnal polyuria was defined when the proportion of nighttime voided volume over 24-hour voided volume was greater than 33% for ≥65-year-old women, and when the proportion of nighttime voided volume over 24-hour voided volume was greater than 20% for \<65-year-old women.

Eligibility Criteria:
Inclusion Criteria:

1. More than 20-year-old
2. Female
3. Diagnosed with overactive bladder

Exclusion Criteria:

1. Younger than 20-year-old
2. Pregnant or planned to be pregnant
Transient Elastography to Assess Liver Fibrosis and Portal Hypertension in HCV Cirrhotic Patients Treated With New Antiviral Drugs (SPLEEN-C)

The purpose of this study is to evaluate the effects of sustained virological response in liver and spleen stiffness in patients with HCV compensated advanced chronic liver disease treated with new all oral antiviral drugs in order to determine factors implicated in stiffness change and its implications for long-term follow-up.

Prospective cohort study including consecutive patients (with baseline liver stiffness measurement ≥10 kPa who meet the Baveno VI criteria for compensated advanced chronic liver disease) who initiate treatment with new all oral antiviral drugs following current recommendations in Spain.

In all these patients the following parameters will be assessed:

* Baseline liver and spleen stiffness and CAP measurements at the time of starting therapy and then, during treatment in week 4 and week 12 (end of treatment). After finishing therapy, these measurements will be repeated at 6 and 12 months of follow-up.
* Routine lab tests, including liver enzymes and viral load, will be performed at baseline, 4 and 12 weeks of therapy, and at 3 and 6 months after finishing therapy according to standard clinical practice.
* Liver ultrasound will be performed every 6 months as a routine procedure in patients wiht liver cirrhosis.
* Patients who were known to have esophageal varices prior to therapy will be assessed with an upper endoscopy 12 months after finishing therapy if they achieve SVR.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 90 years.
* History of chronic hepatitis C infection.
* Compensated advanced chronic liver disease (Baveno VI definition):

  * Baseline liver stiffness ≥15 kPa or,
  * Baseline liver stiffness 10-15 kPa and one of the following: platelet count \<150x10e9/L, spleen size ≥13 cm, nodular liver or collateral circulation in abdominal ultrasound, HVPG \>5 mmHg, upper gastrointestinal endoscopy showing gastroesophageal varices or previous liver biopsy showing bridging fibrosis or cirrhosis.
* Indication to start antiviral treatment with new oral drugs.
* Willingness to enter the study.
* Sign the informed consent.

Exclusion Criteria:

* Chronic liver disease due to other etiology than HCV.
* Terminal illness.
* Treatment with interferon.
* Liver stiffness measurement \< 10 kPa at baseline.
Biomarker Study in Bone Marrow Samples From Patients With T-Cell Acute Lymphoblastic Leukemia

RATIONALE: Studying samples of bone marrow from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

PURPOSE: This research study is studying biomarkers in bone marrow samples from patients with T-cell acute lymphoblastic leukemia.

OBJECTIVES:

* To confirm an association between induction failure (IF) status predicted by a previously identified 116-member genomic classifier and actual induction therapy outcome observed on COG study AALL0434.
* To explore whether there is an association between early relapse (as defined by bone marrow or extramedullary relapse within 18 months of diagnosis) predicted by previously identified 5-member (primary) and 57-member (secondary) genomic classifiers, and actual relapse status at 18 months on COG study AALL0434. (Exploratory)

OUTLINE: RNA from cryopreserved bone marrow samples are analyzed for gene expression by microarray methods. Samples are then compared with the 116-member genomic classifier.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Newly diagnosed T-cell acute lymphoblastic leukemia
* Cryopreserved bone marrow from the Children Oncology Group (COG) Cell Bank of patients enrolled on COG-AALL03B1 and COG-AALL0434, including the following:

  * 30 samples from patients who had \> 25% bone marrow blasts at day 29 (induction failure \[IF\] cases)
  * Samples of cases of bone marrow and/or CNS relapse occurring within the first 18 months of treatment
  * Random samples of 105 non-IF cases who achieved remission at the end of induction therapy (at least 18 months)

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Speed-based and Mechanical Work Considered HIIT for Football Referees

Majority of the existing studies on the high intensity training of referees are heart rate-based prescription. It is probably the most commonly measured physiological marker used to control or measure exercise intensity in the field.Indeed, speed-based intensity training is more acute than heart rate-based training on the intensity of physical work performed above v/pVO2max. This study the setting of exercise intensity reference the ending velocity of the 30-15 intermittent fitness test.

This study was carried out during the 10 weeks of before the seminar which conducted before the season. The assessments were carried out pre and post training intervention in the before and after week of the intervention, it includes 30-15 intermittent fitness test(VIFT),dynamic Yo-Yo intermittent recovery test, 40m repeat speed ability test, change direction test and cooper test.The experimental group(EG) take 10 weeks Speed-based (VIFT) HIIT protocol performed on each Wednesday and Saturday, 60 min for each session. One EG with mechanical work combined in the HIIT exercises, and another EG is not. The control group during the study performed on the same occasion heart rate-based HIIT.

The TL was assessed using the 0-10-point rating perceived exertion (RPE) scale according to the procedures. With the aim to obtain more detailed information especially the muscle strain, during each occasion (i.e., training session or match) the referees should provide differentiated RPE (dRPE) for respiratory (RPEres) and leg muscle (RPEmus) exertion perception.

Eligibility Criteria:
Inclusion Criteria:

* the female referees who register as reserve national degree and above for 2022 and 2023.

Exclusion Criteria:

* Injured
* Any reason can not complete all the required training sessions.
A Study of RO4917838 (Bitopertin) in Patients With Sub-optimally Controlled Symptoms of Schizophrenia (WN25305)

This randomized, multi-center double-blind, parallel-group, placebo-controlled study will evaluate the efficacy and safety of RO4917838 (bitopertin) in patients with sub-optimally controlled symptoms of schizophrenia. Patients, on stable treatment with antipsychotics, will be randomized to receive daily oral doses of RO4917838 or matching placebo for 52 weeks, followed by an optional treatment extension for up to 3 years.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Diagnosis of schizophrenia
* Clinical stability for 16 weeks (4 months) prior to randomization
* Antipsychotic treatment stability for the past 12 weeks prior to randomization
* With the exception of clozapine, patients are on any of the available marketed atypical or typical antipsychotic (treatment with a maximum of two antipsychotics)

Exclusion Criteria:

* Has treatment resistant schizophrenia as judged by the treating physician OR have failed two trials
* Evidence that patient has clinically significant uncontrolled or unstable medical disorder (e.g. cardiovascular, renal hepatic, gastrointestinal, hematologic, immunological, neurological, endocrine, metabolic or pulmonary disease)
* Patient has a body mass index (BMI) of \<17 or \>40 kg/m2, respectively)
* Diagnosis of mental retardation or severe organic brain syndromes
* In the investigator's judgment, a significant risk of suicide or violent behavior"
Salivary Expression of SOX7 in Oral Squamous Cell Carcinoma: Diagnostic Accuracy Study

The study will include patients with oral cancer and healthy controls of both sexes. Subjects having any systemic diseases or other types of cancer will be excluded. All subjects will be selected from Oral Medicine Department, Faculty of Dentistry, Al Ahram Canadian University and Fayoum University. Informed consent will be obtained from all subjects enrolled in this study after explanation of the whole procedure.


Eligibility Criteria:
Inclusion Criteria:

* patients with oral cancer

Exclusion Criteria:

* any systemic diseases or other types of cancer will be excluded
Yhteispeli - Effectiveness Study on Promoting Childrens' Socio-emotional Skills in School

The purpose of this cluster randomised trial is to investigate whether the Yhteispeli whole school programme is effective in improving children's socio-emotional skills and mental health and socio-emotional skills.

All Finnish elementary schools and their classes in 1-3 grades were invited to participate in the study. The schools were randomly allocated to receive either Yhteispeli programme or two lectures


Eligibility Criteria:
Inclusion Criteria:

* All children from volunteering elementary schools and classes (grades 1 to 3) whose parents gave consent to participate

Exclusion Criteria:

* None
Brain Densitometric Assessment With Axial Computerized Tomography After Severe Brain Trauma.

Processing the Digital Imaging and COmmunications in Medicine (DICOM) of tomographic using Mannheim Lung Analyzing software (MALUNA®) , to obtain volumetrical and densitometric data of brain tissue after patients with severe brain trauma

Quantitative analysis of brain and structures in it, in terms of volume, weight and density, in patients with severe brain trauma, using MALUNA dedicated software to process DICOM images.

1. st endpoint: compare these data with those obtained by CT scans analysis of patients that recur to this kind of diagnostic investigation for non-traumatic events and with negative diagnostic related to cerebral pathological implication.
2. nd endpoint: relate data obtained with clinical evaluation of the patient (cerebral physiology and outcome)
3. rd endpoint: evaluate differences in terms of volume, weight and density of brain and its structures, between patients with diffuse cerebral injury and those with localized lesions.

Eligibility Criteria:
Inclusion Criteria:

* Male and female, any ethnic group
* Patient with severe brain trauma (GCS \< 8)
* Need of mechanical ventilation
* Clinical need of urgent CT study of brain.
* Need of clinical control of CT study of brain within first 72 hours from event
* Informed consent obtained from solicitor, due to the fact that patient is

Exclusion Criteria:

* Age minor than 18 yrs old at hospitalization day
* Cardiac arrest pre-hospital or in-hospital and post-anoxic coma
* Non traumatic coma
* Exaggerated ingestion of depressors of central nervous system
* Documented abuse of narcotic drugs;
* Documented abuse of alcohol
TipTraQ Home Sleep Test Study, SHH

The clinical study aims to develop and validate the TipTraQ system, created by PranaQ, a home sleep test for sleep apnea screening. The system comprises a wearable device and a cloud-based AI for estimating Total Sleep Time (TST) and Apnea-Hypopnea Index (AHI).

Sleep-disordered breathing is a common disease that affects life function and quality of life, and it also imposes a great burden on the public health system. Obstructive sleep apnea accounts for the largest proportion of sleep-disordered breathing, and because of the oriental facial structure, the prevalence of sleep-disordered breathing is relatively high. The current gold standard for diagnosis OSA is polysomnography (PSG). Although the physiological information collected by PSG is complete and detailed, it requires a considerable amount of manpower and medical resources, and changes in the sleep environment also cause bias in the accuracy of inspection. So far, the tools for simple and accurate screening and diagnosis OSA are relatively limited. In this study, TipTraQ, a wearable device developed by PranaQ, was used to collect photoplethysmography (PPG) of patients during the night of PSG inspection. The reliability and validity analysis was carried out by comparing with the corresponding indicators of PSG, and the feasibility of TipTraQ as a tool for home sleep test (HST).

Eligibility Criteria:
Inclusion Criteria:

Subjects from the age of 20 and older that have an indication for an in-lab PSG study.

Exclusion Criteria:

* Heart transplant
* Heart failure, New Youk Heart Association (NYHA) classification III or IV
* Chronic opioid medication user
* Devastating severe strokes, with the modified Rankin score (mRS)≥4
* Tracheostomy
* Incapable of comprehending and signing the informed consent and questionnaires, including but not limited to subjects with severe Alzheimer's, unconscious by head trauma, or of someone with limited mental capacity
* Cannot correctly follow the order to use the TipTraQ device
Phase 1 Study Evaluating BA3182 in Patients With Advanced Adenocarcinoma.

The objective of this study is to assess safety and efficacy of BA3182 in Advanced Adenocarcinoma

This is a multi-center, open-label, Phase 1 study designed to evaluate the safety, tolerability, PK, immunogenicity, and antitumor activity of BA3182 in patients with advanced adenocarcinoma.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed locally advanced unresectable or metastatic adenocarcinoma
* Age ≥ 18 years
* Adequate renal function
* Adequate liver function
* Adequate hematological function
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Exclusion Criteria:

* Patients must not have clinically significant cardiac disease.
* Patients must not have known non-controlled CNS metastasis.
* Patients must not have active autoimmune disease or a documented history of autoimmune disease.
* Patients must not have a history of ≥ Grade 3 allergic reactions to mAb therapy as wellas known or suspected allergy or intolerance to any agent given during this study.
* Patients must not incomplete recovery from the effects of major surgery or significant traumatic injury before the first dose of study treatment.
* Patients must not have known human immunodeficiency virus (HIV) infection, active hepatitis B and/or hepatitis C.
* Patients must not be women who are pregnant or breast feeding.
TUC3PII-01_TU2670 Phase IIa Clinical Study

This Protocol for TU2670 is to investigate the efficacy, safety, pharmacokinetics (PK), and pharmacodynamics (PD) of multiple doses of TU2670 in subjects with moderate to severe endometriosis-associated pain.

Treatment Groups and Duration:

Following a washout period of up to 12 weeks, subjects will enter a screening period of up to 12 weeks including an observation period consisting of a complete menstrual cycle.

Subjects will be randomly assigned in a 1:1:1:1 ratio to receive either 12 weeks of TU2670 320 mg QD, TU2670 240 mg QD, TU2670 120 mg QD, or matching placebo. TU2670 or a matching placebo will be administered in the clinic on Day 1. Subjects in the PK subset population will also receive the following additional doses in the clinic: Day 2 (after collection of the 24-hour PK sample); the dose on the day scheduled for subsequent serial PK sample collection (Week 4 or Week 5); and the next scheduled dose (after collection of the 24-hour PK sample). All other doses can be taken by the subject at home. Following the end of treatment, subjects will be followed up for safety for 12 weeks.

Statistical Methods:

All formal statistical tests will be done at the 5% 2-sided significance level. Point estimates will have 2 sided 95% confidence intervals (CIs) where applicable.

Where appropriate, variables will be summarized descriptively (frequency and percent will be summarized for categorical variables; n (number of available subjects), mean, standard deviation \[SD\], median, minimum, and maximum will be presented for continuous variables) by study visit and by treatment group.

Statistical summaries will be presented for the changes from baseline to each time point in efficacy endpoints that it is applicable.

Eligibility Criteria:
Inclusion Criteria:

* Independent Ethics Committee (IEC)-approved written informed consent/assent and privacy language as per national regulations must be voluntarily obtained from the subject.
* Premenopausal female subject, 18 to 45 years, inclusive
* Subject has moderate to severe endometriosis-related pain

Exclusion Criteria:

* Subject has used hormonal contraceptives or other drugs with effects on gynecological endocrinology within 12 weeks
* Subject has been nonresponsive to GnRH-agonist or antagonist therapy for the management of endometriosis.
the Impact of EECP on Intraocular Pressure

EECP therapy may affect the intraocular pressure while improving the ischemia systemic organ blood perfusion the same time. The present study investigated the impact of Enhanced Extracorporeal Counterpulsation treatment on the intraocular pressure.

Select 40 cases of patients (80eyes) who had counter pulsation treatment at Enhanced External Counter Pulsation (EECP) Specialist in First Affiliated Hospital of Sun Yat-sen University during Apr 2012 - Mar 2013. Separated the patients into 2 groups according to having glaucoma history or not.The cases whose eyes have erythralgia and who have received corneal surgery or intraocular surgery in recent one month are excluded.

Eligibility Criteria:
Inclusion Criteria:

* counter Enhanced External Counter Pulsation treatment

Exclusion Criteria:

* whose eyes have erythralgia
* who have received corneal surgery or intraocular surgery in recent one month
* Hemorrhagic disease
* Atrial fibrillation
* Aortic regurgitation
* thrombophlebitis or infection lesions
* severe hypertensive
The Effects of Anti-HIV Drugs on the HIV Virus in HIV-Infected Patients

The purpose of this study is to examine the HIV virus in the blood and lymphoid tissues of patients taking anti-HIV medications.

HIV infection is closely linked to the growth of the HIV virus in the body. Much of this information was obtained from studying how the HIV virus grows in circulating blood. Recent studies have shown that the lymphoid tissue (part of the immune system) is a major site where HIV is found in the body and is also where much of the HIV virus growth occurs. This study will examine not only blood but also lymphoid tissue to gain a better understanding of the disease and how to treat it.

The natural history and pathogenesis of HIV-1 infection are linked closely to the replication of virus in the body. Studies obtained entirely from analyses of peripheral blood led to a shift in the understanding of HIV-1 pathogenesis. Recent studies have shown that lymphoid tissues are a major reservoir for HIV and the primary site of virus replication. The proposed studies will provide the first comprehensive assessment of HIV-1 expression and lymphocyte response in both blood and lymphocyte tissue compartments. The data obtained will provide new insight into HIV-1 pathogenesis and provide a more rational basis for treatment decisions concerning early therapy of HIV-1 infection.

Patients are admitted to the hospital for insertion of an angiocath to collect blood samples periodically over 48 hours on the day study medication from the parent study is initiated. After discharge, additional blood samples are obtained over a 6-month period. Within 7 days prior to a scheduled biopsy, patients have physical examinations and laboratory evaluations done. All patients undergo some combination of the following during the 2-week prestudy evaluation period and at Weeks 4 and 24: a) superficial lymph node biopsy from cervical, axillary, or inguinal area; b) rectal biopsy; and/or c) tonsillar biopsy. The tissue samples provide an assessment of viral and cellular dynamics.

Eligibility Criteria:
Inclusion Criteria

Patients may be eligible for this study if they:

* Are at least 18 years old.
* Are participants in other University of Alabama studies.

Exclusion Criteria

Patients will not be eligible for this study if they:

* Are pregnant.
* Are receiving treatment for an AIDS-defining opportunistic infection, other than preventive treatment.