cyrilzakka/clinical-trials huggingface dataset:
Efficacity of Cognitive Remediation Treatment Compared to a Controlled Group in Young Patient With Anorexia Nervosa

The aim of research is to test in a randomized clinical trial with active sessions, the efficacy of cognitive remediation therapy in children anorexia nervosa compared to a controlled group. The investigators want to confirm the efficacy of cognitive remediation treatment in children's flexibility problems.

In this research, the investigators want to evaluate remediation cognitive therapy in anorexia nervosa compared to a controlled group (relaxation) based on different factors that testified the cognitive improvement of patients: one week after therapy, six months after and one year after.

Those factors are:

Weight, perfectionism and food symptomatology, temperament, therapeutic alliance and change motivation, clinical evolution of anorexia nervosa, self esteem, executive functions, neuropsychological performance (flexibility and central coherence).

Eligibility Criteria:
Inclusion Criteria:

* Pathology

  * DSM IV criteria of restrictive anorexia nervosa (AN- R), but not requiring amenorrhea or DSM V
  * Accepting and their parents to participate in the study ( signed consents )
* Topics

  * Female supported for AN- R
  * Aged 8 to 16 years
  * Fluent French
  * Inpatients or outpatients suffering of restrictive anorexia nervosa
* Treatments

  * Supports standard load ( family psychotherapy , dietary management , medical monitoring )
  * In case of anxiety or depression , patients may receive additional psychotropic prescription which should be mentioned in the record
  * Treatments previously followed by patients and treatments for other conditions should be described

Exclusion Criteria:

* Pathology

  * Mental Retardation
  * Schizophrenia
  * Organic brain disorder ( encephalitis , degenerative brain tumor , cerebral neuro- degenerative disease , multiple sclerosis , amyotrophic lateral sclerosis, epilepsy )
  * Metabolic Pathology interfere with feeding or its regulation
  * Trouble consumption current substance
  * Severe somatic pathology , progressive or likely to be life -threatening
* Topics The subjects are not mastering the French language will not be considered

  * Subjects or parents do not have sufficient capacity for understanding instructions and consent
  * No affiliation in social security ( beneficiary or legal )
Report of the Survival Outcomes of Patients With Esophageal Cancer After Definitive Radiotherapy in China

In this study, data of esophageal cancer patients undergoing definitive radiotherapy in 14 institutions from various provinces in China were evaluated to help strengthen confidence in anti-cancer, including rehabilitation, economic burden, and quality of life.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with esophageal cancer who received definitive radiotherapy (radiotherapy dose ≥50Gy) from 2015 to 2016
2. Age ≥ 18
3. The radiation field included primary esophageal tumor with or without lymph node metastasis

Exclusion Criteria:

1. Radiotherapy dose \< 50Gy
2. Palliative radiotherapy
3. The radiation field are metastatic areas, such as bone, brain, adrenal gland, isolated metastatic lymph nodes, etc
Efficacy and Safety of QGE031versus Placebo and Omalizumab in Patients Aged 18-75 Years With Asthma

This study assessed the effect on asthma control of different dose levels and regimens of QGE031 in asthma patients that are inadequately controlled with inhaled steroid and beta-2 agonist medication. Safety was assessed also. Comparison was to placebo and omalizumab. Information from this study was planned to support the design of future studies.


Eligibility Criteria:
Key Inclusion Criteria:

* A diagnosis of allergic asthma , uncontrolled on current medication.
* History of at least 1 asthma exacerbation during the last 1 year
* Forced Expiratory Volume in one second (FEV1) of ≥ 40% and ≤ 80% of the predicted normal value; reversibility following administration of bronchodilator must also be demonstrated (historical positive reversibility or bronchoprovocation result can be used).

Key Exclusion Criteria:

* Baseline IgE levels or body weight outside the omalizumab dosing table.
* Use of tobacco products within the previous 6 months (Social occasional smokers may be included).
* Recent asthma attack/exacerbation or asthma worsening/ respiratory infection.
Retrospective Comparison of the Efficacy of Methotrexate and Azathioprine as Background Treatment for Uveitis of Undetermined Origin: Single-centre Retrospective Study From 2005 to 2020

Retrospective study at the Brest universitary hospital to evaluate the efficacy of methotrexate (MTX) and azathioprine (AZA) in background treatment of unidentified non anterior uveitis.

Uveitis is a major cause of ocular damage, responsible for 5 to 10% of blindness in the world. More broadly, up to 35% of patients with uveitis have visual acuity impairment ranging from "significant" to "legal blindness" \[4\]. The figures of "legal blindness" up to 25% according to the studies

The objective of any anti-inflammatory therapy strategy for uveitis is to:

* Quickly control eye inflammation to minimize irreversible structural damage and maintain visual function.
* Prevent inflammatory recurrences, which cause complications and co-morbidity.
* Limit the use of systemic corticosteroids over the course of their deleterious metabolic effects.
* Optimize the risk-benefit balance and promote compliance.

The studies concerning uveitis linked with another disease are multiple and are therefore well documented. Uveitis of undetermined origin is classified, by definition, as uveitis of non-infectious origin.

Anterior uveitis are available for local treatment prior to any discussion of introducing systemic treatment. Intermediate uveitis, posterior and panuveitis justify systemic treatment.

Systemic treatments used in these uveitis are METHOTREXATE, AZATHIOPRINE, MYCOPHENOLATE MOFETIL CICLOSPORINE, INTERFERON ALPHA, anti-TNF alpha. Antimetabolites (azathioprine, mycophenolate mofetil and methotrexate) are the most commonly used immunosuppressants.

Several randomized studies (retrospective or prospective) compared the use of METHOTREXATE (MTX) and MYCOPHENOLATE MOFETIL (MMF), in the management of non-infectious inflammatory ocular disease as a corticosteroid-sparing treatment.

Although MMF has a faster response time compared to MTX for inflammation control, the success rate is equivalent. These studies found no superiority of one molecule over the other .

There are no studies in the literature comparing the use of MTX versus AZA in treatment of these non-prior uveitis of undetermined origin. These two molecules are frequently used in our center as first-line treatment of idiopathic uveitis in an undifferentiated way.

The objective of this study is therefore to determine whether one of these molecules should be preferred for the management of our patients.

Eligibility Criteria:
Inclusion Criteria:

* Patient age\>18 years
* Intermediate, posterior or panuveitis diagnosed clinically by an ophthalmologist.
* Patient treated with azathioprine or methotrexate

Exclusion Criteria:

* Patient under legal protection
* Methotrexate dose \< 10mg or azathioprine \< 50mg
* Systemic or ophthalmological disease (Behçet, sarcoidosis, Retinopathy of Birdshot, etc.)
* Infectious uveitis
* Ophthalmological surgery \< 30 days
* Delayed corticosteroid ocular implant \> 3 months
* Introduction of biotherapy simultaneously or prior to immunosuppressive treatment
Study To Evaluate 24 Hour Blood Sugar Control (24-hour Mean Weighted Glucose) In Subjects That Are Taking Saxagliptin 5 mg Added Onto Metformin XR 1500 XR mg Compared To Subjects Taking Metformin XR 1500 mg Up-titrated To Metformin XR 2000 mg

The purpose of this study was to compare effect of Saxagliptin as add-on to Metformin on 24-hour mean weighted glucose (MWG) to the effect of uptitrating Metformin in subjects with T2DM inadequately controlled on metformin alone.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* 18-78 years of age
* Taking stable dose of metformin immediate release (IR) or XR ≥850 mg and ≤1500 mg as monotherapy for at least 8 weeks prior to screening
* Glycosylated hemoglobin A1C (A1C) 7.5-11.5% at screening
* Fasting C-peptide: ≥1.0 ng/mL
* FPG≥126 mg/dl obtained at the Day -7 visit
* Body mass index (BMI): ≤ 40kg/m²
* A1C ≥ 7.0% and ≤ 11.0% obtained at the Day -7 visit for randomization

Exclusion Criteria:

* Women of childbearing potential unable or unwilling to use acceptable birth control
* Women who are pregnant or breastfeeding
* Significant cardiovascular history
* Active liver disease
* Renal impairment
Detecting Minimal Residual Diseases (MRD) and Monitoring Clonal Evolution Using Ultrasensitive Chromosomal Aberrations Detection (UCAD) in Multiple Myeloma

The presence of minimal residual disease (MRD) is an important prognostic factor for multiple myeloma, while copy number variation (CNV) is a widely accepted biomarker used for multiple myeloma (MM). Detecting MRD and monitoring clonal evolution by monitoring CNV using low-pass whole genome sequencing is promising due to its high analytical sensitivity. To evaluate the correlation between MRD detected by flow cytometry and low-pass whole genome sequencing, nearly 200 samples were collected for this study. We applied ultrasensitive chromosomal aberrations detection to detect CNV for each patient. The follow-up samples were then collected and sequencing used the same method.


Eligibility Criteria:
Inclusion Criteria:

* Subjects diagnosed with MM.
* With available baseline and sequential next-generation flow-MRD data.

Exclusion Criteria:

* Subjects without baseline and sequential next-generation flow-MRD data.
Headache After Coil Embolization for Unruptured Intracranial Aneurysms

Perform a prospective cohort study to compare the incidence and severity of headache between non-stent assisted coiling and stent assisted coiling of unruptured intracranial aneurysms.

severity of headache - assess with visual analogue scale characteristics of headache after stent deployment or simple coiling Duration of headache after intervention

Eligibility Criteria:
Inclusion Criteria:

* patients with unruptured intracranial aneurysms
* patients over 20 years old
* patients who can communicate with each other
* patients who agreed to this study (with informed consent)

Exclusion Criteria:

* patients with recurrent aneurysms after coiling or clipping
* patients with allergic reaction to antiplatelets
* patients with high risks of hemorrhage
* patients with coagulopathy
* patients with thrombocytopenia (\<100,000/mm3)
* patients with liver disease (\> 100 of aspartate aminotransferase or alanine aminotransferase)
* patients with renal disease (\> 2mg/dL of serum creatinine)\\
* patients with uncontrolled heart failure or angina
* patients with malignant tumor
* pregnant patients
* patients with past history that may associated with headache, including subarachnoid hemorrhage, head trauma, intracerebral hemorrhage, trigeminal neuralgia, arteriovenous malformation, brain tumor)
* Patients who are determined to be disqualified by researchers
A Single Arm, Tolerability and Safety Phase IV Study of Fulvestrant(Faslodex® ) as 2nd Line and Later Therapy in Postmenopausal Women With Locally Advanced or Metastatic Breast Cancer

This single-arm study aims to assess the safety and tolerability profile of Fulvestrant(Faslodex®) as 2nd line and later therapy in postmenopausal women with locally advanced or metastatic breast cancer. The primary objective is to evaluate the adverse events after Fulvestrant (Faslodex®) for about 6 months

This study is a Phase 4, single-arm, safety and tolerability study of fulvestrant (Faslodex®) as 2nd line therapy in postmenopausal women with locally advanced or metastatic breast cancer.

All of enrolled patients in this study will be injected fulvestrant (Faslodex®). This study will be performed for about 3 years and approximately 100 patients(actual target will be 80 treated patients) will be enrolled in about 10 investigational sites.

After obtaining the written informed consent from the patients, the information of demographic and medical history will be collected and laboratory tests will be performed.

Patients who meet the inclusion/exclusion criteria will be injected the fulvestrant (Faslodex®) 500mg/month for about 6 months with an additional 500mg dose given 14 days after the initial dose injection. The information of adverse events will be collected after the 1st dose of IP injection. In case that the evaluation of tumor response might be performed in regular clinical practice, those data will also be collected as well. The quality of life will also be measured.

Eligibility Criteria:
Inclusion Criteria:

* Post menopausal status women
* Outpatient or inpatient with locally advanced or metastatic breast cancer who have failed with prior anti-estrogen therapy.
* Estrogen receptor positive
* Radiographic progression of disease after the prior therapy
* Patients who agree to participate in this study and sign the informed consent

Exclusion Criteria:

* Patients who are treated with fulvestrant
* Patients who are being treated with the other antitumor agents
* Pregnancy or lactating women
* History of hypersensitivity to any of included ingredients (eg. Castor oil)
* Patients who are considered not fit for the study by investigators
* Patients who have severe dysfunction of liver or kidney
Radiographic Stability of Hip Prosthesis Prior to Revision Surgery

The goal of this validation study is to compare the preoperative implant stability, assessed by Implant Movement Analysis (IMA), provocation dual CT scans, with the intraoperative stability evaluation in revision hip arthoplasty. The main question it aims to answer is:

Does IMA reflect the intraoperative clinical evaluation of implant stability? Participants scheduled for revision hip arthoplasty will undergo IMA preoperativelly in addition to rutine clinical work up. During revision arthoplasty, a surgeon blinded to the IMA results will assess clinically the stability of the hip prosthesis. IMA will be compared with the intraoperative findings to assess IMAs sensitivity and specificity


Eligibility Criteria:
Inclusion criteria: 600 consecutive patients scheduled for revision THA due to aseptic loosening, in whom, one component has no convincing loosening signs, based on the preoperative plain radiographs and clinical assessment by the attending surgeon. The radiographs should be not older than 8 weeks prior to surgery.

Exclusion criteria:

Both cup and stem have been preoperatively evaluated as loose by the attending surgeon, based on the preoperative plain radiographs.

Instability with repeating dislocation of the THA Non-aseptic revision surgery, based on preoperative work up. Participants are excluded after inclusion if revision surgery is cancelled.
Familial Hypercolerstremia as Risk Factor in Stemi Patient Who Underwent Ppci

Famulial hypercolerstremia as risk factor

Familial hypercolerestremia ad risk factor in stemi patient who underwent Ppci

Eligibility Criteria:
Inclusion Criteria:

-all patient that underwent Ppci

Exclusion Criteria:

* Previous ischemic patient
* Patient with raised renal chemistry
* Patient for CABG
Effects of Weight Loss on Vascular Function in Obese Subjects

To evaluate the effect of weight loss on vascular function in obese with poor cardiovascular health. The investigators will evaluate the effects of weight loss on total and central body adiposity, blood pressure, central hemodynamic parameters, arterial stiffness, endothelial function, apnea-hypopnea index, insulin resistance and inflammatory markers.

Excessive adipose tissue is associated with adverse metabolic effects and is an important risk factor for chronic diseases. According to the American Heart Association, most cardiovascular events can be prevented by adhering to healthy practices, reflecting cardiovascular health as poor, intermediate, and ideal. Methods: Both sexes, aged between 40 and 70 years, with body mass index ≥ 30 and \< 40 kg/m² will be included and clinical, anthropometric, body composition and laboratory tests will be assessed. In vascular tests, the investigators will evaluate the sympathetic tone using a frequency meter (Polar® RS800), oscillometric pulse wave analysis by Mobil-O-Grah®, post-occlusive microvascular reactivity and carotid ultrasound to measure intimamedia thickness. In the sleep study, the investigators will analyze the presence and degree of obstructive sleep apnea (OSA) through the home polysomnography device (WatchPAT 200®). The first visit will be for screening, clinical and anthropometric evaluation. On the second visit, the vascular tests, instructions and device delivery for sleep study will be performed. Patients will return the following day to return the WatchPAT and to receive the hypocaloric nutritional intervention (800kcal reduction of daily total energy value), which should be followed for 16 weeks. Eight weeks after the beginning of the nutritional intervention a new visit will be scheduled for clinical, nutritional assessment and dietary adjustment. After completing 16 weeks, the patients will return for clinical, laboratory, nutritional, vascular and sleep tests.

Eligibility Criteria:
Inclusion Criteria:

* Patients of both sexes;
* Age between 40 and 70 years;
* Body mass index (BMI) ≥ 30 kg/m² and \<40 kg/m².

Exclusion Criteria:

* Systolic blood pressure ≥ 160 and/or diastolic blood pressure ≥ 100 mmHg;
* Diabetes mellitus; Hormone replacement therapy;
* Evidence of secondary hypertension;
* Clinically evident changes in thyroid function;
* Acute or chronic kidney or liver disease;
* History of cancer in the last 5 years;
* Clinically evident coronary disease with a history of acute myocardial infarction and/or myocardial revascularization, clinical signs of heart failure, cardiac arrhythmia or clinically significant valve disease;
* Previous stroke;
3D Foot Scanner Reliability for Footwear Fit and Design

The investigators will carry out a proof-of-concept study in 20 adult healthy male and female volunteers in order to: assess a 3D foot scanner's reliability. Specifically, the investigators will assess its variability during repeated foot scans of the same subject's foot. Three repeated foot scans will be carried out by two different examiners to measure intrarater and interrater reliability (Intraclass Correlation Coefficient

Evidence of reliability is essential for use of a 3D foot scanner in diabetes footwear fit evaluation and orthopaedic footwear design. The investigators will carry out a proof-of-concept study in 20 healthy adult male and female volunteers in order to: assess the 3D foot scanner's reliability. Specifically, the investigators will assess its variability during three repeated foot scans of the same subject's foot. Three half weightbearing foot scans will be carried out by two different examiners to measure intrarater and interrater reliability (Intraclass Correlation Coefficient).

The investigators will carry out a proof-of-concept study in 20 healthy adult male and female volunteers (10 each) in order to assess the Elinvision 3D foot scanner's (i) intra-rater reliability through repeated foot scans (3 times each) and (ii) inter-rater reliability of these scans as carried out by two independent examiners whilst participants are half weightbearing to establish adequate reliability (0.80+ ICC) for use in subsequent diabetes footwear fit assessment and orthopaedic footwear design and manufacture.

Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women aged 18 years or over
* Able to walk unaided
* Able to walk up steps (the 3D scanner requires a small step on to the device to enter the correct position for measurement)
* Willingness and capacity to participate in the study and to sign the informed consent form

Exclusion Criteria:

* Diabetes mellitus diagnosis
* Inability to ambulate independently without walking aids
* No obvious foot deformities
* No history of foot surgery
* No pain, injuries or medical conditions affecting the legs or lower back
* Any issues around balance (participants must remain standing in position for the approximately fifteen seconds required to obtain the 3D scan of their feet)
* Health conditions that impact foot morphology
Non-Invasive Plasma Treatment for Cervical Infections: Targeting High- and Low-Risk HPV Variants

This is a prospective, single-center, observational proof-of-principle clinical trial at the Department of Women's Health of the University Hospital Tübingen.

The aim of this study is to investigate the HPV (Human papillomavirus)-eradicating efficacy of NIPP (non-invasive physical plasma) in patients with confirmed HPV infection but without cervical dysplasia. Another objective is to examine cellular/molecular/immunological effects of NIPP on the cervix through molecular biological methods following in-vivo treatment. Tissue samples will be obtained at defined intervals via minibiopsy, and analyses will be conducted using molecular biological, histological, and microscopic methods, potentially in collaboration with other research institutes.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria for NIPP treatment

  * Age ≥ 18 years
  * mRNA or DNA-based virus detection by smear (also external findings)
  * Clearly visible transformation zone of the cervix and margins of the lesions corresponding to T1/T2
  * Written informed consent to participate in the study
* Inclusion criteria for control group

  * Age ≥ 18 years
  * Swab-based mRNA or DNA-based virus detection (also external findings)
  * Clearly visible transformation zone of the cervix corresponding to T1/T2
  * Written informed consent to participate in the study

Exclusion criteria:

The following exclusion criteria apply to both groups of patients (NIPP treatment and control group).

* Transformation zone not fully visible
* Evidence of invasive disease
* Serious cardiovascular diseases
Feasibility of Lifestyle Intervention in BRCA1/2 Mutation Carriers

BRCA1/2 mutation carriers have a considerably increased risk to develop breast and ovarian cancer during their lifetime. There is evidence from the literature that for sporadic breast cancer disease risk and the course of disease can be significantly influenced by physical activity, nutrition and weight. The hypothesis of this 3 year, prospective randomized multicenter feasibility trial is that a structured life-style intervention program with exercise training and mediterranean diet is feasible and improves the nutritional and fitness status as well as the weight, the quality of life and stress reacting capacity.


Eligibility Criteria:
Inclusion Criteria:

* women with proven pathogenic BRCA1/2 mutation

Exclusion Criteria:

* metastatic tumor disease
* life expectancy \<3 years
* clinically limiting cardiovascular or respiratory disease
* significant orthopedic disability which prevents from participating in the exercise training
* severe concomitant disease which prevents from participating in the group interventions
* Karnofsky index \<60
* VO2max \>150%
* Maximal exercise capacity \< 50 W
* food allergies which prevent from mediterranean diet
* vegan diet
* body mass index \<15 kg/m2
* pregnancy
* insufficient knowledge of German language
* insufficient compliance
* active participation in other interventional trials
* no informed consent