cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate Pre- or Post-operative HYPOfractionated Radiation Therapy in Aged (≥ 70 Years Old) or "Fragile" (≥ 65 Years) Patients With Limb or Trunk Soft Tissue SARComa.

This is a phase II, multicenter, non-randomized study.

The main objective is to evaluate the treatment with hypofractionated radiation therapy in neo-adjuvant and adjuvant situations on wound healing in a population of aged patients (≥ 70 years old) or ≥ 65 years of age defined as "fragile" and treated for soft tissue sarcoma.

A maximum of 70 patients will be included in this study, divided in 2 groups (35 patients per arms): a neo-adjuvant cohort and an adjuvant cohort.

In the neo-adjuvant cohort, patients will receive an hypofractionated radiation therapy prior to surgery.

In the adjuvant cohort, patients will undergo a surgery before receive the hypofractionated radiation therapy.

Each patient will be followed for up to 3 years after the end of complete treatment (radiotherapy + surgery or surgery + radiotherapy).


Eligibility Criteria:
Inclusion Criteria:

1. Patient with histologically confirmed soft tissue sarcoma of the limbs or trunk.
2. Indication for neo-adjuvant or adjuvant radiotherapy.
3. Patient aged ≥ 70 years with a performance status ECOG ≤ 2 and/or aged 65 to 70 years with an ECOG of 2 and identified by the investigator as "fragile".
4. Patient affiliated to a Social Health Insurance in France.
5. Patient able to participate and willing to give informed consent prior performance of any study-related procedures.

Exclusion Criteria:

1. Retroperitoneal, ORL and visceral sarcomas.
2. Previous radiotherapy in the area.
3. Metastatic disease.
4. Concomitant or sequential chemotherapy.
5. Patient requiring total surgery (amputation).
6. Other cancer under treatment.
7. Any condition or pathology contraindicating MRI.
8. Any psychological, familial, geographic or social situation, potentially preventing the provision of informed consent or compliance to study procedure.
9. Patients included in another therapeutic interventional trial.
10. Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).
Temporomandibular Disorders Among Patients With Tinnitus

The incidence of temporomandibular disorders will be studied among patients with tinnitus, by the use of patient's history and physical examination.

The patients with tinnituswill be asked about symptoms related to temporomandibular disorders, and also will be examined in order to diagnose such disorders.

Eligibility Criteria:
Inclusion Criteria:

* Tinnitus lasting more than 3 months

Exclusion Criteria:

* Head and Neck Space Occupying Lesion
* Previous degenerative disease of the temporomandibular koint
Effects of Exercise Training on Functional Physical Fitness, Balance and Walking in the Community-dwelling Older Adults

This study aimed to determine whether a 12-week combined exercise intervention program with extra emphasis on balance, muscle strength, and walking ability was designed to improve functional fitness, balance, walking speed in community-dwelling older people.

1. Written informed consent must be obtained before any study specific procedures are undertaken.

2. The process of the experiment (brief describe)

1. The 30 participants of the experimental group will be recruited from the "community eldercare service" activities, and this group will receive a 12-week combined exercise intervention program with extra emphasis on balance, muscle strength, and walking ability. The other 30 community-dwelling older people of the comparison group who have been involved in a other regular exercise style will not receive our exercise intervention. The comparison group only receives 2 times measurement at an interval of 12 weeks.
2. Subjects completed medical histories, exercise histories, and information on lifestyles by questionnaire and physical examination before participation in the study to ensure they were free from exclusion criteria. The baseline measurements will be conducted before the exercise intervention.
3. The experimental group will receive a 12-week combined exercise intervention program with extra emphasis on balance, muscle strength, and walking ability which involved two 2-hour sessions per week. The exercise program contained aerobic exercises, activities of balance, coordination exercises, strength training, and walking training.
4. After 12 weeks group exercise, the experimental group will receive the second measurements.

Eligibility Criteria:
Inclusion Criteria:

* Independent in basic daily living activities
* At least one or more given assistance in the instrumental Instrumental Activities of Daily Living (IADL) scale

Exclusion Criteria:

* Diagnosis of neurological disease or heart disease
* Assessment do not suitable resistance exercise training, or cannot perform intense activity by doctor
A Global Registry on Second GEneration and Long-acting InTegrase InhibiTor FAilures

Integrase strand transfer inhibitors (INSTI) inhibit HIV replication by preventing the integration of viral HIV DNA into the host's genome. INSTIs are used as part of combination antiretroviral therapy (cART) regimens for both treatment-naive and treatment experienced patients.

In clinical practice, virological failure to second generation INSTIs is rare and often without selection of known resistance mutations. Considering the use of INSTIs in first line regimens in high income countries and the increasing roll-out in lower and middle income countries, a better understanding of relevant resistance development and clinical failure is urgently needed.

The ROSETTA registry aims at systematically collecting otherwise scattered information on individual cases failing second generation integrase inhibitors, with the goal to inform policy and future use of INSTIs in the treatment of people living with HIV.

Attending physicians of individuals who are experiencing virological failure on a second generation integrase inhibitor-containing regimen are invited to contribute data to the registry.

The ROSETTA study collects clinical data and HIV sequences from individuals experiencing failure of ART containing second generation INSTIs from Americas, Africa and Europe. If resistance testing is not available, the ROSETTA team can perform genotypic resistance testing of RT, protease, integrase and 3'-PPT.

Research objectives:

To set up a database with data of individuals who have experienced virological failure on a regimen containing a second generation INSTI To determine the prevalence of resistance mutations in integrase and 3'-PPT in the dataset To identify possible new resistance mutations outside integrase and 3'-PPT. providing additional funding is retrieved.

The study design will be a multicenter observational cohort study. Patients will be included from HIV care centers in Europe, America and Africa, if they fullfill the inclusion criteria.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed HIV-1 infection
* Using cART (any regimen) for at least the last 6 months
* Experiencing virological failure\* on a second generation INSTI-containing regimen (including monotherapy and dual-therapy regimens)
* Data on current regimen and previous INSTI exposure available (start/stop dates and dosing mandatory)
* Integrase genotypic data available (performed locally) or a plasma/DBS (or CSF if available) sample(s) drawn at time of failure available to perform genotypic testing centrally \* Virological failure is defined as at least 2 consecutive viral loads (VL) above 50 copies/mL in plasma or 1 VL above 200 copies/mL in plasma. We will also include patients who have a VL of \>50 copies/mL in CSF, independent of the VL in plasma.

Exclusion Criteria:

* Submitted fasta file not passing quality control and unavailability of a stored sample to repeat sequence analysis
* Missing Mandatory data
* Documented treatment interruption for at least 2 weeks prior to viral load testing.
User Charges for General Practitioner Services in Denmark

Currently, office visits at general practitioners is free of charge for patients. However, public commissions and the Danish Economic Council have suggested to implement user charges for services that currently is free of charge. The aim of this study is to examine the consequences of introducing user charges for general practitioner services. Data for the project will be collected from patients who have an appointment with a general practitioner. Patients will be asked whether they are willing to pay a specified amount for the consultation that they have scheduled. After the consultation, the GP register diagnoses.


Eligibility Criteria:
Inclusion Criteria:

* Patients with an appointment for a visit in a general practitioner clinic
* Reads and understand Danish

Exclusion Criteria:

-
Lyon Granulomatous Hepatitis Study

Granulomatous hepatitis are histopathologically defined by the presence of epithelioid and gigantocellular granulomas within the hepatic parenchyma. Hepatic granulomas are observed in 2 to 15% of liver biopsies. Causes of granulomatous hepatitis can be related to ethnic and environmental factors and in western countries granulomatous hepatitis are mostly related to sarcoidosis and autoimmune cholangitis. Infections (mycobacteria, coxiella burnetii, hepatitis C) and medications also provide granulomatous hepatitis.

Sarcoidosis is a systemic disease of unknown etiology, which in third of cases has a chronic course. Five percent of patients die of their disease, mainly because of respiratory distress. Hepatic involvement is most often asymptomatic or pauci-symptomatic (moderate cholestasis and conglomerates of granulomas visible on imaging). More rarely, it can cause portal hypertension and its complications and be life-threatening.

The aim of the Lyon Hepatitis Granulomatous (LHG) study is to better characterize granulomatous hepatitis and within these, severe hepatic sarcoidosis. This is a retrospective study conducted from January 2008 to December 2016 proposed to all patients with granulomatous hepatitis followed in the internal medicine and / or Hepato-gastroenterology departments (Croix-Rousse Hospital, Edouard-Herriot Hospital, Lyon Sud Hospital Center). This study will cover 596 patients who had a liver biopsy showing granulomas.

The main objectives of the Lyon Hepatitis Granulomatous (LHG) study are to analyze i) the etiology of the disease and the contribution of molecular biology for infectious etiologies, ii) the contribution of nuclear imaging for sarcoidosis diagnosis versus conventional imaging, iii) treatment used and prognosis.

This study will permit a better characterization of granulomatous hepatitis, and liver sarcoidosis in terms of prognosis as well as therapeutic management.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of granulomatous hepatitis
* Patient followed in the internal medicine and / or Hepato-gastroenterology departments (Croix-Rousse Hospital, Edouard-Herriot Hospital, Lyon Sud Hospital Center)
* Collection of non-opposition

Exclusion Criteria:

-
Coated Mongolian Aneurysm Treatment Study 2

The purpose of this study is to assess safety and effectiveness of the p64 MW HPC or p48 MW HPC Flow Modulation Device under prasugrel.

Title: Observational Registry With p64 MW HPC in Unruptured Anterior Circulation Aneurysms Under prasugrel

Purpose: To assess safety and effectiveness of p64 MW HPC or p48 MW HPC under prasugrel in consecutive patients with unruptured anterior circulation aneurysms.

Follow-up intervals: Independent follow-ups (after 3 to 6 months and after 12 months and after 24 months) according to site specific standard.

Eligibility Criteria:
Inclusion Criteria:

* At least one unruptured sidewall aneurysm in the anterior circulation
* No implant (e.g., stent) in the target vessel segment
* Age \>18 years and \<80 years
* Not pregnant and in women of childbearing age, on oral contraception for two years following the procedure
* No participation in another trial
* No concomitant disease limiting the life expectancy to \<2 years
* No allergy to non-ionic contrast medium or to ASA and P2Y12 receptor antagonists
* No other neurovascular disorder in the same vascular territory requiring treatment in the foreseeable future
* Ability and willingness to comply with the medication requirements within the study,
* Ability to understand the goal and risks of this study.

Exclusion Criteria:

* Intracranial aneurysm considered not suitable for FD using p64 MW HPC or p48 MW HPC.
* Aneurysm previously treated with a device in the parent vessel (e.g., stent, flow diverter).
* Another intracranial procedure scheduled for the following 6 months.
* Age \< 18 years and \> 80 years.
* Pregnancy possible or confirmed. Patient not able or willing to arrange contraception for 12 months after treatment.
* Patient not able or willing to adhere to the study protocol.
* Patient not able or willing to undergo the scheduled follow-up examinations.
Impact of General Practice Follow-up on Emergency Hospitalization of Patients Admitted for Chest Pain

This is a prospective observational study carried out in the emergency department of Emile Roux Hospital. Its aim is to compare the medical, psychological and social characteristics of patients followed up by a general practitioner and those without regular follow-up, using an anonymous questionnaire completed by the general practitioner in the emergency department, for patients consulting for the reason "chest pain".


Eligibility Criteria:
Inclusion Criteria:

* Patient admitted to Emile Roux hospital emergency department with chest pain
* Patient affiliated to the Social security system
* Patient able to give informed non-opposition to participating in research

Exclusion Criteria:

* Patient under guardianship, curatorship, safeguard of justice or prisoners
* Patient with cognitive disorders
* Pregnant or breast-feeding women
* Refusal to participate
Effectiveness of Antipsychotic Combination With Psychosocial Intervention on Outcome of Patients With Schizophrenia

Antipsychotic alone is limit to improve the overall outcome of schizophrenia and has a high discontinue rate.To solve these problems, we provide practical and available psychosocial intervention. We hypothesize that there will be significant difference in the overall effectiveness between antipsychotic and antipsychotic combination with psychosocial intervention.

The study is designed as a national, multicenter, randomized, naturalistic trial, with research assessors intended to be blind to the intervention status.

We plan to recruit 1400 patients at 10 china sites and randomly assign them to two group. the control group only receive antipsychotic and the study group receive antipsychotic combination with psychosocial intervention. The course is 12 months. Patients use one of the seven study drugs (chlorpromazine, sulpiride, clozapine, olanzapine, risperidone, quetiapine, and aripitrazole)to the maintain treatment. The psychosocial intervention include psychoeducation, family intervention, skills training, and cognitive-behavioral therapy. The primary aim is to delineate differences in the overall effectiveness of the two treatment model.The assessments include the outcome of symptomatology，neurobiology，social psychology，medical economics.

Eligibility Criteria:
Inclusion Criteria:

* Eligible patients were 16 to 50 years of age;
* had received a diagnosed of schizophrenia in accordance with criteria set out in the Diagnostic and Statistical Manual of Mental Disorders-fourth edition (DSM-IV);
* were confirmed to be clinically stable by the investigator (the total score ≤60 on the Positive and Negative Syndrome Scale \[PANSS\] or a decrease of fifty percent from acute period in the total score on PANSS)
* and taken maintenance treatment with any one of the following seven oral antipsychotics:

  * chlorpromazine
  * sulpiride clozapine
  * risperidone
  * olanzapine
  * quetiapine
  * aripiprazole

Exclusion Criteria:

* Patients were excluded if they had received a diagnosis of schizoaffective disorder, mental retardation, or other cognitive disorders;
* had a history of serious adverse reactions to the proposed treatment;
* were pregnant or breastfeeding; or had a serious and unstable medical condition.
* Patients were excluded if they were unable to provide informed consent
A Study Designed to Evaluate the Safety and Pharmacokinetics of Intravenously Administered Superoxide Dismutase Mimetic GC4711 in Healthy Volunteers

The study will be a Phase 1, randomized, double-blind, placebo-controlled, single dose escalation study designed to evaluate the safety and PK of intravenously administered superoxide dismutase mimetic GC4711 in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy men and women between 18 and 50 years
2. Subjects who provide written informed consent
3. Body Mass Index (BMI) of 18 to 32 kg/m2 and weighing at least 50 kg
4. Subjects in general good health
5. Blood pressure and pulse within normal limits
6. Male subjects must practice effective contraception
7. Female subjects must:

   * Have a negative serum pregnancy test during
   * Be non-lactating;
   * Be at least 2 years postmenopausal, surgically sterile, or practicing effective contraception.

Exclusion Criteria:

1. History of clinically significant illness or medical history which would preclude them from the study.
2. Known contraindication, hypersensitivity and/or allergy to study drugs
3. Use of any prescription or over-the-counter medication within one week prior to study drug administration
4. Anticipated need for any medication during the study
5. Use of nitrates or erectile dysfunction drugs such as phosphodiesterase type 5 (PDE 5) inhibitors
6. Use of other drugs that may, in the judgment of the Investigator, create a risk for a precipitous decrease in blood pressure
7. Presence of orthostatic hypotension at screening
8. Use of any vitamin or mineral supplement 24 hours before dosing or throughout study
9. Positive human immunodeficiency virus (HIV), hepatitis B (HBV) or hepatitis C (HCV)
10. Known history of substance abuse, drug addiction, or alcoholism within 3 years
11. Anticipated inability to abstain from alcohol, tobacco, or caffeine use from 48 hours before the administration of study drug and throughout the the study;
12. Positive drug and alcohol toxicology screens during Screening
13. History of smoking or any use of a tobacco product within 6 months
14. Donation of blood or blood products within 30 days before Baseline and throughout the study;
15. Mentally unstable or incapable of being compliant with the protocol
16. Receipt of an investigational test substance within 3 months before the administration of study drugs, or anticipated receiving any study drugs
17. Subject has previously participated in this study, or in a prior Galera study
On Demand Treatment of Reflux Disease

A comparison of the effect of on demand treatment with a pectin-containing natural product (Aflurax) with that esomeprazole (Nexium)

A randomized, controlled, open trial comparing the symptomatic effect of a pectin-containing product (Aflurax) with that of esomeprazole (Nexium 20 mg) given on-demand for 6 weeks.

Eligibility Criteria:
Inclusion Criteria:

Mild and moderate reflux symptoms Age \> 17 years Informed consent -

Exclusion Criteria:

Other conditions that might explain the symptoms Abuse of drugs or alcohol

-
A Comparison of the LMA Unique and LMA Supreme in Children

The goal of this study is to compare the LMA Unique and LMA Supreme in children having surgery. We hypothesize that the airway leak pressures with the LMA Supreme will be superior to the LMA Unique. Airway leak pressures will be measured by recording the circuit pressure at which equilibrium is reached. The ease of placement, fiberoptic grade of laryngeal view, feasibility of use, and complications (airway related, gastric insufflation, trauma) will also be assessed.

The LMA Supreme is a newer version of the current model, the laryngeal mask airway Unique. Both models are approved for use by the FDA, and are routinely used for airway management during general anesthesia. Three main features distinguish the laryngeal mask airway Supreme from the original LMA: i) a curved rigid airway tube, ii) provision for a gastric drain tube, and iii) a larger mask for improved fit and airway seal.

The aim of this randomized prospective study is to compare two types of the laryngeal mask airway: the laryngeal mask airway Unique and the laryngeal mask airway Supreme, in pediatric patients without the use of neuromuscular blockade. Based on the design features listed above, we hypothesize that the airway leak pressures with the LMA Supreme will be superior to the LMA Unique. Airway leak pressures will be measured by recording the circuit pressure at which equilibrium is reached. The ease of placement, fiberoptic grade of laryngeal view, feasibility of use, and complications (airway related, gastric insufflation, trauma) will also be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Children undergoing general anesthesia using a supraglottic airway device
* weight 10-25kg
* age 6 months-6 years

Exclusion Criteria:

ASA class IV, V Emergency procedures

* History of a difficult airway
* Active gastrointestinal reflux
* Active upper respiratory tract infection