cyrilzakka/clinical-trials huggingface dataset:
Fibromyalgia Study In Adults

A study to investigate ropinirole for treatment of the symptoms of fibromyalgia and in particular the widespread pain associated with this condition. A total 160 subjects (80 per treatment arm) are being recruited from approximately 25 centres in 9 European countries. Male and female subjects greater than 18 years of age with a diagnosis of primary fibromyalgia, as defined by the American College of Rheumatology (ACR) criteria, are eligible for study entry. Subjects will receive either ropinirole (1-24mg) or placebo, depending upon a statistically defined allocation to treatment. The primary endpoint is improvement in pain score by 12 weeks of treatment. An 11 point numerical rating scale for the assessment of the subject's pain is being collected on a daily diary. In addition, the overall improvement in quality of life for the subject will be assessed by means of a number of subject-completed questionnaires during the treatment period. Safety of the treatment regimen will be assessed throughout the study.


Eligibility Criteria:
Inclusion criteria:

* Diagnosis of primary fibromyalgia as defined by the American College of Rheumatology (ACR).
* Females of childbearing potential will only be eligible if taking adequate contraceptive measures.
* Other co-existent chronic pain conditions such as osteoarthritis, will not exclude the subject if the pain associated with the condition is less severe than the pain of fibromyalgia.
* Only subjects experiencing moderate/severe pain (pain intensity score \>= 4 on the pain numerical rating scale) will be eligible for this study.
* Subjects that are generally well.
* Have the ability to discontinue prohibited medications for the duration of the study.

Exclusion criteria:

* Subjects with 'flare' of arthritic conditions.
* Evidence of clinically significant medical conditions including cardiovascular conditions (e.g. postural hypotension, and raised blood pressure, ECG abnormalities).
* History of drug and/or alcohol abuse or major depression.
Blood Pressure Variability and the Prognosis of Ischemic Stroke With Intracranial Artery Stenosis

Correlation study about Blood Pressure Variability and the prognosis of ischemic stroke with intracranial artery stenosis

Extracranial atherosclerotic stenosis is the main reason for the European and American white ischemic stroke and transient ischemic attack,while Atherosclerotic intracranial arterial stenosis is an important reason for Asian patients with stroke ,accounting for the 33% to 51% of a etiology ratio.The latest research suggests that varying degrees of blood pressure variability can affect the risk of stroke.This study observe the relationship between blood pressure variability and prognosis of ischemic stroke patients with intracranial arterial stenosis,with cranial magnetic resonance imaging (MRI + DWI),magnetic resonance angiography and Trans-cranial Doppler(TCD) .

Eligibility Criteria:
Inclusion Criteria:

* age : ≥ 18 years of age , ≤ 75 years old
* with intracranial artery stenosis in ischemic stroke
* the diagnosis of ischemic cerebrovascular disease are in line with the diagnostic criteria developed by the Chinese Medical Association Fourth National Cerebrovascular Disease Conference
* the patient admitted to hospital receive at least one examination like cranial MRI + DWI, MRA and TCD examination, clearly associated with intracranial arterial stenosis
* MRS score ≤ 3 points

Exclusion Criteria:

* vascular , cardiac , and unknown causes or other reasons lead to ischemic stroke
* associated with significant emotional disorders, cognitive impairment or other mental disorders can not be partners
* severe occlusion of Unilateral intracranial arteries ( over 90 % ) or bilateral stenosis more than 70%
* With extracranial artery stenosis, especially carotid and vertebral artery stenosis .
* patients with extracranial artery stenosis or patients previously done neck or intracranial artery balloon dilation , stent forming surgery or carotid endarterectomy
* Incomplete clinical data collection in patients
Parathyroidectomy in Endstage Renal Disease

To test the hypothesis that total parathyroidectomy retards cardiovascular calcification, improves bone mineral density, reduces cardiac hypertrophy and arterial stiffening in end-stage renal disease patients on maintenance dialysis.

Secondary hyperparathyroidism (SHPT) in patients with end-stage renal disease contributes to increased cardiovascular morbidity and mortality via different mechanisms. Uncontrolled hyperparathyroidism is associated with left ventricular hypertrophy and has been implicated in the development of cardiac interstitial fibrosis and diastolic dysfunction.

Eligibility Criteria:
Inclusion Criteria:

* Endstage renal disease patients receiving either long-term hemodialysis or peritoneal dialysis treatment, with elevated intact parathyroid hormone (iPTH) levels \> 500pg/ml on two or more occasions.
* Patients with parathyroid nodular or diffuse hyperplasia identified by ultrasound imaging or radioisotope scan.
* Patients who provide informed consent for the study.

Exclusion Criteria:

* Patients with significant background valvular heart disease
* Patients who are unfit for general anaesthesia
* Patients with acute myocardial infarction within recent two months
* Patients with poor general condition
* Patients with plans for living related kidney transplant within 1 year
* Patients with previous history of parathyroidectomy
* Patients with calciphylaxis
* Patients with underlying active malignancy
* Patients with contraindication for MRI
Effect of Sand on Knee Load and Muscle Activity During a Single Leg Landing Task

This study evaluates the effect of different surfaces on the load experienced by the knee when landing from a single leg hop. A sand, pliable grass and firm (hard floor) surface will be compared when hopping from a 30 cm height. Each subject will complete 5 hops on each surface in a random order. The muscle activity in selected muscles of the lower limb will also be investigated to see how this differs in the landing leg, when landing on the different surfaces.

The aim of this study is twofold: 1) To investigate the effect of sand on landing kinematics and kinetics at the knee joint when performing a single leg jump landing task (dominant leg), comparing sand with a firm surface and pliable grass control. 2) To investigate the sEMG activity of the hamstring, quadriceps and gastrocnemius muscles of the dominant leg during the jump landing task on these different surfaces (from take off through to terminal knee flexion at the end of the landing phase).

Eligibility Criteria:
Inclusion Criteria:

* Female
* Participate in a minimum of 3 hours sporting activity per week.
* Provided Informed Consent
* Must be over 16 years of age (16-45 years)
* No exclusion criteria

Exclusion Criteria:

* Not willing to provide informed consent
* Pregnant
* History of ACL injury or other knee pathology
* Significant lower limb pathology
* Previous lower limb fracture or surgery
* Lower Limb injury in last 3 months.
* Male
Pharmacokinetics of Dabigatran Etexilate (Pradaxa®) During Haemodialysis

The current study will allow the assessment of pharmacokinetics, pharmacodynamics, elimination rate and clearance of dabigatran etexilate during and following haemodialysis in ESRD patients.


Eligibility Criteria:
Inclusion criteria:

* End stage renally disease (ESRD), undergoing haemodialysis
* ESRD patients in relatively good health
* Age 21 - 60 years inclusive
* Signed and dated written informed consent prior to admission to the study

Exclusion criteria:

* Clinically relevant laboratory or physical examination abnormalities (except for renal function tests or deviation of clinical laboratory values) that are related to renal impairment
* Moderate and severe concurrent liver function impairment
* Surgery of gastrointestinal tract (except appendectomy or herniotomy) or evidence of significant gastrointestinal motility problems
* Recent or contemplated diagnostic or therapeutic procedures with potential for uncontrollable bleeding
* Intake of medication, which influences the blood clotting
* Subjects not able to understand and comply with protocol requirements, instructions and protocol-stated restrictions
* For women with childbearing potential: no reliable contraception
* Participation in another trial with an investigational drug (\<2 months prior to administration or during trial)
* Scheduled to receive a donor kidney transplant during the course of the study
Gemcitabine and ISIS 2503 in Treating Patients With Advanced or Metastatic Cancer of the Pancreas

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine with ISIS 2503 in treating patients who have advanced or metastatic cancer of the pancreas.

OBJECTIVES: I. Determine the 6-month and overall survival rates in patients with locally advanced or metastatic adenocarcinoma of the pancreas treated with gemcitabine and ISIS 2503. II. Determine the response rate of these patients treated with this regimen. III. Assess the toxicity of this regimen in this patient population.

OUTLINE: This is a multicenter study. Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and ISIS 2503 IV continuously on days 1-14. Treatment continues every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 1 year and then every 6 months for 4 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed locally advanced or metastatic adenocarcinoma of the pancreas not amenable to standard curative therapy Duct cell Undifferentiated The following cellular types are not eligible: Islet cell carcinoma Acinar cell carcinoma Cystadenocarcinoma No CNS metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 No underlying disease associated with active bleeding Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) Alkaline phosphatase no greater than 3 times ULN AST no greater than 3 times ULN PT and PTT normal Renal: Creatinine no greater than 1.5 times ULN Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 6 months after study

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior biologic therapy or immunotherapy No concurrent immunotherapy No colony-stimulating factors during first course of therapy Chemotherapy: No prior chemotherapy except radiosensitizing agents used in adjuvant setting or in treatment of locally advanced disease No prior gemcitabine No prior ISIS 2503 No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to 25% or greater of bone marrow No concurrent radiotherapy Surgery: Not specified
Fundamental Modification of the Gut Microbiota in the Treatment of Refractory Crohn's Disease

To determine the effect of a novel gut microbiota-targeted therapeutic regimen (bowel lavage and antibiotics with or without an antifungal) in the management of active Crohn's Disease (CD) that is refractory to conventional, immunosuppressive therapy.


Eligibility Criteria:
Inclusion Criteria:

* Participant is capable of giving informed consent
* Males or females 18-75 years of age
* Normal kidney function (defined by normal serum creatinine \[male: \<1.27 mg/dL; female: \<1.03 mg/dL\])
* Normal aspartate aminotransferase \[AST\] (\<41 U/L), alanine aminotransferase \[ALT\] (\<63 U/L), and alkaline phosphatase (\<126 U/L)
* Active CD defined as HBI ≥ 7
* CRP \> 5 mg/dL or hs-CRP \> 10mg/L (or 1mg/dL) or fecal calprotectin (FCP) \> - - 350 mcg/g (within one month of enrollment)
* Have been treated with one of the following therapies\*\* for at least 8 weeks with primary nonresponse or an initial response, followed by loss of response \[LOR\] (self-reported worsening of symptoms for ≥ 7 days): azathioprine, 6-mercaptopurine, methotrexate, adalimumab, certolizumab, golimumab, infliximab, natalizumab, vedolizumab, or ustekinumab \*\*These medications must have been administered at standard, therapeutic dosages.

Exclusion Criteria:

* Known or suspected stricturing disease producing obstructive symptoms
* Active Clostridium difficile infection
* Unwillingness to provide informed consent
* Allergy or intolerance to the medications used in this study
* History of kidney disease
* History of liver disease
* Pregnant or lactating females
* Baseline QTc interval on EKG \> 430 in males or \> 450 in females
* Participants who, in the opinion of the investigator, may be non-compliant with study schedules or procedures
Comparison of the Effects of the Education Given to Nursing Students by Gamification Method and Flipped Learning Method on the Level of Participation, Attitude, Interest and Motivation

In this study, it is aimed to compare the effects of the education given to nursing students with the gamification method and the flipped learning method on the level of participation, attitude, interest and motivation.

The research was conducted as a randomized controlled experimental study. The study population consisted of 110 student between October 2022 and January 2023, and the sample of the research consisted of 90 individuals selected from the population using the improbable random sampling method. "Descriptive Feature Form," "Teaching Material Motivation Scale," "Course Interest Scale", Attitude Scale Towards Learning and ''absence charts'' were used to collect data.

In the analysis of data; percentile distribution, chi-square, Fisher- Exact test, t-test in independent groups, Repeated Measures ANOVA Test, One Way ANOVA test, and post hoc analyzes (Bonferroni, Games Howell) were used.


Eligibility Criteria:
Inclusion Criteria:

* To be a student,
* 18 years and older
* Volunteer

Exclusion Criteria:

* Students who are not required to attend the course are not included.
High Protein Diet and Physical Activity in COPD

COPD outpatients with severe and very severe (grade III-IV) disease at risk of malnutrition commencing rehabilitation (7-10-week physical activity program) were randomized to receive a high protein diet (≥ 25 energy percentage) or standard care.

Peripheral muscle function was measured by 6MWD (6-meter-walk-distance) and handgrip strength; FFM was measured by bioimpedance, mid upper arm circumference, and mid-thigh circumference; quality of life was measured by CAT (????); and dyspnoea was measured by the Medical Research Council dyspnoea scale and Borg scores at baseline and after 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed COPD stage III or stage IV
* Nutritional risk by screening (NRS-2002)(Kondrup et al, 2002) and/or low-fat free mass (FFMI) (≤ 15% for women and ≤ 16% for men) measured by Bioelectrical Impedance Analysis (BIA)

Exclusion Criteria:

* Terminal phase of COPD
* Lung transplanted patients
* Severe Comorbidities influenzing the end-points (pancreatic insufficiency, severe hepatic failure, inflammatory gastrointestinal disease)

  * Multiple sclerosis
  * Any unwillingness or inability (e.g. not able to make notes of their nutritional intake, come to consultations or manage oral intake)
Psychotherapeutic Augmentation of Brain Stimulation Effects

This study aims to investigate effectiveness and feasability of a 15-week group psychotherapeutic intervention as continuation treatment after electroconvulsive therapy in severely depressed patients. Feasibility and acceptance of the half-open manualized CBT intervention are assessed. Depressive symptoms, quality of life and emotion regulation skills will be assessed before ECT treatment, before and after the 15-week group CBT intervention and at a 6 months follow-up after treatment end and compared to depressed patients treated with ECT who did not partake in group CBT. Moreover, patients will attend two indidivual pre-group sessions with one of the group therapist and one individual post-group session

While Electroconvulsive therapy (ECT) is a highly effective anti-depressant treatment, a relevant number of patients experience recurrence of depressive episodes within 6 months.

One previous study suggested that ECT treatment effects can be effectively sustained by group CBT (Cognitive Behavioral Therapy, Brakemeier et a. 2014). This previous implementation used a closed CBT-group set-up that implicated a longer waiting period for patients after finishing the acute ECT and did not investigate whether patients who did not respond to ECT could sufficiently profit from group CBT. In order to suit the complex needs of patients in a natural clinical setting, the present study aims to investigate the feasibility and effectiveness of a half-open continuous group CBT (named EffECtive 2.0) as continuation treatment for all ECT patients regardless of remission status after ECT.

This prospective study will recruit a total of 30 patients who concluded treatment with right-unilateral ultra-brief ECT for depression. Patients self-allocate to the group that is offered in addition to continuation treatment as usual (TAU, e.g. pharmacological treatment, continuation ECT, individual psychotherapy). ECT completers who choose not to partake in the group for practical concerns or lack of interest and receive treatment as usual are recruited as a control group.

The primary outcome measure is the change depression severity, measured with the Montgomery-Åsberg Depression Rating Scale (MADRS). Secondary outcomes are quality of life assessed with the short-version of the WHO quality of life questionnaire (WHOQOL-Bref) and emotion regulation as assessed with cognitive emotion regulation questionnaire (CERQ). These measures will be assessed before, during, immediately after acute ECT and six and 12 months into continuation therapy.

It is hypothesized that a group CBT as add-on treatment to TAU will lead to more favorable outcomes concerning depression severity, quality of life and emotion regulation.

Eligibility Criteria:
Inclusion Criteria:

* treated with ECT for major depression

Exclusion Criteria:

* severe comorbid personality disorders
* principal diagnosis other than depression
Development and Validation of an Automated Three-dimensional Cephalometry Method

This study is aimed to develop and assess the validity of an algorithm for automated three-dimensional cephalometry.

Cephalometric analysis is a standardized diagnostic method used daily by orthodontists and maxillofacial surgeons. It is based on linear and angular measurements performed on radiographic images. This examination is traditionally done manually on two-dimensional radiographs, which does not allow to analyze finely the bilateral structures which are found superimposed. Cephalometric analysis of three-dimensional imaging (cone beam computed tomography (CBCT) or computed tomography scan (CT-Scan)) may provide additional diagnostic information, particularly for patients with maxillofacial abnormalities or marked asymmetries.

One of the obstacle to the clinical use of three-dimensional cephalometric analysis is the time and expertise needed to manually place the landmarks. Automatic methods described in literature are preliminary and lack validation in a clinical context.

Our retrospective observational study is aimed to develop and validate a new automated three-dimensional cephalometry method. This method will be based on a deep learning algorithm trained from a database of pre-surgery CT-Scans of patients with have undergone an orthognathic surgery. These CT-Scans will be manually annotated to provide a reference standard for the training of the algorithm and its evaluation. The validation of our results will focus on demonstrating the diagnostic effectiveness and robustness of three-dimensional cephalometric measurements obtained in this clinical context.

Eligibility Criteria:
Inclusion Criteria:

1. Patients followed in the maxillofacial surgery department of Pitie-Salpetriere hospital (AP-HP, Paris, France) since 2014;
2. who underwent orthognathic surgery;
3. who had, for surgery planning, a three-dimensional radiographic examination (CT-Scan) which has been segmented for the manufacture of a custom-made device;
4. who did not object to the research.
Endoscopic Full Thickness Resection Versus Standard Therapy of the Colorectal Neoplasia

Most of the cancers develop from the adenomatous polyps. The therapeutic methods have been established already - endoscopic polypectomy (EPE) for stalked polyps and endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) for non-pedunculated polyps. EMR is preferred in European countries over ESD because of its higher feasibility. However, the local residual neoplasia (LRN) after EMR has been reported in 14 - 24 % cases. There is a higher LRN risk in sessile polyps which do not elevate sufficiently after the submucosal injection (non-lifting sign) and the piece-meal resection needs to be used. Therefore, the new method of endoscopic full-thickness resection (FTR) has been developed to resect these lesions.

In this project, 80 individuals (age ≥ 18 years) with colorectal lesions of 10-25 mm size with positive non-lifting sign will be included. Such lesions might be found during the colonoscopies at the trial endoscopy centers or at the cooperating referring endoscopy centers outside the study. Patient will be scheduled for the index therapeutic colonoscopy (iTC) and randomized in two groups - FTR group (therapy with FTRD) and ST group (standard therapy, EMR or ESD due to the indication, decided by the endoscopist). First follow-up colonoscopy (FC1) will be performed in 6 months interval. In case of LRN negativity at FC1, the second follow-up colonoscopy (FC2) will be done after 12 months (18 months since iTC). In case of LRN positivity at FC1, the LRN therapeutic colonoscopy (LRN-TC) will follow with the endoscopic method due the findings (patients will be divided into four groups): APC group (LRN ≤ 5 mm; APC therapy), EMR group (LRN \> 5 mm and negative non-lifting sign negative; EMR therapy), FTR group (LRN \> 5 mm and positive non-lifting sign; therapy with FTRD) and surgery group (complex lesion; surgical therapy). In some LRN positive cases, FC1 will be the same as LRN-TC. The first follow-up colonoscopy after LRN therapy (LRN-FC1) will be performed after 6 months (12 months since TC). In case of re-LRN negativity at LRN-FC1 the second follow-up colonoscopy after LRN therapy (LRN-FC2) will be done after 6 months (18 months since iTC). In case of re-LRN positivity at LRN- FC1 the therapy will be done same as during FC1 and next follow-up will be done outside this trial. In some re-LRN positive cases, LRN-FC1 will be the same as re-LRN-TC. In conclusion, all patients will be followed-up within the study for 18 months, if timely possible.

Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years
* colorectal lesions of 10-25 mm size with positive non-lifting sign
* signed informed consent with the study and with colonoscopy

Exclusion Criteria:

* age \< 18 years
* lesions \> 25 mm
* pedunculated polyps
* colorectal stenosis
* colonoscopy contraindication
* severe acute inflammatory bowel disease
* severe comorbidities
* patient not able to sign the informed consent