cyrilzakka/clinical-trials huggingface dataset:
Biofeedback Vs Electrical Stimulation in Treatment of Fecal Incontinence

Fecal incontinence is one of the most psychological frustrating problems. It occurs in children due to many causes. There is a wide range of non-invasive therapeutic approaches like Kegel exercise, Biofeedback, and posterior tibial nerve stimulation. However, up till now, there are no established guidelines for treatment.

the objective of this study is to evaluate and compare the early effect of Biofeedback therapy versus bilateral transcutaneous posterior tibial nerve stimulation (TPNS) as non-invasive methods in the treatment of functional non-retentive fecal incontinence (FNRFI) in children.

Functional non-retentive fecal incontinence (FNRFI) requires prolonged treatment with a wide range of non-invasive therapeutic approaches like Kegel exercise, Biofeedback, and posterior tibial nerve stimulation (PTNS). However, up till now, there are no established guidelines for treatment.1 The aim of this study is to evaluate and compare the early effect of Biofeedback therapy versus bilateral transcutaneous posterior tibial nerve stimulation (TPTNS) as non-invasive methods in the treatment of (FNRFI) in children.

Methodology: The current prospective randomized controlled study included 93 children with FNRFI who were randomly divided and allocated into three groups. Group A treated by conventional methods through dietetic regulation and Kegal exercises. Group B treated by biofeedback therapy while group C received bilateral (TPTNS). Initial manometric findings including resting pressure, squeeze pressure, 1st sensation, 1st urge, and intense urge were recorded and repeated after 3 and 6 months together with incontinence score recorded in using St' Mark's (Varizey) with the primary endpoint of improvement of the incontinence score more than 50%.

Eligibility Criteria:
Inclusion Criteria:

* FecaI incontinence
* Normal defecation frequency,
* Normal bowel habits and
* Normal stool consistency

Exclusion Criteria:

* Children who are not cooperative,
* Children with traumatic sphincter injury,
* Children with fecal impaction,
* Children with spinal diseases causing incontinence,
* Children with anorectal malformation,
Evaluation of Efficacy and Safety of Symbicort® as an add-on Treatment to Spiriva® in Patients With Severe COPD.

The purpose of this study is to investigate the effect of combined treatment with Symbicort and Spiriva, in terms of improvement of lung function, symptoms and inflammatory markers, in patients with severe COPD.


Eligibility Criteria:
Inclusion Criteria:

* \>=40 years of age, diagnosed COPD with symptoms \>=2 years, pre-bronchodilatory FEV1 \<=50% of PN

Exclusion Criteria:

* Current respiratory tract disorder other than COPD, history of asthma or rhinitis, significant or unstable cardiovascular disorder
The Efficacy of Phosphatidylserine-Omega3 in Elderly Subjects With Memory Impairment

The primary objective of this trial is to assess the ability of Phosphatidylserine-Omega3 to improve cognitive performance in elderly subjects with memory impairment.

This study is a single-center, open-label 15 weeks duration trial to assess efficacy of Phosphatidylserine-Omega3 in elderly subjects with memory impairment.


Eligibility Criteria:
INCLUSION CRITERIA

1. Ability to give written informed consent
2. Age: 90≥ years ≥65
3. Gender: male and female.
4. Clinical Dementia Rating Scale (CDR) ≤ 0.5
5. Mini-Mental State Examination (MMSE) ≥ 26
6. Memory test performance within or below the mean established for adults, with maximum of four neuropsychological subtests of the computerized test scored as 1.5 SD above the mean
7. Language: Subjects must be able to read, write and speak Hebrew.
8. Ability to perform tests and interviews.

EXCLUSION CRITERIA

1. Evidence of delirium, confusion, or other disturbances of consciousness.
2. Any Neurological disorder that could produce cognitive deterioration. Such disorders include AD, Parkinson's disease, stroke, intracranial hemorrhage, local brain lesions including tumors, and normal pressure hydrocephalus
3. History of any infective or inflammatory brain disease including those of viral, fungal, or syphilitic etiologies.
4. Head injury immediately preceding cognitive deterioration.
5. Current psychiatric diagnosis according to DSM IV criteria of depression, mania, or any other major psychiatric disorder, or evidence of depression as determined by the Geriatric Depression Scale (GDS15) score of 5 or more.
6. Current diagnosis or history of alcoholism or drug dependence.
7. Any medical disorder that could produce cognitive deterioration including renal, respiratory, cardiac and hepatic disease, diabetes mellitus, endocrine, metabolic or hematological disturbances unless well controlled, and malignancy not in remission for more than two years.
8. Use of psychotropic drug or any other drug or supplement that may significantly affect cognitive functioning during the month prior to psychometric testing.
9. Use of any experimental medication within 1 month prior to screening or as concomitant medications.
10. History of hypersensitivity or allergy to fish or fish oil.
Comparison of Ceramic-on-Ceramic and Ceramic-on-Highly-Cross-Linked Polyethylene Bearings

The purpose of this prospective, randomized study was to compare the clinical and radiographic results and the prevalence of osteolysis of the cementless total hip arthroplasty with an alumina-on-alumina bearings one side and alumina-on-highly cross-linked polyethylene bearings on the other side in the young and active patients.


Eligibility Criteria:
Inclusion Criteria:

* Primary hip osteoarthritis
* Secondary hip osteoarthritis
* Avascular necrosis of femoral head

Exclusion Criteria:

* Previous surgical history of hip
Riociguat-Discontinue Effects on Right HEART in CTEPH (RED-HEART)

Riociguat and balloon pulmonary angioplasty (BPA) are established standard-of-care interventions for inoperable chronic thromboembolic pulmonary hypertension (CTEPH) with comparable evidence levels. However, the optimal combined treatment strategy remains unclear. Specifically, there is no consensus on whether riociguat should be continued long-term after achieving hemodynamic stability with BPA. Additionally, the long-term effects of riociguat discontinuation on right ventricular (RV) structure and function remain poorly characterized, particularly due to the lack of comprehensive noninvasive evaluations integrating cardiac magnetic resonance (CMR) and echocardiography. This prospective study aims to determine the hemodynamic impact of riociguat discontinuation in inoperable CTEPH patients who have achieved BPA treatment endpoints using right heart catheterization (RHC). Evaluate RV remodeling and functional changes after riociguat cessation through multimodal noninvasive imaging (CMR, echocardiography). Assess safety outcomes and identify potential rebound pulmonary hypertension or decompensated RV dysfunction associated with riociguat withdrawal.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years old
* CTEPH was diagnosed and one of the following three factors was met: Pulmonary endarterectomy was technically impossible; Pulmonary endarterectomy is technically feasible, but the risk-benefit ratio is poor; Residual/recurrent pulmonary hypertension after pulmonary endarterectomy
* Subjects had been treated with BPA and had received a stable dose of riociguat for ≥12 weeks
* mPAP \< 30mmHg
* Male subjects and female subjects of reproductive age are required to use effective contraception for at least 28 days after signing the informed consent form. Male subjects are not allowed to donate sperm and female subjects are not allowed to breastfeed.
* Subjects voluntarily sign written informed consent

Exclusion Criteria:

* Severe hepatic and renal insufficiency (Child-Pugh Grade C/creatinine clearance \< 30ml/min·1.73m²)
* The presence of severe infectious disease or severe bleeding tendency
* Combined with pulmonary hypertension of other types than CTEPH
* Other pulmonary hypertension targeting drugs are being used
* The expected survival time with cancer or other diseases is less than 6 months
* Pregnancy, lactation
* Subjects are currently participating in an interventional clinical trial
* In the investigator's judgment, a subject's medical abnormality, physical condition, or medical history may affect his or her ability to participate in or complete the study
Schizophrenia, Antipsychotic Treatment and the Risk for Diabetes Mellitus

This preliminary study aims to investigate the mechanism of higher rates of type 2 diabetes mellitus in patients with schizophrenia. As part of the study, we collect neuroendocrine-immune data on patients with first episode, treatment naive psychosis, patients with newly diagnosed schizophrenia and normal healthy controls.

Regardless the treatment status, we collect the same neuroendocrine-immune data on the participants after 2 months.

This preliminary study aims to investigate the mechanism of higher rates of type 2 diabetes mellitus in patients with schizophrenia. As part of the study, we collect neuroendocrine-immune data on patients with first episode, treatment naive psychosis, patients with newly diagnosed schizophrenia and normal healthy controls.

Regardless the treatment status, we collect the same neuroendocrine-immune on the participants (patients and controls) after 2 months. Thus, our study does not control treatment. Patients take treatment in consultation with their physician. Some of them even decide not to take any medications. At the 2nd visit, we do ask them about the the medications they are taking if any.

Eligibility Criteria:
Inclusion Criteria:

* Psychotic disorder as per DSM-IV criteria of the American Psychiatric Association

Exclusion Criteria:

* Diabetes, type 1 or 2
* Prominent substance abuse (i.e. psychotic symptoms attributable entirely to substance use)
* Age above 50 or age below 14
Retrospective Study of the Relationship Between Human Papillomavirus Genotype and Cervical Epithelial Lesions

Human papillomavirus (HPV) infection plays a key role in the carcinogenesis of cervical cancer and pre-invasive lesions. There are hundred types of HPV, including high risk and low risk types, and it is proved the close association between the cervical cancer and high risk HPV. While HPV 16 and 18 are known to be the leading two genotypes detected in women with cervical neoplasm worldwide, there is considerable difference in the other prevalent high risk genotypes in different geographic areas. It is important to establish the local database about the cervical intraepithelial lesions and the related prevalent HPV genotypes. The investigators designed a retrospective study which included total 784 patients managed at our hospital from January 1, 2000 to December 31, 2007. The present study was to investigate the HPV genotypes in the Taiwanese female patients with abnormal cervical cytology and analyses the association between HPV types and cervical pre-invasive lesions. It could provide the guide for the clinicians in the management of patients with abnormal cytological change of Pap smear.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* People infected with HPV type 16 but without CIN lesions
* Patients with CIN lesions
* Patients with cervical cancer from National Taiwan University Hospital
* Informed consent is obtained, and the protocols are reviewed and approved by the appropriate Investigative Review Boards.

Exclusion Criteria:

* None
Early Intervention Coping Kids (TIM) Follow up Study

The project objectives are to investigate if a preventive intervention targeting anxious and sad children aged 8 to 12 years has haf the anticipated long-term effects, 5 years after receiving the intervention. Hence: will an indicated intervention reduce the incidence of common mental disorders in youth in the long term? The current study is a 5 year follow up of the previously completed RCT called the TIM-study (Clinical Trials identifier: NCT 02340637).

The aim of this study is to determine the long-term effects of the intervention to examine if true preventive effects are achieved as indicated by lower symptom levels, better functioning og fewer diagnosis of anxiety and depression 5 years after receiving an indicated preventiv intervention.


Eligibility Criteria:
Inclusion Criteria:

* Participants who participated in the previous randomized controlled TIM study (children then aged 8- 12 years selfreporing elevated symptom levels of anxiety and/or depression)

Exclusion Criteria:

* all earlier participats from the TIM study may enter the follow up study
* participants who chose to not participate in the 5-year follow-up of the TIM study are excluded from the follow-up study.
Study of Gemcitabine/Taxotere/Xeloda (GTX) in Combination With Cisplatin and Irinotecan in Subjects With Metastatic Pancreatic Cancer

This study will be looking at whether gemcitabine, taxotere, and xeloda (GTX) in combination with cisplatin and irinotecan is effective (anti-tumor activity) and safe in patients with metastatic pancreatic cancer.

The study is being done in 2 parts. The first part is the dose escalation (Phase I) part of the study where the dose of irinotecan is increased until the highest safe dose of irinotecan is defined that can be given with gemcitabine, taxotere, xeloda, and cisplatin.

After the safe dose of irinotecan in combination with gemcitabine, taxotere, xeloda, and cisplatin is defined, the second part of the study (Phase 2) will use these defined doses to look at how effective these drugs are against advanced pancreatic cancer.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically or cytologically confirmed untreated metastatic pancreatic adenocarcinoma.
2. Have measurable disease.
3. Male or non-pregnant and non-lactating female of age \>18 years.
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 . ECOG 0 indicates that the patient is fully active and able to carry on all pre-disease activities without restriction; and, ECOG 1 indicates that the patient is restricted in physically strenuous activity but is ambulatory and able to carry out work of a light or sedentary nature
5. Subjects must have adequate organ and marrow function.
6. Must use acceptable form of birth control prior to study and and for the duration of study.
7. Willing and able to comply with study procedures

Exclusion Criteria:

1. Patient who have had any prior chemotherapy within 5 years of enrollment.
2. Patient who have had radiotherapy for pancreatic cancer.
3. Age ≥ 76 years
4. Patient who is receiving or have received any other investigational agents within 28 days prior to Day 1 of treatment in this study.
5. Patient who has undergone major surgery, other than diagnostic surgery within 28 days prior to Day 1 of treatment in this study.
6. Patient who has known brain metastases.
7. Patient with history of hypersensitivity or allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine, taxotere, xeloda, cisplatin, or irinotecan.
8. Patient with uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
9. Patient who has serious medical risk factors involving any of the major organ systems.
10. Patient who has known history of infection with HIV, hepatitis B, or hepatitis C.
11. Pregnant or breast feeding.
12. Patient is unwilling or unable to comply with study procedures
13. Patient with clinically significant wound
Evaluation of the Pharmacokinetics of NRL972 Following Pre-Administration of Rifampicin and Cyclosporine

A study in healthy volunteers to determine whether different drugs metabolised by the liver have any effects on how NRL972 is processed within the body.


Eligibility Criteria:
Inclusion Criteria:

1. Males or females (females of non-childbearing potential or of childbearing potential while taking medically appropriate contraception)
2. Caucasian
3. Age: 21 - 40 years
4. BW 50 - 100 kg
5. BMI 20 - 26 kg.m-2
6. healthy based on the pre-study examination
7. willing and able to provide informed consent

Exclusion Criteria:

General - all subjects

1. Previous participation in the trial
2. Participant in any other trial during the last 90 days
3. Donation of blood during the last 60 days or a history of blood loss exceeding 300 mL within the last 3 months
4. History of any clinically relevant allergy (including hypersensitivity to the trial medications)
5. Presence of acute or chronic infection
6. Presence or history of any relevant co-morbidity
7. Resting systolic blood pressure \> 160 or \< 90 mmHg, diastolic blood pressure \> 95 or \< 50 mmHg
8. Clinically relevant ECG-abnormalities, prolonged QTc with \> 450 msec in males and \> 460 msec in females in particular
9. Presence of any relevant abnormality in the laboratory safety tests, especially low haemoglobin, increased liver enzymes
10. Positive serology for HBsAg, anti HBc and anti HCV
11. Positive HIV test
12. Positive alcohol or urine drug test on recruitment (and upon admission)
13. History of alcohol and/or drug abuse and/or daily use of \> 30 gr alcohol
14. Smoking more than 15 cigarettes/day or equivalent of other tobacco products
15. Use of prohibited medication
16. Suspicion or evidence that the subject is not trustworthy and reliable
17. Suspicion or evidence that the subject is not able to make a free consent or to understand the information in this regard

    General - all females
18. Positive pregnancy test
19. Lactating
20. Not using appropriate contraception in pre-menopausal women (note: under the conditions of the present study, women using hormonal contraceptives will be informed that this method is not sufficient during the study and that further i.e. mechanical methods \[condom, diaphragm with spermacide gel\] should be used in addition).
Validation of a Predictive Nomogram of Response or Resistance to Targeted Therapies in Metastatic Clear Cell Renal Cell Carcinoma

The purpose of this study is to validate of a predictive nomogram of response or resistance to targeted therapies in metastatic clear cell renal cell carcinoma


Eligibility Criteria:
Inclusion Criteria:

* patients with metastatic ccRCC
* Underwent nephrectomy at the University Hospital of Rennes
* treated by sunitinib first line treatment

Exclusion Criteria:

* translocation renal cell carcinoma
* other targeted therapies before the sunitinib
Stereotactic Radiology Versus Chemotherapy for Recurrent/Progressive Glioblastoma After Second-Line Chemotherapy

This clinical trial is a prospective study of radiosurgery treatment for progressive GBM to test 1)the efficacy of radiosurgery for recurrent/progressive GBM compared to chemotherapy , and 2) the role of diffusion-weighted image (DWI) to predict the early tumor progression and treatment response.


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven intracranial glioblastoma multiforme with pathologic or imaging confirmation of tumor progression or regrowth after failure of two previous treatment regimens
* Initial low-grade glioma and a subsequent diagnosis of glioblastoma or gliosarcoma
* History and physical exam, including neurologic examination, within 4 weeks prior to registration

Exclusion Criteria:

• Warfarin or LMW heparin patients must have no active bleeding or pathological condition that carries a high risk of bleeding
The Safe Fast Track Study

Emergency departments (ED) internationally are treating an increasing number of patients.

Most require hospital services but some could be better cared for on alternative pathways.

D-dimer has some unique properties. It is non-specific and is elevated in many acute condi- tions; but conversely remains normal in the absence of significant disease. Previous studies have shown that having a normal D-dimer on arrival to the emergency department is associated with a very low risk of 30-day all-cause mortality.

The investigators propose a multicenter randomized controlled trial using D-dimer to identify patients at low risk and test if providing this information will change time to discharge disposition by the treating physician.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or above
* Able to provide oral and written informed consent in Danish
* Blood tests ordered on arrival as part of standard of care
* Ambulatory on arrival or walking to the ambulance (i.e., stable independent gait)
* Normal vital signs (i.e., National Early Warning Score \&lt; 3)

Exclusion Criteria:

* Unstable condition requiring immediate care in the resuscitation area
* Triage level red (i.e., the most urgent patients)
* Trauma (minor and major) patients
* High likelihood of requiring a D-dimer analysis on clinical indications during the current hospital contact (e.g., suspected venous thromboembolic disease) that will be ordered on arrival regardless of this study
* Previous participation in the study
Prospective, Open-label Study of Pharmacokinetics of Ertapenem in the Muscle Using Microdialysis in Mechanically Ventilated Intensive Care Unit Patients, Treated or Not by Norepinephrine

Goal of study:

To assess the tissular and plasma kinetics of ertapenem;

To determine the optimal dosages in the patients according to norepinephrine administration:

* to assess muscular diffusion of free form of ertapenem after administration to mechanically ventilated patients requiring such a treatment. The patients are included in the groups "with norepinephrine" or "without norepinephrine" according to their hemodynamic status.
* to assess the plasma pharmacokinetics of ertapenem in mechanically ventilated patients treated or not by norepinephrine.

Open-label, prospective study performed in a single ICU (16 beds) of a tertiary hospital (700 beds).


Eligibility Criteria:
Inclusion Criteria:

* 18 years and more
* negative pregnancy test
* HIV/HBV, HCV negative tests
* Mechanical ventilation with pneumonia or intraabdominal infection requiring ertapenem

Exclusion Criteria:

* refractory septic shock requiring use of additional catecholamines
* patients with positives tests for HIV, HBV, HCV
* pregnant females
* allergic insufficiency
* hemodiafiltration
* contraindication to microdialysis catheter set-up
* severe arteritis of lower extremities
* treatment with vasodilatators
* prior history of aorto-iliac shunt
* involvement in a clinical trial in the last three months
* exclusion from national records
* non affiliated to "securité sociale"
Dural Arteriovenous Fistulas Research at China INI

Dural arteriovenous fistula (DAVF) refers to abnormal connections between meningeal arteries and dural venous sinuses and/or subarachnoid veins. DAVF accounts for approximately 10% to 15% of intracranial vascular malformations. With advancements in imaging technology, increased awareness among physicians, and an aging population, the incidence of DAVF appears to be on the rise. Some literature even suggests it may surpass the occurrence of arteriovenous malformations. Several large-scale retrospective studies have been conducted internationally, involving over 1,000 cases, but some of their findings differ from what is commonly understood. Currently, there is a lack of large-sample single-center studies on DAVF, highlighting the urgent need for such research.

Title：Dural Arteriovenous Fistulas Research at China INI.

Purpose：The incidence of DAVF is low. By collecting clinical data, we aim to establish a comprehensive database and biobank. This will help us elucidate the potential pathogenesis, vascular architecture, biological markers, and treatment outcomes of DAVFs. Furthermore, this study aims to address current controversies (such as treatment strategies for DAVF with pial arterial supply), unresolved issues (such as the optimal treatment and prognosis of infantile type DAVF), and further explore possible mechanisms of DAVF development.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with DAVFs who were admitted to Xuanwu Hospital.

Exclusion Criteria:

* Non-DAVF lesions confirmed by DSA.