cyrilzakka/clinical-trials huggingface dataset:
Lumbar Stabilization Exercises in Adult Patients With Lumbar Arthrodesis Surgery

The purpose of this study is to determine which type of lumbar stabilization exercise is more effective to improve functionality and reduce pain in patients operated with lumbar arthrodesis, to guide clinical practice in the rehabilitation of these patients.

The objective of this study is to determine which exercise modality (global, local or mixed) is most effective in reducing pain and improving function at 6 and 12 weeks after the operation. The methodology will be a randomized experimental clinical trial. The study population will be subjects who underwent surgery for lumbar spinal stenosis due to decompression and posterolateral fusion. The estimation of the sample size was made on the basis of the ANOVA test measures, following the guidelines established by Stevens, for which an α = 0.05 and β = 0.2 were used, power = 80% and moderate effect size. As a result, the program (GPower) gave us a total sample size of 24 subjects, so we will use a sample of 30 subjects due to the possibility of departure of some of them abandoning during the process. The sample will be taken from a waiting list of lumbar spinal stenosis surgery at the Traumatological Institute of Santiago (IT). To measure the level of functionality, we will use the Oswestry Disability Index 2.0 in Spanish, and for pain, the Visual Analogue Scale, in addition to recording general data. For each instrument, 3 measurements will be taken: preoperative, 6 and 12 weeks after the operation. To analyze the data, the program of the latest version of IBM SPSS Statistics Base will be used, a Shapiro Wilks normality test will be performed to confirm a normal distribution and then an ANOVA of repeated measures to confirm the hypothesis.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged over 18 years old, operated of lumbar spine arthrodesis for degenerative spinal stenosis at Traumatological Institute of Santiago de Chile

Exclusion Criteria:

* Overweight
* Underweight
* Previous Surgeries
* Postoperative complications
* Higher pain in lower limbs than in low back
* Inability to exercise
Effect of Care Management on Diabetes Outcomes

The purpose of the study is to determine if a nurse managed, protocol driven, disease management process for diabetes results in improved attainment of therapeutic goals for diabetes compared to usual care. It is hypothesized that implementation of the disease management process will improve the percentage of diabetic individuals attaining all three therapeutic targets (HgbA1C\<8.0%, LDL\<100mg/dl, and BP\<130/80mmHG) by 10% compared to usual care.


Eligibility Criteria:
Inclusion Criteria:

* Enrolled at Minneapolis VAMC
* Type 1 or 2 diabetes
* Blood pressure at screening visit \> 140mmHg systolic or \> 90mmHg diastolic OR HgbA1C at screening visit \> 9.0% OR LDL at screening visit \> 100mg/dL

Exclusion Criteria:

* Primary care provider unwilling to have participant included in study
* Life expectancy \< 1 year
* Unable to give consent
* Severe mental health condition
* pregnant or planning on becoming pregnant
Evaluation of Safety and Efficacy of Nasea(R)/Ramosetron Inj. in Patients Undergoing Facial Bone Fracture Operations

Postoperative nausea and vomiting (PONV) is one of the most common and distressing complications after anaesthesia and surgery, and may lead to serious postoperative complications This prospective, randomized study designed to evaluate the best injection time to get the prophylactic anti-emetic efficacy of ramosetron, a newly developed 5-HT(3) antagonist in patients undergoing facial bone surgery.

1. Participants

   * 100 patients with undergoing facial bone surgery are going to be randomly allocated to one of the 3 groups
2. Randomization

   * G1(n=33) - Ramosetron 0.3mg i.v. just before the beginning of the surgery
   * G2(n=33) - Ramosetron 0.3mg i.v. just after the end of the surgery and moving into the Recovery room
   * G3(n=33) - No medication but regular antiemetics i.v. if the patient wants
3. The primary endpoint

   * the incidence of nausea and vomiting for 24 h after surgery at 0-6h, 6-12 h and 12-24 h
4. The secondary endpoints

   * the severity of nausea, need for rescue medication
   * patient satisfaction with efficacy

Eligibility Criteria:
Inclusion Criteria:

* Patient who sign informed consent form for the study
* patient who are considered as surgical candidates with facial bones fracture

Exclusion Criteria:

* Patient who have had nausea/vomiting episodes
A Prospective, Pilot Evaluation of Device Equivalence

Patients with chronic wounds will be imaged using 3 imaging devices. Two types of images will be acquired with each device, as standard photograph (ST-image) and a fluorescence image (FL-image). The images captured with the 3 imaging devices will be compared off-line by 5 interpreters to assess for any differences in the images that would alter a clinical decision.

Patients (n = 50) with chronic wounds will be imaged using 3 imaging devices. Two types of images will be acquired with each device, as standard photograph (ST-image) and a fluorescence image (FL-image). The images captured with the 3 imaging devices will be compared off-line by 5 interpreters to assess for any differences in the images that would alter a clinical decision.

Eligibility Criteria:
Inclusion Criteria:

* Subjects (inpatient/outpatient) presenting with a wound
* Wound size less than 15 cm in length
* 18 years or older

Exclusion Criteria:

* Treatment with an investigational drug within 1 month before study enrolment
* Subjects with recent (\<30 days) biopsy or curettage of target wound
* Subjects with wounds that cannot be completely imaged by study device due to anatomic location
* Unable or unwilling to consent
Effect of a Psychological Intervention on Antiretroviral Therapy and Mental Health Outcomes in HIV-positive Adults in Zimbabwe

The aim of the study is to examine the effect of a psychological intervention on antiretroviral therapy outcomes and symptoms of common mental health disorders among adults living with HIV and common mental disorders in rural Zimbabwe.

Common mental disorders are highly prevalent among people living with HIV. Left untreated, common mental disorders cause substantial disability and undermine individuals' ability to adhere to antiretroviral therapy, leading to poor antiretroviral therapy outcomes.

A recent cluster-randomized controlled trial from Harare, Zimbabwe showed that the friendship bench intervention (i.e. six sessions of problem-solving therapy delivered by lay health workers followed by a peer support group) effectively reduced symptoms of common mental disorders, but the effect of the intervention on antiretroviral therapy outcomes and its effectiveness in the rural setting has not been studied.

To examine the effect of the friendship bench intervention on antiretroviral therapy outcomes and symptoms of common mental disorders among adults living with HIV and common mental disorders in rural Zimbabwe, a cluster-randomized trial is conducted.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Use of first-line antiretroviral therapy for at least 6 months
* Resident in Bikita District
* Knowledge of English or Shona language
* Ability to comprehend the information on the study
* Positive screening for common mental disorders (SSQ-14 score ≥9)
* Providing informed consent

Exclusion Criteria:

* Current psychosis / cognitive impairment
* Clinical AIDS (WHO clinical stage 4)
* Known pregnancy or ≤3 months postpartum
Intraoperative Pathway in DIEP Flap Breast Reconstruction

Efficiency in the operating room can be difficult in long cases with multiple surgeons. We used a team based approach to develop an intraoperative pathway for microsurgical breast reconstruction with a deep inferior epigastric perforator flap.

A team based approach was developed with an intraoperative pathway for microsurgical breast reconstruction with a deep inferior epigastric perforator flap.

Eligibility Criteria:
Inclusion Criteria:

* All cases prior to pathway

Exclusion Criteria:

* None
Gastric- Versus Jejunal Feeding Tubes in Alcoholic Liver Diseases

The study is an unblinded randomized trial, designed to examine whether gastric- or jejunal feeding tubes are the most effect full to feed patients with alcoholic liver diseases and non-sufficient oral intake.

The primary outcome will be differences in nutrition intake between the groups. Secondary outcomes will be: the amount of unplanned tube discontinuations; handgrip and patients' quality of life, nausea \& vomiting.

The study will include 40 patients at Aarhus University Hospital, Denmark.


Eligibility Criteria:
Inclusion Criteria:

* Alcoholic liver disease
* nutrition intake less than 75% of needed intake
* Signed informed consent form

Exclusion Criteria:

* Hepatic encephalopathy, grade 3 - 4
* Anatomic barriers to have a tube placed
Recruitment of Patients Through Invitation Letters

Recruitment of patients with schizophrenia to clinical trials is difficult and in an ongoing project different methods of recruitment have been used in order to recruit. One of the methods used have been sending potential participant to the study an invitation letter with information of the study and an invitation to make contact with a project nurse. Not many patients have replied.

The aim of this study is to examine whether a simplified version of the invitation Letter, in terms of information structure and written style will encourage more patients to make contact to a project nurse.

It is found that patients suffering from Schizophrenia have a positive attitude concerning participation in a research project but this doesn't always lead to recruitment. This might be due to schizophrenia being a disease causing self-disturbances in communication and contact to the surrounding World. It may lead to vulnerability in decision-making an a lower decision making capacity. Language disability is one of the most notable cognitive deficits in patients suffering from Schizophrenia and can be devided in to main components of usage and comprehension. Patients experience poorer listening comprehension and reading comprehension with no correlation to either age or education level and studies have shown that patients with schizophrenia have low literacy.

Therefore the aim of this study is to examine whether a rewritten version of an invitation Letter, taking in consideration patients low literacy and therefore written in simple sentences and with a sequential structure of information will make more patients take contact to a project nurse compared to patients receiving the original invitation Letter. The study design is a randomized controlled trial testing the old letter against the new letter.

Eligibility Criteria:
Inclusion Criteria:

* \>18 years
* Patients with a diagnosis within the spectre of Schizophrenia (F-20 to F-25) for at least ten years
* At the time of recruitment, a diagnosis of either F-20 or F-25 ( all diagnoses from ICD-10)
* Recidency in the Northern part of Jutland
* In treatment by an outpatient team
* Low frequency of contact with a clinician, once a month at the most

Exclusion Criteria:

* No exclusion criteria for receiving an invitation Letter
Metabolite Biomarkers Related to Acute Rejection in Kidney Transplantation

The development of acute rejection can only be considered in cases with increasing serum creatinine in patients with kidney transplantation. However, the serum creatinine itself is not specific but also accurate for detection of acute rejection. So The specific biomarker is required for acute rejection of kidney transplant. In this study, the investigators will enroll 200 consecutive kidney transplant patients in Seoul National University Hospital and follow up. Serial collection of urine and serum will be done. Acute rejection specific urine metabolite will be found by LC MS/MS.


Eligibility Criteria:
Inclusion Criteria:

* Kidney transplant patients in Seoul National University Hospital
* Patients with triple maintenance immunosuppression including Tacrolimus, mycophenolate and steroid

Exclusion Criteria:

* History of other organ transplantation
* ABOi and/or crossmatch(+) transplantation
Short- and Medium-term Evaluation of Mastoid Filling Using Bioactive Glass"

Adult patients referred to the ENT surgery department of the Hospices Civils de Lyon with cholesteatoma that had never been operated on.

All patients will benefit from surgical management for cholesteatoma initially in the operating room under general anesthesia. The surgical technique (closed technique) is the reference technique for the management of cholesteatoma in adults. It involves a cartilaginous removal to reconstruct the attical region. Then a filling material is used to fill the mastoid (GlassBONE™ or Bonalive™), and above all to stabilize the cartilaginous fragment to prevent a recurrence.

Patients are operated on as an outpatient and receive a phone call the next morning to look for an initial complication. The patients will be reviewed in consultation at D8, D45, 3 months, 6 months and at 18 months with clinical examination (otoscopy) and audiometry at each consultation. The consultation on D8 is used for removal of the expandable cotton put in place in the external auditory canal (CAE) during surgery to guide healing, control post-auricular healing and look for signs of complication during the examination. A cone beam (CBCT) is performed during the consultation on D45 to confirm the correct position of the ossiculoplasty and check the persistence of the initial filling. The proportion of filled mastoid at D45 will serve as a reference to then be compared to the CT scan at 6 months and at 18 months. During surgery, and at the consultation at 6 months and 18 months, patients will also have to complete a quality of life questionnaire (Chronic Ear Survey French version; in the Appendix).

Eligibility Criteria:
Inclusion Criteria:

* Patients at least 18 years old
* Patients with proven cholesteatoma
* Patient requiring and agreeing to surgery with filling of the mastoid or tympanic epi (closed technique with filling)
* Patient having a surgery with filling in first intention

Exclusion Criteria:

* Background:
* Known outer, middle or inner ear malformation
* Congenital cholesteatoma
* Previously operated cholesteatoma
* Cholesteatoma requiring an open technique or presenting with chronic non-cholesteatomatous otitis
* Contraindications to the use of GlassBONE™ or Bonalive™
* Pregnant, parturient or nursing mothers
* Persons deprived of their liberty by a judicial or administrative decision, persons subject to psychiatric care, adults subject to a measure of legal protection or unable to express themselves
* Patient participating in interventional research excluding routine care research (old regulations) and category 2 research that does not interfere with the analysis of the primary endpoint
* Patient objecting to the use of their data
Near Death Experience (NDE) and Migraine

Migraine is a common disabling primary headache disorder. Epidemiological studies have documented its high prevalence and high socio-economic and personal impacts. Migraine affects more than 20% of the French population. However, the physiopathology of migraine is always partially known. Cortical spreading depression (CSD) is the widely accepted as the electrophysiologic substrate of migraine aura. CSD is a slowly propagating wave of transient neuronal and glial depolarization. The near death experience (NDE) is a rare, but well known phenomenon. NDE are profound psychic experiences commonly occuring in life-threatening conditions. Among the neurological hypotheses, epilepsy, temporal lobe disorders , REM-sleep intrusion have been discussed. However, the role of DCE has never been discussed. The goals of this study are : to see if there is an epidemiological link between NDE and migraine/ to specify if NDE was followed by a migrainous headache.


Eligibility Criteria:
Inclusion Criteria:

* Subject who experienced an NDE defined by the occurrence, when the subject is in a state of clinical death or a particular state of consciousness of a following event: body output experience, disembodiment, for a tunnel and / or light;
* Topic recorded in the EMI database (Dr. Postel, National Center for Education, Research and Information on the conscience;
* Topic agreeing to participate in the study.

Exclusion Criteria:

* Patient mental condition or disorder or psychiatric history or any other factor limiting the ability to participate in an informed manner and compliant to the study;
* Other than obtained Participation Agreement.
A Phase II Study of CODOX-M/ IVAC in Relapsed/Refractory ALL

A Phase II Study of CODOX-M/ IVAC in Relapsed/Refractory ALL

The feasibility will be evaluated in terms of complete remission rate, duration of complete remission, disease-free survival, overall survival, and toxicities.

Eligibility Criteria:
Inclusion Criteria:

* Patients with relapsed/resistant acute lymphoblastic leukemia
* Patients must be between 15 and 65 years of age.
* Estimated life expectancy of more than 3 months
* ECOG performance status of 2 or lower, Karnofsky scale \> 60 (see appendix I)
* Adequate cardiac function (EF\>45%) on echocardiogram or MUGA scan
* Adequate kidney function (estimated Ccr \>50 ml/min)

Exclusion Criteria:

* Patients with CNS involvement of leukemic blasts will not be excluded.
* Patients with extramedullary relapse(s) only will be excluded.
Systemic Consolidation Therapy After Primary Chemoradiation Therapy for Locally Advanced Cervical Cancer

The purpose of this study is to determine the therapeutic efficacy and complications of systemic consolidation therapy with paclitaxel plus carboplatin following primary chemoradiation for locally advanced cervical cancer.

Systemic consolidation therapy with paclitaxel plus carboplatin (3 cycles per 3 weeks) following primary chemoradiation (3 cycles per 3 weeks) for locally advanced cervical cancer will elevate the therapeutic efficacy by removing the microscopic metastatic lesions which could not be identified by naked eye and diagnostic imaging tests.

Eligibility Criteria:
Inclusion Criteria:

* patients who underwent three cycles of concurrent chemoradiation therapy with paclitaxel and carboplatin for non-small cell type cervical cancer stage IB2, bulky size (\>4cm) IIA,IIB-IVA
* above 20 years
* GOG performance status 0-2
* Informed consent
* Platelet\>100K, Hb\> 10.0 g/dl, ANC\>1500/mm3, Cr \<1.25\*upper normal limit, bilirubin\<1.5mg/dl, AST \& ALT\<\*3 upper normal limit
* Expected life \> 6 months

Exclusion Criteria:

* Peripheral neurotoxicity \> NCI CTCAE grade 2
* Sever infection
* Previous history with chemotherapy or radiation therapy
* Pleural effusion, pericardial effusion, and ascites which could cause dyspnea \> NCI grade 2
* Paraaortic lymph node metastasis
* Allergy with platinum
* Previous history of atrial or ventricular arrhythmia or congestive heart failure
* Uncontrolled infection, diabetes mellitus, hypertension, ischemic heart disease, myocardiac infarct within 6 months
* Severe disease such as acute or chronic renal failure and acute cerebral infarct, cerebral hemorrhage, recurrent hepatitis, liver cirrhosis, unknown fever above 39 degrees centigrade
Endoscopic Full Thickness Resection in the Lower GI Tract With the "Full Thickness Resection Device"

Observational prospective multicenter study to investigate efficacy and safety of endoscopic full thickness resection in the lower GI tract using a novel over-the-scope full thickness resection device.

The FTRD ("Full Thickness Resection Device", Ovesco Endoscopy, Tübingen, Germany) is an over the scope device consisting of a transparent cap with a preloaded monofilament snare and and a 14 mm modified Over-the-scope Clip. The device is CE marked for full thickness resection in the lower GI tract.

The study was designed to investigate efficacy and safety of this device for full thickness resection of colorectal lesions.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 y
* Adenoma with negtive lifting sign
* Adenoma involving or next to a diverticulum
* Adenoma involving or next to the appendical orifice
* T1 carcinoma with indication for endoscopic (re-)resection
* Subepithelial colorectal tumor with indication for resection

Exclusion Criteria:

* Lesions \>3 cm
* T1 carcinomas with known high-risk features (submucosal infiltration\>1000 um, invasion of lymphatic vessels, poor differentiation (G3))
* Lesions in the upper GI tract
* Patients with colorectal stenosis
* Patinets not able to undergo informed consent
* Pregnancy
* Patients with urgent indication for dual thrombocyte aggregation inhibition
Eliminate Coronary Artery Disease

The purpose of this study is to determine whether pharmacologic lowering of low density lipoprotein cholesterol (LDL), initiated in healthy young to middle aged adults can eliminate or markedly reduce the composite endpoint of incident all cause mortality, myocardial infarction, stroke or coronary revascularization.


Eligibility Criteria:
Inclusion Criteria:

* Men 35-50 years of age
* Women 45 - 59 years of age (must be sterile or \>2 years postmenopausal)
* LDL cholesterol greater than 1.8 mmol/L (70 mg/dL) based on testing performed within 1 year
* One risk factor for Coronary Heart Disease other than lipid abnormality:
* Obesity and hypertension \[BP \>140 mmHg systolic and waist circumference \> 100 cm in men and \>90 cm in women\]
* family history of premature myocardial infarction \[\<60 years\]
* South Asian ethnic history
* currently smoking

Exclusion Criteria:

* Currently taking cholesterol lowering medication
* Qualify for cholesterol lowering medication based on current guidelines
* Significant renal dysfunction (creatinine clearance \<30 ml/min)
* Significant hepatic dysfunction (AST/ALT \>2.0 times upper limit of normal)
* Active malignancy
* Diabetes
* Progressive or terminal illness, or other condition in which subject is unlikely to survive the study period
* Known allergy, hypersensitivity (anaphylaxis) ar adverse reaction to any statin
* Participation in a clinical trial (except observational studies) within previous 30 days
* Received any investigation product within 30 days prior to participation in this clinical trial
* Previously enrolled in this clinical trial
24-Hour Intraocular Pressure (IOP) Control With Travoprost/Timolol Fixed Combination

The purpose of this study is to compare the short-term (8 week) mean 24-hour intraocular pressure control and safety of TravTim fixed combination given once in the evening with placebo once in the morning versus TravTim given once in the morning with placebo once in the evening in patients with open-angle glaucoma.


Eligibility Criteria:
Inclusion Criteria:

* POAG
* Exfoliation syndrome

Exclusion Criteria:

* Advanced glaucoma