cyrilzakka/clinical-trials huggingface dataset:
Effect of MOPs During Orthodontic Movement in Periodontitis Patients

Micro-osteoperforations (MOPs) cause cortical bone injuries and consequently increase the expression of inflammatory mediators, allowing for increased bone and periodontal ligament remodeling associated with orthodontic movement. It remains unclear the effect of orthodontic intrusion combined with MOPs application on teeth with reduced periodontium. The general objective will be to determine the efficacy of MOPs during orthodontic tooth movement (OTM) in terms of periodontal and orthodontic outcomes in stage IV periodontitis patients, case type 2 with pathological tooth migration (PTM), characterized the presence of at least one flared tooth of the upper-anterior sextant with an intrabony defect (intrabony component \<5mm)

This is a comparative 2-arm parallel single-blinded randomized controlled clinical trial, with allocation ratio of 1:1, aimed to test an intervention (the use of MOPs) on CAL changes 12 months after placing orthodontic appliances. The control intervention will be the same treatment without the bone traumatic intervention.

Sample: Patients with stage IV periodontitis case type 2 characterized with PTM characterized the presence of at least one flared tooth of the upper-anterior sextant with an intrabony defect (intrabony component \<5mm) attending the Post-graduate Program of Periodontology and the Post-graduate Program of Orthodontics of the Faculty of Dentistry at the Complutense University of Madrid (UCM).

Eligibility Criteria:
Inclusion Criteria:

Patients will be included if agreeing to undertake combined periodontal and orthodontic therapy following the clinical practice guideline of stage IV periodontitis patients, and fulfilling the following criteria:

* adult patients older than 18-year-old;
* systemically healthy (see exclusion criteria);
* diagnosed as stage IV (Papapanou et al., 2018) case-type 2 (Herrera et al. 2022) periodontitis;
* the presence of at least one flared tooth of the upper-anterior sextant with an intrabony defect (intrabonny component \<5mm) (experimental teeth);
* in need of orthodontic therapy.

Exclusion Criteria:

* systemic diseases (diabetes mellitus, obesity, cardiovascular diseases);
* any medication that could affect the level of inflammation, (such as chronic antibiotics, phenytoin, cyclosporin, anti-inflammatory drugs, systemic corticosteroids, or calcium channel blockers);
* pregnant or lactating woman;
* inability to respond questions or to attend follow-up visits;
* extreme skeletal malocclusions requiring orthognathic surgery;
* patients smoking more than 10 cigarettes/day; and
* the presence of PD greater or equal to 5mm with BOP after step 3 of periodontal therapy
Mobile Sipoo - Telemonitoring With Combined With Active Assistance Technology

Mobile Sipoo is a randomized controlled trial aiming to improve selfcare and outcomes of diabetes and hypertensive patients by introducing a remote patient monitoring system supported with automatic patient decision support. The feedback system is coupled with back-office health coaching.

Self-monitored data from blood pressure meters (SMBP), glucometers (SMBG), scales and pedometers are transferred by mobile phone terminals to a tethered personal health record (PHR) integrated with the provider EHR. The PHR application includes tools to display of self-monitoring data.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of diabetes or hypertension made at least 6 months prior to inclusion to study.
* For hypertensive patients: Blood pressure over 140/90 mmHg (systolic and diastolic separately) treated or untreated
* Diabetes patients: Glycohemoglobin A1c over 6.5% but lower that 11%
* use of diabetes medication

Exclusion Criteria:

* Patients who decline to participate
* Patients specifically excluded by the health centre physician
* Patients unable to co-operate, expected poor study compliance (IT illiterate) or reluctance to perform self monitoring
* Pregnancy
* Patients with a life expectance of less than one year
* Patients with major elective surgery planned within 6 months or patient has had major surgery within last 2 months.
* Patients with psychiatric disorders (depression), abuse of alcohol or narcotics complicating or disabling participation in the study
Correlation Between Intestinal Parasites and Serum Level of Eosinophils and IgE in Individuals With HIV or AIDS

Correlation between intestinal parasites and serum level of eosinophils and IgE in individuals with HIV or aids attended at clinical hospital of the Botucatu Medical School-UNESP

The present study correlates intestinal parasitism and levels of eosonophils and of serum IgEs in patients attended at the C.H. of the School of Medicine - Botucatu/UNESP. Thirty adult patients with AIDS were analyzed in the use of HAART, aged 42 ±11 years, 14 (46.7%) male, excluding those that had used anthelminthics 30 days prior to collection. Socioeconomic questionaires were applied and 3 samples of feces were taken for parasitological exams (TF-test® method) and 5 ml of blood for counting eosinophils (automated hematological counter, Pentra 80, ABX) and IgE doses (equipment BN-100, Dade-Behring). The index of parasites was 10%, with E.nana (3.3%), E.coli (3.3%) and B.hominis (3.3%). Parasitized individuals were from an urban region with complete basic sanitation and good socioeconomic level. Normal eosinphil values were found in all samples and increased IgE values in 1 (33.3%) sample. The index of parasites was low due to good socioeconomic level and disease control. Augmented IgE levels corroborate the literature, which reports an increase characteristic of immune response in the face of parasitic infections in individuals with HIV or AIDS. In conclusion, new studies should be undertaken to evaluate the level of eosinophils associated with cytokines to obtain a better understanding of this correlation.

Eligibility Criteria:
Inclusion Criteria:

* HIV or AIDS
* age same or superior to 18 years,
* both sexes
* assisted by the Hospital of the Clinics of Botucatu Medical School-UNESP

Exclusion Criteria:

* use of anthelminthic in the period of 30 days antecedents the it dates from collection
* individuals that don't have all of the necessary evaluations to the objectives of the study
* individuals that abandon the attendance, or that you/they are to death during the study
Standard Treatment for Non-specific Low Back Pain Combined With Multimodal Osteopathy Treatment on Pain Intensity and Functional Capacity

Background: Low back pain is one of the most common musculoskeletal health problem with the highest prevalence in the adult population; globally, it represents a relevant cause of medical, social and economic burden. The aim of the proposed study is to determine the effect of a standard treatment for non-specific low back (CNSLBP) combined with multimodal osteopathy treatment on pain intensity and functional capacity.

Methods: This will be a blind randomized clinical trial, with 44 patients with CNSLBP, randomly assigned into two groups: Experimental group (EG) treated with therapeutic exercises and multimodal osteopathy treatment (n=22) and Control group (CG) treated with therapeutic exercises (n=22). Participants will receive treatment twice a week (total of 16 sessions). The primary outcome is pain, measured by numeric rating scale (NRS: score 0-11 points). Secondary outcomes are: Patient-specific functional scale (scored from 0 to 30), Oswestry Disability Questionnaire (ODQ), finger-to-floor distance test (FFD). Participants will be evaluated pre- and post-treatment and after 1 and 3 months (follow-up).

Results: Analysis will be by intention to treat using linear mixed models. Comparisons between groups before and after treatment will demonstrate whether osteopathy treatment exerts a supplementary effect on pain and functional capacity in patients with CNSLBP. The data will be published after the study is completed. The study will support the practice of evidence-based physical therapy for individuals with CNSLBP.


Eligibility Criteria:
Inclusion Criteria:

* Individuals within the age range of 18-70 years;
* Chronic low back pain in the region between the 12th rib and the gluteal fold, with a minimum duration of 6 weeks with or without referral of pain in the lower limbs;
* no specific cause detectable, such as infection, neoplasia, metastasis, osteoporosis, rheumatoid arthritis, fracture, inflammatory process or radicular syndrome.
* baseline pain: minimum intensity score of 3 out of 10 (0 = no pain, 10 = most intense pain) considered and verified by the Numerical Pain Rating Scale (NPRS).

Exclusion Criteria:

* Previous history of spinal disorders (local trauma, cauda equina syndrome, spinal canal stenosis, congenital abnormalities tumor);
* Inflammatory or infectious diseases (rheumatoid arthritis, fibromyalgia and vertebral osteomyelitis);
* Previous lumbar spine surgery;
* Pregnant women;
* Regular opioid analgesics (≥2 times per week) or opioid patches;
* Receiving disability benefits for back pain or even for another health reason;
* Previous injections for back pain, such as facet joint blocks, nerve root or epidural steroid injection in the previous year;
* Having undergone physical therapy, massage, acupuncture or any other therapeutic intervention for back pain in the previous two weeks;
* Osteopathy techniques that are not used as a treatment for low back pain;
* Neuropathic pain tested with Laségue and Valsalva clinical tests.
Group Interpersonal Psychotherapy for Depressed Adolescents in School-based Clinics

This study will assess the effectiveness of group interpersonal psychotherapy (IPT-AG) versus treatment as usual (TAU) in improving the treatment of depressed adolescents in school-based health clinics.

Depression is a serious medical condition. It occurs in people of all ages, but only in the past two decades has depression in children and adolescents been taken seriously. Children and adolescents with depression may exhibit such behaviors as pretending to be sick, refusing to go to school or getting in trouble at school, clinging to a parent or worrying that the parent may die, sulking, or acting in a negative or grouchy manner. A previous study demonstrated that, when administered by clinicians in school-based clinics, individual interpersonal psychotherapy is effective in reducing depressive symptoms and improving global and social functioning. This study will assess the effectiveness of group interpersonal psychotherapy (IPT-AG) versus treatment as usual (TAU) in improving depressive symptoms of adolescents in school-based health clinics.

Participants in this 16-week single-blind study will be randomly assigned to receive either IPT-AG or TAU in a school-based clinic. Participants assigned to receive IPT-AG will attend two to three, 40-minute individual pre-group sessions, followed by 12, 90-minute group therapy sessions and two additional individual sessions-one midway through the group sessions and another upon completion of group therapy. TAU will consist of counseling sessions as regularly conducted by the school clinic social worker and/or referral to another agency. Study visits will occur at baseline and Weeks 4, 8, 12, and 16, or upon early termination. At the end of 16 weeks, participants assigned to receive IPT-AG will continue in a maintenance program in which they will receive IPT-AG once a month for an additional 6 months. All participants will also be assessed 6 and 12 months post-treatment to measure depressive symptoms, global and social functioning, satisfaction with care, and utilization of other services.

Eligibility Criteria:
Inclusion Criteria:

* Meets diagnostic criteria for major depression, dysthymic disorder, depressive disorder not otherwise specified, or adjustment disorder with depressed mood
* Score of 24 or greater on the CES-D
* Score between 10 and 28 on the HRSD
* Score of 65 or less on the C-GAS
* English-speaking
* Parental or legal guardian consent to participate

Exclusion Criteria:

* Actively suicidal
* Score greater than 28 on the HRSD
* Mentally retarded
* Any life threatening medical illness
* Meets diagnostic criteria for current substance abuse, schizophrenia, or bipolar disorder
* Any evidence of psychosis, conduct disorder, or active eating disorder
* Currently in active treatment for depression
* Taking antidepressant medication at the time of baseline assessment
* Recent death of someone close
Study About Patient Comfort and Long-term Outcome After Stapled Hemorrhoidopexy

The purpose of this study was to determine the influence on Patient comfort after Stapled Hemorrhoidopexy versus Milligan Morgan (two surgical procedures)in third degree circular hemorrhoids.

There are well known advantages in the short-outcome, however, there are still some uncertainties about the long-term results and recurrence rates, and only a few data of randomized trials are available.

In most studies the patient population was heterogeneous with a varied degree of treated hemorrhoids, and different surgical procedures were performed. Therefore we initiated this prospective randomized controlled study of a homogeneous patient population with only circular third-degree hemorrhoids and clearly defined operative procedures. All patients with symptomatic, reducible circular third-degree hemorrhoidal disease were randomly assigned to undergo either the Milligan-Morgan technique or the stapling procedure. Patients were excluded from the study if they had single third-degree hemorrhoids, acute incarcerated hemorrhoids, intercurrent acute anal fissure and/or acute anal fistula, or prior hemorrhoidectomy. The main end point parameter of this study was to compare both groups with respect to patient comfort and postoperative pain. Secondary end points included the long-term recurrence rate of hemorrhoidal disease after a minimum of 4 years.

Eligibility Criteria:
Inclusion Criteria:

* third degree circular hemorrhoids
* symptomatic
* reducible

Exclusion Criteria:

* single third-degree hemorrhoids
* acute incarcerated hemorrhoids
* intercurrent acute anal fissure
* acute anal fistula
* prior hemorrhoidectomy.
Endovascular Repair of AAA

We study differen t endovascular techniques as an alternative to surgical reconstruction to repair AAAS regarding ; success rates, 30-day mortality, endoleak events secondary intervention rates


Eligibility Criteria:
Inclusion Criteria:

* Older than 18

Exclusion Criteria:

* inflammatory or mycotic AAA
Functional Neuroimaging in Depression

Oral administration of escitalopram during 8 weeks; PET scan with 18F-FDG at inclusion and after 8 weeks


Eligibility Criteria:
Inclusion Criteria:

* Major Depression, Depressive episode, following DSM-IV criteria
* MADRS-score \> 25
* Age: 18-65 yrs
* Medication-free or anti-depressant wash-out 7 days (for fluoxetine: 6 weeks)
* Lorazepam 1mg or zolpidem 10mg are allowed

Exclusion Criteria:

* Suicidality
* Bipolar disorder, following DSM-IV criteria
* Psychotic symptoms
* Substance abuse
* Personality disorder, following DSM-IV criteria
* Cognitive dysfunction due to trauma capitis or dementia
* Diabetes mellitus
* Women without contraceptive protection, with pregnancy or breast feeding
* Pharmacological treatment or ingestion of substance that can influence cerebral perfusion less than a month before inclusion
* IQ below 80
* Conditions not compatible with SPC
Intranasal Dexmedetomidine Versus Intranasal Midazolam as a Premedication in Pediatrics Undergoing Upper GI Endoscopy

compare the effectiveness of intranasal dexmedetomidine and midazolam as a premedication in sedation of preschool children in GI endoscopy


Eligibility Criteria:
Inclusion Criteria:

* Children of preschool age (2-6 years old).
* American scocity of anaesthesiology (ASA) I - II children.
* Expected duration of the procedure is less than 50 minutes.

Exclusion Criteria:

* Cardiac arrhythmia, congenital heart disease, or hemodynamic or respiratory instability; children at risk for airway obstruction.
* Behavioral, mental or developmental abnormality (example: mental retardation, Attention Deficit Hyperactivity Disorder "ADHD", Autism, Down syndrome).
* Regular intake of either brain stimulant or depressive drugs (example: Methylphenidate, amphetamine-dextroamphetamine and diazepam respectively).
* Parent's refusal.
* Emergency case.
* Allergy to any of the used drugs
A Study of an Oral Short-course Regimen Including Bedaquiline for the Treatment of Participants With Multidrug-resistant Tuberculosis in China

The purpose of this study is to evaluate efficacy and safety of an oral bedaquiline-containing multidrug-resistant tuberculosis (MDR-TB) short-course regimen (SCR) compared to an oral SCR not including bedaquiline at the end of treatment in participants with pulmonary MDR-TB in China.


Eligibility Criteria:
Inclusion Criteria:

* Has a positive sputum Mycobacterium tuberculosis culture from a test performed at screening
* Has microbiological confirmation of rifampicin resistance by GeneXpert and to isoniazid (INH) via molecular drug-susceptibility testing (DST) showing katG mutation
* Has a chest imaging result compatible with a diagnosis of pulmonary Tuberculosis (TB)
* Agrees to use effective contraception during the 40-week study treatment phase. A female participant must be: of nonchildbearing potential; of childbearing potential and practicing effective methods of contraception during the 40-week study treatment phase
* Is willing to undergo human immunodeficiency virus (HIV) testing

Exclusion Criteria:

* Has received prior treatment with bedaquiline
* Has prior exposure to at least 1 second-line drug in the regimen for at least 4 weeks
* Has any grade 3 or 4 laboratory abnormality as confirmed by a clinical expert
* Has a known allergy or intolerance to bedaquiline or other drugs in the regimen
* Is infected with a strain of nontuberculous mycobacteria
* Is HIV-positive
Efficacy of Dolasetron in Patients With Fibromyalgia

This study offers a new treatment, dolasetron or ANZEMET ®, which will be administered by intravenous way once a day during a 4 days Hospitalization.

This study is double blind (neither you nor the physician will know if you are receiving active study drug or placebo).

Randomisation at the beginning of the study will decide whether you receive active treatment or its placebo.

This treatment will be renewed after one month, after 2 months and after 3 months.

If the study staff determines that you are eligible and you decide to participate, there will be approximately 6 study visits in about 9 months. During these visits, you will undergo routine health exams and complete different kinds of questionnaires.

Following this first period of 3 months, you agree to come back for consultation at month 4, month 6 and month 12 for monitoring and evaluating the effects of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 to 75
* Primitive Fibromyalgia according to ACR criteria
* Patient no responding to conventional treatment
* Women of childbearing age using an efficace contraception
* Signed consent

Exclusion Criteria:

* Inflammatory rheumatic diseases
* Diseases of the system: Gougerot Sjögren, polymyositis, vasculitis,
* Infectious diseases: hepatitis B and C, lyme disease, HIV,
* Hypothyroidism,
* Bone and mineral metabolism disorders
* Disorders of cardiac conduction
* Failure of Heart, of kidney or liver,
* Patient allergic to dolasetron
* Pregnant or nursing women
* Women without means of contraception,
* Age \<18 or \> 75 years.
Pelvic Drains After Radical Hysterectomy in Treating Patients With Uterine, Cervical, or Vaginal Cancer

RATIONALE: The use of pelvic drains may help to prevent complications following radical hysterectomy and pelvic lymphadenectomy. It is not known whether receiving pelvic drains during surgery is more effective than receiving no pelvic drains during surgery in patients with uterine, cervical, or vaginal cancer.

PURPOSE: Randomized phase III trial to determine if the use of pelvic drains following radical hysterectomy and pelvic lymphadenectomy is effective in treating patients with uterine, cervical, or vaginal cancer.

OBJECTIVES: I. Evaluate postoperative complications associated with the use or omission of pelvic drains following radical hysterectomy and node dissection that includes suturing of the vaginal cuff and no peritonealization.

OUTLINE: This is a randomized, two-arm study. All patients receive radical hysterectomy (Rutledge-Piver II-III type) and pelvic lymphadenectomy, without pelvic and parietal peritonealization, with suturing of the vaginal cuff and closure of fascia and cutaneous layers; lumboaortic node dissection is optional. Patients are randomized during surgery to one of two arms: those on arm I receive pelvic drains and those on arm II do not. Those in arm I have drains applied in the pelvis, and lymph is collected by vaginal and/or transabdominal drains located in both retroperitoneal fossa. Drains are removed when the loss is less than 50 mL in 24 hours. Patients in both arms are followed at 2-3 months and 12 months after surgery.

PROJECTED ACCRUAL: 214 patients will be accrued for this study within 2 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven cervical, vaginal, or endometrial carcinoma for which abdominal radical hysterectomy (Rutledge-Piver II or III type) and pelvic node dissection is indicated The following are excluded: Extensive intraoperative retroperitoneal blood loss (more than 3000 mL) Excessive postsurgical hemorrhage or oozing of the wound area requiring postoperative drainage Concurrent urinary or bowel injury/deviation or surgical procedures for urinary incontinence (Burch etc.) Application of prophylactic abdominal mesh for subsequent radiotherapy

PATIENT CHARACTERISTICS: Age: Not specified Performance status: WHO 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Not pregnant

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior neoadjuvant chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: See Disease Characteristics
Static Implant Versus Dynamic Implant in the Surgical Treatment on Ankle Syndesmosis Rupture

Ankle fracture is frequent and its number is increasing. In Canada, surgical treatment of these lesions is advised and the options currently used all have in common a rigid fixation of the syndesmosis which results in residual stiffness and a high level of secondary surgery, mostly to remove the implant.

The purpose of the study is to compare the treatment of ankle syndesmotic rupture by a dynamic fixation to a static fixation suggesting that the dynamic fixation method will improve the Olerud-Molander functional score of more than 15 points at the 3 months follow-up.


Eligibility Criteria:
Inclusion Criteria:

* men or women ≥ 18 years-old;
* ankle fracture type 44-C (AO classification) with an AP, lateral and mortise X-ray views of the ankle and an AP and lateral X-ray views of the leg;
* open fractures (Gustilo I-IIIb) or closed;
* trauma-surgery delay of less than 7 days;
* consent form signed.

Exclusion Criteria:

* ankle fractures without syndesmotic lesion;
* fracture associated with neuro-vascular lesions (Gustillo IIIc);
* pathologic fracture;
* fracture in a polytraumatized patient;
* fracture of a bone in the ipsilateral leg;
* men or women \> 65 years-old;
* chronic cardiac insufficiency (ejection fraction \< 30%);
* lower leg chronic venous insufficiency;
* neuro-arthropathic foot (Charcot, diabetes, etc...);
* body mass index ≥ 40;
* past medical history of fracture of the same ankle;
* medical conditions too serious for a surgery;
* men or women unfit to consent;
* any other conditions that make the examinator thinks that the follow up would be problematic.