cyrilzakka/clinical-trials huggingface dataset:
Human Papillomavirus (HPV) Vaccination in Barretos (Pio XII Foundation - Barretos Cancer Hospital)

PROJECT JUSTIFICATION: Cervical cancer is a serious public health problem in Brazil, and is the cause of significant morbidity and mortality among Brazilian women. In spite of government efforts to improve the coverage rates of Pap tests, the disease-related incidence and mortality rates remain high and the diagnosis is still too late.Considering that the chronic human papillomavirus (HPV) related genital infection leads to cervical cancer development, cervical cancer should be the target of primary prevention through vaccination.

PROJECT OBJECTIVES: This project aims to evaluate de following vaccination indicators: 1) Program acceptance rate; 2) Vaccine coverage rate; 3) Three-dose completion rate; 4) Rescue vaccination demand; 5) Adverse event rate;

TARGET POPULATION: Schoolgirls attending the 6th and 7th grades of elementary school (mean age = 11.9 yo).

VACCINATION PROGRAM: The program adopted the quadrivalent vaccine because it is considered superior to the bivalent vaccine in preventing HPV-induced lesions. In addition to preventing the development of pre-cancer lesions and cervical cancer, the quadrivalent vaccine has also proved to be effective in preventing condyloma, and vaginal and vulvar cancer. The girls received the vaccines doses at their schools (school-based program) and also at the Barretos Cancer Hospital.

RESULTS:

Program acceptance rate = 91.8% (95%CI: 87.0%-96.8%);

Vaccine coverage for 1st, 2nd and 3rd doses = 87.5% (95%CI: 82.9%-92.2%), 86.3% (95%CI: 81.8%-91.1%) and 85.0% (95%CI: 80.5%-89.7%).

Three dose completion rate = 97.2% (95%CI: 92.0%-100.0%). Reasons for dropping out of the vaccination program included: moving out of town (17), lost during follow up (16), guardians' decision but without a reasonable justification (3), girl refused to continue in the program (1) and pregnancy (2). Two girls interrupted the vaccination because of adverse events reported by the parents.

Rescue vaccination demand = 279 girls on the first dose (20.3%; 95%CI: 17.9%-22.8%), 357 on the second dose (26.3%; 95%CI=23.6%-29.1%) and 291 on the third dose (21.7%; 95%CI=19.3%-24.4%).

Thirty adverse events were recorded or observed in 4,074 doses, providing an adverse event rate of 0.7% (95%CI: 0.5%-1.1%). There was no severe adverse event.


Eligibility Criteria:
Inclusion Criteria:schoolgirls, attending the 6th and 7th grades of the elementary school.

Exclusion Criteria:Pregnant and breastfeeding adolescents and girls who did not attend classes.
A Randomized Controlled Trial of Imago Relationship Therapy

The primary goal of this study, A Randomized Controlled Trial of Imago Relationship Therapy, is to evaluate the efficacy of Imago Relationship Therapy, a form of couples therapy.

Imago relationship therapy (IRT; Hendrix, 2008) is an integrative approach to couples therapy that has been practiced and extensively disseminated for more than 30 years. IRT may be delivered through traditional therapy with a couple, or the Imago principles and skills may be taught to couples through the "Getting the Love You Want" Workshop (GTLYW Workshop), a manualized, 2-day, psychoeducational workshop conducted by certified presenters to groups of couples. The present study is a RCT designed to examine the efficacy of IRT for couples experiencing distress in their committed romantic relationships, and to extend the findings of previous research. Seventy-two (72) couples with relationship distress will be recruited for the study. Couples will be randomly assigned to one of two conditions: Imago therapy alone or bibliotherapy, a control condition, in which couples will be given a self-help book on dyadic communication to read during a 12-week waiting period, followed by a GTLYW workshop.

Eligibility Criteria:
Inclusion Criteria:

1. Straight or LGBTQ couples; both members at least 18 years of age
2. Ability to speak and understand, and read and write, in English language
3. Married/cohabitating for a minimum of 1 year
4. Currently experiencing relationship distress
5. Interest in improving relationship satisfaction/have no immediate plans to terminate the relationship
6. Willingness to participate in study procedures via telehealth and access to the equipment and pricacy required to do so.

Exclusion Criteria:

1. Current alcohol or substance dependence (with active use) in one or both partners
2. Serious suicidal ideation and behavior in one or both partners (i.e., ideation with plan or intent)
3. Current physical violence or partner abuse
4. One or both partners currently involved in a secret affair (i.e., the partner is unaware of this relationship)
5. Current couples-focused psychotherapy treatment that is on-going
6. Couple received IRT or GTLYW workshop within the past 5 years
Sensory Recovery of Reconstructed Breast With Breast Reconstructive Options

Over the past 10 years, there have been substantial improvements in breast reconstruction by plastic surgeons, and much has been achieved in aesthetic restoration after mastectomy. Advances in both microsurgery and implants have allowed for a wider variety of surgical methods, and procedural skills that minimize donor site complications have been developed.

With such satisfactory aesthetic results, interest has recently increased not only in breast reconstruction but also in sensory recovery. Due to the growing expectation of patients, sensory discomfort may decrease overall patient satisfaction with breast reconstruction despite good aesthetic results. Hence, for qualitative improvement of breast reconstruction surgery, efforts must be made to restore sensation in the reconstructed breast. There has been little research on the mechanism of sensory recovery despite its clinical importance. This study aimed to compare the degree of sensory recovery in the reconstructed breast using various reconstruction methods as well as to evaluate the status of neural regeneration with harvesting the tissues when nipple reconstruction is performed.


Eligibility Criteria:
Inclusion Criteria:

* Female adults over 20 years of age
* Patients who have undergone or plan to undergo total mastectomy and immediate breast reconstruction after the diagnosis of breast cancer (including carcinoma in situ)
* written consent to study participation

Exclusion Criteria:

* presence of neuropathy that may hinder accurate assessment of sensation
* presence of dermatological condition that may hinder accurate assessment of sensation
* inability to provide written consent
* decided by the research team to be unsuitable for this study
The Role of Milk Derived Peptides on Glycaemic Control

This study aims to ascertain the potential of novel milk derived hydrolysates to improve glycaemic control to promote metabolic health. A comprehensive characterisation of the metabolic response to these milk derived hydrolysates will ascertain the effect of the hydrolysates in terms of insulin sensitivity. These hydrolysates have been shown to improve insulin resistance in cell and animal models. Therefore the investigators aim is to test their efficacy in overweight, insulin resistant individuals at risk of developing type 2 diabetes.

Recent figures estimate 60% of Irish adults are overweight or obese. As obesity is associated with the development of insulin resistance, which precedes type 2 diabetes development by decades, novel food based solutions are required to improve glycaemic control and attenuate insulin resistance.

In the current study insulin resistant individuals will undergo 4 study visits, 1 screening visit and 3 subsequent visits. At each of the 3 visits they will receive an oral lipid load consisting of 100mL soya bean oil, followed by either a water control; the hydrolysate being tested or the parent protein from which the hydrolysate was derived. After which they will undergo a 4 hour hyperinsulinemic-euglycaemic clamp at each visit to assess their insulin sensitivity.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 - 65 years
* BMI \> 26 kg/m2
* Prepared to maintain a constant body weight for the duration of the study
* Free of any chronic or infectious disease
* Not taking any medication for the regulation of blood sugars
* Diet controlled type 2 diabetes
* Free of any milk allergies or lactose intolerance
* Without anaemia

Exclusion Criteria:

* \<18 or \>65 years
* Diabetes (pharmacologically treated) or other endocrine disorders.
* Chronic inflammatory conditions.
* Kidney or liver dysfunction.
* Anaemia (Haemoglobin \<12g/dl men, \< 11g/dl women).
* Taking any medication for the regulation of blood sugars.
BLOOM Forward: Investigating Weight Loss Impact on TJAC Patients

The goal of this clinical trial is to prospectively assess the efficacy of the BLOOM program, a comprehensive weight loss dietary and lifestyle program, in a population of patients living with obesity and awaiting hip or knee surgery. The main questions it seeks to answer are:

1. Can the BLOOM program support these patients to lose up to 10% of their initial body weight?
2. Will patients continue to lose weight for the next six months after completing the program?
3. Does the BLOOM program help patients to improve their overall quality of life?

Study participants will undergo the BLOOM program, a virtual pre-operative weight management program that spans 24 weeks and is carefully supervised by medical professionals. They will be recruited at the LEAF Clinic after being referred by their primary care physician.

During the BLOOM program, they will meet with a physician (initially, then once monthly) and a dietitian (initially, and then biweekly as part of virtual group coaching). They will have access to LEAF's online learning portal. These are normal elements of the BLOOM program.

Furthermore, as part of their participation in the research study, participants will be asked to complete the following questionnaires: the Mediterranean dietary score, the Oxford Hip and Knee Questionnaire and the EQ-D5-5L quality of life assessment. They will complete these initially, and then at completion of the program and 3 and 6 months post-program. We will also collect their height and weight at these intervals.


Eligibility Criteria:
Inclusion Criteria:

* To be eligible for the study, subjects must meet all the following criteria:

  1. Age ≥ 18 years old
  2. Body mass index (BMI) ≥ 35 kg/m2
  3. Have being identified as a potential orthopedic surgery candidate by the Total Joint Assessment Clinic (TJAC)
  4. Have a referral by their primary care practitioner
  5. Ready to participate actively in the program (i.e., readiness to change scale score ≥7)
  6. Acquisition of the required technology tools and skills to use the virtual platform (the BLOOM program will be conducted via virtual video conference)
  7. English comprehension at a level that allows for active participation in the program

Exclusion Criteria:

* Subjects who meet any of the following criteria are not eligible for the study:

  1. Active eating disorder
  2. Active substance use disorder
  3. Active smoking
  4. Currently or past enrollment in another weight loss program in the previous year prior to enrollment in the study
  5. Ongoing pregnancy or breastfeeding
Oxygen Saturation Patterns in Post-Op Patients at Risk for Obstructive Sleep Apnea

This study will include patients who have major surgery and are at risk for or have been diagnosed with sleep apnea. The patients will be monitored the night after surgery for repeating episodes of reduced breathing and oxygen levels. The study will determine if episodes of decreased breathing are reflected in the oxygen monitor.

There is no further detailed description available.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years undergoing thoracic, vascular, head and neck, gynecological, urological, general, orthopedic, and plastic surgery.
* Patient must require analgesia and/or sedation postoperatively by any route (intravenous, intramuscular, oral, epidural or intrathecal) for the duration of the study
* Postoperative patients with at least one anticipated over night stay on the general ward with a minimum length of 14 hrs.
* Patients in the ASA category 1-4
* Patients at high risk for obstructive sleep apnea (OSA) as identified by the STOP-Bang Questionnaire or patients previously diagnosed with OSA and not using a CPAP device. (No screening with STOP needed for these patients.)
* Spontaneous breathing

Exclusion Criteria:

* Age less than 18 years
* Patients receiving or anticipated to receive postoperative positive airway pressure support
* Previous allergic/contact reactions to adhesives
* Patients unable to give informed consent
* Pregnancy
Assess the Risk of Cerebrovascular Disease

Intracranial artery stenosis is an important cause of ischemic stroke, but the degree of intracranial artery stenosis is not completely matched with the symptoms of ischemic stroke. Asymptomatic carotid stenosis (ACS) refers to does not appear related neurological symptoms of carotid stenosis and stroke or transient ischemic attack of carotid stenosis, did not happen cerebrovascular events such as stroke, but there have been a different degree of cognitive impairment, be badly in need of development of noninvasive imaging methods, objective evaluation of the ACS group cognitive impairment, and predict the ACS risk of ischemic stroke. Therefore, this topic proposed comprehensive cognitive assessment, CTA, double modal MRI techniques, clinical and biochemical indicator detection, mathematical modeling and statistical analysis techniques, assess the ACS group and normal person the cognitive ability, the difference of NVC and local perfusion, and follow-up ACS crowd of ischemic stroke and other cardiovascular events, discuss ACS and cognitive impairment, the correlation of NVC and local perfusion abnormalities, screening of radiographic predictor of ischemic stroke, and in the follow-up of ACS population in testing the sensitivity of the series of indicators and specific degrees.


Eligibility Criteria:
Inclusion Criteria:

1. Mild stenosis group: CTA suggested carotid stenosis \< 30%;
2. Moderate stenosis group: CTA suggested carotid stenosis of 30-69%;
3. Severe stenosis group: CTA indicated carotid stenosis ≥70%;

Exclusion Criteria:

1. dementia, MMSE score \< 21;
2. previous carotid stenosis related neurological symptoms or transient ischemic attack;
3. other craniocerebral lesions, such as craniocerebral trauma, tumor, inflammation, and complications of great vessels (cerebral infarction or cerebral malacia);
4. contraindications for MRI examination;
5. recent use of psychoactive drugs or hormones.
Efficacy and Safety of Fertility Treatments and Fertility Preservation

This study analyses clinical data prospectively collected for over a decade in several clinical databases. Electronic medical records are available since 1998.

Since 2011 the subgroup of patients that undergo fertility preservation are invited to participate in a prospective study aiming at long-term follow-up after fertility preservation for oncologic and non-oncologic conditions.

In this study, the investigators aim at analyze the treatment outcomes of patients with infertility, their clinical characteristics and biochemical parameters aiming at identifying predictors for the treatment outcomes.

For the cohort of patients that have undergone fertility preservation at Karolinska University Hospital, the investigators aim at investigating efficacy and safety of the procedures.

The data can be expanded by using additional databases such as the Regional Cancer Registry and other registries.

Analysis of data collected will allow the investigation of efficacy and safety of fertility preservation, identification of predictors for fertility outcomes,prediction of future activities and costs of the procedures.

Eligibility Criteria:
Inclusion Criteria:

* infertile patients and patients who undergo fertility preservation

Exclusion Criteria:

* Healthy individuals, fertile population
Study Comparing Risperidone vs Placebo as add-on Therapy in Patients With Generalized Anxiety Disorder Who Are Sub-optimally Responding to Standard Therapy.

The purpose of this trial is to determine the effectiveness of risperidone as an adjunctive treatment in patients with GAD who demonstrate a less-than-optimal response to their current anxiolytic treatment.

Many patients with Generalized Anxiety Disorder (GAD) do not benefit or show only partial benefit from current psychotropic therapies. This trial was conducted for the purpose of determining the effectiveness of risperidone as an adjunctive treatment in patients with GAD who demonstrate a less-than-optimal response to their current anxiolytic treatment (either allowed antidepressants, benzodiazepines, or buspirone, or combination). Patients were randomized (patients are assigned different treatments based on chance) to either risperidone or placebo for 4 - 6 weeks of double-blind (neither the patient nor the physician knows whether drug or placebo is being taken, or at what dosage) treatment. Patients randomized to risperidone continued on their current anxiolytic treatment (treatment for anxiety) and received risperidone 0.25 mg per day for the first 3 days, 0.5 mg per day for days 4 through 14, and 1 mg per day for days 15 through 28 of the trial. If clinically indicated, on day 29, the dose could be increased to 2 mg per day for the rest of the trial (4 to 6 additional weeks). At each dose level, risperidone was taken by mouth in a single daily dose. Patients were asked questions every one or two weeks, depending on the phase of the trial, to determine efficacy (effectiveness) and safety. The study hypothesis is that risperidone will be more effective as an adjunct to standard psychotropic treatments for symptoms of Generalized Anxiety Disorder than placebo, as measured by a composite of the four most troubling symptoms identified at baseline.

Risperidone 0.25 mg per day for the first 3 days, 0.5 mg per day for days 4 through 14, and 1 mg per day for days 15 through 28 of the trial. If clinically indicated, on day 29, the dose could be increased to 2 mg per day for the rest of the trial (4 to 6 additional weeks). At each dose level, risperidone was taken by mouth in a single daily dose.

Eligibility Criteria:
Inclusion Criteria:

* Healthy on the basis of physical exam
* Treatment with one or more allowed antidepressants and/or anxiety medications for at least the past 8 weeks
* Judgement of the clinician that the patient has shown a sub-optimal response to this treatment
* Current diagnosis of Generalized Anxiety Disorder
* Maintained on a stable, therapeutic dose(s) of the allowed medication(s) for at least the past four weeks

Exclusion Criteria:

* Presence of other serious medical illnesses
* Active use of cocaine or heroin
* History of suicide attempt in past 12 months
* Changes to antidepressant/anti-anxiety regimen (medication or dose) within the four weeks preceding study baseline (Day 1)
* History of clozapine use
The Effect of Hibiscus Sabdariffa L. Tea on Blood Pressure

The goal of this study is to find out whether the plant compounds present in Hibiscus sabdariffa, a plant commonly used in herbal tea blends and other beverages, will have a beneficial effect on blood pressure in people with mildly elevated blood pressure.


Eligibility Criteria:
Inclusion Criteria:

* Systolic blood pressure 120-150 mm Hg
* Diastolic blood pressure 95 mm Hg or less
* Body mass index (BMI) 18.5-34.9 kg/m2

Exclusion Criteria:

* Smoking
* Use of medications that influence blood pressure
* Cardiovascular disease
* Chronic kidney disease
* Diabetes
* Regular use of vitamin C supplements (min 500 mg/day) within prior 30 days
* Regular strenuous aerobic activity greater than 30 min/day
* Excessive intake of caffeine or alcohol
* Pregnancy within last 6 months or during study period
* Abnormal complete blood count (CBC), urinalysis or electrocardiogram (EKG)
Atypical Antipsychotics in the Treatment of Affective Symptoms of Schizophrenia in Hungary

This is a noninterventional observational study lead amongst psychiatrists, to assess the the overall status of schizophrenic outpatients with affective symptoms treated with atypical antipsychotics.

Atypical antipsychotics in the treatment of affective symptoms of schizophrenia in Hungary

Eligibility Criteria:
Inclusion Criteria:

* Schizophrenic outpatients diagnosis based on DSM -IV above 18 years of age with affective symptoms.
* Atypical antipsychotic treatment at least for a month before study inclusion.

Exclusion Criteria:

* Pregnancy.
* Hepatic disease.
* Diabetes mellitus.
* Severe cerebro- or cardiovascular disease.
Effects of Play Based Therapy on Attention Level of Children With Down Syndrome

The aim of the study is to examine the attention level of children with down syndrome receiving play based therapy as compared to children receiving child centered play therapy.


Eligibility Criteria:
Inclusion Criteria:

* Age: 3-5 years
* Gender: Both male and female
* Children who are currently taking speech therapy sessions with parental involvement.
* Medically stable children with no severe ongoing health issues that could interfere with their participation in the study.

Exclusion Criteria:

* Children with severe sensory impairments
* Co-morbid neurological conditions that may confound the results
* Children who received intervention from any other institute
Clinical and Radiographic Outcomes in Arthroscopic Cuistow Procedure and Arthroscopic Modified Bristow Procedure

To evaluate the clinical and radiographic outcomes of arthroscopic Chinese Unique Inlay Bristow procedure (Cuistow procedure) and arthroscopic Bristow procedure in treating recurrent anterior shoulder instability.

Aim: To compare the clinical and radiographic outcomes following the arthroscopic Chinese Unique Inlay Bristow (Cuistow) procedure and the arthroscopic Bristow procedure.

Background: The Cuistow procedure is a modified Bristow surgery in which a Mortise and Tenon structure was added to the contact surface between the coracoid tip and the glenoid. In previous study, patients received Cuistow procedure have satisfying clinical performance and excellent postoperative bone healing rate (96.1%). However, no comparative studies was performed.

Study Design: Retrospective comparative case-cohort study

Methods: Patients who underwent the arthroscopic Cuisotw procedure and modified Bristow procedure between Jan 2017 and Mar 2018 were selected. 70 patients with recurrent anterior shoulder instability were included. Radiological evaluations with 3D CT scan were performed preoperatively, immediately after the operation, and postoperatively at three months and during the final follow-up (more than 2 years). Clinical assessment for a minimum of 24 months including the 10-point visual analog scale for pain and subjective instability, University of California at Los Angeles scoring system (UCLA score), American Shoulder and Elbow Surgeons score (ASES score), ROWE score, Subjective Shoulder Value (SSV) and active range of motion were completed by independent observers and analyzed.

Eligibility Criteria:
Inclusion Criteria:

1. a glenoid defect ≥10% but \<25%,
2. participation in high-demand (collision and overhead) sports combined with the presence of a glenoid defect \<25% of the glenoid or without defect
3. failure after Bankart repair.

Exclusion Criteria:

1. multidirectional shoulder instability (MDI),
2. uncontrolled epilepsy
3. pathological involvement of other soft tissue such as the long head of the biceps or a rotator cuff tear
4. previous shoulder stability surgery other than Bankart repair
5. Follow-up was less than 2 years or incomplete follow-up data.