cyrilzakka/clinical-trials huggingface dataset:
Effect of Male Circumcision on HIV Incidence (ANRS 1265)

Observational studies suggest that male circumcision may provide protection against HIV-1 infection. A randomized, controlled, intervention trial was conducted in a general population of South Africa to test this hypothesis.

This study is a randomized controlled intervention trial. This multi-centre study will take place in 3 centers located around Johannesburg, in the areas of Orange Farm, Sebokeng and Evaton. The intervention group patients (circumcised at the beginning of the trial) and the control group (uncircumcised men) will be followed during 21 months (from M.0 to M. 21). Randomization and medicalized circumcision will be performed at M.0 in the intervention group and might be optional in the control group at end of study. The medicalized circumcision effectiveness will be evaluated on and after M.3 (3 months after medicalized circumcision). Incidences (of HIV, HSV-2 infections and genital ulcer disease) will be compared from M.3 to M.21 between the intervention group and the control group. An intermediate analysis will take place at M. 12.

Eligibility Criteria:
Inclusion Criteria:

* Uncircumcised men aged 18-24 years
* Be in good general condition with normal physical and genital examinations
* Consenting to participate in the trial and to sign an informed consent
* Consenting to randomization of the medicalized circumcision schedule (performed at the beginning of study for the treated group, optional at the end of study for the control group)
* Consenting to avoid sexual contact (except with condom protection) during the 6 weeks following the medicalized circumcision
* Consenting to blood tests at M.0, M.3, M.12 and M.21 tested for HIV, HSV-2 and syphilis.

Exclusion Criteria:

* Men with AIDS
* Men with contraindication for circumcision
* Men thinking of moving away from the trial sites within the 21 months following inclusion
* Men with clinical sexually transmitted diseases (STDs) (those men could be included after treatment)
Mindfulness and Intercare Based Intervention for Medicine Students (MIIM)

The effects of Coronavirus Disease (COVID-19) pandemic on health, economy and social network has an impact on mental health, specially students. The aim of the study was to evaluate the effectiveness of a brief online mindfulness, compassion and intercare based intervention in medicine students in Santiago de Chile.

Randomized controlled trial was conducted. Enrolled participants were randomly assigned to 1) a mindfulness, compassion and intercare based intervention, 2) a psychoeducational intervention or 3) waiting list. Both intervention lasted 1 hour per week for 4 weeks. Academic flexibility, breaks and individual psychological help was offered to the whole group. An online assessment of well being, anxiety and depression symptoms was completed at the beginning, 1 month and 3 month.


Eligibility Criteria:
Inclusion Criteria:

* Medicine Students
* 1st to 7th class year

Exclusion Criteria:

* Recent Grief
* Severe acute depression disorder
* Active suicidal ideation
* Active Psychosis
* Active addiction
* Post Traumatic Stres Disorder
Duo Partnership Adherence Commitment Therapy

This is a randomized controlled trial of a new behavioral intervention designed to improve engagement in HIV care for couples. Investigators will compare the HIV viral load outcomes of couples randomized to a couples-based adherence intervention (DuoPACT) or to an individual adherence intervention (LifeSteps).

The investigators will test the intervention to improve HIV care engagement by enrolling 150 sexual or gender minority couples and randomizing 75 couples each to one of two conditions: 1) DuoPACT, a newly-developed couples intervention; or 2) LifeSteps, a standardized antiretroviral adherence intervention for HIV+ individuals. After randomization, intervention sessions will be delivered weekly (6 DuoPACT sessions, or 3 Life Steps sessions). All couples will be assessed pre/post intervention to evaluate intervention effects via behavioral indicators of engagement in HIV care, the couple's relationship dynamics, and the primary outcome of HIV viral load.

Eligibility Criteria:
Inclusion Criteria:

1. 18+ years old;
2. Identifies as a sexual or gender minority;
3. In a primary romantic relationship for at least 3 months;
4. At least one partner is HIV+;
5. English-speaking;
6. Able to provide informed consent; and
7. For HIV+ participants: Evidence of suboptimal engagement in HIV care.

Exclusion Criteria:

1. Must be able to consent to and follow study protocol;
2. Evidence of severe cognitive impairment or active psychosis;
3. Lives outside California or plans to relocate from the state of California in the next 6 months; or
4. Participation in the DuoPACT pilot.
Evaluation of Targeted Axillary Lymph Node Dissection in Node Positive Breast Cancer Patients Post Neo Adjuvant Therapy

evaluation of targeted axillary lymph node dissection in node positive breast cancer patients post neo adjuvant therapy

Targeted axillary dissection (TAD) is a novel technique in the field of surgical oncology. During TAD, patients with node-positive breast cancer who clinically responded to neoadjuvant chemotherapy undergo resection of a previously proven metastatic node together with sentinel lymph node dissection (SLND).

Compared to sentinel lymph node dissection (SLND), axillary lymph node dissection \[ALND\] is associated with increased morbidity, higher rates of lymphedema, paraesthesia, sensory loss in the arm, and impairment in shoulder function. Patients undergoing SLND have fewer infections and a better quality of life, so axillary dissection has been largely replaced by SLND in early-stage breast cancer.

Targeted axillary dissection (TAD) is an innovative surgical procedure that emerged in an attempt to further decrease the false negative results of SLND.

Breast cancer patients suitable for neoadjuvant systemic therapy \[NAST\] with node-positive disease (N1,N2) were assessed by the multi-disciplinary team and if potentially eligible for TAD, a metallic marker\[clip\] is inserted in the suspicious node prior to neoadjuvant therapy.

The procedure is performed together with SLND using a single-tracer technique. Towards the end of NAST, a progress ultrasound and mammogram are performed to assess the breast and axillary response, Clip position within node is confirmed.

A standard surgical approach for sentinel lymph node dissection \[SLND\] is used for TAD, Patent blue dye is administered intraoperatively. dissection down to the localized node is performed. node contained the clip is subsequently sent for histology. Any residual sentinel nodes or palpable abnormal nodes are excised and examined separately.

Eligibility Criteria:
Inclusion Criteria:

1. females with invasive breast cancer with axillary metastasis, staging of n1: n2
2. complete axillary response to neoadjuvant therapy by clinical examination and imaging

Exclusion Criteria:

* 1. breast cancer patients who are not candidate for neoadjuvant chemotherapy 2. breast cancer patients with positive axillary node post neoadjuvant chemotherapy 3. breast cancer patients with distant metastasis 4. patients with axillary lymph node metastasis from another primary tumour \[not breast cancer\]
Pathological Tumor and Lymph Node Responses After Neoadjuvant Immunochemotherapy in Initially-unresectable NSCLC

This is a real-world study with the largest sample size investigating the pathological tumor and lymph node responses to neoadjuvant immunochemotherapy in non-small cell lung cancer to date. Patients with initially unresectable NSCLC underwent immunochemotherapy and response to treatment was assessed after every two treatment cycles. Clinicopathologic features of patients including epidemiological data, clinical manifestations, operation strategies, pathological findings, and prognostic information were recorded and evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Patients with stage III NSCLC who received neoadjuvant immunochemotherapy.
* early-stage NSCLC patients who were initially unresectable.
* 18 years of age or older.
* Karnofsky performance status (KPS) score of 100 or 90.

Exclusion Criteria:

* Patients with stage IV NSCLC
* Patients with known ALK translocations or EGFR mutations.
* Karnofsky performance status (KPS) score \<90.
Comparison of Airtraq in Class 2-3 Obese and Nonobese Men During Intubation: a Prospective Randomized Clinical Study

Morbid obesity is a growing disease. Intubations of these patients mostly difficult. Video laryngoscopes have to be used during the intubation of these patients. The intubation of men is more complicated and difficult than obese women. There were no trials compared to the new video laryngoscopes in morbidly obese men. Patients will be divided into two groups; non-obese and klas 2-3 obese. Airtraq will be used for their intubation. The time for intubation will be the primary aim of this prospective randomized study. The insertion time, perioperative hemodynamic variables, and postoperative complications will also be recorded.

Morbid obesity is a growing disease. Intubations of these patients mostly difficult. Video laryngoscopes have to be used during the intubation of these patients. The intubation of men is more complicated and difficult than obese women. There were no trials compared to the new video laryngoscopes in morbidly obese men. Patients will be divided into two groups; non-obese and klas 2-3 obese. Airtraq will be used for their intubation. The time for intubation will be the primary aim of this prospective randomized study. The insertion time, need of optimization menuvers, perioperative hemodynamic variables, and postoperative complications will also be recorded.

Eligibility Criteria:
Inclusion Criteria:\> 18 age men gender elective operation requring intuabtion -

Exclusion Criteria:\<18 age women emergency operation

-
(Phosphodiesterase 5 Inhibitors & α-blockers): Single Versus Combined Therapy in Benign Prostatic Hyperplasia

To compare between efficacy of phosphodiesterase5 inhibitors (tadalafil 5 mg) and Alpha Blockers (tamsulosin 0.4 mg) monotherapy vs combined therapy in treatment of lower urinary tract symptoms of benign prostatic hyperplasia.

The proposed research aims to answer the question about efficacy and safety of phosphodiesterase 5 inhibitors (tadalafil 5 mg) and Alpha Blockers (tamsulosin 0.4 mg) monotherapy vs combined therapy in treatment of lower urinary tract symptoms of benign prostatic hyperplasia .

Benign prostatic hyperplasia (BPH) is a disorder histologically characterized as the non-malignant hyperplasia of prostatic cells. Most of patients with BPH present with lower urinary tract symptoms (LUTS). About half of men develop BPH, among those; about half develop some degree of bladder outlet obstruction (BOO). BOO and/or changes in smooth muscle tone and resistance that can accompany BPH may result in (LUTS).

Alpha-blockers have been widely used for the treatment of LUTS/BPH for a long time. Some alpha-blockers may cause ejaculatory dysfunction in some individuals. Tadalafil, a (PDE-5), was approved by the Food and Drug Administration (FDA) for the treatment of (ED) in 2003 and for the treatment of BPH in 2011.

The PDE5 inhibitors are used in the treatment of ED and there are increasing data of effects of these drugs on bladder and urethral relaxation as well as of prostatic smooth muscles that may relief the symptoms of BPH.

Medical treatments for LUTS/BPH are able to significantly impact on sexual function. Sexual side effects like ejaculatory dysfunction, reduced or lost libido, and ED have been widely reported in patients treated with alpha blockers (ABs) and 5-alpha reductase inhibitors, the most utilized drugs for the treatment of LUTS/BPH.

The inclusion of Tadalafil in complex of combined conservative therapy of patients with BPH not only improves sexual function but has a positive effect on symptoms of the disease and the psychological state of the patient.

Eligibility Criteria:
Inclusion Criteria:

1 - Men \> 45 years with LUTS/BPH for \> 6 months 2- IPSS of ≥ 8 and Qmax of ≥ 4 to≤ 15 mL/s

Exclusion Criteria:

1. PSA level of \> 10.0 ng/mL (if ≥ 4.0 to≤ 10.0 ng/mL prostate cancer will be excluded).
2. Post-voidresidual urine volume of ≥ 150 mL.
3. Previous Urine Retention or Urethral Catheterization .
4. other pathology such as urinary bladder stone , bladder mass or neurogenic bladder .
5. Any case of LUTS other than BPH (urinary bladder stone, neurogenic bladder, bladder neck contracture,rethral stricture, bladder cancer, acute or chronic prostatitis, acute or chronic urinary tract infection).
6. patients supposed to undergo intraocular operation (as cataract operation) .
7. History of head injury or cerebrovascular stroke or spinal injury.
8. pelvic fracture.
9. Uncontrolled diabetic patient.
10. Patients with chronic obstructive lung disease on medical treatment.
11. Parasympatholytic drugs are contraindicated during the study. 12. Patients refusing to share in the study.
Parents Resources for Decreasing the Incidence of Change Triggered Temper Outbursts

'PREDICTORS' (Parents Resources for Decreasing the Incidence of Change Triggered Temper Outbursts) aims to evaluate web-based training packages for caregivers of children who show frequent temper outbursts following changes to their routines and plans. The training packages will teach caregivers how to apply strategies that aim to reduce the number of temper outbursts that the children show following changes, as well as making any outbursts they do show less severe (less functionally impairing).

The aims of PREDICTORS are: 1. To refine the tools to implement and evaluate a resource-efficient caregiver training program for signalling changes to children with intellectual disabilities or autism spectrum disorders. 2. To pilot the program to test the feasibility of taking it forward into a clinical trial. 3. To conduct a process and economic evaluation of the pilot intervention to provide further data on its suitability for a clinical trial.

Parents/caregivers of children aged 7-16 years old who frequently show temper outbursts when things change in their routines or plans will keep a web-based diary accessed via smart phone or other device on their child's temper outbursts for a 6 month period (baseline). After 6 months of keeping this diary, parents/caregivers will then access web-based training for approximately 1 month which will include sessions to study once or twice per week as well as exercises to practice in between sessions.

After the training is complete parents will be asked to implement the strategies they have learnt in the 6 months that follow. In addition researchers from the university will telephone parents/ caregivers to ask some questions about their child's temper outbursts and on the effects this behaviour has on daily life. Parents will be interviewed at three points during the study (before baseline, after baseline, before intervention and after intervention phases). Interviews will focus on gathering information of their child's behaviour.

Focus groups with relevant experienced professionals and parents (not participating in the main part of the study) will guide the training resource development and development and content of the behaviour diary used by parents during the study.

Eligibility Criteria:
Inclusion Criteria:

* children aged 7-16 years of age, with temper outbursts triggered by change to routine or plans and their parent(s)/caregiver(s)

Exclusion Criteria:

* children who show less than one change triggered temper outburst (temper outbursts following an unexpected change in plan, routine or expectation) per month
A Clinical Trial for Hospitalized Patients With COVID-19 in Ceará: ResCOVID Study

This is a case series of patients with COVID-19 admitted to the northeast Brazil region, in a referenced hospital for COVID-19, during the 2020 COVID-19 pandemic. Data will be collected prospectively and retrospectively.

The main objective is to describe the characteristics of critically ill patients with COVID-19 and their clinical outcomes, and to identify risk factors associated with survival, to guide the strategy to mitigate the epidemic, both within each hospital and ICU and in public health management.

The world's population has been recently dealing with a new infectious disease, SARS-CoV-2 epidemic, which was first reported in December 2019 in Wuhan, China. The virus transmission was rapidly spread around the globe and the World Health Organization declared it as a public health emergency and it has been reported that SARS-CoV-2 is related to high morbidity and mortality rates.

The total number of infected patients has risen fastly and at the end of February 2020, the first case in Brazil was confirmed, suggesting that the SARS-CoV-2 is a pandemic situation.

The clinical aspect of SARS-CoV-2 ranges from pneumonia to critically ill cases, including clinical treatment, mechanical ventilation, and SARS.

The acute respiratory failure of critically ill patients with COVID-19 has different aspects, including hypoxemia of difficult treatment, associated in some cases with clotting disorders, changes in immunity and inflammatory phenomena that pose challenges for the management of these patients, whose mortality can be higher than expected.

The Public Health School in Fortaleza, Ceara, Brazil, implemented an action plan that provides several actions against COVID-19, including a specialized hospital and crew to treat these patients. Knowing the characteristics of critically ill patients with COVID-19 and their clinical outcomes is extremely important to inform clinical decision-making and to guide the strategy to mitigate the epidemic, both within each hospital and ICU and in public health management.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed COVID-19

Exclusion Criteria:

* N/A
Multi-country Survey on Violence Against Women Among Medical Staff

The goal of this observational study is to investigate the knowledge, attitude, and practice (KAP) towards violence against women (VAW) among medical staff in the Department of Obstetrics and Gynecology in Asia and Oceania countries

The main question it aims to answer is:

* the KAP towards VAW among medical staff in the Department of Obstetrics and Gynecology in Asia and Oceania countries
* the KAP towards support service of VAW among medical staff in the Department of Obstetrics and Gynecology in Asia and Oceania countries

Participants will be asked to complete the online self-administrated questionnaire.

The medical staff in the Department of Obstetrics and Gynecology or Women Health Units are in an optimal position to address VAW.

This survey aimed to investigate 1) the KAP towards VAW among medical staff in the Department of Obstetrics and Gynecology in Asia and Oceania countries, and 2) KAP towards the support service of VAW among medical staff in the Department of Obstetrics and Gynecology in Asia and Oceania countries.

This multinational, cross-sectional study will be carried out using an online self-administrated questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Any medical staff in Department of Obstetrics and Gynecology or Women Health Units, who are aged 18 and over and agree to fill out the questionnaire will be eligible to participate in this study.

Exclusion Criteria:

* There is no demographic restriction on participation.
Influences of Balance Training With a Dynamometric Platform in Total Knee Arthroplasty

Knee osteoarthritis produces degeneration and joint wear that greatly affects the patient's proprioceptive system increasing instability. After total knee arthroplasty intervention, it is recommended that the patient performs a rehabilitation procedure to minimize deficits caused by surgery. In this job it is essential to insist on the importance of recovering balance after total knee arthroplasty intervention, and assess a specifically designed protocol to restore its function. An intervention which includes a dynamometric platform as a training method was proposed. The randomized clinical trial compared a control group that performed balance exercises on parallel bars, unstable plates, ramps and stairs against an experimental group that included dynamometric platforms training as a differentiator.


Eligibility Criteria:
Inclusion Criteria:

* Age between 65 and 85.
* Subjects with knee osteoarthritis that have not been operated before.
* Patients operated with the same total replacement prosthesis.
* Patients operated with the same surgical procedure.
* Time before intervention over 4 weeks.
* Time to start rehabilitation after surgery must be less than 4 weeks.
* The Result in Berg scale must be greater than 21, indicating a medium-low risk of falling.
* the Result of the Mini-Mental State Examination must be equal or greater than 20, which means they do not have moderate or severe cognitive impairment.
* Once the informed consent is read and explained, patients must accept and agree to participate in the study.

Exclusion Criteria:

* Patient does no accept sign the informed consent.
* Patient with morphological alterations hip or ankle (also knee).
* Patient that presents knee flexion out of the range between 70 ° and -20 ° because of the risk posed to suffer a fall.
* Patient with suspected deep vein thrombosis.
* Patient with post-surgical infection of the operated knee.
* Patient with psychiatric disorders: depression, anxious syndrome, etc.
* Patient with pathology of central origin (i.e. cerebellar) that could interfere with the results of the test of balance or strength
* Patient with vestibular pathology that could interfere with the results of the test of balance
Efficacy and Safety Study of Teneligliptin (MP-513) in Combination With Insulin in Patients With Type 2 Diabetes

The purpose of this study is to evaluate the efficacy and safety of Teneligliptin in combination with Insulin in patients with type 2 Diabetes for 16 weeks administration and to evaluate the safety and efficacy of Teneligliptin in combination with Insulin with an extension treatment for up to 52 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Patients who has been receiving a stable dose and regimen of insulin over 12 weeks before administration of investigational drug
* Patients who are under dietary management and taking therapeutic exercise for diabetes over 12 weeks before administration of investigational drug
* Patients whose HbA1c is between 7.5% and 10.5%
* Patients who were not administered diabetes therapeutic drugs prohibited for concomitant use within 12 weeks before administration of investigational drug.

Exclusion Criteria:

* Patients with type 1 diabetes, diabetes mellitus caused by pancreas impairment, or secondary diabetes (Cushing disease, acromegaly, etc)
* Patients who are accepting treatments of arrhythmias
* Patients with serious diabetic complications
* Patients who are the excessive alcohol addicts
* Patients with severe hepatic disorder or severe renal disorder.
* Patients who are pregnant, lactating, and probably pregnant patients, and patients who can not agree to contraception