cyrilzakka/clinical-trials huggingface dataset:
RETRIeVE: ReversE TranscRiptase Inhibitor hiV Practice

An observational retrospective study of NNRTI experienced patients who have virologically failed. The study aims to assess resistance profiling and subsequent prescription patterns of patients on NNRTIs

This is a cross-sectional study involving retrospective review of HIV-1 positive patient records who began treatment with a non-nucleoside reverse transcriptase inhibitor (NNRTI) and subsequently failed. Patients who have virologically failed previous NNRTI treatment, or have resistance to 1 drug in the NNRTI class are examined further. Such patients will have attended the clinic every 3-6 months for routine medical care. The data source for variables collected is the patient's electronic medical records. This database is located at Holdsworth House Medical Practice (HHMP), Sydney.

Eligibility Criteria:
Inclusion Criteria:

1. Documented HIV infection
2. Attended Holdsworth House Medical Practice 1999-2009.
3. Chosen ART regime includes an NNRTI

Exclusion Criteria: N/A
The Effect of Smart Ring Assisted Physiotherapeutic Intervention After TKR

The goal of this randomized controlled trial is to learn about the effect of a wearable activity tracker assisted physiotherapeutic intervention on the risk of poor patient reported outcome after a primary total knee replacement.

The main question it aims to answer is whether a wearable activity tracker assisted physiotherapeutic intervention and remote monitoring may help to decrease the number of the poor patient reported post-operative outcome 12 months after a primary total knee replacement.

Participants will receive standard postoperative care which includes physiotherapy appointments 4 weeks and 3 months after the surgery and they will use smart rings (Oura ring) 3 months postoperatively. Patients will be remotely monitored to follow their recovery from total knee replacement surgery: the study group physiotherapists will follow the patients' activity and sleep and if necessary, make a contact with patient if there seems to low activity indicating difficulties with recovering from the surgery.

Researchers will compare the intervention group to a group of participants who will receive only standard postoperative care with physiotherapy appointments 4 weeks and 3 months, to see if the use of the Oura ring may decrease the number of participants with poor patient reported post-operative outcome after total knee replacement.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing primary TKA for primary osteoarthritis.
* Patients able to consent and willing to comply with the study protocol.
* Patients aged 18 to 70 years
* Patients is able to use a smartphone and a smart ring.

Exclusion Criteria:

* Patients unwilling to provide informed consent
* \>15 degrees varus or valgus, or \> 15 degrees fixed flexion deformity
* Physical, emotional, or neurological conditions that would compromise the patient, e.g., poor compliance with postoperative rehabilitation and follow-up (e.g., drug or alcohol abuse, serious mental illness, general neurological conditions, such as Parkinson, MS, etc.)
* Patients unable to attend the study physiotherapy appointments at the outpatient clinic.
* Patients unable to wear Oura ring (example in case of OA or rheumatoid arthritis in the finger joints).
* Patients with cardiac arrhythmia.
The Role of Lipofilling After Oncoplastic Breast Surgeries : Evaluation of Outcomes and Patient Satisfaction

The Role of Lipofilling After Oncoplastic Breast surgeries : Evaluation of Outcomes and Patient Satisfaction

Lipofilling is the process of relocating autologous fat to change the shape, volume, consistency and profile of tissues. For over a century, surgeons have used autologous fat to enlarge and reshape the breasts.

Autologous fat grafting has gained popularity in recent years, although concerns exist regarding the safety and efficacy of this practice in breast surgery . Autologous fat grafting represents an important tool for the management of secondary contour deformities of reconstructed breasts; fat grafting is a simple, safe, and effective treatment option, with low morbidity. it is a straightforward and quick reconstructive technique that does not generally interfere with adjuvant therapies .patient surveys have demonstrated that irradiation has a significant and negative effect on patient satisfaction . Fat grafting seems to reduce radiation induced complications .improve cosmetic results, and reduce postoperative discomfort and pain. The aim of this study is to measure patient satisfaction with their breasts, as well as quality of life.

With the advent of liposuction in the 1980s, large amounts of unwanted fat could be removed from different body areas using small access incisions and a suction cannula. In this setting, fat grafting was re-introduced in the early 80s, pioneered by the American Mel Bircoll, who first described a series of fat transplantation for breast augmentation and reconstruction

Eligibility Criteria:
Inclusion Criteria:

Female gender.

Age of 18 years and older.

History or in candidate for a mastectomy in the near future.

Patients undergoing prophylactic mastectomy.

Patients' choice to undergo a breast reconstruction.

Wanting to participate in this study.

Patient is able to wear the BRAVA (BRA like VAcuum-based external tissue expander) device.

Exclusion Criteria:

Active smoker or a history of smoking 4 weeks prior to surgery.

Current substance abuse.

History of lidocaine allergy.

Four weeks or less after chemotherapy.

History of radiation therapy in the breast region.

Oncological treatment includes radiotherapy after mastectomy.

Kidney disease.

Steroid dependent (daily or weekly).

Immune-suppressed or immune-compromised disease.

Uncontrolled diabetes.

body mass index of \>30.

Large breast size (ie, larger than cup C), unless the patient prefers reduction of the contralateral side towards cup C.

Extracapsular silicone leaking from the encapsulated implant from a previous breast reconstruction.
Isoflavones and Radiation Therapy in Treating Patients With Localized Prostate Cancer

RATIONALE: Eating a diet high in soy foods may slow the progression of some types of cancer. Isoflavones are compounds found in soy food that may slow the growth of prostate cancer cells and prevent further development of prostate cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving isoflavones together with radiation therapy may be an effective treatment for prostate cancer.

PURPOSE: This randomized phase II trial is studying the side effects and how well giving isoflavones together with radiation therapy works in treating patients with localized prostate cancer.

OBJECTIVES:

* Determine the effect of soy protein isolate (isoflavones) and radiotherapy on the modulation of biomarkers in patients with localized prostate cancer.
* Determine the toxicity of this regimen in these patients.
* Determine the effect of this regimen on the quality of life of these patients.

OUTLINE: This is a randomized, placebo-controlled study. Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive oral soy protein isolate (isoflavones) twice daily for 6 months in the absence of disease progression or unacceptable toxicity.
* Arm II: Patients receive an oral placebo twice daily for 6 months in the absence of disease progression or unacceptable toxicity.

In both arms, patients also undergo radiotherapy while receiving isoflavones or placebo.

Quality of life is assessed periodically.

PROJECTED ACCRUAL: A total of 70 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed adenocarcinoma of the prostate that is localized to the prostate gland
* Must be scheduled to receive curative radiotherapy for prostate cancer
* Not eligible for a higher priority study at the Karmanos Cancer Institute

PATIENT CHARACTERISTICS:

Performance status

* 0-3

Life expectancy

* Not specified

Hematopoietic

* Not specified

Hepatic

* Not specified

Renal

* Not specified

Other

* No organ function restrictions

PRIOR CONCURRENT THERAPY:

Chemotherapy

* No prior chemotherapy

Endocrine therapy

* No prior hormonal therapy

Radiotherapy

* See Disease Characteristics

Other

* No other concurrent micronutrient supplements, herbs, or vitamins except 1 daily multivitamin
Immediate Treatment Outcomes of b-CPAP vs Oxygen Therapy in Preterm Babies Presenting With RDS at KCMC

Bubble - Continuous positive airway pressure (CPAP) has been reported to be effective, cheaper, simpler and more accessible compared to mechanical ventilator and surfactant treatment for preterms with respiratory distress syndrome in the neighbouring countries. This study aims to implement and determine the effectiveness of bCPAP and its immediate outcomes compared to oxygen therapy in preterm babies presenting with respiratory distress syndrome (RDS).

Effective treatment of preterm babies with RDS requires exogenous surfactant and/or mechanical ventilation but these are of limited availability in developing countries.

bCPAP is generated by exhalation against a constant opening pressure that produces positive end-expiratory pressure. This in-turn helps in maintaining lung volume at the end of expiration, preventing atelectasis, improving oxygenation, reducing respiratory fatigue and eventually preventing respiratory failure. bCPAP (Rice 360◦c low cost bCPAP device) consisting of 3 components: : (i)An air compressor connected to an oxygen concentrator with a gas flow fate of 3-4 L/min; (ii) A nasal interface (short nasal prongs) connecting the baby's airway to a two limb circuit i.e the inspiratory limb connected to the bCPAP machine and the expiratory limb connected to the water bottle and; (iii) An expiratory limb with the distal end submerged 6 cm in water to generate an end expiratory pressure

At the neonatal unit at Kilimanjaro Christian Medical Center (KCMC), the standard of care for Preterm babies with RDS is receiving oxygen therapy via nasal prongs from oxygen cylinders.

Eligibility Criteria:
Inclusion Criteria:

* All preterm babies (\< 37 weeks of gestation determined using Finnstorm score) presenting with signs of RDS (tachypnea of \>60breaths /min, intercostal and subcostal recessions, nasal flaring, grunting and cyanosis)

Exclusion Criteria:

* Preterm babies with birthweight less than 1kg (bCPAP machine can only be used in babies with body weight of 1-10kg)
* Congenital malformations (cleft palate and lip, tracheal esophageal fistula and diaphragmatic hernia)
* Mothers who refused to consent
Hemostasis in Sickle Cell Disease--Infancy to Adulthood

To assess in older children and adults with sickle cell disease (SCD) whether intrinsic activation (relevant to the origin of pain and acute inflammation) occurs only during vasocclusive crisis (VOC).

BACKGROUND:

Investigations into hemostatic abnormalities associated with sickle cell disease have been numerous. The data suggested that thrombin generation and fibrin formation were increased during steady state, with conflicting data whether further activation occurred in vaso-occlusive crisis. Platelet activation during VOC occurred, with variable findings during steady state. A selective, concomitant evaluation of the hemostatic pathways i.e. intrinsic, tissue factor (TF) or extrinsic activation, fibrinolysis, and platelet-endothelial activation had not been reported. Neither had a longitudinal evaluation been performed in infants during the unique transition period when HbF levels fall from 70 to 80 percent to less than 10 percent.

The study was part of an initiative on "Coagulation, Platelets and Thrombosis in Sickle Disease Pathophysiology". The Request for Applications was released in October 1994.

DESIGN NARRATIVE:

The studies used appropriate 'negative' and 'positive' control groups. Studies included intrinsic markers \[kininogen profiling, high molecular weight kininogen (HK) and low molecular weight kininogen (LK) cleavages, western blotting of HK and LK, and kallikrein-alpha2 macroglobulin; extrinsic markers \[TF and factor V11a\]; other activation and fibrinolytic markers \[prothrombin F1.2, FPA, TAT, tPA, PAI-I, D-dimer and plasma alpha2 antiplasmin\]; platelet- endothelial markers \[evaluation of activation dependent epitopes\]. Unequivocal demonstration of contact pathway activation during VOC provided a crucial link between VOC and its accompanying phenomenon including pain, and inflammation. Finally, the studies provided a unique perspective on the continuum of hemostatic changes that unfolded during the course of SCD, and those that developed as vascular insufficiencies supervened in the adult.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Periodontal Health and Its Relationship With Psychological Stress

Studies suggest that chronic exposure to psychological stress can lead to oral health deterioration, alter the immune response, and possibly contribute to increased inflammation, which can impact the physiological healing of periodontal tissues.

People with psychophysiological stress disorders tend to acquire unhealthy habits, leading to less self-care, incorrect nutrition, smoking, alcohol consumption, and reduced physical activity.

This cross-sectional study aims to evaluate the correlation between periodontal health and psychological stress.

Patients between the ages of 35 and 70 will be recruited. Each patient must be visited and a periodontal assessment must be performed, recording the percentage of bleeding on probing and the Periodontal Screening and Recording (PSR). Subsequently, patients will be administered the Sheldon Cohen Perceived Stress Scale (PSS) and the Mindfulness Awareness Attention Scale (MAAS) questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Aged \> 18

Exclusion Criteria:

* Pregnancy
* administration of antibiotics in the last 15 days prior to study entry or indications for antibiotic prophylaxis;
* orthodontic appliances
* immunological diseases or use of drugs that can affect oral tissues, (phenytoin, cyclosporine), nifedepine, chronic use of non-steroidal anti-inflammatory drugs);
Evaluation of Clinical and Biomechanical Correlation During Return to Sport After Anterior Cruciate Ligament Injury

Comparison of two groups of subjets (ACL injury who return to sport) and control group non-injured about clinical and biomechanical data :

* clinical test
* functional test
* motion analysis of 2 sport exercises
* tibial translation
* isokinetic evaluation

ACL injury in sport practice is frequent and after surgery subjects want to return to sport. Re injury during return to sport is significant and clinical and biomechanical risk factors are described. But no study investigate link between clinical and biomechanical during this risk period.

The study will search to highlight correlation between clinical and biomechanical factors. Investigators will realize clinical evaluation (pain, translation) and functional tests (single hop test, triple hop test, 6m time hop test, crossover test). For biomechanical data, investigators will test 2 exercises in motion analyse laboratory (drop vertical jump and cutting task), a translation knee test with GnRB and isokinetic evaluation.

Investigators will compared results of injured subjects with a control group non-injured.

Eligibility Criteria:
Inclusion Criteria:

* surgeon repair ACL injury ; sport practice ; signed informed consent

Exclusion Criteria:

* for injury subjects: pain during cutting tasks ; associated injury with ACL rupture
* for healthy subjects: history of ACL injury
Comparison of Volar Locking Plate Fixation Alone and Volar Locking Plate Fixation Plus Calcium Phosphate Bone Cement Augmentation for Distal Radius Fractures Patients Aged More Than 65

The incidence of distal radius fracture (DRF) increases with age, and thus, because of improving life expectancies, these fractures are set to become more common. Fractures of the distal radial metaphysis are known to be strongly related to osteoporosis, and as a result, the management of distal radius fractures in elderly patients is beset with difficulties.

Recently, more aggressive fracture fixation in the elderly has become a topic of interest, in the hope of increasing the rate of recovery to preserve the ability to live independently. Many elderly patients remain active well into their eighth and ninth decades, for example, some pursue activities, such as, golf and tennis, on a daily basis. The introduction of volar locking plating system has increased this interest. This system, which uses a fixed angle principle, has been proposed to be effective at maintaining good anatomic reduction, even in the elderly. However, there is a still concern about remaining metaphyseal defect after reduction of the osteoporotic DRF.

Injectable calcium phosphate bone cement (CPC) has been used to augment the remaining metaphyseal defect after fracture reduction including DRF, specially in osteoporotic old patients. The purpose of this randomized, prospective study was to investigate that additional CPC augmentation has any benefit over volar locking plate fixation in unstable DRF patient who is older than 65. The null hypothesis is that there is no difference of wrist functional outcomes, radiographic outcomes, and complications between treatment of volar locking plate alone and calcium phosphate bone cement as well as volar locking plate in unstable DRF patient who is older than 65.


Eligibility Criteria:
Inclusion Criteria:

* All patients older than 65 years old with an acute DRF were considered for inclusion for this study. Inclusion criterion of this study was an unacceptable closed reduction after one attempt of closed reduction. The criteria of unacceptable closed reduction included dorsal angulation of \> 100, volar angulation of \> 200, an articular gap or step off of \>2 mm, radial inclination of \<100, or radial shortening of \> 5mm.

Exclusion Criteria:

* A preexisting severe illness
* An ipsilateral upper extremity injury
* A previous wrist injury
* Surgical delay of more than 2 weeks
* A concomitant ulnar neck fracture.
The Substance Use and Health Risk Intervention (SUHRI) for Justice-involved Youth

This investigation will adapt and pilot test an integrated health risk-reduction and motivational enhancement intervention for Juvenile Justice (JJ) youth that will ultimately be (after full testing through a subsequent large-scale RCT) a sustainable intervention implemented within a JJ supervision/case management context to teach and facilitate positive, pro-social, and expected behaviors. The intervention will use graphical approaches to encourage introspection and problem identification, enhance self-regulation, improve analytical problem-solving skills, and promote healthy behaviors in two inter-related target areas: substance use and risky sex practices. Existing evidence-based intervention materials will be incorporated and delivered through a web-based application. Sessions will be self-directed (require minimal instruction/interaction assistance), and also include a service referral piece whereby youth are provided with a list of treatment and health agencies at the end of sessions that address specific topics. Research activities will be carried out in two pilot studies: (1) Intervention Adaptation and Feasibility and (2) Protocol Feasibility and Preliminary Efficacy Trial. In Pilot 1, intervention content will be adapted from existing evidence-based interventions so that it is developmentally appropriate for the target population and suitable for a web-based format (N = 30; 20 youth, 10 JJ staff). Pilot 2 will test a scaled-down version of an intervention efficacy trial, testing the web-based intervention using a 1-arm design whereby 60 enrolled youth (who meet eligibility requirements) from one juvenile probation department are enrolled to participate. This clinical trial submission, and the accompanying IRB protocol are based on pilot 2 only.

A 1-arm design was used to examine preliminary efficacy of the adapted intervention. Youth aged 14 to 18 who are disposed to community supervision (deferred adjudication or probation) and meet eligibility requirements (1+ indicator of substance use, under community supervisions, English-speaking, no indication of suicide risk or thought disorder) were sampled from a large urban Texas juvenile probation department. Protocol administration was proctored by a TCU research assistant at a private space within a juvenile justice office or mutually agreed upon location of participant's choosing. Youth were asked to complete all assessments and participate in the 4 individualized technology-based intervention sessions where youth received information and engaged in decision making scenario-based games about substance use, sex risk practices, and related health-risk.

Eligibility Criteria:
Inclusion Criteria:

* on community supervision (e.g., deferred adjudication or probation), 1+ indicator of SU, English-speaking,

Exclusion Criteria:

* no indication of suicide risk or thought disorder
Spine Registration Using 3D Scanning

The primary objective is to assess the capability of the device as measured by its consistency, its accuracy, and feedback from surgical staff over the study period.


Eligibility Criteria:
Inclusion Criteria:

1. Patients that require exposure of bony posterior spine anatomy for localization as standard of care.
2. Clinically planned for spine surgery.
3. Able to provide written informed consent from subject or subject's legal representative, using IRB approved consent form, and ability for subject to comply with the protocol requirements of the study.

Exclusion Criteria:

1. Language problems that would prevent from properly understanding instructions.
2. Requirement of an interpreter.
3. Patients who are excluded from consideration for the surgical procedure are therefore excluded from the research study.
4. Special populations: pregnant women, prisoners.
5. Minimally invasive spine surgery that does not expose the necessary bone/s.
6. Spine surgery without posterior exposure.
Effect of Gui-Lu-Er-Xian-Jiao-Wan on Intradialytic Hypotension

Intradialytic hypotension (IDH), a common complication during hemodialysis (HD) could increase patients' morbidity and mortality. Previous studies considered that some Chinese herbal medicine (CHM) plays a complementary role in reducing the frequency of IDH. This trial is aimed to investigate the effect of Gui-Lu-Er-Xian-Jiao-Wan (GLEXJW) in patients with intradialytic hypotension.


Eligibility Criteria:
Inclusion Criteria:

* End stage renal disease treated with hemodialysis for ≥3 months
* Receive a standard thrice-weekly hemodialysis schedule
* More than 25% of hemodialysis sessions complicated by intradialytic hypotension

Exclusion Criteria:

* Active malignancy
* Life-threatening conditions
* Pregnancy
* Recent participation in another clinical trial for intradialytic hypotension
* History of hypersensitivity or contraindication to herbal medicine