cyrilzakka/clinical-trials huggingface dataset:
Urine HPV Testing for Cervical Cancer Screening Among Women Living With HIV in South Africa

The purpose of this study explores the usefulness of urine samples for cervical cancer screening in human immunodeficiency virus (HIV)-infected women.

Cervical cancer occurs when women are infected with the human papillomavirus (HPV), which can cause changes in the cells that lead to cervical precancer and, eventually, cervical cancer if untreated. However, urine HPV testing has not been well validated low- and middle-income country settings, with no data available to guide its use in HIV-infected women.

Invasive cervical cancer is a significant health burden in low and middle income countries.

HIV-infected women in Africa are particularly affected and have an estimated invasive cervical cancer risk \~20-fold higher than women without HIV. Previous studies have been performed among only HIV-uninfected women or those whose HIV status was unknown. Additionally, HIV infected women are often diagnosed with invasive cervical cancer at younger ages.

Cervical cancer is preventable by regular screenings which includes doing a pap smear or HPV tests. There is also treatment of precancerous cervical lesions and vaccination against high risk types of HPV. World Health Organization currently recommends high risk HPV testing for cervical cancer screening in both high and low resources settings. National Guidelines in many low and middle income countries, including South Africa, have been updated to include plans to transition from cytology or visual screening to primary HPV screening. Urine HPV testing could provide a simpler approach for cervical screening that is more easily scaled in low and middle income countries.

The study hypothesizes that high-risk human papillomavirus (hrHPV) testing on urine specimens will be similar in sensitivity and specificity for the detection of cervical intra-epithelial neoplasia grade 2 or worse (CIN2+) compared to self- or clinician-collected sampling.

This study will investigate whether women can collect their own samples for HPV testing using either urine or a small brush in the vagina. The results of HPV tests on urine, self-collected vaginal samples, and provider-collected cervical samples will be compared to see which sample type works best.

Eligibility Criteria:
Inclusion Criteria:

In order to participate in this study a subject must meet all of the eligibility criteria outlined below.

1. Confirmed HIV-1 infection
2. Age 25 years and older.
3. Be willing and able to provide written informed consent.

Exclusion Criteria:

1. Pregnant or intend to become pregnant within 90 days of enrollment
2. Have been screened for cervical cancer within the preceding year (365 days)
3. Have an active sexually transmitted infection (STI; women may participate once treated)
4. Have a surgically absent cervix
5. Have a history of cervical cancer
6. have been vaccinated against HPV.
Phase I Trial of Continuous Hyperthermic Peritoneal Perfusion (CHPP) With Cisplatin Plus Early Postoperative Intraperitoneal Paclitaxel and 5-FU for Peritoneal Carcinomatosis

Two days prior to planned surgery, paclitaxel is infused IV over 24 hours.

Patients will undergo cytoreductive surgery, to debulk tumor. Scope of procedure will vary with each patient, including a spectrum of possible procedures, such as splenectomy, liver resection, pancreatic resection or bowel resection.

After cytoreductive surgery, continuous hyperthermic peritoneal perfusion (CHPP) surgery with cisplatin will begin by placing an influx and efflux catheters via abdominal wall. Perfusion rate of cisplatin is 1.5 L/min and the duration is 90 min.

Postoperative intraperitoneal chemotherapy will begin 24 hours after CHPP surgery.

Dose escalation will proceed after patients at a given dose level receive 3 courses. In order to properly evaluate hematoxicity, a minimum of 3 weeks will be required before dose escalation. MTD is either the dose level immediately below the level at which 2 of 6 patients in a cohort experience nonhematologic dose limiting toxicity (DLT) or when 4 of 6 patients experience hematologic DLT.

Two to 4 months after surgery, laparotomy will be conducted to determine response to treatment. If tumor size is decreased, patients will undergo a second treatment course identical to the same techniques and chemotherapy agents.

Peritoneal carcinomatosis is considered a terminal stage of tumor progression. Cytoreductive surgery plus aggressive combination intraperitoneal chemotherapy may significantly alter the natural history of this disease. This study will define the maximum tolerated dose of paclitaxel and 5-fluorouracil (5-FU) given as an early post-operative intraperitoneal (IP) dwell therapy after cytoreductive surgery and continuous hyperthermic peritoneal perfusion with cisplatin (CHPP).

Eligibility Criteria:
The patients must have an ECOG performance status of 0 or 1 and have no concomitant medical problems that would place them at increased risk for a major surgical procedure (EG, cardiac or pulmonary disabilities).

Patients at increased risk for coronary artery disease or cardiac dysfunction (e.g., age greater than 65, history of hypertension, first degree relative with atherosclerotic coronary artery disease) will undergo cardiac evaluation and performed which will include an attempt to remove all disease greater than 0.5 cm in diameter.
Comparison of the Blood Sugar Lowering Effect and Safety of Two Insulin Treatments in Type 2 Diabetes

This trial is conducted in Europe, Africa and the United States of America (USA).

The aim of this trial is to compare the safety and efficacy of two different insulin treatments, the "basic" and the "advanced" treatment in type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus for more than 6 months
* HbA1c (glycosylated haemoglobin A1c) between 7.5 % and 10.0% at trial initiation (screening)
* BMI (Body Mass Index) less than 40 kg/m2
* Basal insulin treatment for at least 3 months (NPH once or twice daily, insulin glargine or detemir once daily)
* Treatment with one to 3 OADs

Exclusion Criteria:

* Known or suspected allergy to trial products or related products
* Women who are pregnant, are breast-feeding or intend to become pregnant within the next 48 weeks
* Previous participation in any trial including this for the last 6 months
* Use of more than 1 U/kg of basal insulin daily at trial initiation (screening)
Safety of Intravenous Lidocaine Infusions

The purpose of this study is to prospectively determine the side effects profile in adults with neuropathic pain receiving intravenous infusions of lidocaine 5 mg per kg of lean body weight, infused over 45 minutes.

Eligibility Criteria:

Adults \> 18 yrs with chronic central or peripheral neuropathic pain at the St Joseph's Health Care Pain Clinic between June and December 2009.

Outcome measures: All side effects spontaneously reported. Sedation, nausea, dizziness by Visual Analog Score Q 15 minutes; hemodynamic data q 5 minutes during and after infusion for 30 minutes.

Daily diary of side effects and Visual Analogue score of Pain for 7 days post-infusion.

Eligibility Criteria:
Inclusion Criteria:

* Adult outpatients \> 18 years \< 80 years diagnosed with chronic neuropathic pain

Exclusion Criteria:

* Unable to provide informed consent
* Unable to speak and understand English
* Liver, kidney, or cardiac failure
* Allergy to Lidocaine
Randomized Trial for Optimal Number of Passes Required for Molecular Profiling During EUS-FNB of Pancreatic Cancer

This is a randomized trial to evaluate the optimal number of passes required during endoscopic ultrasound-guided fine needle biopsy for molecular profiling in pancreatic cancer

Endoscopic ultrasound-guided fine needle tissue acquisition is currently the gold standard for sampling solid pancreatic masses. By using novel fine needle biopsy (FNB) needles during EUS-guided tissue sampling, core tissue samples can also now be obtained, with diagnostic adequacy of \>90%.

Molecular profiling is becoming increasingly important in the management of pancreatic adenocarcinoma for targeted therapy. As the procurement of core tissue is possible with EUS-FNB, adequate tissue can now be obtained for molecular profiling. However, the number of passes required during EUS-FNB to obtain sufficient quantity of core tissue to successfully perform molecular profiling is unknown, although usually 2-3 passes are performed as standard of care practice.

The primary aim of this study is therefore to elucidate the optimal number of passes required during EUS-FNB to procure adequate tissue for molecular profiling in patients with pancreatic adenocarcinoma.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years and over
2. Suspected or confirmed pancreatic mass seen on imaging, requiring endoscopic ultrasound-guided fine needle biopsy

Exclusion Criteria:

1. Age \< 18 years
2. Females who are pregnant
3. Pancreatic mass is not accessible for fine needle biopsy via endoscopic ultrasound
4. Biopsied pancreatic mass is not adenocarcinoma on pathology
Analgesia After Total Knee Replacement Surgery

Postoperative pain after total knee replacement surgery is difficult to treat. Mobilisation and hospital discharge might be delayed. Recent research shows that intra-articular infiltration with local anesthetics and perioperative prescription of gabapentin can improve outcome.

Objective of the study: Comparison of mobilisation speed and postoperative NRS-scores of patients after total knee replacement surgery which is treated with epidural analgesia or peroperative infiltration of the knee. Appraisal of the value of gabapentin for reduction of postoperative opiate consumption.

Study design:

Prospective randomised study

Study population:

Patients aged eighteen years or older, in whom knee replacement surgery is indicated. They will have spinal anaesthesia and epidural analgesia if indicated by randomisation. They must not have contraindications for epidural analgesia or the used medication in this study.

Intervention:

The first group will be treated with epidural analgesia. Before surgery the epidural catheter will be placed according to local guidelines. After the operation epidural infiltration with bupivacaine and sufentanil will be commenced. The second group will receive local infiltration with ropivacaine of the knee during surgery. Half of these patients will additionally be treated with gabapentin.

Primary study parameters/outcome of the study:

NRS-score (11-scale Numeric Rating Scale in which 0 means no pain, and 10 means most pain imaginable) in rest.

Secondary study parameters/outcome of the study:

Speed of mobilisation, postoperative opiate consumption. NRS scores during flexion exercise of the knee and during walking exercise.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older and legally responsible
* Waiting for total knee replacement surgery
* Informed consent

Exclusion Criteria:

* Contraindications for epidural analgesia
* Aortic Valve stenosis
* Severely compromised cardiac function
* infection near epidural punction site
* Redo knee surgery
* Previous arthrotomies
* Allergy/Hypersensitivity for study mediation or all other used medication
* Participation in other studies
Contribution of F-18 Fluoro-Deoxy-Glucose PET/CT (Positron Emission Tomography) to the Assessment of HCC (Hepato-cellular Carcinoma) Treatment Efficiency

HCC (Hepato-cellular Carcinoma) is the fifth most frequent cancer in humans and its prevalence is growing. The most effective treatment of HCC is surgical and includes resection and liver transplantation; however, only 20% of the patients can be treated surgically. Local interventional therapy, such as radiofrequency (RF) ablation and transarterial embolization is also used.

Recurrence rate is very high, and extrahepatic disease develops in about 30% of the cases and in up to 20% after liver transplantation.

Systemic treatment is thus an option. Sorafenib (multi-kinase inhibitor) is the first agent to significantly improve the overall survival in advanced HCC. However, the drug has serious side effects and is very expensive.

PET/CT with F18-FDG is a common tool for systemic evaluation and staging of various tumors.

The value of the FDG PET for evaluation of HCC is controversial, in particular due to the unique metabolic pathway of glucose in the HCC cells. Since 2007 more and more studies suggest the feasibility of FDG PET/CT for monitoring local recurrence (especially after RF) and metastatic spread of HCC, including detection of active disease only suspected by AFP (alphafoetoprotein) elevation.

Early detection of treatment response to therapy by whole body FDG PET/CT allows for change of treatment as early as possible,when the tumor is non-responsive before serious side effects appear or before depletion of body resources.

The aim of our study is to investigate the contribution of FDG PET/CT to assessment of treatment response.


Eligibility Criteria:
Inclusion Criteria:

* advanced HCC for systemic treatment

Exclusion Criteria:

* HCC only localized in liver,
* Other liver disease (e.g. metastases and benign lesions)
Effect of Self Management Program on Clinical Status of COPD Patients

This study evaluates the effectiveness of self management programs based on 5A model on the lung function status, dyspnea and exercise tolerance in Chronic Obstructive Pulmonary Disease patients. Participants were randomly assigned to an intervention group or a control group. The control group were receiving standard practice care and the intervention group were receiving intervention in addition to standard practice care. The intervention content include implementation of a self management plan based on 5A model.

5 A model implemented during a period of 12 weeks including 5 stags: assessment of behavior, beliefs and motivation of the patient (Assess); provide information about personal health risks and benefits of change (Advise); mutual contribution of patients and health care provider on setting realistic goals based on the patient's interest and confidence in their ability to change the behavior (Agree); help anticipate barriers and develop practical applications based on the identified patient's strategies, problem-solving techniques and social/environmental support (Assist) and specify plan for follow-up (Visits, Phone calls) and providing support in the course of follow up (Arrange).

Eligibility Criteria:
Inclusion Criteria:

* certified diagnosis of COPD with moderate or severe level by a pulmonologist according to GOLD criteria
* age range of 45-70 years
* BMI\<30
* being literate
* having a strong understanding of the Persian language
* having a constant prescription drug regime
* not suffering from another serious and restrictive disease (such as major psychological disorder, neural disease, musca-skeletal disease, cancer, cardiac or angina attack in last month)

Exclusion Criteria:

* hospitalization during the intervention
* need to use of oxygen or spray during 6-minute walking test
* dealing with serious stress
* failure of patient to attend personal or group education session
* non-compliance with a practical program that was determined at monthly visits for intervention group
Impact of Level and Quality of Immunosuppression on Onset and Pattern of Cardiac Allograft Vasculopathy Evaluated by OCT

The aim of this study is to use the high resolution of optical coherence tomography to assess the prevalence of different types of cardiac allograft vasculopathy (CAV) in cardiac transplanted patients and correlate those results with the level of immunosuppression

CAV is the most common reason for retransplantation at \>1 year and one of the main risk factors for mortality after cardiac transplantation. For this registry, patients planned to undergo coronary angiography either as a part of routine follow-up to screen for relevant cardiac allograft vasculopathy or because of clinical suspicion of relevant cardiac allograft vasculopathy will be considered eligible.

Since the "Transplant Care Guidelines of 2010" recommend the use of intracoronary imaging during angiographic follow-up in patients after heart transplantation to recognize CAV as early as possible, OCT has become integral part of the CAV diagnostic in our center. Through its high resolution OCT (so called virtual histology) provides the earliest possible diagnosis of CAV as well as new insights into the differentiation of CAV types. We aim to correlate the findings of OCT with the level of immunosuppression.

Eligibility Criteria:
Inclusion Criteria:

* Patients after cardiac transplantation undergoing planed routine angiographic examination and intracoronary imaging.
* Written informed consent

Exclusion Criteria:

* Age \< 18 years old
* Hemodynamic and/or electric instability
* Chronic kidney failure with glomerular filtration rate \< 30 ml/min
* Pregnant or breastfeeding women
* Incapacity of providing informed consent
* If in the investigator's opinion the patient has (a) co-morbid condition(s) that could limit the patient's ability to participate in the study or impact the scientific integrity of the study
* Any contraindication to intracoronary imaging
Quality of Life and Pain Pressure Threshold in Response to Scar Release Techniques for Chronic Transverse Abdominal Scar

Postoperative scarring is one of the most common concerns among surgical patients. The incidence of abnormal scarring, i.e. keloid or hypertrophic scar formation after caesarean section (CS) is reported to be 41% .That can lead to functional limitations, pruritus, pain and cosmetic issues. so, the purpose of this study is to investigate quality of life and pain pressure threshold in response to myofascial induction and direct scar release techniques for lower transverse abdominal scar

This study will be conducted on forty women with chronic lower transvers abdominal scar , they will be referred from department of Obstetrics and Gynecology ,Kasr Eleiny teaching Hospital and outpatient clinic of faculty of physical therapy, cairo university, Egypt.

All women will be randomly divided into two equal groups:

* Group A(Study group):It will include 20 women who will be treated by myofascial induction and direct scar release techniques in addition to therapeutic ultrasound, 2 sessions per week for two weeks.
* Group B(Control group):It will include 20 women who will be treated by therapeutic ultrasound, 2 sessions per week for two weeks.

Eligibility Criteria:
Inclusion Criteria:

* Women with a well healed, old , transverse cesarean section scar (more than 6 months resulted in chronic scar pain).
* Pain can be intermittent or constant at rest or with activity, and it is reported to be at least at a level of about 3/ 10 on visual analogue scale at recording sites will be marked on the C-section scar at 2.5 cm intervals (Wasserman et al., 2018).
* Women identified that the pain is either located in the cesarean section scar or caused by palpation of scar and it presents since the time of surgery not prior to the cesarean section.
* Their ages will range from 25-35 years old.
* Their BMI will be 18.5-29.9 kg/ m².

Exclusion Criteria:

* Acute and subacute cesarean section.
* Delayed wound healing.
* History of abdominal or pelvic cancer.
* Active pelvic or abdominal infection.
* Skin irritation/inflammation at the site of scar.
* Currently pregnant women.
CDD Plus Bortezomib or CDDin Relapsed or Refractory Multiple Myeloma With Extramedullary Plasmacytoma

The purpose of this study is to determine whether Cyclophosphamide, Liposome doxorubicin and Dexamethasone（CDD) Plus Bortezomib might have effective in extramedullary plasmacytoma.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients from 18 to 80
* Biopsy-proven EMP with relapsed or refractory Myeloma disease. Patients may be proteasome inhibitor-exposed or naive, but cannot be refractory to proteasome inhibitor therapy
* Disease requiring further treatment
* Measurable disease such as M protein and Objective and measurable of EMP
* Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 2
* Meet the clinical laboratories criteria as specified in the protocol
* Voluntary written consent

Exclusion Criteria:

* Female patients who are lactating, breastfeeding or pregnant
* Evidence of current uncontrolled cardiovascular conditions as specified in study protocol
* Requirement for other concomitant chemotherapy, immunotherapy, radiotherapy, which would be considered as a treatment of EMP.
* Comorbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
* Ongoing or active infection, known HIV positive, active hepatitis B or C infection
* Psychiatric illness/social situations that would limit compliance with study requirements
* Known allergy to any of the study medications
Effect of Depressin Screening and Care Program at Community Health Center

Depression affect between 5% and 10% of older adults seen in the primary care setting.Late-life depression is often chronic or recurrent and is associated with substantial suffering, functional impairment, and diminished health-related quality of life.Depressed, older primary care patients are frequent users of general medical services and may have poor adherence to medical treatments.They are also at increased risk of death from suicide and medical illnesses. The aim of this study is to examine whether depression screening and health care practitioner feedback are increased depression treatment rate.

Depression screening is provided 60 or more who visited community health care center with a 15-item Geriatric Depression Scale.GDS scores of 10 or more were classified depression positive. Intervention group participants received twice remind calls from primary care nurse.


Eligibility Criteria:
Inclusion Criteria:

* 60 or more
* 10 or more in GDS scor

Exclusion Criteria:

* severe cognitive problem
Impact of the BB Box System on Postpartum Maternal Anxiety, Post Traumatic Stress and Mother-child Relationships

The main objective of this study is to compare the degree of maternal anxiety at Day 3 postpartum in mothers who did or did not have access to a video communication system (BB-Box system) from the time of initial separation with their baby.

The secondary objectives of the study are to compare the following between the two arms of the study:

A. The degree of postpartum maternal anxiety at day 1, day 7 and at hospital discharge. Anxiety will be compared point by point but also via kinetics.

B. The incidence maternal post traumatic stress disorder at 6 and 12 months.

C. The incidence of mother-child relationship disorders at 6 and 12 months.

D. Infant vital signs during the hospital stay.

Eligibility Criteria:
Inclusion Criteria:

* The patient must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* The patient is available for 12 months of follow up
* The patient has given birth this day to a premature child (\< 36 weeks of gestation and/or \< 2 kg birthweight)
* Separation of child and mother since birth

Exclusion Criteria:

* The patient or baby is participating in another study, excepting the studies "OASIS" or "PROM8736"
* The patient or baby is in an exclusion period determined by a previous study
* The patient is under judicial protection, under tutorship or curatorship
* The patient or father refuses to sign the consent
* It is impossible to correctly inform the patient
* Preexisting maternal psychiatric pathology
* Major or lethal poly-malformation syndrome
* Severe pathologies that threaten child survival: pulmonary hypertension, septic shock, anoxic-ischemic brain
* Any emergency situation preventing patient involvement
* Mother and/or child not hospitalized at the Nîmes University Hospital
* Death of the patient or child during the study