cyrilzakka/clinical-trials huggingface dataset:
Feasibility of Intravaginal Artesunate as Adjuvant HPV & Cervical Precancer Treatment in Kenya

The objective of this randomized, placebo-controlled trial is to evaluate whether intravaginal artesunate pessaries (vaginal inserts) can be used as adjuvant therapy following thermal ablation to improve Human papillomavirus (HPV) treatment outcomes in Women Living with Human Immunodeficiency Virus (WLWH).

The study will evaluate whether women who use artesunate will have higher HPV clearance at 6 months, compared to those who used a placebo. The study will also assess the safety, adherence, and acceptability of this treatment. 120 participants will be enrolled in the study. Participants will self-administer the study drug nightly for 5 days, take a week off, and repeat twice (use study drug on weeks 1, 3,5) and will return to the clinic on weeks 2, 4, 6, 12, and week 24 for follow-up.

WLWH face up to six times increased risk of cervical cancer, as a result, cervical cancer is a leading cause of death in this population. Cervical cancer is caused by persistent infection with the human papillomavirus (HPV), resulting in precancerous changes that if not adequately treated, progress to cancer. Thermal ablation is a commonly used treatment for cervical precancer in Kenya and other low- and middle-income countries (LMICs). Current treatments for HPV or cervical precancer, including thermal ablation, are associated with high rates of treatment failure in WLWH. In a recent study from Zambia, only 44% of WLWH had cleared HPV at six months following thermal ablation treatment. Other studies have demonstrated up to 30% recurrence rate of high-grade cervical precancer at 12 to 24 months after treatment. Persistent infection with HPV following precancer treatment is a key risk factor for treatment disease recurrence.

Eligibility Criteria:
Inclusion Criteria

* Age 25 years or older
* Known HIV seropositive status
* On antiretroviral therapy for \> 90 days prior to enrollment
* Weight ≥50 Kg at study entry\*
* Positive HPV screening test and within 4-8 weeks of thermal ablation
* Ability to provide informed consent
* Planning to stay within the study locale during the duration of the study (24 weeks)
* Agreement to use contraception (barriers or hormonal) if of childbearing age through week 6 of the study

Exclusion Criteria

* Current pregnancy or breastfeeding status
* Current or past history of invasive cervical cancer
* History of total hysterectomy
* Currently receiving systemic chemotherapy or radiation therapy for another cancer
* Current use of systemic immunosuppressants or steroids (\>10 mg of prednisone or equivalent)
* Current use of efavirenz antiretroviral therapy, phenytoin, carbamazepine, and rifampin
* Have medical comorbidity that, in the opinion of the investigator, would interfere with study participation
* Prior chemotherapy within 30 days prior to day 1 of study treatment
* Male at birth
BARRIERS TOWARDS PHYSICAL ACTIVITY

A cross-sectional study of 323 cardiac patients aged 40 to 60 will be carried out at PNS Shifa and the National Institute of Cardiovascular Diseases. Data will be gathered using surveys and evaluated with SPSS software. The results are likely to show considerable differences in barrier frequency across demographic groups, offering insights into targeted treatments.

Understanding these limitations is critical for establishing successful physical activity regimens, improving heart health, and, eventually, lowering rehospitalization rates. The findings will help to develop specific approaches to overcome these challenges and encourage regular physical exercise among cardiac patients.

Objectives:

1. To identify and categorize the specific barriers to physical activity faced by cardiac patients.
2. To analyze how these barriers differ among various demographic groups (e.g., age, gender).
3. To examine how barriers to physical activity vary according to clinical characteristics.

Methodology:

Using a cross sectional study design, data data was collected from NICVD hospital and PNS shifa hospital by providing questionnaires to patient having cardiac disease. The questionnaires comprises of close ended questions.


Eligibility Criteria:
Inclusion Criteria:

* 1. Heart patients who have been diagnosed with a cardiovascular condition for more than six months.

  2. People between the ages of forty and sixty. 3. It was acceptable to have both male and female participants. 4. Patients either already participating in a cardiac rehabilitation program or those who had yet to engage in one were included.

Exclusion Criteria:

1. Existence of musculoskeletal disorders that might affect their physical activity levels.
2. Neurological conditions that could hinder exercise participation or influence responses to surveys.
3. Chronic illnesses such as diabetes or irritable bowel syndrome that could interfere with the barriers evaluated in the study.
Abdominal Adipose Tissue Distribution in Type 2 Diabetic Patients Treated During 6 Months With Pioglitazone or Insulin

In type 2 diabetic patients with poor glycemic control despite maximum "classic" oral treatment, bed time insulin therapy may lead to a parallel increase in abdominal visceral and subcutaneous fat, whereas pioglitazone treatment should lead to a stability (or even a decrease ) in visceral and an increase in subcutaneous abdominal fat. As visceral fat mass is correlated with insulin-resistance and cardio-vascular risk, the evolution of visceral abdominal fat in type 2 diabetic patients is of great importance.

Main objective:

To compare visceral and subcutaneous abdominal fat compartment after a six-month bed time insulin or pioglitazone treatment in type 2 diabetic patients with poor glycemic control despite a maximal oral treatment with metformin and sulfonylureas.

The study hypothesis is that quantity of visceral and subcutaneous abdominal adipose tissue should differently evolute comparing a 6 month treatment with pioglitazone® (30 or 45mg/j) or NPH " bed-time " insulin (0.2u/kg/

In type 2 diabetic patients with poor glycemic control despite maximum "classic" oral treatment, bed time insulin therapy may lead to a parallel increase in abdominal visceral and subcutaneous fat, whereas pioglitazone treatment should lead to a stability (or even a decrease ) in visceral and an increase in subcutaneous abdominal fat. As visceral fat mass is correlated with insulin-resistance and cardio-vascular risk, the evolution of visceral abdominal fat in type 2 diabetic patients is of great importance.

The study hypothesis is that quantity of visceral and subcutaneous abdominal adipose tissue should differently evolute comparing a 6 month treatment with pioglitazone® (30 or 45mg/j) or NPH " bed-time " insulin (0.2u/kg/

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* BMI= 26kg/m2
* Maximal treatment with metformin and sulfonylurea
* HbA1c between 7.5 and 9.5%

Exclusion Criteria:

* Anterior treatment with glitazones
* Anterior treatment with insulin
* Known heart failure
* Hepatopathy
* Renal filtration less than 60ml/min, Hb\<10g/dl
* Corticoids treatment
Locally Delivered Minocycline in Advanced Periodontitis

Local drug delivery provides higher concentrations in the availability of the drug at the specific infected sites with the advantage of sustained release. Periocline is a long acting , sustained release local drug delivery system consisting of 2% minocycline hydrochloride in an ointment containing microcapsule type particles. Periocline contains 20mg of minocycline in 0.5 gm of gel in a disposable polypropylene applicator (2% minocycline HCl).

Research has yielded promising results with the local application of minocycline in the treatment of periodontal disease, compared with other non-surgical therapies. However, there is scarcity of reports on the use of local delivery agents with respect to new range of putative pathogens in advanced periodontitis, wherein the tissue invasive anaerobic organisms are present and possibly compromised host response, hence resulting in an exaggerated breakdown of periodontal tissues at the affected sites. The effect of Minocycline on new putative pathogens, such as Filifactor alocis and oral phylotypes of phyla Synergistetes and TM7 (referred to hereafter as oral Synergistetes and oral TM7s), has not been investigated yet.

Hence, the aim of the present study is to evaluate the efficacy of a local delivery agent containing minocycline (Periocline, Sunstar, Japan) as an adjunct to SRP in the treatment of deep periodontal pockets around teeth in advanced periodontitis and the antimicrobial effect on the red complex and the new putative pathogens.

The subjects for this randomized controlled, parallel arm study will be selected from the primary health care in the Faculty of Dentistry, MAHSA University. In this clinical trial, 50 patients with advanced periodontitis will be enrolled in the study.

Eligibility Criteria:
Inclusion Criteria:

* systematically healthy patients with age range between 20- 60 years,
* diagnosed with untreated Advanced Periodontitis with a pocket depth ≥6mm around two or more teeth, in two or more quadrants.

Exclusion Criteria:

* Patients given antibiotics or anti-inflammatory drugs in the past 6 months,
* allergic to tetracycline,
* pregnant or nursing females,
* those using chlorhexidine or any other mouth rinse
Efficacy and Safety of Everolimus in Recipients of Heart Transplants to Prevent Acute and Chronic Rejection

This trial was to examine the impact of everolimus and reduced dose of cyclosporine on efficacy and safety compared to mycophenolate mofetil and a standard dose of cyclosporine in heart transplant recipients.


Eligibility Criteria:
Inclusion Criteria:

* Male or female cardiac recipients 18-70 years of age undergoing primary heart transplantation.
* The graft must be functional at time of randomization.

Exclusion Criteria:

* Patients who are recipients of multiple solid organ transplants or tissue transplants or have previously received organ transplants.
* Patients who are recipients of ABO incompatible transplants.

Other protocol-defined inclusion/exclusion criteria may apply.
Evaluation of the Treatment of Multiple Gingival Recession Using Modified Coronally Advanced Tunnel With Subepithelial Connective Tissue Graft Depending on the Positioning of the Graft

Microsurgical coronally advanced tunnel procedures using subepithelial connective tissue grafts (sCTG) are predictable for healing of multiple adjacent type 1 and 2 gingival recessions (RT1 and RT2). In order to reduce patient morbidity and enhance periodontal wound healing with sCTG can be used. The aim of this study is to compare the results of the modified tunneling technique with subepithelial connective tissue graft in gingival recessions placed with the inner side towards the flap cover graft and the outer side towards the flap cover graft.

Condition or disease:Multiple Gingival Recession

Intervention/treatment:

Device: Modified coronally advanced tunnel with connective tissue graft placed with inner side towards the flap Device: Modified coronally advanced tunnel with subepithelial connective tissue graft with the outer side towards the flap Phase :Not Applicable

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Bilateral multiple gingival recessions in homologous teeth in the same arch.

Exclusion Criteria:

* Full-mouth plaque index ≥ 20% (Ainamo \& Bay 1975)
* Full-mouth sulcus bleeding index ≥ 15% (Mühlemann \& Son 1971)
* Smoking
* Systemic diseases with compromised healing potential of infectious diseases
* Drugs affecting periodontal health / healing
* Pregnant and lactating females
* Previous periodontal surgery in the area
Transplantation for EASL-CLIF and APASL ACLF Patients: a Retrospective Cohort Study

The definition and diagnostic criteria of acute-on chronic liver failure (ACLF) differed evidently between the East and the West due to the difference in the underlying etiology. Liver transplantation is the most effective treatment to reverse the progress of ACLF and improve the survival rate of patients. The purpose of this study is to explore the accuracy of the two diagnostic criteria of EASL-CLIF and APASL ACLF in assessing the survival rate of patients with liver cirrhosis after LT.

A retrospective collection and analysis of the preoperative conditions of patients with LT due to cirrhosis in a single center from January 2015 to June 2020 would be conducted, including epidemiological characteristics, etiology, clinical indicators, and short-term (28 days, 90 days) and long-term (1 year, 3 years) survival after LT.

Eligibility Criteria:
Inclusion Criteria:

* patients underwent liver transplantation for cirrhosis
* The diagnosis of ACLF followed APASL and EASL-CLIF definition.

Exclusion Criteria:

* Patients with malignant tumor or underwent living donor liver transplantation (LDLT) were excluded.
Standard vs High-Dose Trivalent Inactivated Flu Vaccine in Adult Hematopoetic Stem Cell Transplant (HSCT) Recipients

Hypothesis 1: The safety profile in adult allogeneic stem cell hematopoietic transplant (SCT) recipients after high dose (HD) trivalent inactivated influenza vaccine (TIV) will not be significantly different from adult stem cell transplant recipients receiving standard dose (SD) TIV.

* Specific Aim 1: To compare safety profile of high dose trivalent inactivated influenza vaccine to standard dose trivalent inactivated influenza vaccine in adult hematopoietic stem cell transplant recipients.

Hypothesis 2: Adult stem cell transplant recipients who received the higher dose trivalent influenza vaccine will have a greater frequency of (at least a 4-fold) rise in antibody titers to influenza antigens compared to those who receive standard dose trivalent influenza vaccine.

* Specific Aim 2: To compare humoral immune responses of adult hematopoietic stem cell transplant recipients influenza virus antigens included in trivalent influenza vaccine after high dose or standard dose trivalent influenza vaccine.


Eligibility Criteria:
Inclusion Criteria:

* Allogeneic hematopoietic stem cell transplant recipients who are \>6 post-transplant
* greater than or equal to 18 years of age
* Available for duration of study
* If patients are on immunosuppressive therapy for treatment of graft versus host disease (GVHD): only those on stable doses for at least 4 weeks or on tapering doses will be eligible.

Exclusion Criteria:

* History of hypersensitivity to previous influenza vaccination or hypersensitivity to eggs/egg protein
* History of Guillain-Barre syndrome
* Evidence of hematologic malignancy or disease relapse post-transplant (mixed chimerisms and molecular evidence of disease is permitted)
* Non-allogeneic (e.g. autologous) hematopoietic SCT recipients
* History of receiving 2011 - 2012 influenza vaccine
* History of proven influenza disease after September 1, 2011.
* Pregnant females
* Have any condition that would, in the opinion of the site investigator, place them at an unacceptable risk of injury or render them unable to meet the requirements of the protocol
* Have any condition that the investigator believes may interfere with successful completion of the study
* Platelet count less than 50,000 cells/μL
* History of known infection with HIV, Hepatitis B or Hepatitis C
* History of known latex hypersensitivity
Prospective Single-center Long-term Observation of the SL-PLUS® MIA Stem

Summary from initial protocol

Goal: Validation of the uncoated SL-PLUS® MIA stem within an observation study

Study design: prospective, single-center, observational, non-comparative study

Study population: 135 consecutive cases (uncoated SL-PLUS® MIA implants)

Intervention (if applicable): Implantation of a total hip endoprosthesis

Main goals/endpoints: Radiological: radiolucent lines, osteolysis, hypo- and hypertrophy of the cortex, loosening of the implant or migration; clinical: Harris Hip Score, implant-related complications, revisions; patient questionnaire (WOMAC)

Type and extent of the risks associated with the study participation as well as benefits for the patient: All patients will benefit from the hip prostheses without exception. There are no increased risks for the patients participating in the study compared to patients who do not participate. Normal, necessary follow-up exams will be performed over the course of 10 years. These follow-up exams will then be quantitatively evaluated within the scope of the study in accordance with a standardized protocol. Accordingly, the benefit for the patients from the participation in the study is currently not yet foreseeable.


Eligibility Criteria:
Inclusion Criteria:

* Patients with primary or secondary hip osteoarthritis
* Patients scheduled for a first implantation
* Age at the time of surgery 40-80 years

Exclusion Criteria:

* Destruction of the acetabulum
* Deformation of the hip joint
* Deformation of the proximal femur
* Revision of failed hip endoprostheses
* Acute or recent infection of the joint or its surrounding region
* Acute or chronic systemic infections
* Marked atrophy or deformation of the upper femur
* Muscle atrophy or a neuromuscular disease
* Pathological fractures
* Per- to subtrochanteric fractures
* Conditions that would prevent secure anchoring of the hip prosthesis
* Obese patients with a BMI \>35
* Patients not expected to have a successful rehabilitation
Polypharmacy Outpatient Clinic

To investigate the effect of physician-initiated, medication reviews in geriatric patients on self-reported health-related quality of life, admissions, mortality and falls.

Aim: To investigate the effect of physician-initiated, medication reviews in geriatric patients on self-reported health-related quality of life, admissions and mortality.

Trial design: Randomized trial with polypharmacy intervention in addition to standard geriatric care. After referral to the geriatric outpatient clinic (but before the first visit), a medical secretary screens the patient's medication on the electronic medication list. If the patient is taking more than 8 different drugs, the patient is randomized to either standard geriatric care or standard geriatric care plus polypharmacy intervention. During the first visit, the patient is informed of the project and asked for written, informed consent. If given, we collect data regarding the patient's medication and any medication changes during the intervention, demographics, frailty (FRAIL Scale), Charlson Comorbidity Index, self-reported history of falls, recent admissions, self-reported, health-related quality of life (EQ-5D-5L) and death. Data is collected at baseline, 4 months follow-up and 13 months follow-up.

Participants: All randomized, polymedicated (\>8 drugs) patients referred to the geriatric outpatient clinic.

Outcomes: The primary outcome is the between-group difference in the EQ-5D-5L difference (self-reported, health-related quality of life) between baseline and 13 month follow-up.

The secondary outcomes are number of medications, number of successful medication discontinuations, number of admissions and visits to the emergency department, self-reported low-energy falls, and death.

Eligibility Criteria:
Inclusion Criteria:

* New referral to the geriatric outpatient clinic
* More than \> 8 different substances in drugs on the electronic medication list before the first visit. Regular and PRN drugs count. Excluding topical treatment (eye drops, ear drops, creams etc) but including inhalation, excluding antibiotics with limited duration, excluding multivitamins, and excluding protein drinks.

Exclusion Criteria:

* Inability (or refuses) to give informed consent (e.g. because of lack of interest, inability to understand the intervention or language barriers).
* Inability to understand the consent form and/or the intervention.
* Patients referred to the dementia diagnostics unit.
A 4-arm Clinical Trial of Fuse®, EndoCuff™, EndoRings™ and Standard Colonoscopy

Adenoma detection rate (ADR) is a validated marker for reducing the risk of interval colorectal cancer after a screening colonoscopy. Recent studies suggest that novel devices attached to the colonoscope tip may improve the ADR of doctors performing a screening procedure

Recent studies indicate that continuing medical education, time of colonoscopy during the day, forced longer withdrawal time, use of high definition colonoscopes all result in improving ADR although the gains have only been modest. To this end, adding novel devices to the tip of colonoscope may improve the ability of doctors to perform a better procedure. We therefore propose to identify the increase in ADR with 3 of these devices compared to standard colonoscopy. Fuse colonoscopy (2 cameras embedded at the side of the colonoscope tip providing an increased angle of view), EndoCuff (a plastic cap to fit the tip with flexible arms which hold the mucosa back aiding in inspection), EndoRings (similar to EndoCuff but the arms are wider) have been shown in tandem colonoscopy studies to improve the adenoma miss rates to 7-15% instead of the miss rates seen with standard colonoscopy which is usually about 40%. All these devices are FDA approved and are distributed in the United States.

Eligibility Criteria:
Inclusion Criteria:

* Screening or Surveillance Colonoscopy

Exclusion Criteria:

* Personal history of Colorectal cancer or Inflammatory bowel disease
* Surgical resection of the colon or known colonic stricture
* Personal or family history of Polyposis syndromes or Lynch syndrome
* Referral for incomplete colonoscopy or known therapeutic polyp clearance
* Severe diverticular disease
* Referral for a positive hemoccult test in the past 6 months
* Known coagulopathy
* Inability to provide informed consent
A Study of c-Kit Mutation as MRD in Acute Myeloid Leukemia

C-Kit is involved in an essential pathway of disease occurrence and is closely related to the poor prognosis of patients. However, the clinical significance of c-Kit mutation as molecular MRD monitoring is still unclear. What are the differences and advantages of using c-Kit mutation as MRD in prognostic assessment compared with other MRDs (MFC or RUNX1::RUNX1T1) widely used today? Existing data suggest that patients with one positive and one negative MRD results obtained by two different techniques have a higher risk of recurrence than patients with two negative MRD results but a lower risk of recurrence than patients with two positive MRD results. Therefore, can combining multiple MRD markers, including c-Kit mutations, overcome the shortcomings of a single molecular marker as MRD monitoring? Therefore, this project intends to confirm the clinical significance of quantitative detection of c-Kit mutation as MRD in acute myeloid leukemia.


Eligibility Criteria:
Inclusion Criteria:

Patients who meet the diagnostic criteria(WHO 2016 criteria) of AML and have c-Kit D816 mutation. And receive treatment.

Exclusion Criteria:

Patients with other factors which were considered unsuitable to participate in the study by the investigators