cyrilzakka/clinical-trials huggingface dataset:
Local Bisphosphonate Effect on Recurrence Rate in Extremity Giant Cell Tumor of Bone

The purpose of the clinical study is to investigate whether the local delivery of bisphosphonate as a surgical adjuvant can decrease the chance of a giant cell tumor of bone coming back to the same location. The hypothesis is that the local administration of bisphosphonate will decrease the rate of the tumor returning compared to traditional aggressive surgical removal of the tumor.

The purpose of the clinical study is to investigate whether the local delivery of bisphosphonate (BP-loaded PMMA bone cement) as a surgical adjuvant can decrease the local recurrence rate of giant cell tumor (GCT) of bone. The investigators will evaluate whether bisphosphonate as a surgical adjuvant improves secondary outcomes, such as pain, function, fever, or wound complications. The hypothesis is that the local administration of bisphosphonate will decrease the recurrence rate of GCT compared to traditional aggressive intralesional curettage.

Eligibility Criteria:
Inclusion Criteria:

* Primary benign GCT of bone
* Lesion located in an extremity
* Lesion amenable to reconstruction (intralesional curettage) defined as having at least one intact column of bone after removal
* No previous systemic bisphosphonate or denosumab therapy

Exclusion Criteria:

* Recurrent GCT of bone
* Non-extremity location
* Lesion too extensive for intralesional treatment, either due to bone loss, joint invasion, or large soft tissue component
* Children and pregnancy
* Previous systemic bisphosphonate or denosumab therapy
Radiofrequency in Anal Incontinence: Randomized Clinical Trials

Anal incontinence (AI) is used to englobe the involuntary loss of both fecal material and gases, which can help to improve quality of life. Based on these experiences objectives were drawn: to evaluate the effectiveness of radiofrequency and it's influence on quality of life of patients with anal incontinence, to correlate the anal incontinence severity and to evaluate a sexual function and to verify an influence with radiofrequency treatment. It is a blind randomized clinical trial. For the collection of data it was used a fecal quality of life questionnaire (FIQL). The questionnaire assess the severity of Anal Incontinence (FISI), the degree of patient's satisfaction using a five-point scale (Likert) and a visual analogue EVA scale). It was divided in two groups, in one group it was used radiofrequency and pelvic exercises and in the other turned off radiofrequency (heated glycerin) and pelvic exercises. It was accomplished in eight sections. As a result, it is expected the efficiency of the treatment of radiofrequency in the quality of life, in sexual function and in it's severity.


Eligibility Criteria:
Inclusion Criteria:

- Individuals between 18 and 66 years of age with a clinical complaint of Anal Incontinence and who agree to participate voluntarily in the research.

Exclusion Criteria:

* Individuals with cognitive impairment, use of pacemakers, women who use the Intra-Uterine Device (IUD) of copper, pregnant women, individuals who are taking vasodilators or anticoagulants and hemophiliacs, patients with cognitive deficits or psychiatric illness, patients with chronic neurological degenerative diseases and individuals with hemorrhoid metallic clamp.
Alternative Dosing Regimens of Subcutaneous Azacitidine for Myelodysplastic Syndromes

The purpose of this study is to determine if azacitidine, combined with Best Supportive Care (BSC), is effective in treating myelodysplastic syndromes (MDS) when given according to a different doses and dosing schedules.

Comparison/Control Interventions: The comparison is azacitidine at different doses and schedules.

Duration of Intervention: Treatment lasted for a maximum of 18 cycles, which is up to 24 months.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of refractory anemia, refractory anemia with ringed sideroblasts and at least one of the following: a)Anemia with hemoglobin \<110g/L and requires at least 1 unit packed red blood cell transfusions every 28 days; b)Thrombocytopenia with platelet counts \<100 x 10\^9/L; or c)Neutropenia with absolute neutrophil count \<1.5 x 10\^9/L.
* OR, Refractory anemia with excess blasts or refractory anemia with excess blast in transformation, according to the French-American-British classification system for MDS.
* At least 18 years of age.
* Have a life expectancy of \>7 months.
* Unlikely to proceed to bone marrow or stem cell transplantation therapy following remission.
* Have serum bilirubin levels less than or equal to 1.5 times the upper limit of the normal (ULN) range for the laboratory.
* Have serum glutamic-oxaloacetic transaminase (aspartate aminotransferase) or serum glutamic-pyruvic transaminase (alanine aminotransferase) levels less than or equal to 2 x ULN.
* Have serum creatinine levels less than or equal to 1.5 x ULN.

Exclusion Criteria:

* Secondary MDS.
* Prior treatment with azacitidine.
* Any prior history of Acute Myeloid Leukemia (AML).
* Malignant or metastatic disease within the previous 12 months.
* Uncorrected red cell folate deficiency or vitamin B12 deficiency.
* Hepatic tumors.
* Radiation, chemotherapy, or cytotoxic therapy for non-MDS conditions in the previous 12 months.
* Known or suspected hypersensitivity to azacitidine or mannitol.
* Prior transplantation or cytotoxic therapy to treat MDS. Prior use of Revlimid and Thalomid allowed after 30 day washout.
* Serious medical illness likely to limit survival to less than or equal to 7 months.
* Treatment with androgenic hormones during the previous 14 days
* Active viral infection with known human immunodeficiency virus or vial hepatitis Type B or C.
* Treatment with other investigational drugs with the previous 30 days.
Come As You Are - Assessing the Efficacy of a Nurse Case Management HIV Prevention and Care Intervention Among Homeless Youth

The purpose of this study is to to determine the efficacy of the Nurse Case Management HIV (NCM4HIV) intervention on HIV prevention compared to usual care among Youth Experiencing Homelessness (YEH).


Eligibility Criteria:
Inclusion Criteria

* youth engaged in high-risk sexual activity or intravenous drug use
* speak English
* homeless
* not planning to move out of the metro area during the study

Exclusion Criteria:

* youth with very low literacy
* severe acute mental symptoms
Effects of Growth Hormone Administration on Muscle Strength and Body Composition in Men Over 50 Years Old

The growth hormone (GH) secretion declines gradually with age, with studies demonstrating a progressive reduction of 14% secretion per decade of life beginning in the second decade. Other studies suggest a disruption in GH secretion in elderly people. These findings suggest a possible association between growth hormone deficiency (GHD) and the ageing process.GH replacement is well known to improve body composition, leading to a decrease in total body fat and an increase in lean body mass. However, GH replacement has only shown an effect on muscle strength in GH-deficient adults subjected to long-term GH therapy. Few studies have evaluated the effect of GH replacement on muscle strength in elderly people engaged in a program of exercise training.Our purpose is to evaluate the effect of GH therapy on muscle strength in healthy, non-sedentary men over 50 years old.

At baseline, subjects are submitted to evaluation of GH secretion, testosterone level, body composition, and muscle strength. Absence of GHD and normal testosterone levels were necessary for the inclusion in the study. These parameters will be evaluated after 6 months of GH use x placebo.

Eligibility Criteria:
Inclusion Criteria:

* Healthy and non-sedentary men aged 50-70 years

Exclusion Criteria:

* pituitary disease, GH use in the last 12 months, severe acute disease, hepatic and/or renal chronic disease, uncontrolled systemic arterial hypertension, diabetes mellitus, psychiatric disorders, history of cancer, non-treated hypogonadism and the presence of any other disease that could interfere with the somatotrophic axis.
Reno Diet Heart Study

To study weight maintenance behaviors, weight trends, and behavioral differences between healthy, normal weight and mildly obese adults.

BACKGROUND:

The treatment of obesity has met with limited success and clinically significant weight losses have been difficult to achieve and maintain. Screening to determine which patient will benefit most from treatment, emphasis on maintenance of weight loss and understanding individual weight trends and goals, all have demonstrated significant impact on long-term treatment outcome. Stunkard established a new classification of obesity according to severity and predicted outcome to treatment, distinguishing mild and moderate overweight from severe forms of obesity. Those who were classified as mildly obese were those who were most likely to be successful in traditional forms of treatment. A comprehensive study of this mildly obese population and normal weight maintenance behaviors provided important information on which to build future treatment interventions and/or effective strategies. This would be of particular importance in the prevention of obesity and progressive escalation of the obese state.

DESIGN NARRATIVE:

Subjects were studied retrospectively by history and prospectively in their natural setting for five years. A 2 x 2 x 5 multifactorial design was used where sex (males versus females) and weight (obese versus normal) were crossed with five different age groups according to decades (20-29, 30-39, 40-49, 50-59 and 60 or more years) respectively. A total of 50 (25 normal and 25 obese) were recruited for each age/sex group. Dependent variables included: weight, weight trends, fluctuation, body composition; diet; activity or exercise; weight maintenance behaviors and adaptive responses; general well-being, emotional states, psychopathology; routine blood and urinalyses; cardiovascular disease risk profile including lipids, blood pressure, sodium, potassium, calcium and phosphorus levels, diet, smoking, alcohol and caffeine use, onset of menopause and changes in medical status or medication use. Comprehensive assessment was done yearly.

The study was renewed in 1992 to extend follow-up and evaluation of the RENO Diet Heart Study and to complete and extend testing of the primary hypotheses. The three major hypotheses tested included: 1) weight fluctuations affected cardiovascular disease (CVD) risk factors over and above weight change alone; 2) weight changes, fluctuations and patterns interacted with nutritional, behavioral, psychological and medical factors, but these factors also affected CVD risk independent of weight; and 3) retrospective, self-reported weights, fluctuations and patterns were predictive of prospective weights and weight fluctuations.

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
Study of Relationship Between UGT1A1 Gene Polymorphism and Toxicity and Efficacy of Irinotecan in Small Cell Lung Cancer

The purpose of this study is to find out the correlation between uridine diphosphate glucuronosyl transferase 1A1(UGT1A1) gene polymorphisms and the side effect and efficacy of irinotecan in patients with small cell lung cancer.

In multiple studies of metastatic colorectal cancer,uridine diphosphate glucuronosyl transferase 1A1(UGT1A1) gene polymorphisms and its correlation with irinotecan-associated side effects have been confirmed.Data from several studies indicated an improved clinical outcome of patients who had received an irinotecan-based regimen.In order to find out the correlation between UGT1A1 gene polymorphisms and the side effect and efficacy of irinotecan in patients with small cell lung cancer,we designed this study.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of refractory or relapsed small cell lung cancer
* Physical examination and routine laboratory tests show no contraindications to chemotherapy

Exclusion Criteria:

* Pregnant and nursing women
* Brain metastasis with symptoms
A Clinical Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of MegaLT Injection for Treating Refractory Thrombocytopenia Following Radiotherapy, Chemotherapy, or Transplantation.

A study to evaluate the safety, efficacy, and pharmacokinetics of MegaLT in treating refractory thrombocytopenia following radiotherapy, chemotherapy, or transplantation.

A single-center, open-label, dose-escalation study to assess the safety, efficacy, and pharmacokinetics of MegaLT for treating refractory thrombocytopenia following radiotherapy, chemotherapy, or transplantation.

Eligibility Criteria:
Inclusion Criteria:

* Age between 4 and 75 years (inclusive) at screening; gender is not restricted;
* Diagnosed with refractory thrombocytopenia following radiotherapy/chemotherapy or transplantation;
* Adequate organ function：Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) \< 2.5\*upper limit of normal (ULN); Serum creatinine \< 1.5\* ULN; Total bilirubin level \< 1.5\* ULN; Coagulation function: International Normalized Ratio (INR) ≤ 1.5\* ULN, Activated Partial Thromboplastin Time (APTT) ≤ 1.5\*ULN; Hemoglobin ≥ 60 g/L, or hemoglobin maintained at this level after transfusion; Absolute neutrophil count (ANC) ≥ 1.0×10\^9/L;
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
* Voluntarily participating in the clinical trial, with full understanding of the trial details and having signed the informed consent form.

Exclusion Criteria:

* Patients with any malignant tumor relapse;
* Pregnant or breastfeeding women;
* Life expectancy less than 3 months;
* Severe infections or severe concurrent conditions such as heart, liver, lung, kidney, neurological, or metabolic diseases;
* History of severe thrombotic events or known thrombotic risk factors. Exceptions: Participants for whom the potential benefits of the study, as determined by the investigator, outweigh the potential risks of thromboembolic events;
* Uncontrolled infectious or other serious diseases, including but not limited to infections (e.g., HIV positive), congestive heart failure, unstable angina, arrhythmias, psychiatric disorders, or conditions that limit the ability to meet study requirements or pose unpredictable risks as judged by the primary physician;
* Active hepatitis B or C infection;
* Refractory thrombocytopenia post-transplant with Grade III-IV acute graft-versus-host disease (GVHD) \[according to NIH standards\] or severe chronic GVHD (NIH 2014 standards);
* History of organ transplantation or planned organ transplantation (excluding hematopoietic stem cell transplantation);
* Participation in another clinical study within 30 days prior to the baseline visit, involving any investigational drug or device; observational studies are allowed;
* Any other conditions deemed by the investigator to make the participant unsuitable for the clinical trial.
Assessment of the Clinical Condition and Way of Nutrition Patients Before and After Sleeve Gastrectomy

Conservative treatment of patients with morbid obesity is inefficient, which is why surgical treatment is necessary. Although bariatric treatment is associated with the occurrence of complications resulting from the procedure or from nutritional insufficiencies, it leads to significant body mass reduction and metabolic improvement of obese patients.

The aim of the study was to determine the clinical condition of obese patients after laparoscopic sleeve gastrectomy ( LSG) in terms of nutritional status, metabolic disorders and way of nutrition.

The study conduced 4 visits: preliminary visit (1 day before the surgery) and control visits (1, 3 and 6 months after the surgery). Based on the inclusion and exclusion criteria the observational study was conducted among 30 participants (15 women and 15 men).


Eligibility Criteria:
Inclusion criteria

* women and men aged 18-64
* BMI ≥ 40 kg/m2 or BMI ≥ 35 kg/m2 with comorbidities such as type II diabetes (T2DM), hypertension, sleep apnea and other respiratory disorders, non-alcoholic fatty liver disease, osteoarthritis, lipid abnormalities, gastrointestinal disorders, or heart disease

Exclusion Criteria:

* pregnancy
* gastrointestinal cancers
* cardiorespiratory failure
Myofascial Release in Shoulder Pathologies

Shoulder pathology has a high prevalence in the field of musculoskeletal diagnoses, as well as being a common etiology in cases of disability. Passive and active-assisted kinesitherapy are used in the physiotherapy protocol. These techniques sometimes lead to feedback of fear and increased sensation of pain on the part of the patient that can slow or hinder the optimal recovery. A randomized clinical trial is intended to demonstrate that techniques for myofascial release of muscles important in the biomechanics of the shoulder, it is more effective than kinesitherapy in improving myofascial and also by eliminating the aforementioned unwanted effects and, therefore, improving the recovery of these processes.

The purpose of this study was to compare the efficacy of myofascial therapy and kinesitherapy in improving function in shoulder pathology with prolonged immobilization. Design Prospective, single-blind randomized controlled trial. Setting Inpatient department of a secondary university hospital. Participants Shoulder pain patients (N=44) were consecutively recruited and randomly assigned to an intervention or control group. Interventions Patients were randomly assigned to a Control Group, to which conventional kinesitherapy was applied, or to the intervention group to which a Myofascial therapy protocol was applied. Both groups completed a therapeutic exercise program based on specific mobilization and strengthening exercises. Main Outcome Measures The QuickDash questionnaire was the primary outcome, visual analog scale and the passive range of motion of the shoulder joint, grades were the secondary outcomes. The outcomes were evaluated at baseline (T0) and at 4 (T2),

Eligibility Criteria:
Inclusion Criteria:

* Be between 20 and 80 years old.
* Patients who have been immobilized due to the following diagnoses: Suture of the rotator cuff or fracture of the proximal extremity of the humerus.
* Have signed the informed consent of acceptance in the participation of the study

Exclusion Criteria:

* Present neurological pathology.
* Be subdued corticoid therapy.
* Have anticoagulant treatment or have had it less than a month ago.
* Insulin-dependent diabetic patients.
* Patients with hemophilia.
* Having diagnosed a psychological or psychiatric pathology.
* Non-intervened displaced humerus fractures.
Sedation Strategies for Therapeutic Bronchoscopy 2

Therapeutic bronchoscopy is a common procedure to treat respiratory diseases. The procedure includes stent implantation, bronchus dilation, electronic incision, laser therapy, and so on. Most of these procedures are painful and require general anesthesia. Conventionally, the general anesthesia for therapeutic bronchoscopy was performed using laryngeal mask. But in the previous experiences, the investigators found that sedation with dexmedetomidine and remifentanil was as effect as laryngeal mask anesthesia. The present study was performed to compare the two approach for sedation or anesthesia in therapeutic bronchoscopy.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled for flexible therapeutic bronchoscopy
* Adult patients aged 18 to 65 years
* American Society of Anesthesiologists (ASA) Physical Status Classification I-II
* BMI 18.5-25kg/m2
* Subjects provide informed consent

Exclusion Criteria:

* Severe airway obstruction
* Coagulation disorder
* Repeat bronchoscopy (more than 3 times)
* Severe liver and renal dysfunction
* Cardiovascular and cerebrovascular diseases
* Pregnancy
* Chronic opioid user
* Drug abusers or addicts
Optimizing the Dose of Flucytosine for the Treatment of Cryptococcal Meningitis

Cryptococcal meningitis (CM) is a fungal infection that causes a severe syndrome of meningitis that is 100% fatal without antifungal therapy. Even with antifungal therapy, mortality rates remain high, especially in Africa where the ongoing HIV/AIDS pandemic leads to higher prevalence of cryptococcosis. Combination of amphotericin and flucytosine (5-FC) is the mainstay of therapy for the initial management of CM. Indeed, it has even been shown that effective delivery of these therapies in Africa can lower mortality rates by 90%.

This is a prospective open-label trial to compare the efficacy and safety of lower doses of 5FC during induction therapy to historical controls with standard 5FC dosing. Participants in the trial will receive 60mg/kg/day of 5-FC in 3 divided doses for 10 days. Single-dose liposomal amphotericin (10mg/kg) is preferred, if available. Amphotericin B 0.7-1.0 mg/kg/day may be used if needed. Historical controls drawn from the AMBITION trial will be used as a comparison group, selected weighted by inclusion/exclusion criteria, baseline characteristics and therapies received. Induction therapy for control group participants followed the 2018 WHO cryptococcal guidelines with 7 days of 5-FC 100mg/kg/day and 7 days of IV Amphotericin deoxycholate followed by 1200mg fluconazole/day for 7 days. The intervention group received single- dose liposomal amphotericin plus 5-FC and fluconazole 1200 mg/day.

All participants will receive fluconazole 1200mg/day during consolidation therapy from day 1 to 14 then 800mg/day from day 15 to 10 weeks, and 200mg/day after 10 weeks. All participants will receive lumbar punctures at diagnosis, day 3, day 5-7, day 10-14, and additionally as required for control of intracranial pressure and documentation of CSF sterilization. Controls from Ambition will be matched for the same LP windows. Therapeutic LPs conducted during the first week have a \~70% relative survival benefit.


Eligibility Criteria:
Inclusion Criteria:

* CSF cryptococcal antigen (CrAg) positive meningitis
* Ability and willingness to provide informed consent
* Willing to receive protocol-specified lumbar punctures

Exclusion Criteria:

* Age \<18 years
* Inability to take enteral (oral or nasogastric) medicine
* Cannot or unlikely to attend regular clinic visits
* Receiving chemotherapy or corticosteroids
* Suspected Paradoxical immune reconstitution inflammatory syndrome (IRIS)
* Pregnancy or breastfeeding
* CrCl \< 20 mL/minute
* Absolute neutrophil count \<500 x10 6 cells/L
* Thrombocytopenia \< 50,000 x 10 6 cells/L
* Patients with prior 5-flucytosine exposure \>3 days in the 12 months prior to enrollment
* Any condition for which participation would not be in the best interest of the participant or that could limit protocol specified assessments.