cyrilzakka/clinical-trials huggingface dataset:
Toe Amputations in Patients With Diabetes

This study is a randomized controlled trial (RCT) to evaluate outcome after toe amputation due to diabetic foot infection. Aim of this RCT is to evaluate wound healing and functional outcome based, whether wound is closed or left open. As a part of this study, emerging technology of thermal imaging is evaluated as a possible tool to predict complication after amputation.

Patients with diabetes undergoing toe amputation due to infection, are recruited for this study. Based on randomization, wound is either closed or left open during the amputation procedure. If primary closure is not possible (e.g. deep abscess) and patient is randomized to closed group, delayed closure is performed when feasible. Patients are followed up in outpatient clinic 3 month after amputation. Primary outcome is wound healing that is evaluated during follow ups in the outpatient clinic. Functional outcome is evaluated with PROM questionnaires preoperatively and during the follow up.

Eligibility Criteria:
Inclusion Criteria:

* Toe amputation due to diabetic foot infection

Exclusion Criteria:

* Deep foot infection
* Sepsis
* No clinical infection (amputation due to trauma, deformity or uninfected necrosis)
Comparing Study Between Concurrent Chemoradiation and New Combination Treatment in Cervical Cancer Patients

The purpose of this study is:

* to compare the effectiveness between the new strategy of treatment (given cis-platinum plus gemcitabine-neoadjuvant chemotherapy followed by surgery),and standard treatment (given cis-platinum/carboplatin during radiation-concurrent chemoradiation)in specific group of cervical cancer patients (stage Ib2-early IIb)
* to evaluate quality of life in both group of patients(standard treatment vs.experimental group)

According to FIGO classification of cervical cancer, stage Ib2 was classified as clinically visible lesion more than 4.0 cm in greatest dimension and stage IIb was classified tumor invades parametrium must not to pelvic wall. These were the common stages in Thai cervical cancer patients,and made a troublesome effect to Thai women. According to this study,stage early IIb with 1/3 of parametrium involvement. Mostly these two stage was treated with concurrent chemoradiation, challenging the possibility of late sequelae of radiation effect. This specific group of patients can be avoid the referred side effect by using neoadjuvant chemotherapy followed by radical hysterectomy with pelvic lymphadenectomy and para-aortic node sampling in operable cases (at least partial response- PR) and concurrent chemoradiation (CCR) in inoperable cases (less than PR). Due to high risk type of these subspecific group, combination chemotherapy instead of single chemotherapy was used as CCR. However in operable cases with identified poor prognostic factor should be receive post operative radiation as the usual manner.

Eligibility Criteria:
Inclusion Criteria:

* Cervical cancer patients with FIGO stage Ib2-early IIb
* Pathological proven squamous cell carcinoma or adenocarcinoma or adenosquamous cell carcinoma
* ECOG performance status 0-1
* No previous treatment for cervical cancer
* Acceptable hematological,renal,liver function

Exclusion Criteria:

* Previous history of cancer
* Underlying disease not fit for surgery
* Psychological problem
* Obvious pelvic/para-aortic node involvement
* Pregnancy
* HIV positive
* History of bowel obstruction
SINUS LIFT 100% Anorganic Bovine Bone vs. 50% Anorganic Bovine Bone + 50% Autologous Bone

Background: Maxillary sinus floor augmentation is a standard surgical procedure to increase bone height in the atrophic posterior maxilla for dental implant placement. In bone reconstructive surgery, in general, autogenous bone is considered as the gold standard, primarily due to its osteogenic potential and remodelling capacity. Bone substitutes are available that can overcome the limitations of autologous bone due to their osteoconductive properties and biocompatibility. Several studies seem to validate these concepts, but further comparative trials are needed.

Aim: To compare the outcome of implants inserted in maxillary sinuses augmented with bovine bone grafts vs 50% bovine bone graft and 50% autologous bone according to a lateral approach.

Material and Methods: This study was designed as a randomised, controlled, clinical trial. Sixteen partially or fully edentulous patients, 20 sinuses, (four patients have been bilaterally treated) having 1 to 4 mm of residual crestal height below the maxillary sinuses were randomised according to a parallel group design. Sinuses were grafted according to a lateral approach. Group A (10 sinuses) was grafted with 50% anorganic bovine bone (Bio-Oss) and 50% autogenous bone, group B (10 sinuses) was grafted with 100% anorganic bovine bone (Bio-Oss). According with a two stages approach, after 7 months a total of 32 implants (Nobel Replace tapered groovy) were inserted with an insertion torque between 35 and 45 Ncm. At same surgical procedure a sample of bone was harvested for histomorphometric analysis . All implants were delayed loaded with screw retained temporary crowns 3 months after implants insertion and with screw retained definitive crowns 4 months later. Outcome measures were implant survival, biological and prosthetic complications, radiographic marginal bone-level changes, PPD and BOP. Clinical data were collected at baseline 6,12 months. Statistical significance was tested at the 0.05 probability level, and all values were presented as mean and standard deviation.


Eligibility Criteria:
Inclusion Criteria:

* Need for implant-supported prosthesis in maxillary posterior area.
* Need to insert implant in atrophic posterior maxilla, with a residual alveolar bone height 1 4 mm.
* ≥ 18 years of age.
* Provided written informed consent.
* Smokers of fewer than 10 cigarettes per day.
* Absence of sinus cyst or active sinusitis.

Exclusion Criteria:

* General contraindications to implant surgery.
* Occluding dentition in the area intended for implant installation
* Periodontitis.
* Bruxism.
* Immunosuppression.
* Previous history of irradiation of the head and neck area.
* Uncontrolled diabetes.
* Heavy smoker (\>10 cigarettes/day).
* Poor oral hygiene.
* Current or past treatment with bisphosphonates.
* Substance abuse.
* Psychiatric disorder.
* Inability to complete follow-up ≥1 year.
* Lactation.
Survey of Smokers Treated in the Emergency Department (ED) on Ownership and Usage of Cell Phones

To study ownership and use of cell phones in low-income smokers. This may help us better understand the impact of cell phone ownership plans on low income smokers' access to quitlines. Use of quitlines may be impeded by limited access to landline phones and limited airtime minutes on cell phones.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or over
* speak and understand English
* willing and able to give informed consent
* have smoked more than 100 cigarettes lifetime
* are currently a daily or some day smoker

Exclusion Criteria:

* too ill or unable to consent
* not interested in participation
* actively psychotic or mentally ill and unable to give consent
* in police custody
* resides in an extended care facility.
Stimulation of the Larynx to Treat Unexplained Chronic Cough

Researchers will test the effect of non-invasive vibrotactile stimulation of the larynx on symptom severity of unexplained chronic cough.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18-88
* \>8 weeks of cough
* Cough visual analogue scale (VAS): Rating of 30 or greater on a 0-100 cough severity scale
* Ability to provide informed consent and independently complete questionnaires
* Ability to read and speak English

Exclusion Criteria:

* Electronic implants (e.g., pacemaker)
* Currently doing speech therapy for cough
* Contraindications to safe or effective VTS device use
* No regular access to wifi internet Neuromuscular impairment that may affect cough/laryngeal sensation and/or function (e.g., multiple system atrophy, Parkinson, CVA, vocal fold paralysis or paresis)
* Untreated carotid disease
* BMI \> 40 (for transmission of VTS through soft tissue)
* Current or recent (quit \< 3 months ago) smoking
* Known currently infectious cause for cough (e.g., TB, pertussis, COVID)
* History of known or suspected aspiration pneumonia
* Diagnosis or clinical suspicion of chronic obstructive pulmonary disease (COPD)
* Diagnosis or clinical suspicion of interstitial lung disease (ILD)
* Unmanaged reflux
* Unmanaged allergies/postnasal drip
Therapeutic Drug Monitoring of Risankizumab in Psoriasis Patients (BIOLOPTIM-RIS)

Biologics such as risankizumab are currently the most effective treatment option for patients with moderate to severe psoriasis. But they are costly for healthcare systems and still described according to a 'one dose fits all' dosing regimen, leading to potential over-and undertreatment. In this study the investigators aim to investigate the predictive value of early serum trough levels of risankizumab and determine the therapeutic window of risankizumab in psoriasis patients.

Patients will be included after signing informed consent. After inclusion, patients will continue on standard dosing schedule of risankizumab (i.e. subcutaneous injections at weeks 0 and 4, then every 12 weeks (2x 75mg)). During each study visit blood will be taken in order to quantify Ctroughs and/or anti-drug antibodies towards risankizumab. In addition, Psoriasis Area and Severity Index (PASI) and Investigator's Global Assessment (IGA) score will be evaluated by a physician. Patients complete the Dermatology Life Quality Index (DLQI) and European quality of life EQ-5D instrument at each visit.

Eligibility Criteria:
Inclusion Criteria:

* Participants must have a clinical or histological diagnosis of chronic plaque-type psoriasis
* Participants must sign an ICF indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study.

Exclusion Criteria:

* Participants who have currently a predominant nonplaque form of psoriasis
* Participants who are pregnant, nursing or planning a pregnancy
* Participants who are unable or unwilling to undergo multiple venapunctures
* Participants who are treated according to a different dosing schedule than standard dosing of risankizumab
Investigation of the Effectiveness of Short Wave Diathermy Treatment in Patients with Hand Osteoarthritis

The aim of this randomized, double-blind, placebo-controlled study was to evaluate the effects of shortwave diathermy therapy on pain, grip strength, and functionality in patients with hand osteoarthritis.

Patients who apply to the physical medicine and rehabilitation outpatient clinic between January 2024 and February 2025 will be included in the study according to the inclusion and exclusion criteria specified below. Demographic data of the patients such as age, gender, height, and weight will be recorded. In the initial evaluation, VAS, hand dynamometer and pinchmeter measurements, Duruöz Hand Index questionnaire and Moberg Addition Test results of the patients will be noted. The G\*Power 3.1 (Faul, Erdfelder, Lang, and Buchner, 2007) program was used to calculate the sample size. In the comparisons of different parameters between groups in reference studies, the effect size was calculated to be at the level of 0.9. This corresponds to a large level according to Cohen's effect size classification. Accepting a statistical significance coefficient of 0.05 with an effect size of 0.9, it was decided to include a minimum of 16 people in each group to obtain 80% power. A total of 36 patients (with a 10% drop-out margin) will be included in the study and will be randomly divided into two groups as treatment and control groups. Randomization will be done by closed envelope method. The treatment group will be given 15 sessions: 20 minutes (27.12 MHz, continuous mode, 400W output) short wave diathermy treatment, hand osteoarthritis exercise program. The control group will be given 15 sessions: sham short wave diathermy and hand osteoarthritis exercise program. Patients will complete 15 sessions, 1 session per day, 5 sessions per week. All evaluation parameters will be recorded before treatment, at the end of treatment and at the end of treatment at the 12th week. Intra-group and inter-group differences will be examined statistically.

Eligibility Criteria:
Inclusion Criteria:

* To be between 35-75 years old
* Diagnosis of hand osteoarthritis according to the ACR 1990 Criteria

Exclusion Criteria:

* Chronic inflammatory diseases (rheumatoid arthritis, seronegative spondyloarthropathy, gout, hemochramatosis, etc.)
* Malignancy
* Having uncontrolled systemic disease (cardiovascular, pulmonary, hematologic, hepatic, renal, endocrinologic)
* Synovitis, tenosynovitis, entrapment neuropathy, contracture, open wound in hand/wrist
* History of hand fracture and/or operation
* Regular use of nonsteroidal anti-inflammatory drugs in the last three weeks
* Regular use of diaserin, chondroitin sulfate, glucosamine in the last three months
* Body Mass Index greater than 35
Boron Neutron Capture Therapy, Radiation Therapy, and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

RATIONALE: Boron neutron capture therapy and radiation therapy use high-energy x-rays and other types of radiation to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving boron neutron capture therapy followed by radiation therapy and temozolomide may kill more tumor cells.

PURPOSE: This phase II trial is studying the side effects of giving boron neutron capture therapy together with radiation therapy and temozolomide in treating patients with newly diagnosed glioblastoma multiforme.

OBJECTIVES:

* Evaluate the overall survival of patients with newly diagnosed glioblastoma multiforme treated with boron neutron capture therapy, radiotherapy, and concurrent and adjuvant temozolomide.
* Evaluate tumor response in patients treated with this regimen.
* Evaluate the adverse effects of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients undergo boron neutron capture therapy followed by radiotherapy and concurrent and adjuvant oral temozolomide.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed glioblastoma multiforme

  * Newly diagnosed disease
* Tumor located at a supratentorial hemisphere

  * Deepest part of tumor \< 6 cm from the scalp
  * Bottom of the tumor \> 6 cm from the scalp allowed provided air instillation into tumor-removed cavity is possible
* No cerebrospinal fluid dissemination

PATIENT CHARACTERISTICS:

* Karnofsky performance status 70-100%
* Life expectancy \> 3 months
* Leukocyte count ≥ 3,000/μL
* Platelet count ≥ 10.0 × 10\^4/μL
* Hemoglobin ≥ 8.0 g/dL
* Serum creatinine ≤ 1.5 mg/dL
* ALT and AST ≤ 100 IU/L
* No phenylketonuria
* Not pregnant or nursing
* No NYHA class III-IV heart failure
* No patient whose participation in the present study is considered inappropriate by a Principal Investigator or Clinical Investigator

PRIOR CONCURRENT THERAPY:

* No prior chemotherapy or radiotherapy
A Study of Renal Denervation in Patients With Treatment Resistant Hypertension

The purpose of this study is to evaluate the clinical and economic impact of implementation of renal denervation with the Symplicity™ Catheter System for treatment-resistant hypertension in Ontario, Canada.

This is a pragmatic randomized trial of renal nerve denervation for treatment resistant hypertension. This is part of a ministry sponsored MaRS-EXCITE program, to conduct early market health technology assessment, in order to determine appropriateness for provincial funding. We will assess the effectiveness, safety, economic attractiveness and feasibility of implementation of renal nerve denervation for treatment resistant hypertension. This will involve a new model of care which will include a multi-disciplinary team approach to these patients. Treatment resistant hypertension is defined as patients with uncontrolled hypertension despite being on optimal doses of 3 or more anti-hypertensive medications. Patients will be randomized to either standard treatment or renal nerve denervation and followed for 6 months to determine impact on blood pressure.

Eligibility Criteria:
Inclusion Criteria:

* Ontario residents
* Aged 18 and over
* Diagnosis of treatment-resistant hypertension after assessment and optimization by a hypertension specialist following recommended evaluation and diagnosis as outlined by the American Heart Association
* Office systolic blood pressure ≥ 160 mmHg (≥ 150 mmHg for patients with type II diabetes mellitus) prior to optimization by a hypertension specialist
* Baseline average systolic 24 hour ambulatory blood pressure of ≥ 135 mmHg after optimization and prior to randomization
* Prescribed 3 or more antihypertensive medications of different classes, both prior to optimization and at randomization, one of which must be a diuretic (a medication can be counted more than once if it acts on different receptors)
* Suitable renal artery anatomy based on CT/MRI/renal angiography imaging: both renal arteries \> 20 mm in length and \> 4 mm in diameter without significant fibromuscular disease or renal artery stenosis (\>50%)

Exclusion Criteria:

* Secondary causes of hypertension:

  1. Primary aldosteronism (secondary to adrenal adenoma)
  2. Chronic kidney disease: creatinine clearance or eGFR \< 45 ml/min/1.73m² (measured on 24 hour urine preferably or MDRD)
  3. Pheochromocytoma
  4. Cushing's syndrome
  5. Aortic coarctation (differential in brachial or femoral pulses, systolic bruit)
* Type 1 diabetes mellitus
* Pregnancy
SU011248 Versus Interferon-Alfa As First-Line Systemic Therapy For Patients With Metastatic Renal Cell Carcinoma

The purpose of this study is to test whether SU011248 has activity and is safe compared to interferon-alfa as first-line therapy in patients with metastatic renal cell carcinoma (RCC).


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed renal cell carcinoma of clear cell histology with metastases
* Evidence of measurable disease by radiographic technique
* Eastern Cooperative Oncology Group \[ECOG\] performance status of 0 or 1

Exclusion Criteria:

* Prior systemic (including adjuvant or neoadjuvant) therapy of any kind for RCC
* History of or known brain metastases
* Serious acute or chronic illness or recent history of significant cardiac abnormality
Patient/Caregiver Perceived Quality of Care

Hospitals quality, safety, and staff workload problems are common in all countries. Findings from the multicountry Nurse forecasting in Europe (RN4CAST) cross sectional study show that patient risk of mortality within a 30 days of hospital stay increases of 7% when a patient is added to the nurse-patient 1:6 proportion in a surgical unit; in Italy, the ratio was found to be 9.5 patients per nurse. Organizational environment, health workers wellbeing and work satisfaction were also found to impact patient safety and perceived patient satisfaction; hospitals nurses high workload, work dissatisfaction and burnout were found related to poor patients outcomes. In a systematic review and meta-analysis, an association of more than 60% between physicians and nurses development of burnout and patient safety in pediatric settings was found; when health workers wellness and teamwork in wards was poor lower perceptions of safety culture was found. Moreover, occupational exposure to medically complex children and their families along with direct care providers unexpressed grief further increase pediatric settings staff risk of developing burnout syndrome and compassion fatigue. Recent findings of Covid-19 pandemic negative impact on health workers well-being worldwide also enhances the risk of compromising the quality of care provided. The aim of this study is to evaluate factors that affect health workers well-being, their perception of work environment and patient/caregiver satisfaction and perceived quality of care in a maternal and child health hospital.


Eligibility Criteria:
Inclusion Criteria:

* Health workers directly involved in patients care and employed for more than 6 months
* Patients (adults, school-aged children)
* Caregivers of children

Exclusion Criteria:

* Health workers employed for less than 6 months
A Study of Pralsetinib Versus Standard of Care for First-Line Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC)

This is an international, randomized, open-label, Phase 3 study designed to evaluate whether the potent and selective RET inhibitor, pralsetinib, improves outcomes when compared to a platinum chemotherapy-based regimen chosen by the Investigator from a list of standard of care treatments, as measured primarily by progression free survival (PFS), for participants with RET fusion-positive metastatic NSCLC who have not previously received systemic anticancer therapy for metastatic disease.


Eligibility Criteria:
Inclusion criteria:

* Participant has pathologically confirmed, definitively diagnosed, locally advanced (not able to be treated with surgery or radiotherapy) or metastatic NSCLC and has not been treated with systemic anticancer therapy for metastatic disease.
* Participant must have a documented RET-fusion
* Participant has measurable disease based on RECIST 1.1 as determined by the local site Investigator/radiology assessment.
* Participant has an ECOG Performance Status of 0 or 1.
* Participant should not have received any prior anticancer therapy for metastatic disease.

  * Participants can have received previous anticancer therapy (except a selective RET inhibitor) in the neoadjuvant or adjuvant setting but must have experienced an interval of at least ≥ 6 months from completion of therapy to recurrence.
  * Participants that received previous immune checkpoint inhibitors in the adjuvant or consolidation following chemoradiation are not allowed to receive pembrolizumab if randomized in Arm B
* Participant is an appropriate candidate for and agrees to receive 1 of the Investigator choice platinum-based chemotherapy regimens if randomized to Arm B.
* For women of childbearing potential: participants who agree to remain abstinent (refrain from heterosexual intercourse) or use contraception.
* For men: participants who agree to remain abstinent (refrain from heterosexual intercourse) or use a condom and agree to refrain from donating sperm.

Exclusion criteria:

* Participant's tumor has any additional known primary driver alterations other than RET, such as targetable mutations of EGFR, ALK, ROS1, MET, and BRAF. Investigators should discuss enrollment with Sponsor designee regarding co-mutations.
* Participant previously received treatment with a selective RET inhibitor.
* Participant received radiotherapy or radiosurgery to any site within 14 days before randomization or more than 30 Gy of radiotherapy to the lung in the 6 months before randomization.
* Participant with a history of pneumonitis within the last 12 months.
* Participant has CNS metastases or a primary CNS tumor that is associated with progressive neurological symptoms or requires increasing doses of corticosteroids to control the CNS disease. If a participant requires corticosteroids for management of CNS disease, the dose must have been stable for the 2 weeks before Cycle 1 Day 1.
* Participant has had a history of another primary malignancy that has been diagnosed or required therapy within the past 3 years prior to randomization.