cyrilzakka/clinical-trials huggingface dataset:
Long Term Outcome of Combined Phacoemulsification and Excisional Goniotomy With the Kahook Dual Blade

Purpose: Characterize changes in intraocular pressure (IOP), IOP-lowering medications, and visual acuity (VA) through 3 years in patients undergoing combined phacoemulsification and excisional goniotomy with the Kahook Dual Blade (phaco-KDB), with simultaneous goniosynechialysis in cases of angle-closure glaucoma, by a single surgeon (A.H.) in King Fahd Hospital of the University, Dammam, Saudi Arabia.

Methods: Prospective, non-comparative, uncontrolled, non-randomized interventional case series. Consecutive patients with medically-treated glaucoma and visually-significant cataract underwent combined surgery. Subgroup analysis of glaucoma subtypes was performed.


Eligibility Criteria:
inclusion criteria:

* adults 18 years or older
* medically-managed glaucoma
* visually significant cataract

Exclusion Criteria:

* Patients undergoing any other combined procedures
* active uveitis
* coexisting retinopathy that limits visual acuity potential
* active neovascularization
* angle dysgenesis
* those with less than 6 months of follow-up, were excluded.
Impact of Protein Supplementation and Resistance Training on Body Composition, Functional Parameters, Metabolic Adaptation, and Nitrogen Balance in Adults Aged 45 Years and Older With Overweight or Obesity Receiving Incretin-based Medications

This study aim to evaluate the effects of protein supplements and resistance training on body composition, functional parameters, metabolic adaptation, and nitrogen balance in adults (aged ≥45 years) with overweight/obesity receiving weekly Incretin-Based obesity management medication treatment for 6 months.

A parallel design, open-label, multicenter randomized controlled trial will be conducted among 240 patients (aged ≥45 years) initiating Incretin-Based obesity management medication. Participants will be recruited through obesity clinics at the Tel-Aviv Sourasky Medical Center and the Tel-Aviv Assuta Medical Center, obesity clinics of HMOs, and social media groups. They will be randomly assigned to one of two groups in a 1:1 ratio: protein supplements ('Easy Whey' 25 gr protein/day) plus weekly resistance training and no intervention. Data will be collected at baseline, 3, and 6 months, including demographics, medical status, body composition, functional parameters, resting metabolic rate, nitrogen balance, and physical activity performance.

All participants will be advised to follow an exercise regime, a reduced-calorie diet based on the principle of the Mediterranean eating pattern and be encouraged to follow a regular meeting schedule with a registered dietitian.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged ≥45 years.
* Overweight or obese (BMI ≥30, or BMI ≥27 with at least one obesity-related comorbidity).
* Eligible to receive incretin-based weight loss medications (e.g. Wegovy or Mounjaro).
* Able to read and speak Hebrew fluently.

Exclusion Criteria:

* Medical contraindications for incretin-based weight-loss medications.
* Current treatment with insulin or sulfonylurea medications.
* Inflammatory bowel disease.
* Active or unstable psychiatric disorders or cognitive impairment.
* Active bulimia nervosa.
* Previous bariatric surgery or bariatric endoscopic procedures.
* Use of other weight management medications within the past month.
* Weight loss of ≥5% within the past three months.
* Implanted cardiac pacemaker or other electronic implants.
* Regular resistance training within the past three months.
* Regular use of protein supplements.
* Allergy or intolerance to dairy proteins or vegan lifestyle.
Concurrent Radiotherapy With Weekly Topotecan for Primary Treatment of Inoperable Localized Non-small Cell Lung Cancer

Given the activity of single-agent Topotecan in NSCLC, there is both scientific rationale and a medical interest in studying this agent in combination with radiation. In addition, Topotecan administered on a weekly basis offers advantages over the daily x 5 regimen, i.e., the convenience of administration and fewer visits to the clinic.

This is a study of chemoradiation for patient with inoperable non small cell lung cancer with poor pulmonary function. These patients have usually very limited treatment options because of the compromised lung function. Chemoradiation is usually superior to radiation alone, but has not been extensively tested in this patient population. Topotecan is a drug approved for lung cancer that has synergistic activity with radiation. The study will determine what is the safest dose of topotecan to use with radiation in this patient population

Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically proven non-small cell lung cancer Stage I to IIIA.
* Inoperable lung cancer because of poor respiratory lung function, or other medical reasons, as determined by the thoracic surgeon.
* PS \< 2
* Age \> 18 years
* Life expectancy of \> 12 weeks
* Normal hematologic, liver, and renal function
* No metastatic disease as determined by CT-PET scanning and bone scan.
* No brain metastasis by MRI
* No contraindication to radiotherapy

Exclusion Criteria:

* Patients with uncontrolled CNS metastases.
* Active systemic infection.
* Serious, uncontrolled intercurrent medical or psychiatric illness.
* Secondary active primary malignancy.
* Inability to comply with requirements of the study.
* Any metastases outside of the mediastinum
* Histologically positive pleural or pericardial effusion
* Any chemotherapy within five years prior to enrollment on this protocol
* Prior radiotherapy administered to the chest
* Women who are pregnant or lactating
* FEV1 \< 1 liter/minute
Dysphagia After Thyroidectomy

The goal of this observational study is to develop a questionnaire for measuring swallowing and throat discomfort symptoms in patients with goiter or thyroidectomy, which complies with the model of Rasch and which satisfies the fundamental measurement axioms (e.g., unidimensionality, linearity, generalizability). Developing a scale with such characteristics would provide clinicians and researchers with a reliable tool for assessing the impact of goiter and for measuring the outcomes after surgery.

Also, the study will assess the psychological impact of goiter and thyroidectomy, as well as the characteristics of the surgical scar after thyroidectomy.

The questionnaire will be developed in the first phase of the study. Items and response categories will be identified through interviews performed with patients affected by goiter or after thyroidectomy.

In the following phases of the study, the questionnaire will be administered to patients before and after thyroidectomy.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of goiter or thyroidectomy.

Exclusion Criteria:

* Diagnosis of other neurological disorders or disorders involving the aerodigestive tract that could cause swallowing disorders.
* Previous surgery of the neck or involving the aerodigestive tract.
Hydroxychloroquine Use in Hospitalized Patients With COVID-19: Impact on Progression to Severe or Critical Disease

The primary objective is to assess the impact of hydroxychloroquine in hospitalized patients with COVID-19 and risk factors for severe/critical disease.

This study will utilize a randomized, placebo-controlled, double-blinded design. Patients admitted with confirmed COVID-19, and at least 1 of the following: requiring oxygen supplementation (≤4 liters of oxygen via nasal cannula or increase from baseline), bilateral infiltrates on CT/CXR, age \>65, diabetes, hypertension, BMI \> 35, chronic lung disease, cardiovascular disease, chronic kidney disease, cancer (hematologic malignancies, lung cancer, and metastatic disease), will be randomized in a 1:1 fashion to hydroxychloroquine 400 mg PO BID x 2 doses, then 200 mg PO BID x 8 doses or placebo at a matching schedule.

Eligibility Criteria:
Inclusion Criteria:

* Admitted to Wellstar Kennestone Hospital
* Age 18 years or older
* Laboratory-confirmed COVID-19
* At least 1 of the following:

  1. Requiring oxygen supplementation at ≤ 4 liters via nasal cannula or increase from baseline
  2. Bilateral infiltrates on CXR or CT of chest
  3. Age 65 or older
  4. Diabetes
  5. Hypertension
  6. BMI \> 35
  7. Chronic lung disease
  8. Cardiovascular disease
  9. Chronic kidney disease
  10. Cancer (hematologic malignancies, lung cancer, and metastatic disease)

Exclusion Criteria:

* Unable to provide informed consent
* Unable to take oral medication
* Severe/critical COVID-19 disease at presentation

  1. Intensive care or intermediate care required at admission or within 48 hours
  2. Requiring oxygen supplementation via high flow nasal cannula, bipap, or non-rebreather mask at admission or within 48 hours
* Likelihood of survival \<48 hours in the opinion of the primary physician or transitioned to comfort measures within 48 hours of admission
* Inability to take hydroxychloroquine due to allergy, QTc \> 500 ms (male) or 520 ms (female) prior to initiation of hydroxychloroquine, pre-existing retinopathy, known G6PD deficiency, known porphyria, or significant drug- drug interactions
* Pregnant or breastfeeding
* Severe liver disease (Child-Pugh Class C)
Very Rapid and Rapid Virological Response as Predictors of Response of HCV Tretment

assessment of very rapid virological response and rapid virological response as predictors of response to sofosbuvir and daclatasvir in treatment of cirrhotic and non-cirrhotic patients with HCV, eligible to treatment.

Chronic hepatitis C infection (CHC) is a global health problem, with an estimated 120 to 130 million chronic hepatitis C virus (HCV) carriers worldwide Therefore, early recognition and effective management of the disease can modify its natural history

. There is a growing body of evidence that suggests that treatment will help reduce liver inflammation, may reverse liver damage (scarring),slow down disease progression and improve symptoms and quality of life. All of these factors are important reasons to seek HCV medical treatment Identifying host-viral factors that predict the likelihood of SVR prior to initiating therapy would be a very useful clinical tool that could help reduce costs and avoid unnecessary exposure to therapy with significant side effects Little is known about predictors of failure to achieve SVR with DAAs. Although numerous clinical parameters predicted poor response to pegylated IFN treatment , none of them have been shown to be associated with virological relapse after DAA based therapy

Treatment response terms:

The ultra rapid virological response (uRVR) is a new endpoint that we defined as an undetectable serum HCV RNA at the end of 1st week of therapy.

The very rapid virologic response( vRVR )defined as undetectable serum HCV RNA level at week 2.

The rapid virological response (RVR) defined as undetectable serum HCV RNA after 4 weeks of treatment sustained virological response (SVR), which is defined by the undetectable serum HCV RNA 12-24 weeks after the end of treatment Relapser was defined as undetectable viral load at the end of DAA treatment but subsequent detectable viral load at 12 weeks after treatment end.

Eligibility Criteria:
Inclusion Criteria:

* Anti HCV positive patients either chronic HCV or liver cirrhosis.
* Detectable HCV RNA by quantitative PCR prior to treatment.
* Naïve patients (not received any HCV treatment regimen before)

Exclusion Criteria:

* Patients with hepatocellular carcinoma( HCC)
* Patients with combined HBV and HCV
Identifying Inflammatory Biomarkers of Chronic Obstructive Pulmonary Disease

Chronic obstructive pulmonary disease (COPD) is a condition that is characterized by airway obstruction due to inflammation. Levels of inflammatory proteins may be linked to when and to what extent COPD develops. This study will use data collected during the Tucson Epidemiological Study of Airway Obstructive Disease (TESAOD) and its 33-year follow-up to determine the relationship between inflammatory protein expression and COPD.

COPD is a term that encompasses both chronic bronchitis and emphysema, two diseases that are characterized by airway obstruction that interferes with normal breathing. Airway inflammation can stem from exposure to harmful fumes in the air, chronic bacterial infections in the airways, and a genetic predisposition to an inflammatory response to these agents. In people with COPD, the airway inflammation may extend beyond the lungs and contribute to systemic symptoms and, ultimately, to an increased mortality risk. Markers of systemic inflammation have been identified, but the relationship between these markers and when and to what extent COPD develops has not been determined. This study will use data collected during the TESAOD and its 33-year follow-up to determine the relationship between COPD and the expression of various inflammatory proteins, including pro-inflammatory cytokines (e.g., IL-6, IL-8, TNF-alpha) and acute phase proteins (e.g., C-reactive protein, soluble CD14).

This study will not recruit any new participants. Detailed respiratory phenotypic information and serum samples that were collected during the TESAOD study will be evaluated in conjunction with newly generated biomarker and protein information. No new phenotypic data or biological specimens will be collected in this study.

Eligibility Criteria:
Inclusion Criteria:

* Enrolled in the Tucson Epidemiological Study of Airway Obstructive Disease (TESAOD)
The Study on the Pulmonary Vessel Disease and Its Changes in Metabolism of Small Molecules

The purpose of this study is to investigate the changes of the pulmonary vessel disease and its metabolism of small molecules.

The patient with acute respiratory distress syndrome and sepsis come to hospital ,the investigators will blood them to study the changes in metabolism of small molecules.

Eligibility Criteria:
Inclusion Criteria:the aged between 18 and 85;Patients with ARDS and sepsis;Patients with only sepsis;normal

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Exclusion Criteria:Age \<18 or \>85, pregnancy, diabetes mellitus, cardiac pulmonary edema, can lead to other conditions of ARDS: severe trauma, a large number of blood transfusions, severe acute pancreatitis, etc., end-stage tumor.
Nutritional Assessment in Non-tuberculous Mycobacteria Pulmonary Disease

Non-tuberculous mycobacterial (NTM) pulmonary disease (PD) is an emerging condition with heterogeneous manifestations from both the microbiological and the clinical point of view. Diagnostic and therapeutic guidelines are available but there are still unmet patients' and physicians' needs, including the exams to perform in the nutritional evaluation and intervention to improve health-related QoL and to control gastrointestinal side-effects during antimicrobial therapy, particularly in those with low body mass index and history of weight loss.

The aim of the study is to evaluate the nutritional status in patients with non-tuberculous mycobacterial pulmonary disease (NTM-PD) and to provide an initial assessment of the potential impact of the introduction of targeted antibiotic therapy on the nutritional status itself.

Specifically, the primary objective is the assessment of the proportion of underweight subjects, i.e. with Body Mass Index (BMI) \<18.5 kg/m2, to confirm that it is significantly higher than that of the general Italian population.

Study Design: Multicenter Cohort Pilot Observational Study

Participation in the study consists of two pneumological visits, as per normal clinical practice, (at the beginning of the study, T1, after 6 months, T3, and at the end of the antimicobacterial antibiotic therapy, T5) in which the collection of past medical history, measurement of oxygen saturation, pulmonary functional tests and 6-minute walking tests will be performed. In addition, nutritional assessments (T2, T4, T6) will be carried out at the same time as the pulmonary visits. Nutritional assessments will include anthropometric measurements, questionnaires on nutritional status and physical activity, performing blood chemistry tests, bioimpedance, dynamometry and gait speed 4 meters, to evaluate body composition and physical performance.

Eligibility Criteria:
Inclusion Criteria:

* age greater than or equal to 18 years;
* diagnosis of NTM-PD according to the BTS 2017 guidelines

Exclusion Criteria:

* severe renal failure, defined as a GFR (glomerular filtration rate) lower than 30ml / min; NYHA class IV;
* severe liver failure, defined as Child-Pugh score class C;
* active solid or haematological neoplasms;
* having already received (currently or in the prior 6 months) antimicobacterial therapy;
* severe immunosuppression;
* inability to walk without help;
* need for oxygen therapy at rest;
* participation in other interventional experimental protocols with use of a medicinal product.
Sexual Function, Body Image, Kinesiophobia and Physical Activity in Pregnant Women

This study compares sexual function, body image, kinesiophobia and physical activity level in women with and without pregnancy-related pelvic girdle pain.

Pelvic girdle pain (PGP) is a condition felt around the posterior iliac crystals, gluteal region and the sacroiliac joints, may spread to the back of the thigh, and may occur together or separately with pain in the symphysis pubis. Pregnancy-related PGP causes problems in the sexual life of women. Body image differs with the development of physical symptoms and changes in body size and shape during pregnancy. Body dissatisfaction resulting from physical changes can cause problems in women's attitudes towards sexuality. Sexual function is affected by physiological, anatomical and psychological changes that occur during pregnancy. Sexual function during pregnancy has been associated with conditions such as body image, physical activity level, and pain.

In the literature, there are studies evaluating the relationship between sexual function and body image in pregnant women and in different populations. However, in these studies, questionnaires specific to pregnant women were not used to evaluate sexual function and body image, and a comparison of these parameters was not investigate in women with and without pregnancy-related PGP.

Therefore, this study was planned to compare sexual function, body image, kinesiophobia and physical activity levels in women with and without pregnancy-related PGP.

The outcome measures are Pregnancy Sexual Response Inventory (PSRI), Body Image in Pregnancy Scale (BIPS-Turkish), Tampa Kinesiophobia Scale (TKS) and Pregnancy physical activity questionnaire (PPAQ).

The clinical diagnosis tests are Active Straight Leg Rise, Posterior Pelvic Pain Provocation Test, Long Dorsal Sacroiliac Ligament Palpation, Pelvic Compression, Pelvic Distraction, Patrick-Faber Test and Gaenslen Test.

Eligibility Criteria:
Inclusion Criteria:

* Being between 18 and 40 years-old,
* Being second or third trimester of pregnancy
* Being literate in Turkish

Exclusion Criteria:

* Having a pregnancy complication (preeclampsia, pregnancy-induced hypertension, diabetes, etc.),
* Having a known gynecological or urological problem that may mimic PGP
* Having neurological (multiple sclerosis, spinal cord injury, etc.), orthopedic (hip dislocation, etc.), cardiopulmonary (heart failure, chronic obstructive pulmonary disease, etc.) problems that affect sexual function and physical activity,
* Having situations in which sexual activity is contraindicated and should be restricted (placenta previa, risk of premature birth, cervical insufficiency, antepartum hemorrhage, premature rupture of membranes, genital infection, etc.),
* Having visual, auditory and cognitive problems that may prevent participation in the study.
Microwave Ablation With MRI-Guided SBRT Boost in Renal Cell Carcinoma

The specific aims of this study are:

1. To determine the safety and feasibility of treating patients with a combination of MRI guided stereotactic body radiation therapy and microwave ablation.
2. To assess short and long-term toxicity rates of patients treated with a combined modality approach.
3. To assess local control, survival, and pathologic response to treatment

Renal cell carcinoma is traditionally managed via a surgical approach. Increasingly, local therapy with radiofrequency and microwave ablation is being utilized as an alternative for patients who may not tolerate a nephrectomy or who refuse one. Although local control rates for small lesions are excellent, they drop off precipitously for lesions over 4 cm. Furthermore, lesions in critical areas such as the renal hilum may be difficult to treat with this method. Stereotactic body radiation therapy (SBRT) has had a long record of treating patients with inoperable tumors in locations such as the lung and central nervous system, and there is increasing evidence that it may be useful for patients with renal cell carcinoma. The recent emergence of MRI-guided radiation therapy allows for direct visualization of tumors during treatment, and may potentially allow clinicians to treat tumors more precisely. This phase I study will treat renal cell carcinoma patients using a combination of MRI-guided stereotactic body radiation therapy and microwave ablation.

Eligibility Criteria:
Inclusion Criteria:

* Patients with imaging findings consistent with renal cell carcinoma
* Deemed medically inoperable per urology evaluation
* Tumor size \>4cm in largest dimension
* ECOG performance status of \<2
* Signed informed consent document(s)
* Patients with metastatic disease will not be excluded

Exclusion Criteria:

* Patients who fail MRI screening
* Pregnant or nursing women
* History of prior radiation therapy to the upper abdomen
* History of invasive cancer in the last 3 years (except for appropriately treated low-rist prostate cancer, treated non-melanoma/melanoma skin cancer, appropriately treated ductal carcinoma in situ or early stage invasive carcinoma of breast and appropriately treated in-situ/early stage cervical/endometrial cancer)
* Treatment with a non-approved or investigational drug within 28 days of study treatment
PP100-01 (Calmangafodipir) for Overdose of Paracetamol

Investigate the safety and tolerability of PP100-01 add-on treatment to the 12hr NAC treatment regime in patients treated for paracetamol/acetaminophen overdose (POD) when NAC treatment is initiated before 24hours post POD.

The study will be an open label, randomised, exploratory, rising dose design, NAC controlled, phase 1 safety and tolerability study in patients treated with NAC for paracetamol/acetaminophen overdose.

Entry into the study will depend on the patient's blood results confirming the need for NAC. A total of 24 patients will be assigned into one of 3 dosing cohorts of 8 patients (N=6 for PP100-01 and NAC; N=2 for NAC alone).

The study will primarily evaluate safety and tolerability for treatment with PP100-01 in combination with NAC as compared to NAC alone.

Eligibility Criteria:
Inclusion Criteria:

1. Any patient with capacity admitted to hospital within 24 hrs either a single acute POD or more than one dose of paracetamol (staggered) and deemed to require treatment with NAC.
2. Provision of written informed consent
3. Males and females of at least 16 years of age

Exclusion Criteria:

1. Patients that do not have the capacity to consent to participate in the study
2. Patients detained under the Mental Health Act or deemed unfit by the Investigator to participate due to mental health.
3. Patients with known permanent cognitive impairment
4. Patients who are pregnant or nursing
5. Patients who have previously participated in the study
6. Unreliable history of POD
7. Patients presenting after 24hrs of POD
8. Patients who take anticoagulants (e.g. warfarin) therapeutically or have taken an overdose of anticoagulants
9. Patients who, in the opinion of the responsible clinician/nurse, are unlikely to complete the full course of NAC e.g. expressing wish to self-discharge
10. Prisoners
11. Non-English speaking patients. (Study information material will only be produced in English in view of the known and stable demographic of the Edinburgh self-harm population).