cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Extracorporeal Shock Wave Therapy, LASER Therapy and Cryotherapy in Patients Having Sacroiliitis

This research aimed to determine the effect of extracorporeal shock wave therapy, LASER therapy and cryotherapy on PPT, Pain and functional disability in patients having Sacroiliitis.

The study will be based on a three-arm parallel group randomized control design. sixty participants of sacroiliitis will be recruited from the Physiotherapy department, at Najran University, K.S.A. Study objectives and procedure will be properly explained and written informed consent will be obtained at the beginning of the study. All the participants will be randomly divided into three groups 1, 2 and 3.

All the participants in first week will receive the ice pack for 15 minutes 3 times a day at the lumbosacral area to reduce inflammation in the area, along with rest to reduce irritation at the lumbosacral area for the first week.

From the 2nd week:

Group 1 will be administered ESWT plus exercise, Group 2 will be administered LASER plus exercise, and Group 3 will be administered cryotherapy and exercise.

Eligibility Criteria:
Inclusion Criteria:

* Pain in one or both buttocks, hip pain, thigh pain, or even pain more distal.
* Patients may report that their pain is worse after sitting for prolonged periods or with rotational movements that will be intensified when bending laterally or backward and
* Positive outcome in a minimum of three out of five pain-provocation tests (i.e., compression test, distraction test, Faber sign, Gaenslen test, and thigh thrust.
* Pain close to the posterior superior iliac spine and the patient could point with a single finger to the location of pain (Fortin Finger Test).

Exclusion Criteria:

* The Participant who had undergone surgery or experienced significant trauma to the spine, pelvis, lower limb, chest, or abdomen within the past 12 months.
* The participants with lower extremity musculoskeletal disorders, localized spinal pathology, congenital anomalies of the hip, pelvis, or spine that limited mobility.
* having a positive straight leg raising test
* receiving nonsteroidal anti-inflammatory drugs, hormonal therapy, or corticosteroid injections
* individuals with tumors, fractures. ankylosing spondylitis.
Risk Stratification Among Individuals Who Have Many Moles on Their Skin

The investigators are doing this study to improve our ability to identify which people with many moles on their skin are most likely to develop skin melanoma. The investigators hope to identify features of moles that are associated with melanoma risk. The investigators hope to use this information to customize and tailor melanoma screening to the individual patient based on a better estimate of their individual risk.


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years of age
* High-risk nevus phenotype (≥ 50 nevi (≥ 2mm in size) and ≥ 1 atypical nevus)
* First presented to MSKCC for cutaneous melanoma-related care on or after April 2016
* Cases: diagnoses of unequivocal invasive cutaneous melanomas (AJCC Stages I-IV) confirmed by MSKCC pathology on or after April 2016
* Cases: completion of surgical treatment of primary melanoma
* Ability to sign or verbally consent to the informed consent

Exclusion Criteria:

* Controls: Histopathologically borderline melanocytic tumors for which melanoma could not be excluded or that were treated as possible melanomas.
* Known germline high-penetrance melanoma predisposition mutation (that is, CDKN2A, CDK4, and BAP1)
* Cases: history of invasive cutaneous melanoma (AJCC Stages I-IV) not confirmed by MSKCC pathology
* History of acrolentiginous type of cutaneous melanoma or history of mucosal melanoma
* Cases and controls: prior administration of systemic medications known to modify nevus phenotype, including but not limited to: MEK inhibitors (trametinib, cobimetinib, etc.), BRAF inhibitors (vemurafenib, dabrafenib, etc.), and immunotherapy (pembrolizumab, nivolumab, atezolizumab, ipilimumab, etc.). Controls: history of Stage 0-IV melanoma confirmed by MSKCC pathology
* History of limb amputation or other condition (e.g., tattoos, burns) per investigator discretion that would modify nevus phenotype
* Physical inability to undergo total body photography or reflectance confocal microscopy imaging (that is, remain relatively still for durations of 3-5 minutes)
* Known hypersensitivity to adhesive rings used for reflectance confocal microscopy
* Inability to give informed consent
* Have skin afflicted with anther skin condition (for example, psoriasis) that would affect ability to characterize nevus phenotype (per investigator discretion)
* Familial cutaneous melanoma history (families with at least one invasive melanoma and two or more other diagnoses of invasive melanoma or pancreatic cancer among first- or second-degree relatives on the same side of the family). We will confirm melanoma family history via medical record documentation, whenever possible, as recommended by previous studies that disproved about half of the reported family histories of melanoma among first-degree relatives in case-control studies.
* Age 70 or above
Dexmedetomidine and Blood Coagulation

Dexmedetomidine may alter whole blood coagulation. However, little is known about the dose-response relationships according to the blood concentration of dexmedetomidine. The investigators have therefore performed the present study to measure the effect of dexmedetomidine on the coagulation pathway according to the drug concentration level using a rotational thromboelastometry test.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* Age: 20 to 65 years
* Body weight \> 50 kg
* Volunteers who provided informed consent

Exclusion Criteria:

* Hematologic disease
* Anticoagulant medication
Effect of Liraglutide or Glimepiride Added to Metformin on Blood Glucose Control in Subjects With Type 2 Diabetes

This trial is conducted in Asia. The trial is designed to compare the effect on glycaemic control of liraglutide or glimepiride added to metformin in subjects with type 2 diabetes


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* Subjects diagnosed with type 2 diabetes and treated with one or more oral antidiabetic drugs (OADs) for the last 3 months
* HbA1c: 7.0-11.0% (both incl.) for subjects on OAD alone
* HbA1c: 7.0-10.0 % (both incl.) for subjects on OAD combination therapy
* BMI less than 45.0 kg/m\^2

Exclusion Criteria:

* Treatment with insulin within the last 3 months prior to the trial
* Impaired liver or/and renal function
* Significant cardiovascular disease over the last 6 months
* Known retinopathy or maculopathy
* Recurrent major hypoglycaemia or hypoglycaemic unawareness
Telehealth Stepped Exercise Program for Rural Veterans With Knee Osteoarthritis

The goal of this study is to evaluate a telehealth Stepped Exercise Program for Knee OsteoArthritis (STEP-KOA) among rural veterans. Methods: This is a single arm, pre-post pilot trial of the 6-month STEP-KOA program among rural Veterans with a physician diagnosis of knee OA who self-report knee pain ≥3 on a 0-10 scale and self-reported difficulty with either walking or stair climbing. We aim to enroll 20 Veterans in this project but may enroll up to 30 in order to obtain sufficient information to evaluate the program, particularly among Veterans who live in very rural areas. Assessments will be conducted via a combination of telephone and video at baseline and 2-, 4-, and 6-month follow-up. Assessments will include questionnaires related to pain, function and physical activity, as well as several physical performance tests. STEP-KOA begins with a low cost, primarily self-directed exercise program (supported by an internet-based tool; Step 1). Patients are then assessed for degree of improvement in symptoms, and then can step up sequentially to telephone or video-based physical activity coaching (Step 2) and physical therapy (Step 3) if they do not make clinically relevant improvements in prior steps. For this project, patients will be assessed approximately every 2 months to determine step progression. Participants will advance to the next step if they do not meet response criteria for pain and function established by the Outcome Measures in Rheumatology group and the Osteoarthritis Research Society International (OMERACT-OARSI). The Step 2 intervention involves bi-weekly telephone or video calls. Step 3 involves 3 telehealth PT visits, based on standard care for knee OA.


Eligibility Criteria:
Inclusion Criteria:

* Rural dwelling Veterans (VA healthcare users)
* Clinician diagnosis of knee osteoarthritis
* Self-reported knee pain =\>3 on a scale of 0-10 and self-reported difficulty either walking or stair climbing.

Exclusion Criteria:

* Advanced Dementia
* Psychosis
* Active substance abuse disorder
* Meniscus or ACL tear in the past 6 months
* Total joint replacement or other major lower extremity surgery in the past 6 months
* Severe hearing or visual impairment (e.g. unable to participate in STEP-KOA intervention components)
* Serious / terminal illness
* Unstable angina
* History of ventricular tachycardia
* Unstable chronic obstructive pulmonary disease (two hospitalizations within the previous 12 months and/or on oxygen)
* Uncontrolled hypertension (diastolic blood pressure \>110 mm/Hg or systolic \> 200mm/Hg)
* Stroke with moderate to severe aphasia
* Recent history of falls
* Resident of a long-term care facility
* Hospitalization for a cardiovascular condition in the past 3 months
* Other health conditions that would make home exercise unsafe or participation in the program not feasible
A Study of MAb-3F8 Plus Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) Versus 13-cis-Retinoic Acid (RA) Plus GM-CSF in Primary Refractory Neuroblastoma Patients

This is a multicenter, randomized, controlled, open-label study. Patients meeting inclusion/exclusion criteria will be randomized (1:1) to receive two cycles of MAb-3F8 plus GM-CSF or RA plus GM-CSF. Patients who do not respond to their assigned treatment after two cycles may cross-over to receive the alternate treatment. Disease response and safety will be assessed in all patients after cycle 2 and after cycle 4.


Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of stage 4 neuroblastoma diagnosed in accordance with the International Neuroblastoma Staging System: either (a) histologic confirmation which may involve immunohistochemical, ultrastructural, and/or cytogenetic studies, or (b) elevated urinary catecholamines plus tumor cells/clumps in the bone marrow.
* Have evaluable disease or biopsy-proven stable disease in BM by histology or MIBG scan with MIBG-positive disease confined to the bone or bone marrow, plus urine catecholamine results, documented \>3 weeks after conventional chemotherapy or \>6 weeks after stem-cell transplantation. CT, MRI, or bone scan (if necessary) can be done at 2-3 weeks after conventional chemotherapy confirming that the chemotherapy, radiotherapy, and ABMT are not realistic curative options.
* Be between 18 months to 13 years old at diagnosis.
* Have recovered to grade 2 or better toxicities since their prior therapy.
* Must, if female of childbearing potential, be willing to use two forms of medically acceptable contraception (at least one barrier method) and have a negative pregnancy test at screening and monthly thereafter through the first four cycles of treatment.
* Have a performance score of at least 60 from Lansky Play Performance Scale if aged up to 16 years or at least 60 from Karnofsky Scale if aged more than 16 years.
* Have voluntarily agreed to participate.

Exclusion Criteria:

* Have measurable disease ≥ 1 cm assessed by CT or MRI.
* Have progressive disease (any new lesion; increase of any measurable lesion by \>25%; or previous negative marrow positive for tumor).
* Have disease detectable in CNS (confirmed by CT or MRI of the brain at screening or within 8 weeks of randomization).
* Be receiving alternative therapy for the treatment of neuroblastoma, e.g. radiotherapy or chemotherapy within 3 weeks of randomization.
* Require additional therapy (such as radiotherapy) during the first two treatment cycles.
* Have detectable human anti-mouse antibody titers at screening.
* Have received prior anti-GD2 investigational therapies.
* Have a history of allergies to mouse proteins.
* Have an active infection requiring IV infusion of antibiotics.
* Be currently receiving long-term chronic treatment with immunosuppressive drugs such as cyclosporine, adrenocorticotropic hormone (ACTH), or systemic corticosteroids.
Resveratrol for Exudative Age-Related Macular Degeneration

This is an interventional, prospective, randomized, comparative monocentric study aiming to evaluate the safety and efficacy of Resveratrol to reduce the progression of exudative Age-Related Macular Degeneration.

Interventional, prospective, randomized, comparative monocentric study aiming to evaluate the safety and efficacy of Resveratrol to reduce the progression of exudative Age-Related Macular Degeneration.

Comparison of incidence of choroidal neaovascularization between each study group will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Men or women aged 55 or more with unilateral exudative AMD
* Visual acuity less or equal to 20/25 in the most affected eye

Exclusion Criteria:

* Allergy to an investigational product
* atrophic Age-Related Macular Degeneration or age related maculopathy
* significant media opacities
* Other retinal pathology (diabetic retinopathy, high myopia, retinal dystrophy)
* Recent Cataract surgery
* Previous history of vitrectomy
* Acute or chronic severe organ failure
* Present participation in other clinical research study
Green Tea Extract in Treating Patients With Advanced Solid Tumors

RATIONALE: Green tea extract contains ingredients that may slow the growth of certain cancers, as well as prevent the development of new cancers.

PURPOSE: Phase I trial to study the effectiveness of green tea extract in treating patients with advanced solid tumors that are refractory to standard therapy.

OBJECTIVES: I. Determine the maximum tolerated dose of green tea extract administered daily to adults with solid tumors. II. Determine the safety of chronic daily administration of green tea extract in these patients. III. Investigate the clinical pharmacology of green tea extract in this study. IV. Document observed antitumor activity of this treatment.

OUTLINE: This is a dose escalation study of green tea extract. Patients receive green tea extract by mouth daily after meals for 4 weeks. One patient is entered at each dose level. If grade II toxicities are experienced, then 2 more patients are entered at the same dose level. One patient must complete 4 weeks of therapy and 2 others must complete 2 weeks of therapy with no greater than grade I toxicity before dose escalation proceeds. If at least 2 patients experience dose limiting toxicity at any dose level, the immediately preceding dose level is considered the maximum tolerated dose (MTD). At least 6 patients are studied at the MTD. Patients may continue therapy for up to 6 months in the absence of toxicity and disease progression. Patients are followed every 4 weeks for the duration of treatment and at least one month after completing treatment.

PROJECTED ACCRUAL: Approximately 30 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Pathologically proven incurable advanced solid tumor refractory to standard therapy or for which no standard therapy exists No known brain metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-2 OR Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: WBC at least 4,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL AST less than 1.25 times normal Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No significant cardiac disease Other: No significant metabolic disorder No significant infection Not pregnant or nursing Effective contraception must be used by fertile women

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 3 weeks (6 weeks for nitrosourea) since prior chemotherapy and recovered Endocrine therapy: Not specified Radiotherapy: At least 3 weeks since prior radiotherapy and recovered Surgery: Not specified
Micropulse Laser Trabeculoplasty (532nm) Versus Conventional Laser Trabeculoplasty (532nm)

This study will investigate if micropulse laser trabeculoplasty (532nm) is as effecttive as or better than the conventional laser trabeculoplasty (532nm), it might be a new treatment strategy for glaucoma patients. It is done with a laser device that can also be used for many other ophthalmic applications, thus reducing the economic burden of treatment.


Eligibility Criteria:
Inclusion Criteria:

* individuals over 18 years old
* willing to sign an informed consent and able to comply the requirements of the study
* having no other ocular diseases besides glaucoma

Exclusion Criteria:

* history of ocular trauma
* intraocular surgery (except for phaco)
* pigment dispersion and exfoliation glaucoma
Stand & Move at Work II: Effectiveness and Implementation of a Worksite Wellness Program

This is a 2-arm group-randomized hybrid effectiveness-implementation (HEI type 2) study to test an evidence-based intervention (EBI) known as Stand \& Move at Work(SMW) to reduce sedentary time in the workplace, and to test the role of expert facilitation (SMW+) for improving intervention fidelity.

Primary Aim: To assess worksite-level reduction in sedentary time and intervention fidelity over 12 months Secondary Aim: To assess cost effectiveness of the intervention at 12 and 24 months

Eligibility Criteria:
Worksite-Level Inclusion Criteria:

* More than 80% of employees work full time (30+ hours per week).
* At least 45 employees in the worksite with sit-stand workstations working at least three days per week
* Occupations require primarily desk-based work (e.g., computer- and telephone-based)
* Willing to allow the researchers to distribute online research surveys to all employees in order to allow the program to be evaluated.
* Allow 30 randomly selected individuals to wear an activity monitor in several 7-day intervals across two years.
* Willing to be randomized to either intervention.
* Willing to identify one or more worksite champions to implement the Stand \& Move at Work™ program.

Worksite-level exclusion criteria:

* Involved in previous interventions to reduce sitting and increase standing and moving at work in the last 24 months.
* Involved in the Stand and Move I intervention.
* Another worksite within the same organization is participating in the program and contamination across those worksites cannot be avoided.

Employee-level inclusion criteria:

* 18 years or older
* Willing to provide informed consent
Targeted and Staged Cyber Knife Combined With Interventional Therapy in the Treatment of MHCC

Hepatocellular carcinoma is a highly malignant tumor that is progressing rapidly. Hepatic arterial embolization chemotherapy (TACE) is a common method for the treatment of unresectable of hepatocellular carcinoma.But for patients with \> 10cm hepatocellular carcinoma, the intervention effect was not satisfied.The cyberknife is a kind of stereotactic radiotherapy which can track the movement of tumor and monitor the position deviation of tumor in real time.This stuy is aimed to observe the efficiency and safety of the combination of TACE and cyberknife in the treatment of massive hepatocellular carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed hepatocellular carcinoma
* No lymph node metastasis or distant metastasis
* Tumor diameter at least 10 cm
* Hepatic lesions are not suitable for surgical resection or the patient refuse to surgical treatment
* Eastern Clinical Oncology Group (ECOG)score is 0， 1or2
* No history of abdominal radiotherapy
* Inoperable and untransplantable,Child-pugh score A or B
* Normal liver volume exceeds 700 cm3

Exclusion Criteria:

* Previous history of abdominal radiotherapy;
* The maximum diameter of tumor is less than 10cm;
* The liver Child is graded C;
* Contraindication for radiotherapy;
* Active gastrointestinal bleeding occurred within 2 weeks before enrollment
* Pregnancy
* Undergoing chemotherapy throughout the past six months
* Diffuse hepatocellular carcinoma
* Main portal vein tumor embolization
* Undergoing other simultaneous treatment
The Role of TLR-4 Polymorphisms in Children With Urinary Track Infections

Purpose So far anatomical abnormalities (mostly congenital) were, in the majority of the patients, associated with urinary track infections. In this study the researchers will try to investigate the role of TLRs as molecular interactions between bacterial virulence and host response.

TLRs are important mediators in the development of the natural immunity against bacteria. They recognize microbial pathogen associated molecular patterns and alert the host's immune system to the presence of invading microbes

The aim of his observational case-control study is to :

1. investigate if the expression of TLR2 and TLR4 mediate in the development of the natural immunity of the uroepithileal cells against bacteria.
2. evaluate the effect of the TLR-gene Asp299Gly and Thr399Ile polymorphisms on the development and clinical severity of urinary tract infections (UTI) in children.
3. determine the association of the expression of TLR-2 and TLR-4 and TLR-4 polymorphisms with the formation of renal scar in children.
4. investigate the expression of TLR-2 and TLR-4 and TLR-4 polymorphisms in healthy children and elaborate the results to the possible carriers of these polymorphisms.

Eligibility Criteria:
Inclusion Criteria:

* For the patients

  * 6months -14 years of age
  * unrelated male and female children with one episode of acute urinary track infection (positive urine culture and clinical symptoms )
  * with/without anatomic genitourinary anomalies .
  * children with upper UTI or children with lower UTI
  * Sign written informed consent

Inclusion Criteria:

For the controls

* 6 months-14 years of age
* age and gender matched with the patients
* unrelated male and female children with no recorded history of urinary track infection and negative urine cultures .
* Sign written informed consent

Exclusion Criteria:

* For the patients

  * Subjects who do not meet the criteria above
  * Severe or chronic illness
  * Symptoms of acute infection
  * Immune deficiency or immune suppressor therapy
  * Medication

Exclusion Criteria:

For the controls

* Subjects who do not meet the criteria above
* Severe or chronic illness
* Symptoms of acute infection
* Immune deficiency or immune suppressor therapy
* Medication