cyrilzakka/clinical-trials huggingface dataset:
A Study to Compare the Safety and Effectiveness of Two Dosing Schedules of Lamivudine in Combination With Two Other Anti-HIV Drugs

The purpose of this study is to compare the safety and effectiveness of 2 dosing schedules (once daily vs twice daily) of lamivudine (3TC) given with stavudine (d4T) and either indinavir (IDV) or nelfinavir (NFV) for 24 weeks.

Patients are randomized to 1 of 2 groups. Group 1 receives 3TC qd plus d4T plus either IDV or NFV. Group 2 receives 3TC bid plus d4T plus either IDV or NFV. Patients are evaluated for drug tolerance, medication adherence, and genotypic and phenotypic resistance.

Eligibility Criteria:
Inclusion Criteria

Patients may be eligible for this study if they:

* Are HIV-positive.
* Are at least 18 years old.
* Have had an HIV level below 400 copies/ml for at least 3 months prior to study entry.
* Have a CD4 cell count of at least 50 cells/mm3.
* Are currently taking an anti-HIV drug regimen that includes 3TC plus d4T plus either IDV or NFV for at least 6 months prior to study entry. (Note: This must be their first anti-HIV drug regimen.)
* Agree to abstain from sex or use effective methods of birth control during the study.

Exclusion Criteria

Patients will not be eligible for this study if they:

* Have a history of an AIDS-defining illness or certain other medical conditions.
* Are allergic to any of the study drugs.
* Are unable to take medication by mouth for any reason.
* Have received certain medications.
* Will need to receive radiation therapy or chemotherapy (for any cancer other than Kaposi's sarcoma) during the study.
* Are pregnant or breast-feeding.
Handling Medium for ICSI With Ionomycin and Latrunculin A

Using Latrunculin A and Ionomycin would improve the outcome of ICSI if the handling medium during the ICSI procedure has them.


Eligibility Criteria:
Inclusion Criteria:

* indication for ICSI

Exclusion Criteria:

-
Clinical Evaluation of Visual Field Change in Glaucoma: an Assessment of Different Models of Progression

The purpose of this observational study is to collect over time a series of data in patients with glaucoma in order to evaluate different approaches in defining the progression of this pathology. These data will be collected in repeated visits over a 36-months follow-up period. At each visit, the COMPASS fundus perimeter and the Humphrey Field Analyzer (HFA) perimeter will be used to assess retinal functionality; an Optical Coherence Tomography (OCT) examination will also be performed to evaluate and obtain clinical information about the structure of the retina.


Eligibility Criteria:
Inclusion Criteria:

* Glaucomatous optic nerve head in both eyes;
* Age between 40 and 90 years;
* Best Corrected Visual Acuity ≤ 0.3 \[logMar\];
* Spherical refraction between -6D and +6D;
* Astigmatism between -2D and +2D.

Exclusion Criteria:

* Any ocular surgery, except for: uncomplicated cataract surgery and/or glaucoma surgery in both eyes performed within 6 months before enrollment;
* Any ocular pathology that can affect visual field other than glaucoma;
* Use of any drug that can interfere with the correct execution of perimetry or that would produce visual field loss;
* Inability to obtain reliable perimetric examinations;
* Patients with advanced glaucoma for whom, according to the clinician, a 24-2 grid is not advisable to correctly monitor the patient.
Efficacy of Neonatal Release of Ankyloglossia

The purpose of this study is to determine if frenotomy for ankyloglossia will improve infant breastfeeding, decrease maternal nipple pain and increase duration of breastfeeding with the hypothesis that frenotomy will do all of the above.

The primary objective of our study is to determine if frenotomy (or release of tongue tie) for ankyloglossia (tongue tie) will decrease maternal nipple pain with breast feeding and improve infant's ability to breast feed. Our secondary objective is to determine if frenotomy for ankyloglossia will improve the length of time a mother breast feeds. Our hypothesis is that frenotomy will decrease maternal nipple pain, improve infant's breast feeding and prolong the duration of breast feeding.

Eligibility Criteria:
Inclusion Criteria:

* Significant ankyloglossia as judged by Hazelbaker scale (HATLFF)
* Report of maternal nipple pain with feeding
* Report of difficulty with infant breast feeding

Exclusion Criteria:

* Significant craniofacial defects
* Age \>14 days at enrollment
* Any maternal contraindication to breastfeeding
* Neurologic defects that would impair breast feeding
Multislice Computed Tomography Angiography in Acute Mesenteric Ischemia

Acute mesenteric ischemia is a life-threatening condition with high mortality. Acute mesenteric ischemia is responsible for fewer than one in 1000 hospital admissions, but its mortality rate ranges between 30% and 90% . Acute mesenteric ischemia is most commonly secondary to embolism followed by arterial thrombosis, non-occlusive ischemia, and less commonly venous thrombosis . Delay in diagnosis contributes to the continued high mortality rate. Early diagnosis and prompt effective treatment are essential to Correspondence to improve clinical outcomes

However, Acute mesenteric ischemia represents a major diagnostic challenge because of its varied presentations and multiple causes . Patients usually present with non-specific abdominal symptoms and laboratory findings, which leads to delayed diagnoses . Therefore, diagnostic imaging has emerged as one of the most crucial components in the diagnostic work-up of suspected

Recent technical advances have made computed tomography angiography the modality of choice in the setting of suspected Acute mesenteric ischemia.computed tomography angiography is a rapid and non-invasive diagnostic tool for assessing intestinal vasculature and bowel . computed tomography angiography allows early diagnosis and differentiation between occlusive and non-occlusive causes, which is important to direct therapeutic approach . Overall, combining vascular and bowel assessment results in a high diagnostic accuracy . A recent meta-analysis showed a sensitivity of 93% and a specificity of 96% . However, this meta analysis also showed that the prevalence of confirmed .Acute mesenteric ischemia is less than 25% among the patients referred to computed tomography angiograph in the setting of suspected Acute mesenteric ischemia .Knowledge of the prevalence and the demographic distribution of alternative diagnoses in the remaining three-fourths of patients without Acute mesenteric ischemia is important for appropriate patient care. computed tomography angiograph is considered to allow for a variety of acute alternative diagnoses, ensuring timely triage of these patients.

Eligibility Criteria:
Inclusion Criteria:

Clinically suspected acute mesenteric ischemia based on physician evaluation Patients should be evaluated during 48 h of acute presentation

Exclusion Criteria:

* Renal Impairment
* Known allergy to iodine contrast media.
Satisfaction and Recovery After Distal Radius Fracture

Distal radius fracture is the most common fracture in Sweden, but little is known about the patient's experience of pain and hand function during the first three months after the injury. This observational study will provide detailed information on a daily basis regarding pain, use of analgesic drugs, use of splints and hand function as measured weekly by a condition-specific questionnaire.

Two hundred patients who are treated conservatively in a cast and one hundred patients who have undergone surgery will be asked to complete a questionnaire with the following outcome measures for three months:

1. Pain (day-by-day registration on a Likert scale, range 0-10)
2. Analgesic used (day-by-day registration of specific drug, dose and number)
3. PRWE (Patient Reported Wrist Evaluation form, week-by-week registration)
4. Use of and evaluation of efficacy of prefabricated wrist splints (week-by-week registration)
5. Details of sick leave and return to work at completion of the questionnaire at three months.

The study is entirely PROM-based and the patient will not require any additional appointments.

Eligibility Criteria:
Inclusion Criteria:

* Unilateral distal radius fractures in patients without any other significant injuries regardless of ligament injuries and ulnar fractures.
* Signed written consent

Exclusion Criteria:

* Compound injuries
* Open fractures
* Patients with post traumatic function deficits at any level in the affected arm prior to the distal radius fracture.
* Patients with function deficits in the affected arm due to other medical conditions (e.g. Parkinsons disease, Rheumatoid Arthritis)
* Reduced mental capacity (e.g. dementia, substance abuse)
Study to Assess the Safety and Efficacy of Imiquimod 5% Cream for the Treatment of Actinic Keratosis on the Arms and Hands

The purpose of this study is to evaluate the safety and efficacy of imiquimod 5% cream compared to vehicle cream in the treatment of Actinic Keratosis (AK) on the arm and/or hand when the cream is applied once daily 2 days per week for 16 weeks.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age
* Have AK on arm or hand
* Discontinuation of sun tanning and the use of tanning beds
* Discontinuation of the use of moisturizers, body oils, over-the-counter retinol products and products containing alpha or beta hydroxy acid in the treatment and surrounding area
* Withholding of the use of sunscreen in the treatment area for 24 hours prior to all study visits and for 8 hours before applying study cream
* Postponement of the treatment of non-study AK lesions anywhere on the arm being treated until study participation is complete

Exclusion Criteria:

* Subjects must not have any evidence of systemic cancer or immunosuppression or other unstable health conditions
* Participation in another clinical study
* Have previously received treatment with imiquimod within the treatment area
* Have squamous cell carcinoma (SCC), basal cell carcinoma (BCC), or other malignancy in the treatment or surrounding area that requires treatment
Turkish Lower-Extremity Motor Activity Log (LE-MAL)

The Motor Activity Log was developed to measure paretic upper extremity use in daily activities in the real-life context (real world) of people with different health conditions, including stroke. Subsequently, the Lower Extremity Motor Activity Diary was developed. This survey is a semi-structured survey in which the participant is asked to rate himself/herself according to each scale over 14 activities.

The Motor Activity Log was developed to measure paretic upper extremity use in daily activities in the real-life context (real world) of people with different health conditions, including stroke. Real-world use outside the individual's clinical/laboratory environment, including daily activities (e.g., walking indoors and outdoors above ground, climbing stairs, getting in and out of a car, jumping over an object, picking up an object, sitting and standing) It's about what they do.

The Motor Activity Log is a reliable patient self-report measure and correlates significantly with another real-world measure, the accelerometer.

Adaptation of the Motor Activity Log to the lower extremity involved the development of three subscales to measure changes in types of activity that are bilateral in nature and use of the paretic lower extremity: level of assistance, functional ability, and confidence. The Lower Extremity Motor Activity Log is a semi-structured questionnaire in which the participant is asked to rate himself on each scale across 14 activities. The score for each scale is the average of the rate provided for each activity. Additionally, a composite score can be calculated that combines all scales through assistance, functional ability, and confidence scores.

A preliminary study with individuals with stroke using the English version of the Lower Extremity Motor Activity Log-14 showed that the total score was 0.93, 0.90, 0.94, and 0.88 test-retest for the composite score, assistance, functional ability, and confidence scales, respectively. The test showed that it has reliability.

The aim of this study is to investigate the reliability and validity of the Turkish version of the Lower Extremity Motor Activity Log-14.

Eligibility Criteria:
Inclusion Criteria:

* Individuals between the ages of 18-80 living in Gaziantep who applied to the neurology outpatient clinic of Hospital and were diagnosed with stroke.

Exclusion Criteria:

* Patients with a history of trauma within the last year, alcohol and substance addiction, and pregnancy
Solo Single Incision Laparoscopic Cholecystectomy

The purpose of this study is to determine safety of solo surgery in single incision laparoscopic cholecystectomy (SILC) with a camera holder comparing to a camera operator assisted SILC

This study is a multicenter randomized controlled study. The primary outcome based on non-inferior study design(α=0.05, power (1-β)=0.90); comparing a complications rate between Solo-SILC group and conventional cholecystectomy group (Ca-SILC).

Total of 272 patients who were undergoing laparoscopic cholecystectomy for gallbladder disorders will randomly assign to two groups according to a computer-generated table of random numbers Solo-SILC group using a laparoscopic camera holder (n=136) or Ca-SILC group in which a camera operator joins (n=136). .

Demographics (i.e., age, gender, body mass index (BMI), American Society of Anesthesiology (ASA) score, indication for operation, need for conversion to open surgery or additional port will be recorded. Outcome including pain, hernia, complication rates, post-cholecystectomy diarrhea, operator's workload will be investigated

Eligibility Criteria:
Inclusion Criteria:

* all patient need laparoscopic cholecystectomy (check the possibility of routine application of Solo-SILC in clinical practice)

Exclusion Criteria:

* Mirizzi syndrome
* unstable vital sign
* no compliance
* no consent
Device-guided Breathing for Shortness of Breath in COPD

Although drug therapies and pulmonary rehabilitation have greatly improved COPD symptoms, as many as 50% of patients with severe COPD have inadequately controlled dyspnea. Device-guided breathing is a behavioral intervention that guides respiratory rates into a therapeutic range; prolongation of the expiratory phase improves hyperinflation, the most significant driver of dyspnea in this population. Device-guided breathing, has no known side-effects, and may represent a cost effective adjunctive treatment for dyspnea in severe COPD.


Eligibility Criteria:
Inclusion Criteria:

* Current or former cigarette smokers of at least 10 pack-years
* Clinically significant dyspnea, as determined by a score of at least 2 on the Medical Research Council Dyspnea Score questionnaire (0-4), or through pulmonary function test results of a residual volume (RV) of \> 150% predicted or an FEV1 of \<65% predicted
* Clinical diagnosis of chronic obstructive pulmonary disease

Exclusion Criteria:

* Unable to use the slow-breathing device due to hearing impairment
* Poor motivation or lack of interest in using the device
* Pulmonary Rehabilitation ordered as a new therapy at the time of enrollment
To Evaluate the Efficacy of Oral Molecular Hydrogen Supplement in Patients With Chronic Diseases

The supplementation of hydrogen molecules as an aid, adjuvant, may speed up recovering the course of the disease. The purpose of this study is to determine the possible efficacy and safety of solid hydrogen supplements for a clinical study in patients with chronic diseases. Patients will receive hydrogen capsules with their conventional treatment for 24 weeks. Investigators will test for any changes in haematologic, urine analysis and health status during and following the exposure period.

Hydrogen supplement has been shown to have significant removing effects on free radicals. International clinical trials have shown promise that hydrogen molecules may reduce chronic inflammatory and then speed up recovering the course of the disease.The purpose of this study is to determine the possible efficacy and safety of hydrogen supplements in different formula and dose exposures for a clinical study in patients with chronic diseases.Study design: 60 chronic diseases patients will be recruited from the Taoyuan Armed Forces General Hospital and Tri-Service General Hospital for this study. Participants will be screened by doctors for their eligibility and undergo a series of tests (questionnaires and examinations).Consenting participants will then be randomly allocated into 2 groups (experiment group and control group, single-blind study). In experiment group, participants will receive 2 solid hydrogen capsules every day for 24 weeks. In control group, participants will receive 2 capsules not containing hydrogen every day for 24 weeks. Participants will be examined their regular haematology, urine and health status before and after the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Age 20 to 80
* Able to compliant with the protocol
* Able to return to the hospital regularly
* Patients with chronic inflammation, including patients with autoimmune diseases, metabolic-related diseases, chronic kidney disease or nephritis, tumor patients, etc.

Exclusion Criteria:

* Pregnancy
* Expected pregnancy
* Attending other clinical trials with 6 months
CANHelp Working Group Treatment Trials

The CANHelp Working Group Treatment Trials are part of a comprehensive research program carried out by the Canadian North Helicobacter pylori (CANHelp) Working Group. The treatment component involves a series of community-specific trials designed with community input and varying on the specific treatment regimens and number of treatment arms among other study details.

The CANHelp Working Group is a collaborative team that links University of Alberta researchers with Canadian northern community leaders and health officials in a collaborative effort to investigate H. pylori infection with the goal of finding solutions to community concerns about health risks. The research program uses a community-driven research approach in northern communities to characterize the burden of disease from H. pylori infection and exchange knowledge with community members and decision makers to identify ways to reduce health risks from this infection.

For the participating communities, the treatment trials aim to:

1. Estimate the effectiveness of alternate H. pylori treatment regimens to identify optimal regimens for the local setting
2. Identify factors external to the treatment regimen that influence short- and long-term treatment success

Eligibility Criteria:
Inclusion Criteria:

* Over 15 years of age
* Identified as H. pylori infected with a positive urea breath test and/or biopsy-based evidence of H. pylori infection

Exclusion Criteria:

* Allergy to amoxicillin, metronidazole or clarithromycin
* Antibiotic therapy within 4 weeks prior to randomization
* Pregnant or breastfeeding
* Severe cardio-respiratory, pulmonary, endocrine, hepatic or renal disease
A Study of the Safety and Efficacy of a New Treatment for Diabetic Macular Edema

This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone for the treatment of diabetic macular edema.


Eligibility Criteria:
Key Inclusion Criteria:

* 18 years of age or older with diabetic macular edema;
* Decrease in visual acuity in at least one eye as a result of macular edema (20/50 or worse);
* Visual acuity in other eye no worse than 20/200

Key Exclusion Criteria:

* Known anticipated need for ocular surgery within first 12 months of study;
* History of glaucoma or current high eye pressure requiring more than 1 medication;
* Uncontrolled systemic disease;
* Known steroid-responder;
* Use of systemic steroids
* Use of Warfarin/Heparin
Efficacy of Virtual Reality Based Exercise Regimes on Kinesiophobia, Pain and Functional Disability in Patients With Knee Osteoarthritis

Knee Osteoarthritis is one of the most prevalent degenerative conditions in Pakistan. Although a variety of Physical therapy treatments have been proven to be beneficial in patients with early stages of knee Osteoarthritis. However, a few secondary impairments like Kinesiophobia which is the fear of movement have been unaddressed. Usually after conventional physical therapy, patients find immediate or short-term relief and that leads to cessation of follow up sessions. In situations like these, kinesiophobia is the greatest threat to mobility and can eventually effect quality of life by decreasing functional disability.


Eligibility Criteria:
Inclusion Criteria:

* Patients with unilateral knee OA involving mediolateral compartment
* Knee OA grade 2
* Aged 40-65 years
* Both Male and Female
* NPRS value greater than

Exclusion Criteria:

* Patients with history of
* History of systemic disorder (e.g., rheumatoid arthritis, ankylosing spondylitis).
* History of malignancy.
* History of trauma.
* Previous knee surgery.
* Congenital musculoskeletal deformity (e.g., scoliosis, kyphosis).
* Patients with history of fracture
* Patients with history of Chondropatella Malacia
A Pilot Study of Liver Protection Using Prednisone for Patients Receiving Stereotactic Body Radiation Therapy for Hepatocellular Carcinoma

Patients on this study will self administer Prednisone for three days before starting Radiation Therapy (RT) and continue to take 60 mg/day during the first three fractions of RT.


Eligibility Criteria:
Inclusion Criteria:

* Patients with hepatocellular carcinoma are eligible for this trial. Hepatocellular carcinoma is defined as having at least one of the following:

  1. Biopsy proven hepatocellular carcinoma (HCC); or
  2. A discrete hepatic tumor(s) as defined by the AASLD criteria (80) - for cirrhotic patients, \>1cm with arterial hypervascularity and venous or delayed phase washout on contrast enhanced CT or MRI.
* Patients must have recovered from the acute effects of prior liver-directed therapy (e.g., RT, RFA, or TACE), and a minimum of 4 weeks must have passed since the last procedure and protocol therapy.
* Patients must have a performance status of ≤2.
* Patients must be 18 years of age or older.
* Patients with at least one of the following:

  1. ALBI score equal to (-1.81) or higher (worse). This value was calculated as the equivalent ALBI score for CP score equal 7 in Cousins et al study's cohort(59).
  2. Lesion(s) with a cumulative treatment diameter of ≥ 4cm.
  3. CP score equal to 7 or higher (worse).
* Patients must understand and be willing to sign an informed consent form approved for this purpose by the Institutional Review Board (IRB) of the University of Michigan Medical Center indicating that they are aware of the investigational aspects of the treatment and the potential risks.

Exclusion Criteria:

* Any serious disease, comorbidity or intercurrent illness which precludes delivery of radiation therapy, as determined by the treating investigator.
* Any contraindication to the administration of steroids, including

  * Documented hypersensitivity to prednisone or any component of the formulation.
  * Systemic fungal infection.
  * Patients with uncontrolled infections or with chronic infections requiring antibiotics.

Infections are considered controlled if appropriate therapy has been instituted and, at the time of enrollment, no signs of progression are present. Progression of infection is defined as hemodynamic instability attributable to sepsis, new symptoms, worsening physical signs or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as progressing infection.

* Uncontrolled hyperglycemia.

  * Patients with insulin -dependent diabetes.
  * Patients with decompensated liver disease, defined as: clinical ascites requiring paracentesis, hepatic encephalopathy, hepatorenal syndrome or variceal hemorrhage.
  * Active gastrointestinal bleeding within 30 days of enrollment.