cyrilzakka/clinical-trials huggingface dataset:
Advanced Surface Ablation (ASA) vs Laser-Assisted In Situ Keratomileusis (LASIK)

The purpose of this combined retrospective and prospective chart review analysis is to investigate the safety, efficacy, and predictability obtained via Laser-Assisted In Situ Keratomileusis (LASIK) and Advanced Surface Ablation (ASA) over a wide range of refractive errors

The working hypothesis is that there will be no difference in clinical outcomes between patients treated with LASIK or ASA.

Excimer laser vision correction (LVC) is a widely used procedure to correct nearsightedness, farsightedness, and astigmatism by reshaping the surface of the eye (cornea). Laser-Assisted In Situ Keratomileusis (LASIK) and Advanced Surface Ablation (ASA) and are techniques currently used to prepare the cornea for Excimer LVC.

This review is intended to study whether LASIK is equal in visual outcome (null hypothesis), more effective (alternate hypothesis 1) or less effective (alternate hypothesis 2) than ASA in clinical outcome up to one year.

Eligibility Criteria:
Inclusion Criteria:

* Eyes that were treated for LASIK or ASA Excimer laser vision correction before December 1st 2006 and newly recruited eyes that qualify for LASIK or ASA Excimer laser vision correction may be enrolled in this study.

Exclusion Criteria:

* There are no exclusion criteria; all patients that went forward with Excimer laser vision correction may be included.
The Relationship Between Microsatellite Instability and Efficacy of Fluorouracil Based Adjuvant Chemotherapy in Gastric Cancer After Operation

The relationship between Microsatellite instability and efficacy of fluorouracil based adjuvant chemotherapy in gastric cancer after operation.

To explore the relationship between Microsatellite instability and efficacy of fluorouracil based adjuvant chemotherapy in gastric cancer after operation.

Eligibility Criteria:
Inclusion Criteria:

1. Histopathology or cytopathology proven gastric cancer;
2. Operable advanced gastric cancer patients: primary lesions can be completely excision, no distant metastasis;
3. Postoperative patients who can tolerate 5-FU based (5-FU，S-1 or Capecitabine) adjuvant chemotherapy;
4. Life expectancy of at least 6 months;
5. ECOG（Eastern Cooperative Oncology Group ） score 0-1;
6. Age: 18\~80 years old;
7. Normal hemodynamic indices before the recruitment (including blood cell count and liver/kidney function).

   * For example: WBC（White blood cell count ）\>4.0×109/L; NEU（Neutrophils）\>1.5×109/L; PLT（Platelet）\>100×109/L;
8. Roughly normal cardiopulmonary function: No coronary heart disease, myocardial infarction, pulmonary heart disease, refractory hypertension;
9. Not concomitant with other uncontrollable benign diseases before the recruitment;

9. Voluntarily signed the informed consent.

Exclusion Criteria:

1. Advanced gastric cancer patients with distant metastasis and inoperable ;
2. Patients who cannot tolerate 5-FU based adjuvant chemotherapy;
3. Pregnant or lactating women;
4. Patients who have no desire to participate in the study.
A Study of the Efficacy and Safety of Varenicline in Japanese Smokers Motivated to Quit Smoking

The purpose of this study is to evaluate the efficacy and safety of varenicline in Japanese smokers. Efficacy is evaluated by continuous quit rate and withdrawal symptoms of smokers. Safety is evaluated by adverse events, laboratory tests, and other safety tests.


Eligibility Criteria:
Inclusion Criteria:

* Japanese smokers motivated to quit smoking
* No period without smoking of more than 3 months
* Smoked an average of at least 10 cigarettes/day in the past year

Exclusion Criteria:

* Subjects who have used nicotine replacement therapy within 1 month of the study screening visit
* Subjects intending to use nicotine replacement therapy or other smoking cessation treatments during the study
Multiparametric Telemonitoring In Elderly People With Chronic Obstructive Pulmonary Disease

Chronic obstructive pulmonary disease (COPD) determines an important risk of disability and disease-related need of care. Selected interventions were able to reduce the number and the severity of exacerbations. Telemedicine has also been proposed for this purpose. Current evidences, however, are scant. The investigators present a randomized, parallel-group trial of a multiparametric remote monitoring system to test its ability to improve early exacerbation detection rates and impact on clinical outcomes.

All patients performed a simple spirometry that was carried out using a Stead-Wells bell spirometer (Biomedin, Padua, Italy). Upon provision of informed consent, patients in the telemonitoring group were invited to a session during which they were instructed on how to wear the wristband and to operate the cellular telephone. A study physician was available on call during office hours to assist patients needing further instructions. A technician was also available in order to solve ingoing hardware problems.

All participants were also clinically evaluated at baseline and received a multi-dimensional assessment including: Activities of daily living scale (ADL), Instrumental activities of daily living scale (IADL), Mini-mental state examination (MMSE) test. These are well validated and routinely used tools to screen geriatric patients in order to detect global, physical and instrumental autonomy and consequent degree of dependence, as well as cognitive status.

Patients in both groups were followed up for 9 months, during this period they attended the standard schedule of clinical controls. For patients in the SweetAge group, the parameters received were evaluated daily by a study physician. In case of abnormal readings, the physician systematically contacted the patient to verify whether their symptoms had worsened or new symptoms had arose. In this event, the patient's adherence to her/his therapy was checked and, if unsatisfactory, individually tailored interventions promoting adherence were carried up. Otherwise, a diagnosis of exacerbation was made and, on the basis of its severity, an outpatient clinical assessment (for mild exacerbations) or a hospital admission was scheduled.

The outcome measures of these study were: number of exacerbations (defined as a sustained worsening of the patient's condition, from the stable state and beyond normal day-to-day variations, that is acute in onset and necessitates a change in regular medications, and number of hospital admissions.

Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic obstructive pulmonary disease stage II-III (GOLD classification)

Exclusion Criteria:

* Cognitive impairment precluding the use of the experimental device.
Preliminary Clinical Study of NMN Intervention in Mild Ulcerative Colitis

The goal of this clinical trial is to compare the safety and efficacy of nicotinamide mononucleotide (NMN) and placebo in patients with mild ulcerative colitis (UC). The main question it aims to answer is Whether NMN can alleviate the intestinal pathology of UC patients, so as to play a role in UC treatment or adjuvant therapy.

Participants will be randomized into two groups, an NMN group or a placebo group. Patients in the NMN group were treated with NMN intervention for 8 weeks. The placebo group received a placebo intervention for 8 weeks.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years old, ≤75 years old;
2. Clinical diagnosis of mild active UC patients, the diagnosis standard reference inflammatory bowel disease diagnosis and treatment of the consensus of opinion 2018.
3. Agreed to participate in this study, and sign the informed consent.

Exclusion Criteria:

1. Patients with ALT or AST more than 2 times the upper limit of normal, TBIL more than 2 times the upper limit of normal;
2. The creatinine clearance patients less than 60 ml/min.
3. The intestines or other parts have severely active infection patients need to use antibiotics or antiviral drugs;
4. Crohn's disease and intestinal tuberculosis and other chronic intestinal infectious disease, intestinal malignant tumor patients;
5. Pregnancy and lactation women;
6. People with diabetes or screening period more than 7.0 tendency for fasting glucose/L or glycosylated hemoglobin exceed 6.5%;
7. With serious mental illness, such as drugs and alcohol can't cooperate with the patients;
8. Participated in any other clinical investigator within 1 month before the screening period;
9. The researchers determine any other disease or condition is not suitable for patients participate in the study.
Intramedullary Fixation of Humerus Fractures Without Intramedullary Reaming

The purpose of the study is to evaluate the safety and efficacy of the composite Nail - the Quantum interlocking intramedullary nailing system in the reduction of humeral fractures.

The study will include 20 patients who have an acute mid shaft diaphyseal humeral fracture due to injury. The patients will undergo lateral and AP X- ray evaluation of the fracture. Following General anesthesia, closed reduction of the fracture will be performed. It will be followed by nail insertion, percutaneously, according to standard surgical techniques, with the help of the insertion handle and without preliminary reaming. Following insertion the nail will be locked both distally and proximally using interlocking screws. The nail and screws insertion will be monitored by fluoroscopy. Patients will remain under follow up for 6 months following the procedure. In the follow up sessions the fracture will be evaluated by fluoroscopy or X-ray for correct bone alignment, callus formation, and fracture union.

Eligibility Criteria:
Inclusion Criteria:

* Above 18 years old.
* Mid shaft diaphyseal fracture
* Acute fracture

Exclusion Criteria:

* Patients with metabolic or hormonal diseases that could affect bone healing such as diabetes.
* Ongoing infection in fracture site.
Mitochondria and Schizophrenia: Effects of Antipsychotic Drugs

The investigators will investigate

1. the relationships between oxidative stress-, apoptosis-related markers, mitochondria DNA copy numbers and the clinical psychopathology of schizophrenia, including severity of positive and negative symptoms, obesity and metabolic syndrome.
2. the relationships between aberrant mitochondria genes (single nucleotide polymorphism of D-loop region-related genes and haplogroup N9a), DISC1 gene polymorphism, and clinical phenotypes in Taiwanese populations.
3. whether these biological markers could be as clinical markers in schizophrenia for a long-term follow-up study.

In past study, we had shown that there were significant differences in serum Lpo (lipid peroxidation) and Thiol levels between patients with schizophrenia and healthy controls. For patients taking risperidone, there were significant decreases in serum Thiol levels. In addition, there were also significant differences in age of onset of PPAR gamma coactivator 1α (PGC-1α) polymorphism for schizophrenia patients. Therefore, we want to know the relationships between oxidative stress-, apoptosis-related markers, mitochondria DNA copy numbers and the clinical psychopathology of schizophrenia, including severity of positive and negative symptoms, obesity and metabolic syndrome.

In past study, we also found that there were significant differences in 10 SNPs located in the D-loop region-related genes between patients and healthy controls. Three SNPs could be found in Mitomap data, but another seven SNPs not been found in the Mitomap and they could be more confirmed. In addition, Tanaka et al. found that haplogroup N9a was related to diabetes and metabolic syndrome in Asia. Therefore, we were interested to clarify the relationships between above related mitochondria genes and clinical phenotypes in Taiwanese populations,.

In addition, we also want to see whether these biological markers could be as clinical markers in schizophrenia for a long-term follow-up study.

Eligibility Criteria:
Inclusion Criteria:

1. Schizophrenic patients will be recruited in psychiatric inpatients and outpatients departments according to DSM-IV criteria by a semi-structured interview. The assessment will be done by two senior psychiatrists. The intra- rater and inter-rater reliability will be done before this project started.
2. The patients had the ability to complete the written inform consent.

Exclusion Criteria:

1. Alcohol abuse or dependence
2. Smoking more than 1 pack per day
3. Concurrent use of mood stabilizer or beta-blocker
To Characterize the Safety and Tolerability of Eculizumab in Two Japanese aHUS Patients

This protocol is intended to formally collect data on the treatment of aHUS with eculizumab in Japanese patients.


Eligibility Criteria:
Inclusion Criteria:

1. Patient and/or legal guardian must be willing and able to give written informed consent and id the patient is not an adult and able to read and write, the patient is willing to give written informed assent
2. Eculizumab treatment initiated as personal importation for aHUS in 201

Exclusion Criteria:

Not Applicable
Validating the "Foods for Health" Portfolio of Functional Food Products

The objective of this research project is to investigate the ability to affect cardiovascular disease (CVD) risk factors through a novel, easily implemented functional food-based approach. The goal of the proposed project is to evaluate the effect of a range of proprietary products specifically formulated to deliver convenient pre-packaged condition-specific foods to positively impact blood cholesterol levels in statin intolerant and/or statin unwilling participants. The specific aim of this project is to evaluate the changes in serum low-density lipoprotein (LDL)-cholesterol, triglyceride (TG) glucose, insulin and high-sensitivity C-reactive protein (hsCRP) concentrations over a 4 week regimen using healthy tasty foods which are self-selected by a statin intolerant patient group.


Eligibility Criteria:
Inclusion Criteria:

Participants aged \> 21 to \< 65 years will be recruited on the basis of ability to give informed consent and being unwilling to use or intolerant of at-least one statin medication.

Exclusion Criteria:

Participants will be excluded if they are unable to speak/read in English or are unable or unwilling to temporarily hold all statin/lipid lowering therapies including supplements throughout the study period.

Participants with diabetes or severe obesity (body mass index, BMI, \> 35 kg/m2) will be excluded.

Women who are pregnant or planning to be pregnant during the study period will not be eligible for the study.

Participants with any food allergies/intolerances, food restrictions due to medical, religious or philosophical reason - including Kosher, vegan, vegetarian, high protein, low-carbohydrate, low-phosphorus, etc. other than attempting to follow an eating plan as generally advocated by the American Heart Association (low sodium, low cholesterol, reduced fat, etc.) will be excluded.

Participants will not be eligible if their baseline fasting LDL-C is \< 100 mg/dL or \> 190 mg/dL; or evidence of tissue cholesterol deposition; if their baseline fasting TG is \> 400 mg/dL or baseline fasting blood glucose is \> 126 mg/dL.

Consumption of more than 2 alcoholic drink/day or history of alcoholism or drug dependence will also serve as an exclusion criterion.

Smokers will be excluded from the study.

History of non-skin cancer, history of melanoma, history of rheumatoid arthritis or other chronic rheumatologic condition, history of advanced cardiovascular disease (moderate or greater valvular disease, history congestive heart failure, known coronary artery disease, history dysrhythmias requiring medical or surgical intervention), , known chronic liver or renal disease, diabetes, inflammatory bowel disease, celiac disease, uncontrolled thyroid disease, hormonal supplementation(other than thyroid), pancreatitis, gallbladder or biliary disease, neurological/psychological disease, and gastrointestinal disorders that could interfere with fat absorption will be excluded.

Individuals with uncontrolled hypertension having systolic blood pressure \>150 mm Hg or diastolic blood pressure \>100 mm Hg will be excluded from the study.
Effects of Otago Exercise Program in Falls, Balance and Physical Performance in Stroke Patients

This study aims to determine the effects of the Otago Exercise Program (OEP) on falls and balance as well as overall physical performance. Participants will be divided into two groups; control and intervention group. It is a week-long study, the participants will be assessed through the Berg Balance Scale (BBS), Time Up and Go (TUG) and Fugl-Meyer Assessment (FMA).

The previous literature suggested that the Otago exercise showed significant improvement in terms of fall and balance. Most of the Studies were conducted on the elderly population but limited studies are available regarding stroke. This study will look at the effect of Otago exercise on stroke patients. The Otago exercise consists of 17 exercises; strengthening and balancing exercises. The participants will receive Otago exercise and routine physiotherapy treatment for six weeks. The participants will go through three assessments; Baseline Assessment, After 3 weeks assessment and final assessment. For association, a mixed method ANOVA test will be used.

Eligibility Criteria:
Inclusion Criteria:

* Ischemic or hemorrhagic stroke
* Medically stable patients with acute to subacute level of stroke recovery (\< 6 month).
* Patients 40 plus age
* Berg balance scale \<45 and \>20 score
* TUG test scoring \>20 sec

Exclusion Criteria:

* Participants having cognition problem or language barrier
* Physical disability (fracture or amputation) other than stroke
* Previous surgery 6 weeks
* Cardiovascular and pulmonary disease
Post Discharge Trial to Enhance Immunity in Severely Malnourished Children

The goal of this study is to evaluate the efficacy of microbiota-directed food in comparison to zinc with micronutrient powder and Khichuri on changes in circulating immune cells (monocytes, T cells, B cells, and NK cells) in malnourished children after recovery from acute infection.

The study aims to answer the research question:

Does microbiota-directed food (MDF) compared to zinc with micronutrient powder (MNP) and Khichuri therapy enhance immunity in children with severe acute malnutrition? The researcher will compare the effectiveness of microbiota-directed food (MDF) versus zinc with micronutrient powder (MNP) and Khichuri therapy to see if MDF enhances immunity in severely malnourished children.

Severely malnourished children will:

* Receive microbiota-directed food (MDF) or zinc with micronutrient powder (MNP) and Khichuri every day for 12 weeks.
* Phenotyping of circulating immune cells (NK cells, T cells, B cells) will be conducted using flow cytometry and fluorescence-activated cell sorting techniques.


Eligibility Criteria:
Inclusion Criteria:

* Children aged 6 months to 36 months, and
* Severe acute malnutrition as evident by weight-for-length z-score (WLZ) \< -3 and or mid-upper arm circumference (MUAC) \< 11.5 cm, and or edema of both feet, and
* Completed the acute phase management for SAM and stayed at NRU for 7±4 days, with no medical complications, e.g. lethargic/unconscious, convulsions, unable to drink, persistent vomiting, respiratory distress.
* Residing within the Dhaka district.
* Parents/guardians provided written informed consent.

Exclusion Criteria:

* WLZ ≥ -3 or MUAC ≥11.5 cm.
* Presence of lethargy/unconsciousness, convulsions, unable to drink, persistent vomiting, respiratory distress.
* Participants who receive multiple courses of antibiotic (\>2 courses during acute phase) treatment for a prolonged period (\>14 days).
* Persistent diarrhea (≥14 days).
* Chronic illness or disability affecting food intake, e.g. TB, HIV, congenital defects, cerebral palsy
* Treated for SAM in the previous 3 months.
* Known case of soy, peanut, or milk protein allergy.
* Any sibling of the enrolled child.
Study on the Optimal Combination Pattern of the Combined Treatment of Radiotherapy and Immunotherapy for the Abscopal Effect in Non-Small Cell Lung Cancer (NSCLC) With Multiple Metastases

This study aims to conduct a prospective, multicenter, umbrella clinical study to compare the abscopal effects of different radiotherapy fractionation patterns combined with Benmelstobart, and to explore an efficient and low-toxic treatment strategy for non-small cell lung cancer (NSCLC) with multiple metastases. The main objective is to explore and compare the control rates of abscopal lesions in NSCLC patients with multiple metastases when different radiotherapy fractionation patterns are combined with Benmelstobart.


Eligibility Criteria:
Inclusion Criteria:

* Patient must meet all of the following inclusion criteria to be enrolled in this study:

  1. Non-small cell lung cancer confirmed by pathological histology.
  2. More than 3 metastatic lesions.
  3. No brain metastases or stable lesions.
  4. Negative for driver genes (including EGFR, ALK, ROS, BRAF, MET, RET).
  5. Performance status (PS) score of 0-1, with an expected survival period of more than 3 months.
  6. Age between 18 and 75 years old.
  7. Assessment by PET-CT (including FDG and FMISO, not mandatory).
  8. No contraindications to immunotherapy and radiotherapy.
  9. Signed the informed consent form.

Exclusion Criteria:

* Patients with any of the following criteria are not eligible for enrollment in this study:

  1. Those with severe dysfunction of important vital organs (heart, liver, kidney).
  2. Those accompanied by other malignant tumors.
  3. Uncontrolled heart diseases or myocardial infarction within the past 6 months.
  4. Those with a history of mental illness.
  5. Other situations in which the researcher deems it inappropriate for the subject to participate in the study.