cyrilzakka/clinical-trials huggingface dataset:
Novel Use of an Adjustable Single 8-0 Polypropylene Suture of Scleral Fixation Without Conjunctival Dissection

1. observe the effectivity of an adjustable single 8-0 polypropylene suture to scleral fix without conjunctival dissection for the treatment with aphakia or inadequate posterior capsule support.
2. observe the complication of this surgery method.


Eligibility Criteria:
Inclusion Criteria:

* Any patients who used an adjustable single 8-0 polypropylene suture of scleral fixation without conjunctival dissection could be included.

Exclusion Criteria:

* Data from patients with a \< 6-month postoperative follow-up or with incomplete operative or postoperative medical records were excluded from this study. Enrolled patients had complete records pertaining to their visual acuity (VA), slit-lamp photographs, and ultrasound biomicroscope (UBM) findings.
Determination Of Factors Affecting Mobility

This descriptive study was conducted to determine the factors affecting mobility in patients undergoing abdominal surgery.

Surgical factors that may affect the mobility of patients undergoing abdominal surgery should be examined, as well as individual characteristics and characteristics related to the postoperative period. If nurses know about the factors that may affect the patient's mobility after surgery, this may be helpful in effectively managing these factors in clinics and encouraging the patient to be more active.

This study was conducted to determine the mobility of patients who underwent abdominal surgery in the early postoperative period and the factors affecting mobility.

Eligibility Criteria:
Inclusion Criteria:

* • had no chronic pain or no visual or hearing impairment,

  * were 18 years of age or older,
  * were conscious after surgery,
  * had walked for the first time in the patient room after the surgery according to the clinical routine,
  * were voluntary to participate in the study.

Exclusion Criteria:

Fifty four patients who did not speak Turkish and 28 patients who failed to walk for the first time after surgery were excluded from the study.
Self-management for People With Epilepsy and a History of Negative Health Events

This is an investigation of adult individuals with epilepsy, and involves educational and behavioral interventions intended to enhance treatment adherence and self-management.

The investigators are adapting a self-management intervention that they developed in a previous study to individuals with epilepsy and a history of negative health events (NHEs), such as accidents and emergency department (ED) visits, diminished quality of life and poor mental well-being. The intervention "Self-management for people with epilepsy and a history of negative health events (SMART)" is intended to reduce NHEs and improve quality of life in people with epilepsy associated with historically disadvantaged groups.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of epilepsy
* Negative health event within the last 6 months
* Able to provide written consent and participate in study procedures

Exclusion Criteria:

* Immediate risk of self-harm
* Dementia
* Pregnancy
* Unable to read/understand English
Evaluating Immune Function Tests in People With HIV

Some people's immune systems are able to control HIV infection without anti-HIV drugs. Other people with HIV must take drugs to prevent the virus from destroying their immune systems. There are many different laboratory tests that measure immune function in people with HIV. This study will compare some of these tests to see if they consistently measure differences between people who control the HIV without anti-HIV drugs and those who must take drugs.

The efficiency of the immune response to HIV antigens is the critical feature that allows some individuals with chronic HIV infection to maintain low level viremia (less than 3000 copies/ml). The fundamental measurement of this response is the steady state level of viremia in the absence of antiretroviral drugs. However, using this clinical endpoint in vaccine and drug trials is time-consuming. Several laboratory assays of HIV T cell function have been developed to measure the key characteristics of an efficient immune response. This study will evaluate these assays in two distinct patient populations.

Two patient cohorts will be followed in this study. Cohort A will enroll patients who are stable on highly active antiretroviral therapy (HAART). These patients will have been on the same HAART regimen for at least 9 months prior to study entry. Cohort B will enroll patients with chronic HIV infection and efficient immune control. These patients will have not been on any antiretroviral drugs for at least 6 months and will have viral loads less than 3,000 copies/ml. Participants in both cohorts will have blood drawn at study entry and Weeks 12 and 24. Blood samples will be used for CD4/CD8 cell count, plasma HIV-1 RNA, and immunologic assays.

Eligibility Criteria:
Inclusion Criteria for Cohorts A and B:

* HIV-1 infection
* CD4 cell count \> 300 cells/mm3 within 60 days prior to study entry
* Negative pregnancy test within 14 days of starting study
* Agree to use acceptable methods of contraception while in study

Inclusion Criteria for Cohort A (Stable HAART) Only:

* Stable HAART regimen, defined as the suppression of viral load to undetectable levels, for at least 9 months prior to study entry
* Viral load \< 75 copies/ml on at least three occasions within 9 months prior to study entry, with at least one of these values obtained between 6 and 9 months prior to study entry
* No single viral load \>= 75 copies/ml within 9 months prior to study entry

Inclusion Criteria for Cohort B (Efficient Immune Control) Only:

* Not taking any antiretroviral drugs for at least 6 months prior to study entry
* Meets study definition of efficient immune control (generally HIV-1 viral load \< 3,000 copies/ml, with some exceptions)

Exclusion Criteria:

* Pregnancy or breast-feeding
* Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements
* History of an AIDS-defining opportunistic infection
Bioequivalence Study of Torrent Pharmaceuticals's Ltd's Nebivolol 20 mg Tablet

Subjects to compare the single dose bioavailability of Torrent's Nebivolol Tablets 20 mg and Bystolic 20 mg Tablets of Forest Pharmaceuticals Inc., USA. Dosing periods of studies were separated by a washout period of 11 days.

An Open Label, Randomized, 2 -period, 2 -Treatment, 2 Sequence, Crossover, Single-dose Bioequivalence Study of Nebivolol Tablets containing Nebivolol 20 mg (Test Formulation, Torrent Pharmaceutical Ltd., India) Versus Bystolic® 20 mg Tablets containing Nebivolol 20 mg (Reference, Forest Pharmaceuticals Inc., USA) in Healthy Human Volunteers Under Fasting Condition.

Eligibility Criteria:
Inclusion Criteria:

* Sex: male
* Age: 18-45 years (inclusive both)
* Volunteer with BMI of 18-27 (inclusive both) kg/m2 with minimum of 50 kg weight.
* Healthy and willing to participate in the study.
* Volunteer willing to adhere to the protocol requirements and to provide written informed consent.
* Non-smokers or smoker who smokes less than 10 cigarettes per day.

Exclusion Criteria:

* Inability to communicate or co-operate.
* Volunteers suffering from any chronic illness such as arthritis, asthma etc.
* History of pre-existing bleeding disorder.
* Clinically relevant abnormalities in the results of the laboratory screening evaluation.
* Clinically significant abnormal ECG or Chest X-ray.
* HIV, HCV, HBsAg positive volunteers.
* History of significant blood loss due to any reason, including blood donation in the past 3 months.
* Participation in any study within past 3 months before entry to the study,
* History of alcohol or drug abuse.
* History of consumption of prescribed medication since last 14days or OTC medication/ herbal remedies since last 7 days before beginning of the study.
* Positive to breath alcohol test.
* Volunteer found to be positive for Opiate, tetra hydrocannabinol, amphetamine, barbiturates, benzodiazepines, Cocaine positive volunteers based on urine test.
* Systolic blood pressure less than 100 mmHg or more than 140 mmHg and diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg.
* Pulse rate less than 50/minute or more than 100/minute.
* Oral temperature less than 95°F or more than 98.6°F.
* Respiratory rate less than 12/minute or more than 20/minute.
* History of allergy to the test drug or any drug chemically similar to the drug under investigation.
* Recent History of kidney or liver dysfunction.
* Volunteers suffering from any psychiatric (acute or chronic) disorder.
* Existence of any surgical or medical condition, which, in the judgment of the Chief Investigator and/or clinical investigator/physician, might interfere with the absorption; distribution,· metabolism or excretion of the drug or likely to compromise the safety of Volunteers.
Vitamin D3 for the Treatment of Low Vitamin D in Cystic Fibrosis

Vitamin D deficiency is common in cystic fibrosis. Vitamin D deficiency frequently persists despite aggressive treatment with ergocalciferol, a vitamin D preparation also known as vitamin D2. Cholecalciferol, a vitamin D preparation also known as vitamin D3,may work better to increase vitamin D levels.

Vitamin D is important for absorption of calcium from the diet and bone health. Vitamin D more recently has been found to play a role in regulating the normal inflammatory process. Since cystic fibrosis is a state of excessive inflammation, vitamin D may be playing a role in cystic fibrosis.

We hypothesize: cholecalciferol will work better to increase vitamin D levels in patients iwth cystic fibrosis and that it will have an effect on markers of inflammation.

Vitamin D deficiency is common in cystic fibrosis (CF) and persists despite relatively high doses of ergocalciferol, vitamin D2. Replacement has traditionally been focused upon maintenance of calcium and phosphorus homeostasis and bone health. However, non-classic roles of vitamin D have become increasingly recognized and the contribution of vitamin D deficiency to non-bone disorders has become apparent. Vitamin D deficiency has been associated with increased risk of a variety of cancers, autoimmune diseases such as Type 1 diabetes and multiple sclerosis, Type 2 diabetes, tuberculosis, and myopathy. The connection between vitamin D and these disease states likely reflects vitamin D's role as a transcriptional regulator: it participates in cell cycle regulation and in the innate immune system mediates cathelicidin production following activation of toll-like receptors.One hallmark of CF is pulmonary hyper-inflammation with recurrent infections. Additionally, malnutrition and decreased lean muscle mass threaten pulmonary function in CF. While vitamin D and its relation to bone has been explored in CF, the role of vitamin D in inflammation, lean body mass and strength, and pulmonary muscle strength has not been investigated. Moreover, vitamin D replacement has traditionally been with ergocalciferol, vitamin D2. Vitamin D3, cholecalciferol, has a longer half-life and is considered more potent. Thus, cholecalciferol treatment of children and young adults with CF and vitamin D deficiency may be useful for attaining normal vitamin D status and for exploring the impact of vitamin D upon lean body mass, pulmonary muscle strength, and inflammation.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects age 10-25 years
2. cystic fibrosis
3. 25-(OH)-D \< 20 ng/mL
4. FEV1 \> 40% -

Exclusion Criteria:

1. inability to perform pulmonary function or hand-grip tests
2. liver disease (including cirrhosis and portal hypertension) or baseline liver enzymes 21/2-fold greater than the upper limit of normal
3. acute use of glucocorticoids at time of testing
4. acute pulmonary exacerbation at time of testing
5. known non-adherence to enzyme replacement
6. hypercalcemia
7. engages in "suntanning
A Medical Research Study to Evaluate the Effects of ACT-246475 in Adults With Heart Attack

The goal of this study is to find out how fast a drug called selatogrel (ACT-246475) can prevent platelets from binding together. This study will also help to find out more about the safety of this new drug. The drug selatogrel (ACT-246475) will be used in 2 different doses (8 mg or 16 mg) and will be administered in the thigh.

This study is planned in patients presenting with Acute Myocardial Infarction (AMI) scheduled for an invasive strategy. Platelet activation and thrombus formation play a pivotal role in the pathophysiology of acute coronary syndrome. Early platelet inhibition has been shown to reduce the risk of recurrent events after a myocardial infarction.

The screening period starts when the participant provides informed consent and ends with participant's randomization. Eligible participants had an acute myocardial infarction (AMI; ST-segment elevation myocardial infarction \[STEMI\] or non-ST-elevation myocardial infarction \[NSTEMI\]), a life-threatening condition, and will therefore fulfill the ICH-GCP definition of vulnerable subjects ("persons in emergency situations"). Accordingly, a specific process for obtaining consent in compliance with local regulations and approved by the independent ethics committee will be implemented.

The study will be performed during a participant's hospital stay related to the qualifying AMI.

Standard treatment of AMI is allowed including anticoagulants. Ticagrelor will be the only oral P2Y12 receptor antagonist allowed to be initiated during the study and its administration will be possible only after selatogrel administration. Use of fibrinolytics or GPIIb/IIIa inhibitors will be prohibited unless required for bail-out. All other standard-of-care treatments for AMI will be allowed without restriction.

The treatment period starts with the participant's randomization and ends after the end-of-study assessments, approximately 48 hours after the administration of a single study treatment dose.

Eligibility Criteria:
Main Inclusion Criteria:

* Informed consent obtained prior to any study-mandated procedure,
* Males aged from 18 to 85 and postmenopausal females aged up to 85 years,
* Onset of symptoms of AMI of more than 30 min and less than 6 hours prior to randomization,
* Subjects presenting a type I AMI including STEMI or NSTEMI.

Main Exclusion Criteria:

* Cardiogenic shock or severe hemodynamic instability,
* Cardiopulmonary resuscitation,
* Loading dose of any oral P2Y12 receptor antagonist prior to randomization,
* Planned fibrinolytic therapy or any fibrinolytic therapy administered within 24 h prior to randomization,
* Known platelet disorders (e.g., thromboasthenia, thrombocytopenia, von Willebrand disease).
* Active internal bleeding, or bleeding diathesis or conditions associated with high risk of bleeding.
* Known clinically important anemia.
* Oral anticoagulation therapy within 7 days prior to randomization
Lactobacillus Reuteri ProGastria in Helicobacter Pylori-infected Adult Subjects on Proton Pump Inhibitors

The purpose of the study is to confirm that simultaneous use of L. reuteri ProGastria and omeprazole for 28 days can eradicate H. pylori in humans in the absence of antibiotics.

Helicobacter pylori colonises an estimated 50% of the world´s population. Despite clear clinical guidelines on the treatment of this infection there is a drive to find alternative ways to control this infection in a wider perspective without the complications of induction of antibiotic resistance in the pathogen. A good alternative is to use probiotics.

Lactic acid bacteria and in particular lactobacilli have been studied for their effects in humans infected with H. pylori with some success in reducing the infection load. Studies using supplementation with L. reuteri in both symptomatic and non-symptomatic H. pylori-infected subjects show a clear reduction of infection load after 4 weeks of use and this was concomitant with a reduction in symptoms associated with the infection. Further, dietary supplementation with L. reuteri during and after the period of H. pylori eradication therapy has also been shown to reduce the side effects of this therapy without affecting the degree of eradication.

Eligibility Criteria:
Inclusion Criteria:

* Infection with H. pylori defined using the 13C-urea breath test
* Non-ulcer dyspepsia
* No earlier eradication therapy for H. pylori infection
* Written informed consent
* Stated availability throughout the entire study period
* Mental ability to understand and willingness to fulfil all the details of the protocol.

Exclusion Criteria:

* Duodenal or gastric ulcer
* MALT lymphoma
* Gastric resection (at any time)
* First level relatives of gastric cancer patients
* Absence of GI symptoms
* Use of NSAIDs, aspirin or other anti-inflammatory drugs within 1 week (for occasional use) or 3 weeks (for chronic use) of inclusion
* Use of oral antibiotics and/or PPIs and/or H2-antagonists during the 2 weeks prior to ingestion of the study product
* Pregnancy
* Participation in other clinical trials
Study Evaluating the Safety of MOA-728 Administered Orally to Healthy Subjects

This is the first multiple-dose experience in humans with MOA-728 in an oral formulation. This study will provide an assessment of the safety, tolerability, and pharmacokinetics (PK) of MOA-728 following administration of ascending multiple oral doses to healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women
A Study In Patients With Advanced Solid Tumor

This study designed to evaluate the pharmacokinetics and safety of AG-013736 at single doses and multiple doses


Eligibility Criteria:
Inclusion Criteria:

* Patients histologically or cytologically diagnosed with advanced solid tumors
* Patients for whom standard therapies have not been effective, or for whom there are no suitable therapies
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0, 1 or 2
* Patients with no uncontrolled hypertension

Exclusion Criteria:

* Patients who have central lung lesions involving major blood vessels
* Patients who require anticoagulant therapy.
* Patients with active epilepsy seizure or symptoms, with brain metastases requiring treatment, with spinal cord compression and with carcinomatous meningitis.
A Study to Test the Efficacy of the HBV Vaccine and to Look at the Prevalence of HBV Infection

The prevalence of Hepatitis B core antigen in the Thai population is about 70 %, no data of isolated Hepatitis B core antigen is reported. Hepatitis B core antigen is observed in 10%-20% of individuals from low endemic areas of HBV infection. However, this prevalence of isolated antiHBc would be higher in endemic area of HBV infection. There is conflicting data of occult HBV infection in HIV infected patients. In Thailand, perinatal transmission is the main route of transmission which is different from developed countries. Therefore, isolated antiHBc in Thai people has longer duration than low prevalence regions. Moreover, HBV genotype C and B is common in this region. If the HBV vaccination could eliminate an occult HBV infection in these individuals, the liver related mortality might be reduced. The prevalence and clinical importance of isolated antiHBc in Thai have not been investigated yet. There is also limited data of HBV vaccine response in this setting.

The prevalence of the Hepatitis B core antigen (anti-HBc)in the Thai population is about 70 %. No data of isolated anti-HBc is reported. Anti-HBc antigen is observed in 10%-20% of individuals from low endemic areas of HBV infection. The prevalence of isolated antiHBc antigen is expected to be higher in endemic areas of HBV infection. There is conflicting data of occult HBV infection in HIV-infected patients. In Thailand, perinatal transmission is the main route of HBV transmission, different from developed countries. Therefore, isolated anti-HBc in Thai people has longer duration than low prevalence regions. Moreover, HBV genotype C and B is common in this region. HBV genotype C is correlated with more cirrhosis and hepatoma than genotype B. A study from Taiwan demonstrated that HBV DNA \> 100,000 copies/ml is correlated with cirrhosis and hepatoma. Sustained reduction of HBV replication lowers the risk of hepatoma in HBV related cirrhosis. If the HBV vaccination could eliminate an occult HBV infection in these individuals, the liver related mortality will be reduced.

The prevalence and its clinical importance of isolated anti-HBc in the Thai population has not been investigated yet. There is also limited data of HBV vaccine response in this setting.

Eligibility Criteria:
Inclusion Criteria:

* HIV-infected adults followed at HIV-NAT and HIV-NAT affiliated hospitals and Un-infected HIV adults followed at chulalongkorn hospital and blood bank
* AntiHBc positive without HBsAg and antiHBs
* Written inform consent

Exclusion Criteria:

* Patients receiving, or with an anticipated need to receive, any concomitant medications with the potential to decrease the response to HBV vaccine such as long term steroid user, chemotherapy, cancer
Impact of Adductor Canal Block on Functional Recovery

TKA involves extensive bone resection as well as soft tissue excision and therefore is associated with profound postoperative pain. Adequate analgesia after TKA is therefore considered paramount to facilitate early hospital discharge and effective functional recovery.

Osteoarthritis (OA) of the knee has become a major public health issue and imposes a significant healthcare burden and accounts for high annual hospitalizations. Chronic OA of the knee may lead to reduced physical fitness, mobility disability with a resultant increased risk of cardio-metabolic comorbidity and early mortality. Total knee arthroplasty (TKA) is indicated in severe cases to improve long-term pain and function. (1) TKA involves extensive bone resection as well as soft tissue excision and therefore is associated with profound postoperative pain. (2) Inadequate perioperative pain control may prolong hospitalization, hinder early rehabilitation, and is also a strong predictor of persistent pain beyond 3 months. (3) Adequate analgesia after TKA is therefore considered paramount to facilitate early hospital discharge and effective functional recovery. (4) The recently introduced adductor canal block (ACB) typically covers the anterio-medial aspect of the knee and preserves quadriceps function, which presumably enhances postoperative rehabilitation by allowing patients to actively participate in knee movement. The relative effectiveness of this ACB technique added to intrathecal morphine is limited to a single study (1) in which assessment of short-term functional recovery was done and dexamethasone was neither included in the LIA solution nor perineurally in the ACB. Thus, we hypothesize that adductor canal block as an adjunct to intrathecal morphine will have a better impact on functional recovery than peri-articular infiltration.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologist class ( ASA) I - III
* BMI 18-35 kg/m2
* Scheduled for primary unilateral TKR

Exclusion Criteria:

* Known allergy to local anesthetics
* Contraindication to adductor canal block e.g. infection at the site of injection
* Contraindication to spinal anesthesia e.g. coagulopathy.
* Patients with pre-existing motor or sensory deficits in lower extremities.
* Patients who are morbidly obese (BMI≥35) because ultrasound-guided regional anesthesia could be technically difficult.
* Bilateral or revision total knee replacement
* Insulin or noninsulin-dependent diabetes mellitus.
* systemic corticosteroid use within 30-days of surgery