cyrilzakka/clinical-trials huggingface dataset:
Comparing the Effect of the Water Drinking Test on Intraocular Pressure

A test that was common in the 1960's and was used to detect primary open angle glaucoma was the water drinking test (patients drank 1 quart of water to stress the fluid drainage mechanism of the eyes. Intraocular pressure was then measured over the next hour). Recently this test has been demonstrated as a predictor of peak eye pressure during the day. The purpose of this study is to compare the results of the water drinking test between eyes that have undergone trabeculectomy and eyes that have undergone tube shunt surgery.


Eligibility Criteria:
Inclusion Criteria:

* prior trabeculectomy or tube shunt for the treatment of glaucoma
* age 21-90 years

Exclusion Criteria:

* inability to give informed consent
* current ocular infection
* more than 1 prior trabeculectomy, or more than 1 prior tube shunt
* previous refractive surgery
* pregnant women
* heart failure
* renal failure or uncontrolled urine retention
* corneal abnormalities preventing reliable IOP measurement
Single Dose Study of ANX005 in Healthy Volunteers

This is a single-center, randomized, double-blind, placebo-controlled, ascending, single-infusion, sequential group study. Single, ascending doses will be administered to approximately 64 subjects, with an option for 1 additional multi-dose cohort in approximately 8 subjects. The primary objective is to evaluate the safety of ANX005 administered as an intravenous infusion as a single agent and in combination with intravenous immunoglobulin (IVIg). The optional multi-dose cohort will evaluate either additional subjects at the maximum tolerated dose or ANX005 administered as 2 infusions.


Eligibility Criteria:
Inclusion Criteria:

* Male and females 18 years and older
* Females must be postmenopausal, surgically sterilized, or willing and able to use 2 methods of contraception throughout the study and for 1 month after the final study visit
* Willing and able to undergo vaccination if not vaccinated recently

Exclusion Criteria:

* History of any autoimmune disease, meningitis, septicemia or pneumonia
* History of hypercoagulable diseases, hyperviscosity, thrombosis, renal dysfunction or acute renal failure
* Known genetic deficiencies of the complement cascade system
* History of conditions whose symptoms and effects could alter protein catabolism or IgG utilization, e.g. protein-losing enteropathies or nephrotic syndrome
* Body weight less than 50 kg or greater than 100 kg
* Hypersensitivity or allergic reactions to any excipients in the ANX005 drug product
* (Cohorts 4b and 5b) Known selective IgA deficiency or presence of antibodies to IgA at screening
* (Cohorts 4b and 5b) Prior reaction or hypersensitivity to blood products, including IVIg or any of the excipients in IVIg.
Cognitive Functions and BDNF in T2DM and Prediabetes Patients

Clinical and epidemiological studies suggest links between cognitive impairments and Type 2 diabetes (T2DM). The underlying mechanisms and causality in diabetes-related cognitive impairment are largely unknown. The aim of this study is to investigate cognitive impairment and the role of BDNF in prediabetes and diabetes patients.

Cognitive dysfunction is increasingly recognized as a common complication and comorbidity in both type 1 and type 2 diabetes (T2DM). Due to the increasing incidence of diabetes and the life expectancy of individuals with T2DM, it is important to determine the cognitive problems and related factors in these patients. Cognitive impairment can be observed in all age groups in individuals with diabetes, and its severity can range from mild cognitive impairment to dementia. Although there are few studies in the literature investigating cognitive impairment in prediabetes, it is not clear whether it is a risk factor.

The number of studies investigating biomarkers of potential importance for understanding changes in the brain of T2DM patients is increasing rapidly. The relationship of biomarkers associated with the main pathologies of dementia, including Alzheimer's disease (AD) and vascular disease, as well as various biomarkers associated with brain parenchymal damage, blood flow and metabolism, with the cognitive status of diabetic patients are investigated. It has been determined in animal experiments that Brain Induced Neurotrophic Factor (BDNF) may be among the molecular factors linking T2DM with dementia neuropathology. It has also been stated that high glucose levels are associated with cognitive impairment and total hippocampal volume reductions, and hippocampal changes can be used as an early marker of diabetes-related brain damage. Considering that the expression of BDNF in the brain is high in hippocampus neurons, it may be an early marker of cognitive impairment in diabetes.

This research is a cross-sectional observational study. The aim of this study is to investigate cognitive impairment and the role of BDNF in prediabetes and diabetes patients.

Eligibility Criteria:
Inclusion Criteria:

* age from 30 to 65 years
* having at least primary school education

Exclusion Criteria:

* severe psychiatric (e.g,major depressive disorder) or neurologic disorder (demyelinating diseases, stroke or brain tumor)
* using insulin (Insulin therapy was taken as an exclusion criterion to avoid the effect of hypoglycemia on cognition)
* vision and hearing problem
* Hypothyroidism, B12 and folic acid deficiency
* Advanced chronic renal failure (stage 4-5)
* uncontrolled hypertension
* patients with hypoglycemia-hyperglycemia attacks
* Alcohol, substance addiction.
Community Acquired Pneumonia in Telemark and Ostfold

The aim of the study is to investigate the bacterial causes in community acquired pneumonia in adults admitted to hospital in two counties in Norway and to look at possible factors that makes the patients susceptible to pneumonia.

In Norway there is little knowledge of which bacterias that causes pneumonia in patients admitted to hospital. There are also few registered cases of Legionnaires disease every year, compared to our neighbour countries.

Therefore 500 patients with community acquired pneumonia admitted to Telemark hospital and Ostfold hospital in Norway will be tested by urin antigen test for the detection of Legionella pneumophila serogroup 1 and Streptococcus pneumoniae. We will also perform routine bacterial culture of sputum and culture on medium for isolation of Legionella species. A throat swab from the patients will be tested for Mycoplasma pneumoniae, Chlamydophila pneumoniae and Bordetella pertussis using PCR-techniques. Legionella-serology will also be performed. In addition all the included patients are invited to fill in a questionnaire in order to look for risk factors for developing community acquired pneumonia.

Eligibility Criteria:
Inclusion Criteria:

* Symptoms of lower airway infection and radiologic sings of pneumonia.

Exclusion Criteria:

* Age\<18
* Serious psychiatric illness
* Mentally retarded
* Hospitalized last 14 days
Mastering Hospital Antimicrobial Resistance and Its Spread Into the Community

Detailed activity:

* Family members and caregivers of carrier residents will be screened for ESBL and MRSA. Screening will be performed by obtaining nares and perirectal cultures. Nares cultures will be obtained by ward staff or research personnel who are experienced in performing this activity: a moisture swab will be applied gently to the distal part of both nares. Perirectal cultures, will be taken by swab, who will be applied to the perirectal area, either by staff as mentioned above, or will be given to the participants to perform by himself (with explanation on how to perform it).
* The Family and Caregiver Screening Form will be filled out; results of screening will be added to the forms. This data will be stored after removal of all Family members' identifiers for further analysis.
* In order to allow follow up, a list linking between the Family members' study number and his identifying details will be kept separately in the rehabilitation center. This list will not be transferred elsewhere.

Detailed activity:

* Family members and caregivers of carrier residents will be screened for ESBL and MRSA. Screening will be performed by obtaining nares and perirectal cultures. Nares cultures will be obtained by ward staff or research personnel who are experienced in performing this activity: a moisture swab will be applied gently to the distal part of both nares. Perirectal cultures, will be taken by swab, who will be applied to the perirectal area, either by staff as mentioned above, or will be given to the participants to perform by himself (with explanation on how to perform it).
* The Family and Caregiver Screening Form will be filled out; results of screening will be added to the forms. This data will be stored after removal of all Family members' identifiers for further analysis.
* In order to allow follow up, a list linking between the Family members' study number and his identifying details will be kept separately in the rehabilitation center. This list will not be transferred elsewhere.
* Providing results to family members: results of screening will be / will not be reported to the participant (family member) based on local decision in each center.

Eligibility Criteria:
Inclusion Criteria:

* Family members or caregivers of patient hospitalized in rehabilitation center and who is known carrier of the target resistant population.
* Participating member older than 18 years, who attend the patient at least once a week, will be eligible for inclusion.

Exclusion Criteria:

* Age 18 years or less, attending the patient less than once a week.
Prognosis of Resection and Radiotherapy in the Treatment of Intrahepatic Cholangiocarcinoma Patients

The purpose of this study is to confirm that prognosis of Intrahepatic Cholangiocarcinoma (ICC) with resection and radiotherapy ,to find which is safe and effective treatment.

Intrahepatic Cholangiocarcinoma (ICC), the second most common primary liver cancer and constitutes 10% of primary liver malignancies.

Current therapies for the treatment of ICC are ineffective and the role of liver transplantation is not well defined.

This study reviews our experience with this tumor and looks for preoperative and pathologic indices that may help determine long term prognosis

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients \> 17 years and \<=60 years of age. confirmed case (patients with ICC) Tumors can be radical removed and resection volume was ≤50%. Criteria of liver function: Child A level, serum bilirubin ≤ 1.5 times the upper limit of normal value,alanine aminotransferase and aspartate aminotransferase ≤ 2 times the upper limit of normal value.

No dysfunction in major organs; Blood routine, kidney function, cardiac function and lung function are basically normal. Hbg ≥ 90g/L, WBC ≥ 3.000 cells/mm³,platelets ≥ 80.000 cells/mm³.

Karnofsky Performance Score performance over 60. Patients who can understand this trial and have signed information consent.

Exclusion Criteria:

* Patients who have undergone previous treatment by Resection or Radiotherapy. Patients with apparent cardiac, pulmonary, cerebronic and renal dysfunction, which may affect the treatment of liver cancer.

Patients with other diseases which may affect the treatment mentioned here. Patients with medical history of other malignant tumors. Subjects participating in other clinical trials. Extrahepatic metastasis, portal vein or other major vascular involvement. liver function: Child B C.

Patients would not sign the consent to the trial.
The Effects of Focal Vibration on Spasticity in Multiple Sclerosis Patients

This trial consists of application of little devices (named Equistasi®) generating focal vibrations to treat spasticity in neurological patients, affected by multiple sclerosis. The expected effects are on gait and postural instability.


Eligibility Criteria:
Inclusion Criteria:

* Multiple Sclerosis affected
* Spasticity
* EDSS (Expanded Disability Status Scale) 0 - 5,5
* Patients able to sign informed consent

Exclusion Criteria:

* Age less than 18 years old and more than 65 years old
* Pacemaker
* Pregnancy
* Comorbidities as: cancer, hypertension not controlled by drugs
* concurrent therapies with antidepressant or corticosteroids
Calcimimetics in Hypophosphatemic Rickets

Currently, large oral doses of phosphate and 1,25(OH)2D (calcitriol) are the standard treatment of patients with familial hypophosphatemic rickets (XLH). While this therapy is effective in healing the rickets, it is often limited by development of complications due to the high dose of medications required to achieve cure. Among them are the development of calcifications in the kidneys and secondary hyperparathyroidism (HPT) which in some patients may cause complications like high blood calcium level, high blood pressure and damage to the kidney. A drug to treat secondary hyperparathyroidism was just developed. In a short term study we found that it might help the treatment of XLH, by allowing the use of lower doses of the both phosphate and calcitriol. In the present study we will learn if indeed the addition of this new medicine (Cinacalcet) to the long-term treatment will allow the use of lower doses of both phosphate and calcitriol and consequently lower the risk of complications.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with XLH
2. Age 5-21 years old
3. From the Renal and Endocrinology Clinics who have been in a stable clinical, biochemical and radiological condition for the preceding 9 months
4. Who have not received Cinacalcet before

Exclusion Criteria:

1. Treatment with growth hormone
2. Inability to swallow pills.
3. An orthopedic surgery or braces in the past 9 months, or scheduled within 9 months of start.
4. Pregnancy
5. History of seizure disorder
6. Abnormal liver functions (which may change the drug's AUC)
Validity of the 6-Minute Pegboard and Ring Test in Parkinson's Patients

Tests used to assess upper extremity endurance in Parkinson\&#39;s patients are limited. This study aimed to investigate whether the 6-Minute Pegboard and Ring Test (6-MPRT), which has been validated in many respiratory disease groups in previous studies, is an endurance assessment battery that can also be used in Parkinson\&#39;s patients. 6-MPRT, Weight Lifting Test, and 30-Second Arm Curl Test will be applied in the assessments. Assessments will be made twice on the same day by two different evaluators, 1 hour apart. After the first evaluation, the patient will be called for the second time 2 days later, and the same procedure will be repeated.


Eligibility Criteria:
Inclusion Criteria:

* Hoehn \&amp; Yahr staging ≤3 points,
* Individuals who have not undergone a rehabilitation program of at least 20 days in the last 6 months,
* Those with full upper extremity shoulder flexion and abduction active joint range of motion.

Exclusion Criteria:

* Those with severe heart disease such as heart failure, cardiac arrhythmia, hypertension,
* People with any orthopedic problem that will affect the upper extremity,
* Having a secondary neurological disease diagnosis,
* Having vision impairment that may affect measurement methods (not corrected by glasses),
* Having a cognitive disease that may cause difficulty in following the researchers\&#39; commands,
* Those who had changes in their medical use during the test (dose increase/decrease, drug change
The Tolerability and Pharmacokinetics Study of Kangdaprevir Sodium Tablet in Healthy Adult Subjects

The Tolerability and Pharmacokinetics Study of Kangdaprevir Sodium Tablet in Healthy Adult Subjects.

A Phase I, Single Center, Randomized, Double-blind, Placebo-controlled, Single \& Multiple Ascending Dose Study to Access the Tolerability and Pharmacokinetics of Kangdaprevir Sodium Tablet in Healthy Adult Subjects.

Eligibility Criteria:
Inclusion Criteria:

* Able to comprehend and sign the ICF voluntarily prior to initiate the study;
* Able to complete the study according to the protocol;
* Between 18 and 45 years of age（18 and 45 are inclusive）;
* Body weight of male and female subject should be ≥50 kg and ≥45 kg respectively; Body Mass Index (BMI) is between 18 and 28 kg/m2（18 and 28 are inclusive）;
* Physical examination and vital signs without clinically significant abnormalities.

Exclusion Criteria:

* Smokers, who smoke more than 5 cigarettes/day within 3 months before the study;
* Drink frequently, namely alcohol consumption are 14 units per week (1 unit = 285 mL of beer, or 25 mL of strong wine, or 100 mL of grape wine);
* Donated blood or massive blood loss within 3 months before screening (\>450 mL）;
* Have any disease that increases the risk of bleeding, such as acne, acute gastritis or stomach and duodenal ulcers;
* Have take any drug that changes liver enzyme activity within 1 month before taking the study drug
* Have taken any prescription drug, over-the-counter drug, vitamin product or herbal medicine within 14 days prior to screening;
* Have participated in any clinical trial or taken any study drug within 3 months before dosing;
* Viral hepatitis（including CHB and CHC）and positive test result of anti-HIV Ab or syphilis.
* Have taken any alcoholic products within 24 hours prior to taking the study drug
Lack of Antenatal Care in Primiparas

Antenatal care is a key strategy for reducing maternal and neonatal morbidity and mortality rate because adequate utilization of antenatal health care services is associated with improved maternal and neonatal health outcomes. The trend of maternal mortality in developing countries has been increasing and various international organizations have reported that an important factor related to maternal and infant mortality has been linked to lack of antenatal care. According to Federal Ministry of Health, some of the dangers of pregnancy and childbirth can be avoided if the pregnant woman attends antenatal regularly. In order to decrease these mortality rates, regular antenatal care has to be instituted or reinforced which can only be achieved through identifying factors causing poor utilization of antenatal care services


Eligibility Criteria:
Inclusion Criteria:

* Women who agree to participate in the study
* Primipara.

Exclusion Criteria:

* Multipara.
* Women who refuse to participate in the study.
Yang Yin Fu Zheng Therapy in HBV Associated Hepatocellular Carcinoma

Clinical research of Yang Yin Fu Zheng therapy in HBV associated hepatocellular carcinoma basing on immune microenviroment.The purpose of this study is to observe the efficacy of routine medical care combined with Yang Yin Fu Zheng therapy for patients belong to HBV-HCC.


Eligibility Criteria:
Inclusion Criteria:

1. Confirmed of stage HBV-HCCⅡb、Ⅲa、Ⅲb;
2. Ages Eligible for Study: ≤75 years old;
3. TCM syndrome is deficiency of both Qi and Yin;
4. Confirmed of CHB;
5. Surgery cannot be allowed;
6. Informed consent from the patient.

Exclusion Criteria:

1. Patient with other chronic hepatopathy, such as AIH, NAFLD, ALD;
2. Serious problem of heart, lung, or kidney with severe dysfunction;
3. Pregnant or child breast feeding women;
4. Mental or cognitive disorders;
5. Participating in other drug trials;
6. Who are allergic to the study drug.
A Study to Examine the Effects of Telaprevir on the Pharmacokinetics of Cyclosporine and Tacrolimus in Healthy Adults

The purpose of this study is to evaluate the effect that telaprevir has on the pharmacokinetics of cyclosporine and tacrolimus. Pharmacokinetics means how the drug is absorbed into the bloodstream, distributed in the body and eliminated from the body.


Eligibility Criteria:
Inclusion Criteria:

* Healthy female (non-childbearing potential) or male subjects between 18 and 60 years of age (inclusive)
* Body mass index (BMI) from 18 to 30 kg/m2 (inclusive) at the Screening Visit and Day 1, and weigh more than 50 kg at Screening.

Exclusion Criteria:

* History of any illness or condition that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject.
* Participated in a clinical study involving administration of either an investigational or a marketed drug within 2 months or 5 half-lives (whichever is longer) before the Screening Visit.
* Positive result for any of the following infectious disease tests: hepatitis B antigen, hepatitis C virus antibody, human immunodeficiency virus 1 antibody, or human immunodeficiency virus 2 antibody.
Role of Nitrogen Oxide (NO) in the Control of Choroidal Blood Flow During a Decrease in Ocular Perfusion Pressure

Autoregulation is the ability of a vascular bed to maintain blood flow despite changes in perfusion pressure. For a long time it had been assumed that the choroid is a strictly passive vascular bed, which shows no autoregulation. However, recently several groups have identified some autoregulatory capacity of the human choroid. In the brain and the retina the mechanism behind autoregulation is most likely linked to changes in transmural pressure. In this model arterioles change their vascular tone depending on the pressure inside the vessel and outside the vessel. In the choroid, several observations argue against a direct involvement of arterioles. However, the mechanism behind choroidal autoregulation remains unclear.

In the present study autoregulation of the choroid will be investigated during a decrease in ocular perfusion pressure, which will be achieved by an increase in intraocular pressure. Pressure/flow relationships will be investigated in the absence or presence of a NO synthase inhibitor. As a control substance the alpha-receptor agonist phenylephrine will be used.


Eligibility Criteria:
Inclusion Criteria:

* Men aged between 19 and 35 years, nonsmokers
* Body mass index between 15th and 85th percentile (Must et al. 1991)
* Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
* Normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant
* Normal ophthalmic findings, ametropia \< 3 Dpt.

Exclusion Criteria:

* Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
* Treatment in the previous 3 weeks with any drug
* Symptoms of a clinically relevant illness in the 3 weeks before the first study day
* History of hypersensitivity to the trial drug or to drugs with a similar chemical structure
* History or presence of gastrointestinal, liver or kidney disease, or other conditions known to interfere with, distribution, metabolism or excretion of study drugs
* Blood donation during the previous 3 weeks
Cadonilimab Monotherapy as Neoadjuvant Therapy for Resectable II-IIIA Squamous Cell Lung Cancer

Cadonilimab, a tetravalent bispecific antibody targeting PD-1 and CTLA-4, is designed to retain the efficacy benefit of combination of PD-1 and CTLA-4 and improve on the safety profile of the combination therapy. The aim of this study is to evaluate the efficacy and safety of Cadonilimab monotherapy as neoadjuvant therapy for patients with resectable stage II-IIIA squamous cell lung cancer.


Eligibility Criteria:
Key Inclusion Criteria:

Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 2. Have previously untreated and pathologically confirmed resectable Stage II-IIIA Squamous cell lung cancer.

Have at least one measurable lesion per RECIST 1.1 assessed by investigator. Have adequate organ function.

Key Exclusion Criteria:

Mixed adenocarcinoma and small cell lung cancer histology. Patients with other active malignancies within 5 years prior to enrollment. Known active autoimmune diseases. Use of immunosuppressive agents within 14 days prior to the first dose of study treatment.

Presence of other uncontrolled serious medical conditions.