cyrilzakka/clinical-trials huggingface dataset:
Bevacizumab Treatment and Retinal Vessel Monitoring

Bevacizumab might influence the dynamic vessel function after being administered intravenously.

By monitoring different vessel and circulation parameters (e.g. dynamic retinal vessel analyzer) the study will clarify the potential hemodynamic effects of bevacizumab.

Eligibility Criteria:
Inclusion Criteria:

* patients who wish and need bevacizumab treatment for underlying disease

Exclusion Criteria:

* previous bevacizumab treatment
* known eye disease, eye surgery or eye trauma in history
* myopia \>-2.0 dpt
* hyperopia \> +2.0 dpt.
* relevant media opacity of the lens
* acute heart disease, ischemic insult, proven coronary heart disease
* cardiac arrhythmia or vessel anomalies
* seizure disorder or episode in history
* migraine
* treatment with corticosteroids within 4 weeks before study inclusion
* intake of vasoactive drugs like AT-1 or glitazone
* pregnancy
Prostatic Hyperplasia Treatment and Cancer Prevention

Treatment of patients with prostatic hyperplasia with topical papaverine.

Patients with obstructive voiding and high PSA to be studied for the regression of symptoms and declining PSA.

Eligibility Criteria:
Inclusion Criteria:

* patients with symptoms e.g. obstructive voiding, hyperplasia and high PSA

Exclusion Criteria:

* patients on chemotherapy
* abnormal lab values e.g. liver function, GFR and CAD
A Study of Ninlaro in Real World Clinical Practice in China

The main purpose of this study is to collect additional safety information of ixazomib citrate (Ninlaro) when used to treat multiple myeloma in real world clinical practice in China. Participants will be treated with Ninlaro according to the normal clinical practice during this study.

This is a prospective, non-interventional study in Chinese participants with relapsed refractory multiple myeloma (RRMM), newly diagnosed multiple myeloma (NDMM) and non-myeloma who are undergoing or will receive at least one dose of ixazomib citrate. Data will be collected to assess safety information when NINLARO is used in the real world, based on known risks and missing safety information.

The study will enroll approximately 3000 patients. The data will be collected prospectively as part of routine clinical visits of participants. Participants will be assigned to one of the two observational cohorts:

* Cohort 1: Participants with RRMM
* Cohort 2: Participants with NDMM, RRMM, and Non-myeloma

The multi-center trial will be conducted in China. The overall duration of study will be approximately 64 months. All participants will be followed up for 21 months unless withdrawal of Informed Consent Form, loss of follow-up or death, whichever comes first.

Eligibility Criteria:
Inclusion Criteria:

1. Undergoing treatment with Ninlaro (of less than 3 months from initial treatment with Ninlaro) or to be prescribed with Ninlaro capsule.
2. Participants will be able to sign Informed Consent Form to participate.

Exclusion Criteria:

1. Currently participates or plans to participate in any interventional clinical trial.
2. Any other reason that, in the Investigator's opinion, makes the participant unsuitable to participate in this study.
A Phase 1, 2-Part, Single Ascending Dose Assessment of the Safety, Tolerability, and Pharmacokinetics of Rolapitant Intravenous in Healthy Volunteers

The purpose of this study is to assess the safety and tolerability of single increasing doses of intravenously administered rolapitant in healthy male and female subjects.

Part 1 of the study is designed to evaluate the safety and tolerability of a SAD, up to 6 cohorts,of rolapitant IV (2 mg/mL solution) administered as an IV infusion over 30 minutes.

In Part 2 of the study, the safety and tolerability of the highest safe and well-tolerated dose established in Part 1 will be evaluated in an expanded cohort. The highest safe and well-tolerated dose established in Part 1 will be ascertained by the following criteria: an upper limit of 90% confidence interval (CI) for Cmax. A minimum of 40 subjects will be enrolled in Part 2.

Eligibility Criteria:
Main Inclusion Criteria:

* Subject must be a healthy male or female aged 18 to 55 years at Screening
* A female subject must have a negative pregnancy test at Screening and on Day -1.
* A female subject of childbearing potential must agree to use an accepted method of birth control (excluding hormonal birth control methods) from Screening through 30 days after final study drug administration.
* Subject must have a body mass index (BMI) from 18.5 to 32.0 kg/m2 and a weight of

  ≥ 50 kg at Screening.
* Subject must be able to provide informed consent after risks and benefits have been explained. Subject must also be willing and able to comply with the protocol requirements.
* Subject must be in general good health as determined by the Investigator based on pre-study medical, medication, and surgical history; physical examination; and clinical laboratory tests.

Main Exclusion Criteria:

* Subject must not have been dosed with test drug or blinded study drug in another investigational study within 30 days or 5 half-lives of the biologic activity of the test drug, whichever is longer, before the time of first study dose.
* Subject must not have a history of hypersensitivity to rolapitant IV or any of its excipients or who have completed a study visit as part of a previous rolapitant study within the 6 months prior to first study drug administration (Day
* Subject must not have poor venous access or consider venipuncture intolerable.
* Subject must not have a history of significant complications or anxiety associated with the IV administration of medications that, in the opinion of the Investigator, could make the subject unable to complete dosing requirements.
* Subject must not be pregnant or lactating.
Safety, Reactogenicity and Immunogenicity of an H5N1 VLP

This is a Phase I/IIa randomized, double-blind, placebo-controlled study to evaluate the safety, reactogenicity, and immunogenicity of 3 potencies (dosages) of H5N1 VLP vaccine or placebo in healthy adults 18 to 40 years of age.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female 18 to 40 years of age at the time of the vaccination.
2. Subjects who the investigator believes can and will comply with the requirements of the protocol (e.g., return for follow-up visits and completion of the data collection tool).
3. Available by telephone.
4. Free of obvious health problems as established by medical history and clinical examination before entering the study.
5. If subject is of childbearing potential, she must be abstinent or have used adequate contraceptive precautions (e.g., intrauterine contraceptive device; oral contraceptives or other equivalent hormonal contraception) for 30 days prior to vaccination. She must also have a negative pregnancy test at study entry and must agree to continue such precautions for two months after completion of vaccination.
6. Must provide written, informed consent.

Exclusion Criteria:

1. Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the administration of the study vaccine, or planned use during the study period.
2. Has received any other licensed vaccines within 4 weeks prior to enrollment in this study.
3. Has received any influenza vaccine within the prior 12 month period.
4. Has received any investigational vaccine designed for protection against avian influenza.
5. Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the administration of the study vaccine. The use of inhaled and nasal steroids will be permitted.
6. Any medically diagnosed or suspected immunodeficient condition based on medical history and physical examination.
7. Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or during the study.
8. Acute disease at the time of enrollment. Acute disease is defined as the presence of a moderate or severe illness with or without fever ≥ 100.5º F.
9. Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
10. Major congenital defects or serious chronic illness.
11. History of any neurological disorders or seizures, with the exception of febrile seizures during childhood.
Januvia Re-examination Study (MK-0431-181)

The objectives of this survey are: 1) To examine the safety/efficacy profile of Januvia in Korean participants, and 2) To identify factors that might have an influence on the safety and efficacy profile of Januvia in Korean participants.

Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 Diabetes Mellitus
* Treated With Januvia within local label for the first time

Exclusion Criteria:

* Contraindication to Januvia according to the local label
* Treated with Januvia before contract and out of enrollment period

Inclusion criteria for long-term surveillance

* Treated with Januvia for more than or equal to 24 weeks
Utility of Breath-holding Test in Systemic Sclerosis

This study aims to evaluate the utility of breath-holding test as a marker of pulmonary disease severity in patients with systemic sclerosis.

Systemic sclerosis (SSc) is a chronic autoimmune disease of unknown etiology with high morbidity and mortality. SSc manifests by fibrosis of skin and internal organs. Although the underlying mechanisms are still subject to investigation, endothelial dysfunction and abnormal immune response are thought to contribute to vascular dysfunction and fibrosis in SSc.

Pulmonary involvement, such as pulmonary arterial hypertension (PAH) and interstitial lung disease (ILD) is a major cause of death in SSc. Although the 6MWT is generally used for evaluating PAH and ILD, the utility in SSc is undetermined. Several investigators have found weak or moderate correlations of 6MWT in pulmonary involvement in SSc. The 6MWT is influenced by the status of all organ systems involved in exercise (pulmonary, cardiac, peripheral vascular, neuromuscular unit and muscle metabolism) as well as by specifics of test conditions. There is a pressing need for new, practical method which corroborates the current 6MWT for the evaluation of pulmonary disease severity in SSc.

Breath-holding test (BHT) is one of the most useful methods for assessing the sensitivity of peripheral chemoreflex. Recent studies have demonstrated that BHT was correlated to pulmonary function test. BHT can be safely conducted and doctors handle a medical emergency during test easily as well. Therefore, this study evaluates the utility of BHT as surrogate marker of pulmonary involvement in patients with SSc.

Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of systemic sclerosis according to 2013 ACR/EULAR criteria
* Must understand and voluntarily sign an informed consent form including writing consent for data protection

Exclusion Criteria:

* The resting oxygen saturation by pulse oximetry \< 90% in room air
* Unstable angina or myocardial infarction during the previous month
* Patients considered unable to the breath-holding test or 6 minute walk test
A 12-week Post-marketing, Observational Study to Confirm the Safety and Efficacy of Zetia Alone or in Combination With Other Lipid-lowering Drugs in Japanese Subjects With Hypercholesterolemia (Study P05244)

This study is a non-interventional (observational) study in Japan to confirm the safety and efficacy of Zetia when administered alone or in combination with other lipid-lowering drugs in daily medical practice throughout a 12-week period. It is being conducted as a post-approval commitment, in accordance with the Ministry of Health, Labour and Welfare's guideline on Good Post-marketing Study Practice.

Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.

The population will be selected from 2,000 institutions in Japan.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who have hypercholesterolemia, familial hypercholesterolemia, or homozygous sitosterolemia will be considered for this study.

Zetia monotherapy patients must be treated with Zetia alone.

Zetia combination therapy patients must be treated with Zetia in combination with other lipid-lowering drugs for hypercholesterolemia.

Exclusion Criteria:

* Patients with a history of hypersensitivity to any ingredient in Zetia
* Patients with serious hepatic function disorder should not be treated with Zetia in combination with an HMG-CoA reductase inhibitor.
GWAS Identified Susceptibility Loci for Glucocorticoid-induced FHN in the Chinese Population

This is a observation clinical trial. We are collecting the patients with glucocorticoid. They were divided into the experiment group (with femur head necrosis) and control group (without femur head necrosis).Then, we will analyse the patients' genome with genome-wide association study (GWAS). Our purpose is to find susceptibility loci for glucocorticoid-induced femur head necrosis in the Chinese population.


Eligibility Criteria:
Inclusion Criteria:

1. Subject has given the written informed consent voluntarily;
2. Male or female between 18\~60 years;
3. Candidate is clinically diagnosed as avascular osteonecrosis of the femoral head (ONFH), in reference to the diagnostic criteria set forth by Experts' Consensus on the Diagnosis and Treatment of Osteonecrosis of the Femoral Head in Adults (edition 2012);
4. Patient with history of glucocorticoid therapy, in form of oral, muscular or vascular administration, should have total dose equivalent to ≧2000 mg of Prednisone, and maintain on that dose for ≦3 months.

Exclusion Criteria:

1. Subject is not in conformity with diagnostic criteria for ONFH;
2. Patient has a history of trauma in the lower limbs or pelvis;
3. Prolonged addiction to alcohol;
4. Concurrent with renal failure, organ transplant, graft versus host disease, inflammatory bowel disease, HIV infection or leukemia;
5. Patient with familial idiopathic ONFH;
6. Subject suffers from a fatal disease, with life expectancy \< 2 months;
7. Woman of child-bearing potential, who is pregnant, in preparation of pregnancy or breast-feeding during the study period;
8. Other patients deemed ineligible at the discretion of the investigator.
PhysioGlove Versus Clinic Electrocardiogram Comparison

Comparison of the quality of the outpatient clinic electrocardiogram performed on patients sent to a cardiology consultation with a standard cable and the PhysioGlove-ES electrocardiograms performed in the cardiology clinic.

The correct performance of a 12 lead electrocardiogram depends on the correct placement of the electrocardiogram electrodes in internationally agreed upon anatomic locations on the patient's limbs and chest. This process requires specific training and diligence on the part of the electrocardiogram performer. The literature points towards a progressive quality degradation of the electrocardiogram performance probably due to the delegation of it's performance to lesser trained individuals. This study is attempting to ascertain the quality of the electrocardiogram recordings performed in non-specialized out patient clinics.

For this purpose we will compare outpatient electrocardiograms of patients referred to a cardiological consultation with electrocardiogram's acquired using a conventional electrocardiogram cable as well as the PhysioGlove-ES by the well training cardiology clinic personnel.

Eligibility Criteria:
Inclusion Criteria: all consenting male and female patients age 18-95 -

Exclusion Criteria:

1. All patients using shirt-sizes under small mand over extra-large
2. all patients with severe chest malformations or open wounds or contagious skin infections involving the chest and/or arms -
Labour Epidural Top-up With Warmed Ropivacaine

The purpose of this study is to determine weather using warmed (body temperature) 0.75% Ropivicaine to convert labour epidural analgesia to surgical anaesthesia, reduces the onset time of surgical block, compared to standard room temperature

In this prospective, randomised, controlled, double-blind study; parturients with functioning labour epidural analgesia requiring conversion to anaesthesia for surgical delivery (SD) - will be randomised into control and intervention groups: room temperature (RT) and body temperature (BT). The control group (RT) will receive room temperature Ropivacaine 0.75%, as is the standard practice. The treatment group (BT) will receive 0.75% Ropivicaine warmed up to 37°C temperature. Block height will be assessed every 2 minutes by a blinded investigator until the loss of sensation to cold at the level of T4, sensation to touch will be used as second modality.

Primary outcome is the time to loss of sensation to cold at T4 bilaterally as assessed with ethyl-chloride spray. Secondary outcomes will include motor block, haemodynamic stability, and use of vasopressors, shivering, sweating, nausea, pruritus, body temperature, intra-operative supplementation, and Apgar scores.

Eligibility Criteria:
Inclusion Criteria:

* ASA I-II women with an established labour epidural
* Labour analgesia with standard low-dose mixture PCEA
* Need for surgical delivery

Exclusion Criteria:

* Category 1 (crash) CS
* Spinal blockade, suggesting migration of epidural catheter
* Use of epidural bupivacaine 0.25-0.5% within 1 h
* Pyrexial parturian - ≥38°C temperature before administration of top-up
* Multiply pregnancy
* Eclampsia
* An allergy or idiosyncratic reaction to local anaesthetic
* Patient refusal
Effects of PNF on Shoulder Pain in Paraplegic Manual Wheel Chair Users

This project was a Randomized control trial conducted to check the Effects of Proprioceptive Neuromuscular Facilitation on Shoulder Pain due to chronic impingement syndrome in paraplegic Manual Wheelchair users after Spinal Cord Injury so that we can have best treatment option for patients with shoulder pain due to manual wheelchair usage. duration was of 6months,convenient sampling was done, subject following eligibility criteria from Spine welfare trust center, Nawaz Sharif social security Hospital were randomly allocated in two groups via lottery method, Group A participants were given baseline treatment along with PNF exercises , Group B participants were given baseline treatment upto 6 weeks and 3 sessions per, post intervention assessment was done after 6 weeks, by self-generated questionnaire (WUSPI) wheel chair users shoulder pain index, (SRQ) Shoulder rating questionnaire and physical assessment by 2 special test was done, data was analyzed by using SPSS version 25.

In paraplegic manual wheelchair users Shoulder pain is most common problem after spinal cord injury. Due to wheelchair propulsion, weight relief task and other household activities repetitive load induced on upper limb and put substantial load in particular on shoulder.In spinal cord injured patients shoulder pain is because of over use of upper limb and shoulder during wheelchair related activities and personal care activities. less stability and slight muscle mass leads toward pain in their life at some point because of Muscular imbalance and later on shoulder secondary impingement syndrome. This study compared the rhythmic stabilization technique from PNF exercises with conventional treatment on experimental and control group to see the difference in reduction of pain and disability.

Eligibility Criteria:
Inclusion Criteria:

* 18-60 years old paraplegic manual wheel chair users after spinal cord injury.
* Those having level of injury from C7-T12
* Patients who are using wheelchair from more than one year.
* Pain perceived region of one or both Shoulder from last three months or more
* Pain without radicular symptoms radiating to whole upper limbs.
* Wheelchair propulsion in activities of daily living,
* Individuals with positive Neer's test and Hawkins-Kennedy test

Exclusion Criteria:

* Any red flags (tumor, fracture, metabolic diseases, rheumatoid arthritis, resting blood pressure greater than 140/90 mmHg, prolonged history of steroid use, etc.
* Any dislocation ,muscular tear and acute problem of shoulder.
* Presented with a diagnosis of cervical spinal stenosis, exhibited bilateral upper extremity symptoms
* Any recent surgery of the shoulder
* Individuals using other mobility devices with wheelchair.
* Individuals with primary impingement
The Early Administration of Sodium Thiosulfate Should Help to Reduce the Mortality of Dialysis Patients With Calciphylaxis, From a National Cohort

The national drug safety agency authorizes nominatively the use of sodium thiosulfate in dialysis patients with calciphylaxis. To date, it is the largest global cohort (more 600 patients from 2012 to 2016). We wanted to study retrospectively the fate of these patients at 6 months including mortality. Early use improves effectiveness.


Eligibility Criteria:
Inclusion Criteria:

* All dialysis patients with calciphylaxis in France who have obtained a temporary use authorization for sodium thiosulfate by National Agency for the Safety of Medicines

Exclusion Criteria:

* N/A
Management of Patients With Neovascular Age-related Macular Degeneration Undergoing Cataract Surgery

To-date there have been only very few studies to examine the effect of cataract surgery to patients with wet age-related macular degeneration. The evidence on the effects of cataract surgery in such patients suggests improvement of their visual function and quality of life, but at the same time a subclinical susceptibility to macular edema and exacerbation of the choroidal neovascularization. Therefore it is highly important to identify the optimum treatment regime, pursuing the best anatomical and functional postoperative results.

To-date there have been only very few studies to examine the effect of cataract surgery to patients with neovascular age-related macular degeneration (AMD), especially in the era of anti-vascular endothelial growth factor (anti-VEGF) therapy. Furthermore the issue of optimum treatment regimen that should be used in the peroperative period has never been addressed. Since the human life expectancy gradually increases, the number of patients who are under anti-VEGF intravitreal injections for wet AMD will be increasing accordingly. Cataract surgery in such patients, despite guarded prognosis has been proved to improve their visual function and quality of life. On the other hand, it has been shown that cataract surgery induces anatomic changes based on optical coherence tomography analysis, suggesting a subclinical susceptibility to postoperative cystoid macular edema or exacerbation of choroidal neovascularization. Therefore it is highly important to identify the optimum treatment regime, pursuing the best anatomical and functional postoperative results.

Eligibility Criteria:
Inclusion Criteria:

* Active choroidal neovascularization (at least 1 intravitreal injection in the past 12 months) associated with AMD and involving the foveal center
* BCVA of 1.0 (LogMAR) or better
* Duration of wet AMD less than 3 years

Exclusion Criteria:

* Coexisting ocular pathology potentially affecting visual acuity and/or status of the macula including diabetic retinopathy, advanced glaucoma, retinal vein occlusion, retinal detachment
* Newly diagnosed patients with wet AMD who are on anti-VEGF treatment for less than 6 months