cyrilzakka/clinical-trials huggingface dataset:
Safety Study of Subcutaneous Ig NextGen 16% in Patients With Primary Immunodeficiency

The study aims to assess the safety and tolerability of subcutaneous Ig NextGen 16% in patients with Primary Immune Deficiency who require Immunoglobulin (Ig) G replacement therapy. Ig NextGen 16% is a liquid immunoglobulin (antibody) preparation.

This is a Phase 3, open label, multi-centre, study for patients requiring Ig replacement therapy. This study is a follow-on study to patients who have completed the CSLCT-SCIG-05-23 clinical trial and wish to continue subcutaneous treatment with Ig NextGen 16% . Additionally, patients currently receiving IVIg with unacceptable adverse reactions or unable to tolerate IVIg as well as patients receiving alternate IG products via the SC route may be enrolled in this study. Patients must not be eligible for any of the Sponsor's ongoing PID studies that are still open to enrolment.

Eligibility Criteria:
Inclusion Criteria:

1. Age \>3 years of age.
2. PID patients receiving Ig replacement therapy.
3. Patients must have completed or withdrawn from CSLCT-SCIG-05-23 and wish to continue SCIg therapy; or, patients ineligible for CSLCT-SCIG-05-23 but for whom the Investigator believes SCIg may be a suitable form of Ig replacement, for reasons such as: poor tolerability of IVIg, difficult venous access, or, preferred route of administration.
4. Patient is capable of self-administering Ig NextGen 16%

Exclusion Criteria:

1. Patients eligible for CSLCT-SCIG-05-23 if still open for recruitment.
2. Patients with known anaphylaxis reactions to immunoglobulin therapy.
3. Patients with known selective IgA deficiency or antibodies to IgA with a history of reactions to Ig therapy.
4. Patients with protein-losing enteropathies.
5. Patients who are suffering from an acute or chronic medical condition, other than PID, which may, in the opinion of the Investigator, affect their treatment or the conduct of the trial.
6. Females who are pregnant, breast feeding or planning a pregnancy during the course of the study. Females who are of child bearing potential must have a negative pregnancy test at screening.
7. Patients unwilling to comply with the protocol.
Study to Investigate Safety, Tolerability and Pharmacokinetics of a Single Ascending Dose of AZD1704

The primary aim for this study is to investigate the safety and tolerability of the AZD1704, first time in man.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers, man or woman of non child-bearing potential
* Provision of signed informed consent.

Exclusion Criteria:

* History of somatic disease/condition that may interfere with the objectives ot the study, as judged by the Investigator. History of seizures, with the exception of single occasions fever induced seizures in childhood.
* History of previous or ongoing psychiatric disease/condition including psychosis, affective disorder, anxiety disorder, borderline state and personality disorder according to the criteria in the DSM of Mental Disorder, 4th edition
* History of use of antipsychotic, antidepressant or anxiolytic drugs for the treatment of psychiatric disease or symptoms, prescribed as well as non-prescribed use.
Terlipressin Infusion Alone Vs Terlipressin With Noradrenaline Infusion In The Treatment of Hepatorenal Syndrome Type 1

Hepatorenal syndrome (HRS) is defined as a functional renal failure in a patient with chronic liver disease, or liver cirrhosis.The splanchnic circulation undergoes severe vasodilation, as a result of portal hypertension, causing an underfilling of systemic arteries.This results in intense renal vasoconstriction and functional renal failure. The best treatment options for HRS I would be a drug which has renal vasodilator property and additional splanchnic vasoconstriction. An increase in circulating blood volume would be of additional benefit. Currently Terlipressin is considered superior to other drugs in the management of HRS I. Other drugs in use are Noradrenaline and Midodrine. Albumin is added to these drugs in order to expand plasma volume. Terlipressin, a Vasopressin analog, has agonistic activity at V1 receptors. Noradrenaline acts as an agonist at α-adrenergic receptors with mild β-agonistic activity. The two major drugs used in the management of HRS act at different receptors and have completely varied mechanisms of action. Thus, a combination therapy would improve the rate of response considerably. There have been multiple studies, measuring the efficacy, safety and dosing of both drugs, but none combining both Terlipressin and Noradrenaline. Hence our study would be a pioneer in formulating a new and possibly more efficacious treatment protocol for patients of Type I HRS, in whom the treatment options are otherwise very limited. If successful, this would open new horizons of therapy for Terlipressin refractory HRS, which, otherwise is an ominous condition.


Eligibility Criteria:
Inclusion Criteria:

1. age\>18 years and \<80 yrs;
2. Cirrhosis as diagnosed by clinical findings, endoscopy or USG examination or by liver biopsy.
3. HRS I as defined by the following features:

   1. The patient should have Cirrhosis and also ascites
   2. Renal failure of rapid onset -Initial value of sCr, doubling to reach a level of more than 226mmol/L (2.5 mg/dL) in less than two weeks
   3. There should be absence of shock.
   4. sCr value does not reduce to less than 1.5 mg/dl even after 2 days of stopping diuretics and giving Inj.Albumin for plasma volume expansion (1g/kg ) upto 100g/day.
   5. No H/O being treated currently or recently with drugs having nephrotoxicity.
   6. Absence of parenchymal renal disease:

      * Proteinuria \< 0.5g/day
      * Absence of microhaematuria (\<50 red cells/high powered field)
      * Normal renal ultrasonography

Exclusion Criteria:

1. AKI improved after plasma volume expansion
2. Any history of coronary artery disease, peripheral vascular disease, arrhythmias, and cardiomyopathy.
3. Hepatocellular Carcinoma
4. Septic shock
5. Any severe extra-hepatic condition including respiratory and cardiac failure.
6. Any contraindication which precludes the use of Noradrenaline and Terlipressin
Evaluation of Amphotericin B in Optisol-GS for Prevention of Post-Keratoplasty Fungal Infections.

With the increasing popularity of endothelial keratoplasty, a coincident increase in the rate of fungal infections post-keratoplasty has been seen in the United States. In this study, the eye bank will harvest pairs of donor corneas and randomize one cornea from each pair to be stored in Optisol-GS per Eye Bank Association of America guidelines. The eye bank will add amphotericin B 0.255 μg/mL (antifungal) to the storage solution for the mate cornea. The study donor corneas will be assigned to participants who are scheduled to undergo Descemet membrane endothelial keratoplasty. The surgeons, participants, and evaluators will remain masked regarding the donor cornea storage solution assignment. The participants will be followed for 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Male or female at least 18 years of age and any race or ethnicity
* Scheduled to have Descemet membrane endothelial keratoplasty

Exclusion Criteria:

* History of glaucoma surgery in operative eye
* Known allergy or intolerance to amphotericin B
* Presence of anterior chamber intraocular lens
* Corneal stromal or epithelial dysfunction
* Presence of glaucoma defined as optic nerve damage as confirmed on Humphrey visual field testing or retinal nerve fiber layer analysis
* Presence of peripheral anterior synechiae
Primary Prevention Program

A systematic collection of retrospective and prospective data based on non-intervention patient observation, aimed to assess the risks, course and outcomes of a disease or a group of diseases:

* the retrospective part: database of patients with cardiovascular risks;
* the prospective part: observation of patients in the real medical practice

The research program will have two parts:

Stage1: identification of patients with moderate, high and very high cardiovascular risks, not having diseases of atherosclerotic genesis and requiring lipid-lowering drugs.

Stage 2: a prospective observation of patients receiving primary medical prophylaxis of CVD with atorvastatin

Eligibility Criteria:
Inclusion Criteria:

Men and women 40-65 years old with the presence of:

* moderate cardiovascular risk (\<5% but ≥1% on a SCORE scale) and cholesterol level LDL ≥3.0 mmol / l, in which the target is not reached during the improvement of lifestyle level of cholesterol-LDL, and the attending physician considers appropriate the appointment lipid-lowering drugs (statins), or
* high cardiovascular risk (≥5% but \<10% on a SCORE scale) and cholesterol level LDL ≥ 2.5 mmol / l, or
* very high cardiovascular risk (≥10% on the SCORE scale) and cholesterol-LDL ≥1.8mmol / l, or
* atherosclerotic stenosis of the brachiocephalic arteries\> 50% in the absence cerebrovascular diseases and the level of cholesterol-LDL ≥1.8 mmol / l, which do not have contraindications to taking statins and not taking drugs of this group in currently.

Exclusion Criteria:

* The presence of the following clinically significant events in anamnesis: myocardial infarction, stroke, myocardial infarction
* The presence of the following diseases at the time of statin administration: ischemic heart disease; heart failure; atherosclerotic disease of peripheral arteries; atherosclerotic stenosis of the brachiocephalic arteries in the presence of cerebrovascular disease; chronic renal failure with creatinine clearance \<30 ml / min; liver disease with an increase in AST and ALT levels of more than 3 times, compared to the upper limit of normal; history of muscular or neuromuscular diseases, with elevated CPK; alcoholism, oncological, mental and other severe concomitant diseases; intolerance to statins in anamnesis; use of other lipid-modifying agents.
A 12 Week Study in Patients With Type 2 Diabetes Mellitus (T2DM)

This study will assess the effect of LCQ when added to metformin.


Eligibility Criteria:
Inclusion Criteria:

* HbA1c from 7.0-10.0%, Stable Metformin dose

Exclusion Criteria:

* CHF Class III-IV, Liver disease

Other protocol-defined inclusion/exclusion criteria may apply
Forceps Biopsy Versus Cryo-biopsy in the Diagnosis of Lung Cancer

This study was comprised of 30 patients who were scheduled for a diagnostic bronchoscopy due to a suspicion of lung cancer in order to obtain tissue samples for a final diagnosis , four biopsies were taken by each of cryobiopsy and forceps biopsy , to evaluate and compare the diagnostic yield of endobronchial cryobiopsy and forceps biopsy in the diagnosis of lung cancer .

Diagnostic bronchoscopic interventions are used to evaluate and tissue sample from endobronchial lesions utilising variety of devices that can be delivered through the operative channel of a fibrio-optic bronchoscope.

All of the procedures were carried out with 2% lidocaine instillation and midazolam IV sedation All patients signed a written informed consent form for bronchoscopy and tissue sampling with forceps and a cryoprobe.between August 2020 and June 2021. All interventions were performed in the bronchoscopy unit of the Chest Medicine Department at Benha university Data were collected, revised, coded and entered to the Statistical Package for Social Science (IBM SPSS) version 23. The quantitative data with parametric distribution were presented as mean, standard deviations and ranges.

Eligibility Criteria:
Inclusion Criteria:

* severe uncorrected hypoxemia despite supplemental oxygen treatment
* unstable angina
* uncontrolled arrhythmias,
* severe hypercarbia,
* unstable cervical spine.
* Coagulopathy that cannot be reversed
* Chronic obstructive pulmonary disease (COPD) exacerbation
* Severe Illness
* old age
* malnutrition
* Patient who refused to have a bronchoscopy performed

Exclusion Criteria:

Patients' histories, including age, sex, and smoking status, were documented for all participants in the trial Clinical examination and medical history Complete blood count, serum creatinine, liver enzymes, INR, bleeding time, and clotting time are all routine laboratory tests Plain chest X-ray and chest computed tomography were used in the radiological workup\* Arterial blood gas on room air. bronchoscopy and biopsy taking with forceps and cryobiopsy

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Does the Recall by the General Practitioner Improve Patients' Participation in Colorectal Cancer Screening?

The propose of this study is to assess the effect of general practitioner's involvement in the stimulus invitation letter in colorectal cancer screening compared to sending the patient home test (stimulus 2 of reference as contained in the specifications).


Eligibility Criteria:
Inclusion Criteria:

* Age : 50 to 74 years.
* Not having answered the first two solicitations of ADECA75 to participate in screening for colorectal cancer

Exclusion Criteria:

* Patients who have a Fecal Occult Blood Test for less than 2 years or a colonoscopy within the past 5 years or excluded for medical reasons (according to information known from ADECA).
A Study on the Combination Therapy of Eravacycline for Treating Carbapenem-Resistant Acinetobacter Baumannii Pneumonia

This study intends to evaluate the efficacy and safety of eravacycline-based combination therapy in real words for Chinese patients with CRAB pneumonia, providing data reference for clinical treatment of CRAB pneumonia.

This study aims to include 50 patients proven or suspected diagnosed carbapenem-resistant Acinetobacter baumannii pneumonia at Peking University Third Hospital. The physician determines to use a combination regimen of eravacycline, including sulbactam or compound preparations containing sulbactam, polymyxin B, and β-lactam antibiotics, is considered. The clinical response rate at the end of treatment is the primary endpoint of the study; the secondary endpoints include the clearance rate of carbapenem-resistant Acinetobacter baumannii, the incidence of adverse events, and the all-cause mortality rate within 28 days.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 18 years or older.
2. Voluntarily participating in this study and signing an informed consent form. If the subject is unable to read and/or sign the informed consent form due to lack of capacity or other reasons, the informed process and the informed consent form must be signed by their legal guardian.
3. Patients with clinical manifestations and imaging results consistent with bacterial pneumonia, and who are expected to benefit from antimicrobial treatment. Suspected carbapenem-resistant Acinetobacter baumannii infection or Acinetobacter baumannii detected in two consecutive sputum cultures (at least one of which must be from bronchoalveolar lavage or endotracheal aspirate), with resistance to carbapenems.
4. Patients who have been treated with eravacycline for at least 3 days.

Exclusion Criteria:

1. The investigator believes that there are any medical history, current condition, treatment, abnormal laboratory test results, or other situations that may affect the trial results, interrupt the trial process (or the subject cannot complete all trial requirements, operations, and visits), or increase the risk to the subject from receiving the trial medication, including patients with terminal illness, or evidence of an immediately life-threatening disease.
2. Patients with a history of allergic reactions to tetracyclines or any excipients contained in the formulation of the study medication.
A Study of Ibuprofen (IBU) 250mg/APAP 500mg In The Treatment Of Post-Surgical Dental Pain

This study is being conducted to determine the overall analgesic efficacy and safety of a fixed-dose ibuprofen 250 mg / acetaminophen 500 mg formulation compared to placebo in subjects who are experiencing post operative pain following surgical extraction of 3 or more third molar teeth. A review of any reported adverse events will also be completed.


Eligibility Criteria:
Inclusion Criteria

1. Males and females 18 years to 40 years of age (inclusive).
2. Outpatients who have undergone surgical extraction of 3 or more third molars, of which at least 2 must be a partial or complete bony mandibular impaction.
3. Subject must have at least moderate pain on the 4 point categorical scale, confirmed by at least 50 mm on the 100 mm VAS PSR scale within approximately 5 hours (ie, less than or equal to 5 hours, 15 minutes) after surgery is completed.
4. In general good health and have no contraindications to the study or rescue medication.

Exclusion Criteria

1. Presence or history of any significant hepatic, renal, endocrine, cardiovascular, neurological, psychiatric, gastrointestinal, pulmonary, hematologic, or metabolic disorder determined by the Investigator to place the subject at increased risk, including the presence or history within 2 years of screening of the following medical conditions/disorders:

   * Gastrointestinal ulcer or gastrointestinal bleeding;
   * Paralytic ileus or other gastrointestinal obstructive disorders;
   * Bleeding disorder.
2. Hypersensitivity to ibuprofen, naproxen, aspirin, or any other NSAID; or to APAP, tramadol, other opioids, or to their combinations.
3. Prior use of any type of analgesic or NSAID within five half lives of that drug or less before taking the first dose of investigational product, except for pre anesthetic medication and anesthesia for the procedure.

   .
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Doses of AbGn-168 in Psoriasis

The general aim of the trial is to determine the safety, tolerability and pharmacologic profile of single escalating doses of AbGn-168 administered subcutaneously or intravenously to patients with chronic plaque psoriasis


Eligibility Criteria:
Inclusion criteria:

Patients with chronic plaque psoriasis covering at least 3% of body surface area. Female subjects must be postmenopausal or surgically sterilized.

Exclusion criteria:

Recent use of biologic agents, oral psoriasis medications or phototherapy
Evaluation of Bone Union Following Anterior Cervical Fusion Using a NovoMax™

The purpose of this study is to evaluate the efficacy and safety of NovoMax™ in Anterior Cervical Interbody Fusion - Comparison of NovoMax™ versus ChronOs®.


Eligibility Criteria:
Inclusion Criteria:

* The patient who is expected to receive anterior cervical discectomy and fusion operation.
* Volunteer for this study with written consent.

Exclusion Criteria:

* Patient with cervical spine fracture, infection and malignant tumor
* Below -3.5 T-score by DEXA bone densitometry
* Patient who is not suitable for this study judged by principal investigator
Estimating EC95 of Remifentanil for Cough Prevention During Emergence From Total Intravenous Anesthesia With Propofol and Remifentanil in Patients Undergoing Transsphenoidal Hypophysectomy

In patients undergoing hypophysectomy through transsphenoidal approach, preventing cough during anesthetic emergence is important to avoid hemorrhage and cerebrospinal fluid leakage. Previous reports demonstrated that administration of remifentanil during anesthetic emergence could reduce the incidence and severity of cough during anesthetic emergence. Therefore, the objective of this study is to determine EC95 of remifentanil for preventing cough during anesthetic emergence in patients undergoing hypophysectomy with transsphenoidal approach.


Eligibility Criteria:
Inclusion Criteria:

* scheduled to undergo hypophysectomy with transsphenoidal approach
* American Society of Anesthesiologists physical status I or II
* more than 20 years old

Exclusion Criteria:

* acute or chronic respiratory disease
* uncontrolled hypertension
* taking sedatives or anti-tussive
* gastro-esophageal reflux
* pregnant or breast feeding
* patients who cannot understand statements for subjects or this study itself
Long-Term Non-Interventional Study (NIS) To Investigate The Safety And Effectiveness Of MACUGEN In Patients With Neovascular Age-Related Macular Degeneration Under Conditions Of Routine Clinical Practice

To define what procedures were used for the diagnosis and monitoring of the treatment age-related macular degeneration (AMD). What is the effect of the Macugen, compliance with Macugen treatment, safety profile of Macugen, final physician assessment of treatment with Macugen.

no sampling

Eligibility Criteria:
Inclusion Criteria:

* age over 18 years old
* patients with neovascular age-related macular degeneration
* enrollment to study is fully on physician decision in compliance with current SPC

Exclusion Criteria:

* Patient who did not meet indication according to SPC Macugen.
Efficacy of Amodiaquine in the Treatment of Uncomplicated Falciparum Malaria in Young Children of Burkina Faso

Design: Single-centre

Indication: Malaria caused by Plasmodium falciparum Objectives: To determine and compare the efficacy of AQ treatment in young children with uncomplicated falciparum malaria in the rural and the urban study area of the Centre de Recherche en Santé de Nouna (CRSN).

Population: Children aged 6-59 months with uncomplicated falciparum malaria (axillary temperature ≥ 37.5°C + ≥ 2.000 P. falciparum asexual parasites per µl blood) from the health centre situated in the villages of Bagala, Bourasso and Kemena and from Nouna town hospital outpatient department.

Sample size: N=120

Treatment: All children will receive a total dose of 25 mg/kg oral AQ over a period of three days (first and second day: 10mg/kg, third day: 5mg/kg).

Statistical procedures: The primary analysis parameter is the proportion of clinical failures on day 14. Secondary parameters are the rate of clinical failures on day 28 (with and without PCR correction), the rate of early clinical failures, the rate of late parasitological failures (day 14 and day 28), and the rate of adverse events. Data will be analysed in the overall group of study children and for rural (n=50) and urban (n=50) study children separately.

Study duration and dates: The study will be implemented in September-December 2005.


Eligibility Criteria:
Inclusion Criteria:

* Age 6-59 months
* Uncomplicated falciparum malaria (axillary temperature ≥ 37.5°C and ≥ 2.000 P. falciparum asexual parasites per µl blood)
* Written informed consent given by the parents/caretakers

Exclusion Criteria:

* Complicated or severe malaria (repeated vomiting, seizures or other neurological impairment, haemoglobin \< 7 g/dl or haematocrit \< 21%)
* Any apparent significant disease (e. g. pneumonia, meningitis, hepatitis, severe diarrhoea, measles, severe malnutrition)
* Malaria treatment with western drugs and/or antibiotics with anti malarial potency during last 7 days except chloroquine.