cyrilzakka/clinical-trials huggingface dataset:
Biologics and Sublingual Immunotherapy

Most current studies involve using a biological drug to increase the safety of allergen immunotherapy (AIT) especially in the treatment of food allergies, to avoid the risk of anaphylaxis. However, adding Xolair® to AIT may improve the therapy's effectiveness. There are still few observations on this topic, especially in patients with house dust mite (HDM)-driven asthma.

Assess the effectiveness of combined therapy Actair® plus Xolair compared to monotherapy with Actair® or Xolair® or standard symptomatic therapy in patients with mild or moderate allergic asthma to HDM.

Treatment duration: 24 months Follow-up duration:12 months Total duration: 36 months (not including screening and randomization period) May 2024 - March 2028 Consisting of a 4 to 5 months screening phase (with 1 month observation period prior to randomization) a treatment phase of 24 months and post-treatment follow-up phase 12 months

Eligibility Criteria:
Inclusion Criteria:• \>18 years old

* A total IgE between 30-700 IU/mL
* Moderate asthma with perennial symptoms confirmed as HDM-driven asthma based on medical history and positive nasal provocation tests, partially controlled asthma;
* FEV1 \>70% at baseline;
* Positive skin prick test results for D. pteronyssinus, D. farinae

Exclusion Criteria:

* Sensitisation to other allergens with clinical signs not related to HDM
* Uncontrolled asthma,
* Other serious diseases or chronic unstable diseases
* Allergen immunotherapy during the past 5 years
* Contraindicating allergen immunotherapy and omalizumab treatment.
The Impact of Oral Ethanol and Vaped Ethanol on the Evaluation of Impairment

The purpose of this research study is to find out about ethanol-containing e-cigarettes impact ethanol breath tests, field sobriety tests, or other tests of sobriety. Ethanol is a common part of e-cigarette liquids.


Eligibility Criteria:
Inclusion Criteria:

* e-cigarette users
* willing to provide informed consent
* able to attend the lab sessions as needed
* agree to use designated products according to study protocol.

Exclusion Criteria:

* Women who are breast-feeding or test positive for pregnancy (by urinalysis) at screening.
* Some study details about the eligibility criteria are purposely omitted at this time to preserve scientific integrity. Full details will be posted at the conclusion of the stud
Impact Of Sensory Re-Education Paradigm On Sensation And Quality Of Life In Patients Post-Covid 19 Polyneuropathy

This study will be conducted to investigate the effect of a sensory re-education paradigm on sensation and proprioception in patients with post covid-19 neuropathy.

The Coronavirus disease has profoundly impacted the world, altering the functioning of the population and health system. it is so far affected more than 532 million cases and 6.3 million confirmed deaths (WHO., 2020). Recent studies documented that COVID-19-associated peripheral neuropathy is a common and frequent problem, with neuro-muscular complications. This phenomenon is widespread in those with comorbidities, such as diabetes mellitus, which may result from immune processes or as side effects of some medications used to manage COVID-19 symptoms, such as hydroxychloroquine, clindamycin, and steroids. To a lesser extent, prolonged hospitalization may cause entrapment neuropathy (peripheral nerve compression). Most physiotherapists focus on motor improvements rather than sensibility improvements though the sensory system may have the upper hand in improving motor function. Therefore; the sensory re-education paradigm should be assessed in randomized trials with a blinded assessment of functional outcomes to evaluate its effectiveness in patients with post covid-19 neuropathic patients. Currently, there is not enough research addressing the impact of the sensory re-education paradigm on sensation and quality of life in neuropathic patients post-covid19. forty patients will be assigned randomly into two equal groups; the study group will receive sensory re-education paradigm and traditional treatment while the control group will receive traditional treatment only.

Eligibility Criteria:
Inclusion Criteria:

Patients from both genders (male and female). The age of participants ranged from 30 to 40 years old. Participants were required to live in Egypt during the pre-covid and COVID-19 pandemic.

Patients with confirmation of previous covid19 infection PCR TEST. Patients meeting the guide line of world health organization (WHO) of long/post-covid 19 syndromes.

Patients with unknown prior neuropathy. Patients with neuropathy confirmed by EDX with a sensory nerve conduction velocity.

Exclusion Criteria:

Patients with Diabetes mellitus (DM), Rheumatology and Guillain-Barré syndrome (GBS).

Infection other than covid19 leading to sensory neuropathy. Traumatic or compressive lesions leading to central nervous system (CNS), peripheral nervous system (PNS) damages.

Previous surgeries or medications leading to neuropathy.
Rituximab for Serious Aplastic Anemia With Platelet Transfusion Refractoriness

Due to long-term dependence on platelet transfusion, some severe aplastic anemia (SAA) patients suffer platelet transfusion refractoriness (PTR). Unlike immune thrombocytopenia (ITP), glucocorticoids and human immunoglobulin (IVIg) are generally ineffective for PTR. Due to the lack of effective intervention methods, patients with PTR suffer increased platelet transfusions, bleeding events and treatment costs, prolonged hospital stays, and decreased survival rate. SAA with PTR has become a challenge for physicians. The experiment aims to explore the efficacy of rituximab in the treatment of SAA with PTR, and establish a new effective, safe treatment method with relatively low treatment cost.

During the treatment period, Rituximab is administered at a dose of 100mg per week, a total of 4 times.

Eligibility Criteria:
Inclusion Criteria:

* Initial diagnosed SAA with PTR
* Age\>18 years old, regardless of gender
* Initial diagnosed SAA with PTR
* Age\>18 years old, regardless of gender

Exclusion Criteria:

* Allergy to rituximab
* Severe active infection
* Hypogammaglobulinemia
* Pregnant and lactating women
* Heart failure (NYHA classification IV)
* Individuals with epilepsy, dementia, and other mental disorders that require medication treatment who cannot understand or follow the research protocol
* Chronic infections or other chronic diseases that may be risk to the experiment
* The researchers believe that it is not suitable for participants
Interobserver Agreement of Endoscopic Ultrasonography and Endoscopic Sonoelastography in the Evaluation of Lymph Nodes

Endoscopic ultrasound (EUS) is an important part of the pre-treatment evaluation of patients with upper gastrointestinal tract cancer (esophageal, gastric, pancreatic and liver cancer). When planning the optimal therapy in patients with upper gastrointestinal malignancies it is essential to know the exact lymph node stage. Recently endoscopic sonoelastography(ES) has been added to conventional EUS examination and may provide complementary information to distinguish benign for malignant lymph nodes.

The N-stage relates to the treatment choice and the prognosis, and it is therefore of particular interest to know the interobserver agreement in operator dependent techniques. This study evaluate the interobserver agreement of EUS and ES evaluation og lymph nodes.


Eligibility Criteria:
Inclusion Criteria:

* the presence of a lymph node more than 10mm in diameter (short axis) detected during the EUS examination

Exclusion Criteria:

* inadequate ES images were obtained by one of the observers
Single Site, Single Subject, Treatment IND With Mannkind Corporation's Technosphere Inhalation System

The purpose of this program is to allow patients with diabetes and with specific medical needs which require them to use this investigational inhaled insulin product in order to adequately manage their diabetes. Treatment use of this investigational product is only anticipated when exceptional need is identified by a treating physician on a per patient case by case review.

This program is for patients who have been diagnosed with diabetes mellitus and has established a need for treatment with this investigational product documented by a health care professional. The treating doctor, or a member of his/her staff, will discuss the specific requirements for participation with the subject.

INVESTIGATIONAL PRODUCT DESCRIPTION:

Technosphere® Insulin Inhalation System includes Technosphere® Insulin Inhalation Powder and inhaler. The Inhalation Powder comes in 10 unit and 20 unit cartridges.

Eligibility Criteria:
Inclusion Criteria:

Documented diagnosis with diabetes mellitus and have established a need for treatment with the investigational product.

Local Ethics Committee approval has been documented, as needed. Patient has signed the Informed Consent Form for participation. Patient has successfully completed training on the Technosphere Insulin Inhalation System.

Exclusion Criteria:

Allergy to Insulin. Smoking in the previous 6-months. History of asthma or COPD or any other significant pulmonary disease, or exposure to pulmonary toxins.

Clinical significant abnormality in screening laboratory tests. Positive pregnancy test or the intention to become pregnant. Women of childbearing age without appropriate method of contraception.
Home-based Exercise Training for COPD Patients

The aim of this study is to assess the effectiveness of a home-based exercise training program in COPD patients who have completed a pulmonary rehabilitation.

Exercise training is an important component of the management of chronic obstructive pulmonary disease (COPD) and numerous trials have shown large improvements in health-related quality of life (HRQoL) and exercise capacity in persons with COPD. However, the great majority of patients who would benefit from pulmonary rehabilitation (PR) never follow such a program. Moreover, many COPD patients are either not instructed to exercise at all or fail to adhere to exercise training at home after completing pulmonary rehabilitation.

This study evaluates an exercise training program that requires minimal equipment (i.e., only a chair and elastic bands) and can be easily implemented long-term in the patient's home-setting.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent after being informed
* Diagnosis of COPD, defined as forced expiratory volume in 1s/forced vital capacity (FEV1/FVC)\<70% predicted, FEV1\<80 % predicted after bronchodilation, with or without chronic symptoms (cough, sputum production) corresponding to a GOLD stage II-IV
* Completion of an inpatient or outpatient pulmonary rehabilitation not longer than 1 months ago
* Male and female patients ≥40 years of age
* Knowledge of German language to understand study material and assessments

Exclusion Criteria:

* Patients not able to conduct the exercise training program due to physical, cognitive or safety reasons, as judged by investigator; e.g., lower limb joint surgery within preceding 3 months, unstable cardiac disease, predominant neurological limitations.
Biocomparison Study

The effects of two vitamin K-forms on carboxylation of the vitamin K-dependent proteins osteocalcin and matrix-gla protein will be compared after supplementing these vitamins in a nutritional dose range.

The investigators hypothesized that MK-7 is more effective than K1 at a dose comparable to the RDA of vitamin K.

Vitamin K is a group name for the naturally occurring phylloquinone (K1) and menaquinones (MK-n; K2). The latter can be subdivided into the short-chain (e.g. MK-4) and the long-chain (e.g. MK-7, MK-8, and MK-9) menaquinones. Earlier studies have shown that high vitamin K intake leads to improved bone and vascular health by increased carboxylation of vitamin K-dependent proteins in these tissues. In the dietary range, MK-7 has been suggested to be the most effective cofactor for the carboxylation of Gla-proteins, such as osteocalcin (OC) and matrix-Gla protein (MGP).Until now, no randomized controlled trial has compared the efficacy of K1 versus MK-7 in a nutritional dose range. The investigators are therefore interested to compare the effects of K1 and MK-7 on OC and MGP carboxylation after supplementing these vitamins at a dose not exceeding the RDA.

Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women, aged between 20-80 years
* Normal body weight and height (18.5 kg/m2 \< BMI \< 30 kg/m2)
* Stable body weight (weight gain or loss \< 3 kg in past 3 mo)
* Written consent to take part in the study
* Agreement to adhere to dietary restrictions required by the protocol

Exclusion Criteria:

* Abuse of drugs and/or alcohol
* Use of vitamin supplements containing vitamin K
* Pregnancy
* (a history of) metabolic or gastrointestinal diseases, e.g. hepatic or renal disorders, osteoporosis
* Chronic degenerative and/or inflammatory diseases, e.g. diabetes mellitus, cancer, cardiovascular disease
* Use of oral anticoagulants, drugs or hormones that influence bone metabolism
* Corticoid treatment
* Subjects with anaemia or subjects who recently donated blood or plasma
* Systemic treatment or topical treatment likely to interfere with coagulation metabolism (salicylates, antibiotics)
The Prognostic Impact of Surufatinib for the Treatment of Advanced Pancreatic Ductal Adenocarcinoma

Pancreatic ductal adenocarcinoma (PDAC) is a highly aggressive tumor with a poor prognosis, despite the emergence of chemotherapies, unmet medical needs and limited treatment options still exist for patients with metastatic PDAC (mPDAC). Surufatinib is a small-molecule tyrosine kinase inhibitor that targets vascular endothelial growth factor (VEGFR) 1, 2, 3, fibroblast growth factor receptor 1 (FGFR1), and colony stimulating factor 1 receptor (CSF-1R), and ex vivo experiments have demonstrated its effect on PC models.

A retrospective analysis of patients with PDAC who underwent surufatinib at Zhejiang Cancer Hospital (Hangzhou,China) from July 2022 to July 2023.The database was extracted from the preoperative demographics, blood markers, and surgical pathology information of patients undergoing surufatinib in the investigators' hospital.


Eligibility Criteria:
Inclusion Criteria:

(i) were over 18 years old; (ii) had a histological diagnosis of pancreatic adenocarcinoma; (iii) had at least one measurable lesion; (iv) had undergone at least two cycles of surufatinib treatment.

Exclusion Criteria:

(i)non-R0 resection; (ii) Combined with other malignant tumors.
Comparison Between Efficacy of Ketamine and Propofol Mixture With 1:6 Ratio and 1:4 Ratio for Endoscopic Retrograde Procedure Sedation

This study aimed to compare the efficacy of ketamine and propofol mixture with 1:6 ratio and 1:4 ratio for endoscopic retrograde procedure

Approval from Ethical Committee of Faculty of Medicine Universitas Indonesia was acquired prior conducting the study. Subjects were given informed consent before enrolling the study. Intravenous (IV) cannula (20 G) , non-invasive blood pressure monitor, and pulse-oxymetry had been set on the subjects in endoscopic room. Vital signs were recorded. Subjects were then randomized into two groups (Ketamine:propofol ratio of 1:6 \[K16\] and ketamine:propofol ratio of 1:4 \[K14\]). K16 group's drug mixture was ketamine:propofol with ratio of 1:6, filled in 50 cc syringe, which consisted of 1 ml of ketamine (50 mg/ml), 30 ml of 1% propofol (10 mg/ml), and 19 ml of normal saline so that every ml of mixture consisted of 1 mg of ketamine and 6 mg of propofol. K14 group's drug mixture was ketamine:propofol with ratio of 1:4, filled in 50 cc syringe, which consisted of 1 ml of ketamine (50 mg/ml), 20 ml of 1% propofol (10 mg/ml), and 29 ml of normal saline so that every ml of mixture consisted of 1 mg of ketamine and 4 mg of propofol. Patient then was given initial bolus dose of 1 mg/kg body weight (BW) (based on propofol dose) and continued with maintenance dose of propofol (50 mcg/kg BW/minute, based on propofol dose). Maintenance dose could be increased by 10 mcg/kg BW/ minute if the subject still gave response to surgical stimulation or decreased by 10 mcg/kg BW/minute if hypotension occured. Onset of the drug, vital signs every 5 minutes, hypotension and desaturation events were recorded. If there were signs of pain such as tachycardia or hypertension, an additional dose of 25 mcg of fentanyl intravenous was given and recorded. After the endoscopic retrograde cholangiopancreatography (ERCP) finished, drugs were stopped and the total doses of propofol, drug administration speed, total dose of fentanyl used, and recovery time were recorded. Subjects were moved to the recovery room and observed for side effects event. Subjects were moved to the ward after aldrete score of 9-10.

Eligibility Criteria:
Inclusion Criteria:

* Patients who were going to undergo ERCP unders sedation. Patient with American Society of Anesthesiologists (ASA) physical status of I-III, and body mass index of 18-30 kg/m2.

Exclusion Criteria:

* Subjects with history of allergy with drugs used in this trial, subjects with cardiovascular disease, hypertension, respiratory disorder, pregnancy, unstable hemodynamic, psychiatric drugs consumption, possibility of difficult airway, and kidney disorder

Drop out Criteria:

* drug allergy during procedure, hypotension (\>20%) not resolved using ephedrine, desaturation (oxygen saturation \<90%) not resolved using positive pressure ventilation, and endoscopic complication occur
Effects of Iron Supplements on the Pharmacokinetics of MT-6548

The objectives of this study are to investigate the pharmacokinetics and safety of MT-6548 co-administered with iron supplements in healthy male volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Parents and each grandparent of subjects are Japanese
* Subjects judged as appropriate for this study by investigators based on the results of the tests at Screening, Day -1 and Day 1

Exclusion Criteria:

* Subjects with signs of heart diseases on the result of screening test
* Subjects with current conditions or histories of drug addiction or alcohol addiction
* Subjects judged by investigators that they cannot comply with the prohibition during the confinement period
* Subjects who have taken MT-6548 before
* Subjects with current conditions or histories of drug or food allergies
* Subjects with BMI below18.5 kg/m2, BMI above 25.0 kg/m2 or body weight below 50.0 kg at the screening test
* Subjects who have undergone platelet or plasma donation 2 weeks prior to the consent
* Subjects who have undergone blood donation or blood draw of 400 mL or above within 12 weeks prior to the consent, or 200 mL or above within 4 weeks prior to the consent
* Subjects who have undergone blood donation or blood draw of 800 mL or above within one year prior to the consent
* Subjects who have undergone surgical operations that can affect gastrointestinal absorption of medication (appendectomy and hernioplasty do not meet this exclusion criterion)
* Subjects with positive results for HBs antigen, syphilis serum reaction, HCV antibody or HIV antigen / antibody at the screening test
* Subjects who are unwilling to consent to use contraception from the beginning of study period to 90 days following the final dose of the study drug
* Subjects who have participated in another clinical study and received study drugs within 12 weeks prior to consent, or within 5 times the half-life of the study drug (whichever is longer)
* Subjects who have taken any medications except for the drug used for this clinical study within 7 days prior to the first dose of the study drug
* Subjects who have had supplements within 7 days prior to the first dose of the study drug
* Subjects who have had apples, citrus fruits such as grapefruits or any food products that contain apples or citrus fruits within 7 days prior to the first dose of the study drug
* Subjects who have had food products which contain St John's Wort within 2 weeks prior to the first dose of the study drug
Bendamustine Plus Rituximab Versus Fludarabine Plus Rituximab

The study addresses the question if a therapy with bendamustine plus rituximab is comparable (non inferior) with the well-tried combination of fludarabine plus rituximab with regard to event free survival (EFS) in recurrent low malignant Non-Hodgkin and mantle cell lymphomas.


Eligibility Criteria:
Inclusion Criteria:

* Patients with histological verified CD20-positive B-Cell-Lymphomas of the following entities:
* Follicular lymphoma grade 1 and 2
* Immunocytoma and lymphoplasmocytic lymphoma
* Marginal zone lymphoma, nodal and generalised
* Mantle cell lymphoma
* lymphocytic lymphoma (CLL without leucaemic characteristics)
* non-specified/classified lymphomas of low malignancy
* Recurrent disease (remission duration minimum 3 months), independent of type or quantity of prior therapies, except of Rituximab containing regimens, or if remission duration is \> 1 year after Rituximab containing regimen, or refractory to prior therapy (progression under therapy or during 3 months after completion), except refractory disease to purin analogs or Bendamustine
* Need for therapy, except mantle cell lymphomas
* Stadium II (bulky disease, 7.5 cm), II or IV
* Written informed consent
* Performance status WHO 0-2
* Histology not older than 6 months

Exclusion Criteria:

* Patients not establishing all above mentioned prerequisites
* Option of a primary, potentially curative radiation therapy
* Patients refractory to Rituximab containing regimens
* Comorbidities excluding a study conform therapy:

heart attack during the last 6 months severe, medicinal not adjustable hypertonia severe functional defects of the heart (NYHA III or IV) lung (WHO grade III or IV) liver or kidney (creatinine \> 2 mg/dl, GOT + GPT or bilirubin 3 x ULN, except caused by lymphoma

* Active auto immunohemolytic anemia (AIHA)
* HIV positive patients
* Active hepatitis infection
* Severe psychiatric diseases
* No compliance or non-compliance to be expected
* Pregnant or breast feeding women
* Anamnestic malignancies or secondary malignancies, not proven
* Cured/curable by surgery