cyrilzakka/clinical-trials huggingface dataset:
Teclistamab in Previously Treated AL Amyloidosis

This is a phase II study in patients with previously treated immunoglobulin light-chain (AL) Amyloidosis to evaluate the efficacy and safety of teclistamab


Eligibility Criteria:
Inclusion Criteria:

* Biopsy confirmed AL amyloidosis
* Patients must have received at least one line of treatment, including daratumumab and bortezomib
* Relapse from previous treatment, or less than partial response after two cycles of treatment/less than very good partial response after three cycles of treatment
* dFLC \> 50mg/L

Exclusion Criteria:

* Previous anti-BCMA targeted therapy
* Co-morbidity of uncontrolled infection
* Co-morbidity of other active malignancy
* Co-diagnosis of multiple myeloma or waldenstrom macroglobulinemia
* Co-morbidity of grade 2 Mobitz II or grade 3 atrioventricular block (expect for those with implanted pacemaker)
* Co-morbidity of sustained or recurrent nonsustained ventricular tachycardia
* Seropositive for human immunodeficiency virus
* Hepatitis B virus (HBV)-DNA \> 1000 copies/mL
* Seropositive for hepatitis C (except in the setting of a sustained virologic response)
* Neutrophil \<1×10E9/L, hemoglobin \< 8g/dL, or platelet \< 75×10E9/L.
* Severely compromised hepatic or renal function: alanine transaminase (ALT) or aspertate aminotransferase (AST) \> 5 × upper limit of normal (ULN), total bilirubin \> 2 × ULN, eGFR \< 20 mL/min, or receiving renal replacement therapy
Possible Immuno-Modulatory Effect of Tocilizumab in Patients With Refractory Status Epilepticus.

Recently, the pathogenesis of epilepsy is immuno-modulatory and neuro-inflammatory which is commonly activated in epileptogenic brain regions in humans and is clearly involved in animal models of epilepsy. Inflammatory mediators in the blood and molecular imaging of neuro-inflammation could provide diagnostic, prognostic, and predictive biomarkers for epilepsy, which will be instrumental for patient stratification in future clinical studies. Dysfunction of the blood-brain barrier (BBB) may be responsible for abnormal neuronal firing. Disruption of the BBB causes the leakage of serum protein and leucocyte invasion into the brain. These exogenous inflammatory mediators have the potential to lower seizure thresholds, which could alter channel sensitivity, neurotransmitter uptake or release, and glia-associated regulation of extracellular environments, such as potassium concentration.


Eligibility Criteria:
Inclusion Criteria:

* Age: 15-75 years old.
* Gender: Male and female.
* Newly diagnosed refractory status epilepticus patients who are scheduled to receive anti-epileptic drugs.
* Patients with normal renal and hematological functions.

Exclusion Criteria:

* Old age \>75 years old.
* Pregnant or lactating females.
* Severe renal impairment when GFR\<30 ml/min.
* Hepatic patients ( not recommended with active hepatic disease or hepatic impairment specially when ALT or AST \>3 times ULN).
* Neutropenia when neutrophil count \<500 cells/mm3 due to increase the risk of infection.
* Thrombocytopenia when platelet count \< 50000 cells/mm3.
* Patients take Immunosuppressant drugs.
* Cancer patient who taking chemotherapy.
* Patients with a known hypersensitivity to any of the used drugs.
Study to Evaluate the Benefit of RUCONEST in Improving Neurological Symptoms in Post COVID-19 Infection

Randomized, Double Blind, Placebo Controlled, Proof-of-Concept Study to Evaluate the Benefit of RUCONEST in Improving Neurological Symptoms in Post-SARS-CoV-2 Infection.

This study will last approximately 19 weeks including 16 infusions total, each one week apart. This is to help patients that have developed "Post-Viral Fatigue Syndrome" which can include symptoms such as: extreme fatigue, lost of taste, brain fog, and/or seizures.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 and older, male or female
2. Previous confirmed diagnosis of SARS-CoV-2
3. Experiencing SARS-CoV-2 post-viral fatigue syndrome 4 weeks after recovery for SARS-CoV-2
4. Experiencing neurological symptoms including fatigue
5. Willing to comply with all aspects of the protocol, including blood draws
6. Patient is able to understand and fully participate in the activities of the study and the consent in accordance with guidelines
7. Female patients of childbearing potential who are sexually active must be willing to use an acceptable form of contraception. Acceptable forms of contraception are defined as those with a failure rate of \< 1% when properly applied and include: a combination pill, some intra-uterine devices, and a sterilized partner in a stable relationship. Female patients must not be pregnant, planning to become pregnant, or be actively breastfeeding through the entire period.

Exclusion Criteria:

1. Receiving any form of C1-INH therapy either acute or prophylactic treatment
2. History or suspicion of allergy to rabbits
3. Neurological conditions related to injury
4. Neuropathy related to diabetes
5. Participants who are pregnant or lactating
6. Largely incapacitated or bed ridden
7. Currently enrolled in any other clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study or have discontinued with 30 days of study entry from any other clinical study involving an investigational product
8. Patients who, in the investigator's opinion, might not be suitable for the trial for safety reasons
Bioequivalence Study of Two Irbesartan in Healthy Chinese Subjects

The bioavailability of Irbesartan (150 mg) developed by Shenzhen Haibin Pharmaceutical Co., Ltd. was compared with that of reference Irbesartan (Aprovel ®,150 mg) produced by Sanofi Clir SNC. The bioequivalence of single dose of test preparation and reference preparation was evaluated in heathy subjects under fasting and fed conditions.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy male and female aged over 18years
2. Subjects willing to provide written informed consent and to adhere to protocol requirements
3. Subject's weight within normal range according to normal values for Body Mass Index (19.00 to 26.00 kg/m2 (both inclusive)), males with minimum of 50 kg weight, females with minimum of 45kg weight.
4. Subjects have not clinically significant abnormalities, including vital signs, physical examinations, laboratory tests, and ECG as determined by clinical examination

Exclusion Criteria:

1. History or presence of significant cardiovascular, Urogenital, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder
2. Allergic constitution(Allergic to two or more substances) or hypersensitivity to investigational product
3. History or presence of significant gastrointestinal inflammation /ulcer. or other medical history affecting drug absorption
4. Use of any drugs or herbal medicine within 14 days prior to the first dose
5. Can not follow approved birth control methods (a double barrier method) from the screening（Female subjects from two weeks prior to the screening） till 3 months after the last dose -
Retrospective & Prospective Observational Study of Patients With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)

This is a multi-center prospective observational descriptive study complemented by a retrospective chart review. Patients diagnosed with ITP and currently treated for ITP by a hematologist or hematologist-oncologist will be recruited from community-based clinics and academic/referral centers. They will be followed prospectively for a period of 12 months. At inception, participants' charts will also be reviewed from the date of enrollment retrospectively to the date of diagnosis or the previous 36 months, whichever is less.

Time Perspective: 12 months prospective chart review study with a retrospective chart review for a period up to 36 months from the start of the study, since the date of diagnosis for ITP.

Eligibility Criteria:
Inclusion Criteria:

* Has a diagnosis of ITP according to the American Society of Hematology guidelines (George et al., 1996).
* Is equal to or greater than 18 years of age.
* Is willing and able to complete a series of questionnaires.
* Before any study-specific procedure, the appropriate written informed consent must be obtained.

Exclusion Criteria:

* Participated in clinical trial(s) during the past 36 months.
* Is considering participation in a clinical trial within the next 12 months.
The United Kingdom Thrombotic Thrombocytopenic Purpura Registry (UK TTP Registry)

This is a UK (United Kingdom) based registry, involving all sites treating newly presenting Thrombotic Thrombocytopenic Purpura (TTP). From this registry, important epidemiological data will be obtained. Admission and remission samples will be collected. DNA will be collected and analysed from patients wishing to participate to determine if any link exists between mutations/polymorphisms and the risk of TTP. As part of NHS commissioning, we will be undertaking long term follow up, to understand the impact of acute TTP on morbidity and mortality.

The UK TTP registry started in January 2009, following 3 years MRC funding, involving UK collaboration from all sites treating TTP patients. It has resulted in a cohort of data and samples from UK TTP cases. The registry promotes a collaborative approach with all UK patients and physicians involved with this life threatening disorder. The UK TTP registry has been used to provide information for highly specialist commissioning via NHS England and moving forward will be required to provide data relevant to the UK TTP Group and commissioners.

University College London (UCL) Haemostasis Research Unit (HRU) will collect and collate the data and help administrate for those sites participating in the registry. However, ADAMTS13 assays will no longer be subsidised. For those sites undertaking local assays, a record of cases will be shared centrally. The UK TTP registry will be part of the UK TTP Group.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a clinical diagnosis of TTP, defined by thrombocytopenia, MAHA which may be associated with clinical evidence of organ compromise.Confirmed by severely reduced ADAMTS13 levels and/or a positive antibody screen.
* No age restriction.
* Consent for addition to the Registry and collection/storage of admission information once in remission.
* Consent to collect, analyse and store EDTA sample once in remission.
* Consent to store samples once in remission (sample taken as part of standard care).
* For sites undertaking ADAMTS13 analysis, consent to send admission and remission samples for analysis relating to TTP.
* Follow up laboratory and clinical data at least yearly to identify any changes.

Exclusion Criteria:

* Patients with cancer or transplant associated MAHA will not be included.
* Patients not wishing to be involved with the registry.
Lifestyle in Turkish-Background Diabetics

Background: Life-style interventions are indicated in patients with metabolic syndrome and/or type 2 diabetes. However, cultural differences are substantial confounders to not only compliance, but also whether or not the interventions are offered in the first place. In Germany, the large Turkish-background minority has a particularly high incidence of type 2 diabetes, but there is no recorded evidence of a life-style intervention in this patient group.

Objective: The investigators tested the body weight-reducing effect of a 30% calorie-reduced diet, adjusted to individual eating habits and preferences regarding quality and resources of food in a Turkish-background cohort.

The investigators conducted a prospective, randomized, two-arm parallel study. In both arms, patients were instructed in a 12-week diet that was reduced by in caloric content by at least 30% based on calorimetric measurements of 24 h resting energy expenditure and estimated additional expenditures by diet- and activity-induced thermogenesis. Before and after the diet, anthropometric measures and various MetS-associated blood parameters were determined.

The subjects were not instructed in an exercise program. However, the subjects were advised on the value of increased physical activity. For additional motivation, effects were tested by an activity monitor. Therefore, in one of the arms, 24 hour locomotor activity and energy expenditure were determined by means of the SenseWear® MF armband (Body Media Inc., AliphCom dba Jawbone®, Pittsburgh, PA, U.S.A.). This device detects activity contest using accelerometers and assesses daily energy expenditure. For allocation of the subjects, a computer-generated list of random numbers was used. The randomization sequence was created using SPSS 18 (SPSS, Inc., Chicago, IL, USA) statistical software and subjects were assigned to be tested or not for locomotor activity with a 1:1 allocation using random block sizes of 2, 4, and 6.

Eligibility Criteria:
Inclusion Criteria:

* Age 30 - 65 years
* BMI 30 - 40 kg/m2
* non-Insulin dependent diabetes

Exclusion Criteria:

* Pregnancy
* more than 3 anti-diabetic drugs
Study of LX4211 in Subjects With Type 2 Diabetes Mellitus

The purpose of this study is to evaluate the safety, tolerability, and efficacy of LX4211 versus a placebo control in subjects with type 2 diabetes mellitus.


Eligibility Criteria:
Inclusion Criteria:

* Males and females (non-childbearing potential), aged 18-65 years
* Diagnosis of Type 2 diabetes mellitus for at least 6 months prior to screening
* Fasting plasma glucose ≤ 240 mg/dL prior to metformin washout
* Body mass index \< 42 kg/m\^2
* HbA1c value of 7 to 11%
* C-peptide ≥ 1.0 ng/mL
* Ability to provide written informed consent

Exclusion Criteria:

* History of Type 1 diabetes mellitus, diabetic ketoacidosis, hyperosmolar nonketotic syndrome, incontinence, or nocturia
* Use of any blood glucose lowering agent other than metformin
* Prior exposure to insulin, thiazide, or loop diuretics within 4 weeks prior to screening
* Laboratory or electrocardiogram abnormalities deemed significant by the Sponsor or the Investigator
* Positive test result for glutamic acid decarboxylase (GAD) antibody
* Surgery within 6 months of screening
* Exposure to any investigational agent or participation in any investigational trial within 30 days prior to Day 1
* Hypersensitivity to an SGLT2 inhibitor
* History of drug or alcohol abuse within the last 12 months
The Effects of Relaxation Techniques on Pain, Fatigue and Kinesiophobia in Multiple Sclerosis Patients: A Three Arms Randomized Trial

Even though, current treatments including IVIG, corticosteroids, biological agents can provide positive effects on MS symptoms, MS cannot be cured completely today. Therefore, in addition to the available medical treatment options, patients may tend towards complementary and integrative therapies. Relaxation techniques are one of the non-pharmacological and side-effect-free therapy options that are currently used to alleviate the symptoms of many different chronic diseases. Progressive muscle relaxation exercise (PMR) and Benson relaxation technique (BRT) are two common types of relaxation techniques recommended for symptom management in chronic diseases owing to simple to learn and apply compared to other complementary and integrative methods for patients. PMR is uncomplicated and low-cost method, originally designed by Jacobson (1938), which helps individuals to feel calmer through consecutive muscle tension and relaxation of a muscle group. This method can relieve muscle tension, facilitate sleep, and reduce severity of pain and fatigue. There are studies in the literature reporting the positive effects of PMR on fatigue, sleep quality, quality of life, anxiety and stress in MS patients. One of these techniques which is well tolerated is BRT, designed by Herbert Benson in the 1970s as a nonpharmacologic and behavioral method. This technique led to relaxation using mental imagery and mediation. BRT creates a relaxation influence in the body by decreasing the sympathetic nervous system activity and increasing the parasympathetic nervous system activity. There are few studies in the literature reporting that BRT is beneficial on pain and fatigue in MS patients.To the best of our knowledge, there is no study on the impact of relaxation techniques on pain, fatigue and kinesophobia in MS patients. The aim of this study was to examine and compare the effects of PMR and BRT on abovementioned symptoms in MS patients.


Eligibility Criteria:
Inclusion Criteria:

* over the age of 18
* having relapsing-remitting MS type and not had an attack during the study
* not receiving any other complementary and integrative therapy during the research,
* with an Expanded Disability Status Scale score of 5.5 and below,
* volunteer to participate in study

Exclusion Criteria:

* having physical or mental health problems that can interfere with communication
* having heart failure, COPD, asthma disease, renal failure, musculoskeletal problem such as fracture, plaster cast, amputation, fibromyalgia, ankylosing spondylitis, rheumatoid arthritis, deep anemia (hmg \<8 mg / dl) or oncological diagnoses
* not having undergone any surgical operation in the last 3 months
Prednisolone Urinary Excretion Kinetics

The urinary elimination kinetics of glucocorticoids after intra-articular injection is very poorly documented. It is estimated that glucocorticoids may be present in the urine up to 6 weeks after intra-articular injection. However, this is not supported by any scientific literature. Despite this lack of evidence, in doping control practice, any presence of glucocorticoids in urine is accepted when the athlete provides evidence of an intra-articular injection that took place less than 6 weeks prior to the doping control. Many doping cases are open to challenge because they are based solely on measurements of prednisolone concentrations and its blood esterase product, prednisone. In order to demonstrate the use of prednisolone for doping purposes (systemic and not intra-articular use), it is therefore necessary to know the urinary elimination kinetics of prednisolone and prednisone, as well as the evolution of the concentration ratio between these 2 molecules.


Eligibility Criteria:
Inclusion Criteria:

* - Male or female
* 18-65 years old
* requiring intra-articular injection of prednisolone as part of routine care
* naive to any corticosteroid administration
* requiring a blood biology test as part of routine care and before the infiltration procedure
* For women of childbearing age, negative urine pregnancy test at inclusion
* Affiliated to a social health insurance plan
* Able to understand the protocol and give free, informed and written consent

Exclusion Criteria:

* NA
Bupivacaine Verus Pethidine for Post Cesarean Section Pain Relief

The aim of this study is to compare between the effect of wound infiltration with bupivacaine or pethidine for post cesarean section pain relief.


Eligibility Criteria:
Inclusion Criteria:

* Mode of delivery: Cesarean section.
* Gestational age: 37-40 weeks.
* Type of anaesthesia: Spinal anaesthesia.
* No past history of any medical disorder or other medical complications during pregnancy.

Exclusion Criteria:

* Women with known hypersensitivity to bupivacaine or pethidine.
* Women delivered vaginally.
* Women delivered under general anaesthesia.
* Women with known neurological or psychological disease.
Epidemiology of Interstitial Lung Disease

To establish a population-based registry of interstitial lung disease in Bernalillo County, New Mexico.

BACKGROUND:

Although many investigations have been conducted to characterize the pathogenesis of interstitial lung diseases, few examined the epidemiology of these disorders in a general population. The establishment of the registry represented the first step in a sequence of investigations designed to characterize the epidemiology of the interstitial lung diseases. The registry initially served a descriptive purpose; the incidence of the interstitial lung diseases was measured in a defined population. Subsequently the registry served as a mechanism for ascertaining cases for a case-control study. Finally, the registry provided population-based data for clinical purposes on presentation, physiology, and natural history of the interstitial lung diseases.

DESIGN NARRATIVE:

The resources of the New Mexico Tumor Registry were adapted to identify new cases of interstitial lung disease in Bernalillo County. Other sources of information for identifying new cases included pulmonary physicians, primary care physicians, death certificates, and autopsies. After a case of interstitial lung disease had been identified from the various sources of information, data collection included an interviewer-administered symptoms questionnaire, abstracted medical record data, phlebotomy for measurement of serum precipitins, and evaluation of available chest x-rays and biopsy materials. Follow-up was used to determine the natural history of the disease.

The study was renewed in 1993 to complete the work conducted from 1988 through 1992. Case-ascertainment, data collection, and follow-up of incident cases of ILD identified during the period 10/1/88-9/30/92 were completed. The incidence of ILDs was described. The clinical characteristics of patients with ILDs were described. The prognosis of the most common ILDs were described.

Eligibility Criteria:
No eligibility criteria
The Pacing vs No Pacing Study - PNP Study

Pilot interventional study, without drug, randomized 1: 1, open-label comparison of efficacy and safety between the technique of percutaneous balloon aortic valvuloplasty without rapid ventricular pacing vs valvuloplasty during rapid ventricular pacing (using a temporary pacemaker device with CE mark). It is expected to enroll 100 patients. Randomization is done through a dedicated computer program.

The aim is to compare, in terms of procedural success and safety, the procedure of percutaneous balloon aortic valvuloplasty (BAV) without rapid ventricular pacing with the same procedure carried out with the aid of rapid ventricular pacing.

It is a pilot study with the objective to enroll 100 consecutive patients matching inclusion and exclusion criteria who are randomized 1:1 in two arms: in the first patients undergo procedure of BAV without rapid pacing, in the second BAV with rapid ventricular pacing able to help in balloon stabilization during inflations.

Efficacy will be studied analysing changes in transvalvular gradient from baseline to post-BAV. Safety outcomes will be collected both at discharge and at 30-day. Other procedural data will be object of direct comparison.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of severe symptomatic aortic valve stenosis.
* no immediate indication to aortic valve replacement (AVR).
* indication to balloon aortic valvuloplasty (BAV).
* written expression of informed consent.

Exclusion Criteria:

* clinical presentation in cardiogenic shock at the time of BAV.
* clinical presentation in acute pulmonary edema not previously stabilized by medical therapy.