cyrilzakka/clinical-trials huggingface dataset:
Vitamin D Deficiency and Body Composition in the Patients With Hemophilia

Hemophilia is associated with osteoporosis and increased prevalence of low bone mineral density (BMD). Many clinical risk factors have been reported, such as hemophilic arthropathy, reduced physical activity, decreased sun exposure, hepatitis C virus infections, vitamin D deficiency, and low body mass index (BMI). There is no data on the prevalence of vitamin D deficiency and low BMD in hemophilia patients in Taiwan or Asia. To the best of our knowledge, no previous studies have reported the prevalence of sarcopenia and correlation with osteoporosis in hemophilia adult patients. The purpose of this study will evaluate the prevalence of vitamin D deficiency, low BMD, sarcopenia and body composition in a cohort of patients with hemophilia in Taiwan.

Hemophilia is associated with osteoporosis and increased prevalence of low bone mineral density (BMD). Soucek et al. reported sarcopenia and low trabecular BMD at the radius in the boys with hemophilia by CT.The severity of hemophilic arthropathy associated with lower BMD, muscle atrophy and obesity has been shown by some studies.

This is a single-center, cross-sectional, observational study. All participants will sign informed consent that fully disclosed the risks and benefits of study participation. The study will be performed at the Hemophilia Care and Research Center. Sixty adult patients (age ≥ 20) with hemophilia and 20 healthy subjects will be enrolled for scanning of the lean tissue, appendicular skeletal muscle mass (ASM), fat mass, lumbar spine and hip BMD by dual-energy X-ray absorptiometry (DXA) and assess serum vitamin D level. We will collect other clinically relevant information, including age, body mass index (BMI), hemophilia type and severity, inhibitor titer, Pettersson score by x-ray, HJHS, handgrip strength, history of HCV or HIV infection and history of fracture.

Eligibility Criteria:
Inclusion Criteria:

* Hemophilia patients

Exclusion Criteria:

* Severe diseases affecting bone metabolism (such as primary hyperparathyroidism, hypogonadism),
* History of total hip arthroplasty
* History of instrumentation in lumbar spine
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Rising Oral Doses and Multiple Rising Oral Doses of BI 1356 BS in Healthy Male Volunteers

Study to examine the safety, tolerability, pharmacokinetics, and pharmacodynamics of BI 1356 BS administered to healthy male volunteers at single rising oral doses (1 mg, 2.5 mg, 5 mg, and 10 mg) and at multiple rising oral doses (2.5 mg, 5 mg, and 10 mg once daily for 12 days)


Eligibility Criteria:
Inclusion Criteria:

* Subjects will be healthy male volunteers who meet the criteria below: Persons without clinically remarkable findings or clinically evident complications based on their concurrent illness, past medical history, physical examination, vital signs (blood pressure (BP), pulse rate (PR), and body temperature), 12-lead Electrocardiogram (ECG), and laboratory test results
* Persons who are 20 or older and 35 or younger
* Persons with a BMI 17.6 kg/m2 or more and 29.9 kg/m2 or less
* Persons who are willing to participate in this trial before study initiation and who give their written consent in accordance with GCP (Good Clinical Practice, MHW Ordinance No. 28 dated March 27, 1997)

Exclusion Criteria:

* Persons who deviate from the norm and who show clinical findings (BP, PR, and ECG) on consultation
* Persons with any clinically relevant complications
* Persons with gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immune, or hormonal disorders
* Persons with central nervous system disorders (e.g., epilepsy), mental disorders, or neurological disorders
* Persons with a history of significant orthostatic hypotension, syncopal attacks, or blackouts
* Persons with chronic infection or severe acute infection
* Persons with a history of severe allergy/hypersensitivity including allergies to drugs and inactive ingredients
* Persons who will have received a drug with a long half-life (more than 24 hours) within the month before treatment in this trial, within a period 10 times longer than the half-life of each drug, or during the study
* Persons who will have received a drug that may theoretically affect the study results based on the information obtained at the time of preparation of the protocol within the 10 days before treatment or during the study
* Persons who will have participated in another trial of an investigational drug within the 4 months before treatment or during the study
* Smokers (who smoke more than 10 cigarettes or 3 cigars or 3 pipes per day)
* Persons who cannot abstain from smoking throughout the study
* Persons who undoubtedly abuse alcohol
* Persons who abuse drugs
* Persons who donate blood of 100 mL or more within the 4 weeks before treatment
* Persons who perform rigorous exercise (within the week before treatment or during the study)
* Persons with any laboratory test result outside the reference range and for whom the result is considered a clinically relevant change
* Persons who cannot obey the dieting rules of the trial site
* Persons with any ECG value outside the reference range and who are of clinical importance. Examples include, but are not limited to, QRS interval\>120 ms
Prevention of Intradialytic Hypotension in Acute Kidney Injury Patients

Intradialytic hypotension (IH) is a major complication during acute hemodialysis. The aim of this study was to evaluate the effects of dialysate temperature (DT) reduction with Na and ultrafiltration (UF) profiling on hemodynamics of critically ill acute kidney injury (AKI) patients submitted to sustained low-efficiency dialysis (SLED).


Eligibility Criteria:
Inclusion Criteria:

* Acute renal failure with a need of dialysis.

Exclusion Criteria:

* Patients with basal serum creatinine \> 3 mgdL.
* Patients submitted to renal transplantation.
* Patients unlikely to survive.
* Declination in authorization to participation in the study.
Idiopathic Hypertensive Anal Canal: a Place of Internal Sphincterotomy

Idiopathic hypertensive anal canal is a fact and already exists presented by anal pain aggravated by defecation. It can be managed safely by closed lateral sphincterotomy but chemical sphincterotomy had a minor role in its management.

Patient and methods: Sixty three patients complaining of anal pain without any anal pathology and 10 healthy volunteers were examined. All patients underwent clinical evaluation, neurological examination, anorectal manometry, and measurement of pudendal nerve terminal motor latency (PNTML). All patients with hypertensive anal canal were randomized into three groups. Group I (surgical group) underwent closed lateral sphincterotomy LS, group II using nitroglycerine ointment (GTN) and group III received injection of botulinum toxin in internal sphincter. Post procedures data were recorded at follow up period.

Eligibility Criteria:
Inclusion Criteria:

* all patients with hypertensive anal canal

Exclusion Criteria:

* patients who had any pathological anorectal lesions such as anal fissure, piles, rectal prolapse, intussusception, anismus, cancer, patients with normal anal pressure
* patients who previously had anorectal surgery, chemical or surgical sphincterotomy, anal dilatation, IBD, venereal disease, neurological disorder or systemic gastrointestinal disease
Preoperative Microbial Reduction of the Nasal Cavity With Antimicrobial Photodynamic Therapy (aPDT).

The goal of this clinical trial is to investigate the preoperative microbial reduction of the nasal cavity using Photodynamic Therapy (aPDT) in adult patients undergoing surgical intervention at the Department for Craniomaxillofacial Surgery, University Hospital Zurich, Switzerland.

The main question the trial aims to answer is:

- Does aPDT reduce microbial colonization in the nasal cavity more effectively 5 minutes after treatment compared to the baseline (before intervention)?

Participants will be randomized into two groups:

* Study Group: Nasal cavity photodisinfection using aPDT.
* Control Group: Treatment with 0.2% chlorhexidine gluconate and non-light activated methylene blue.

Researchers will compare the effectiveness of aPDT against the control treatment in reducing microbial colonization of the nasal cavity.

Study Procedure:

1. Nasal swab for baseline microbial colonization.
2. Application of 0.2% chlorhexidine gluconate and methylene blue.
3. Insertion of nasal light illuminator into the patient's nostrils:

   * Study Group: Activation of the light source.
   * Control Group: No activation of the light source.
4. Nasal swab taken 5 minutes after the intervention to assess microbial reduction.


Eligibility Criteria:
Inclusion Criteria:

* Provision of a signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Male or female ≥ 18 years of age
* surgical intervention in general anesthesia at the department of Oral and Maxillofacial Surgery of University Hospital Zurich

Exclusion Criteria:

* inability to tolerate insertion of the light illuminator or the photosensitizer applicator due to anatomic variations (size, shape of oro-nasal region) or disease
* inability to follow the procedure of the investigation, e.g., due to language problems or psychological disorders of the subject
* known allergic reactions to components of the nasal decolonization treatment, including methylene blue or chlorhexidine gluconate
* planed surgery in the nasal cavity
* necessary nasal intubation for surgical intervention
* vulnerable persons (subjects incapable of judgment or subjects under tutelage)
* Pregnant or breastfeeding women
The Metabolic Effects of Acute Hyperglycemia in Patients With Type 2 Diabetes

The purpose of the study is to characterize the changes in amino acid, lipid and glucose metabolism in patients with type 2 diabetes exposed to acute hyperglycemia. Moreover we wish to assess the effect of acute hyperglycemia on cardiac output.

Cardiovascular disease is the main cause of death in modern Western societies. Obesity, diabetes and the metabolic syndrome are the main risk factors for cardiovascular disease. People with type 2 diabetes and no history of heart disease have a risk of myocardial infarction similar to the risk in non-diabetic patients with known heart disease.

However, the causal relationship between obesity, diabetes and cardiovascular disease is unclear. Insulin resistance leads to many metabolic abnormalities, including high circulating levels of free fatty acids (FFA). FFA induces insulin resistance and may lead to beta cell failure. In addition FFA may directly worsen the metabolic and electrochemical performance of the working heart. Moreover it is still unclear how acute hyperglycemia affects cardiac output.

In this study our purpose is to characterize the changes in amino acid, lipid and glucose metabolism in patients with type 2 diabetes exposed to acute hyperglycemia (blood glucose between 18 and 20 mmol/L) compared to the amino acid, lipid and glucose metabolism at a normal glucose level (blood glucose between 5 and 7 mmol/L). The results from the patients with type 2 diabetes will be compared with results from healthy controls examined in a fasting basal state. The patients must not suffer from any kind of serious heart disease and should be treated with insulin.

Moreover we wish to compare cardiac output at high and normal blood glucose levels, respectively. Cardiac output will primarily be assessed by doppler echocardiography.

Eligibility Criteria:
Inclusion Criteria:

* Written consent
* Age 40-75 years old
* BMI between 22 and 35
* Type 2 diabetes treated with insulin (\< 60 IE/day)

Exclusion Criteria:

* Severe disease
* Severe cardiac disease
Prospective Evaluation of Ultrasound-guided Percutaneous Cholecystostomy With the Trocar Technique

The purpose of this study is to further evaluate and investigate the safety and efficacy of ultrasound (US)-guided percutaneous cholecystostomy (PC) with the trocar technique by the patient's bedside.

This clinical study will include patients who will undergo US-guided PC with the trocar technique. The study will include all cases requiring PC regardless of the underlying cause, while those requiring computed tomography (CT) guidance and those with uncontrolled coagulation disorders will be excluded.

Patient demographics, height, weight, and body mass index (BMI), comorbidities, ASA score, presence or absence of stones, presence or absence of gallbladder perforation at diagnosis, presence or absence of concomitant ascitic effusion, days of preoperative antibiotic treatment, imaging modality used to establish the diagnosis, technical details of the procedure, laboratory values (before and after surgery), and contact information for patient monitoring will be recorded.

The technical success of the method as well as its complications during hospitalization and during a 3-month follow-up period will be calculated. In addition, the anatomical access route during the PC (transhepatic/transperitoneal and intercostal/subcostal), the duration of the operation, the intraoperative and postoperative pain, and the clinical success of the method will be recorded.

After the operation, the patients will be monitored clinically and with laboratory test and, if deemed necessary, US, CT or both imaging will be performed. Before discharge, written instructions will be given regarding the management and care of the catheter.

This study will not burden the hospital financially, as the clinical, laboratory, and imaging tests required for the diagnosis of the underlying etiology that leads to the need to perform the procedure, the technique used to perform the procedure, as well as the monitoring of the patients and the possible complications of the procedure, are part of the hospital's routine.

Eligibility Criteria:
Inclusion Criteria:

* All patients requiring PC, irrespective of the underlying cause and indication, are suitable for inclusion in the study.

Exclusion Criteria:

* Patients are going to be excluded from the study if they are younger than 18 years, if they require PC catheter placement under CT guidance (according to the operator's judgement), or if they suffer from severe uncontrollable coagulopathy.
Improving Executive Functions After Traumatic Brain Injury (TBI): A Clinical Trial of the "Executive Plus" Program

This is a randomized clinical trial which compares a standard day treatment program for individuals with TBI with the "Executive Plus" program; the latter emphasizes training of attention, emotional self-regulation and problem solving. The goal of the Executive Plus program is to maximize executive functioning, as well as the long-term outcomes of community participation and satisfaction with daily life.

This is a randomized clinical trial comparing two approaches to post-TBI comprehensive day treatment. Executive Plus offers systematic treatment of post-TBI executive function deficits, through a focus on problem solving and emotional self-regulation, as well as systematic treatment of post-TBI attention deficits. It relies on modular, contextual, and embedded approaches to treatment. It will be compared to Mount Sinai's currently operating day treatment program. The 26-week programs will run concurrently and potential participants will be randomly assigned to Executive Plus or the standard program, using rolling admissions. Program staffs will be separate. Outcomes will be assessed using measures that focus on functioning within cognitive domains, across domains and in everyday life, and that assess long-term outcomes. Detailed manuals will be developed to guide the implementation of each program's operation.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old
* Having a TBI as a result of a blow to the head followed by a loss of consciousness or period of being dazed and confused or a period of post traumatic amnesia or clinical signs of altered neurological function; this information must be medically documented (e.g., emergency medical record, hospital record, neuroradiological report, or neurological exam or record of physician's visit within 24 hours of injury).
* At least three months post-injury
* English-speaking (treatment sessions will be conducted in English)
* Reporting executive dysfunction (by self or family)
* Willing and able to participate in and travel to the program daily for six months
* Oriented to time, place and person
* Having a full-scale intelligence quotient (IQ) of at least 75
* Having a score on the Galveston Orientation and Amnesia Test of 75 or more
* Having communication skills adequate to participate in groups
* Having at least a sixth-grade reading level (for testing and use of written materials)
* Willing to complete questionnaires and interviews about mood, thinking skills, participation and the like
* Agree to participate, i.e., completion of informed consent and Health Insurance Portability and Accountability Act (HIPAA) documents

Exclusion Criteria:

* Active substance abuse
* Active psychosis
* Active suicidality
* Disruptive or violent behavior to self or others
* Current cognitive rehabilitation (this does not include psychotherapy)
* No impairment on the Frontal Systems Behavior Scale (FRSBE) or Wisconsin Card Sorting Test (WCST)
A Clinical Trial to Evaluate the Immunogenicity and Safety of sIPV in a '1+2' Sequential Schedule With bOPV in Infants

The purpose of this phrase III clinical trial is to evaluate the immunogenicity and safety of Sabin Inactivated Poliovirus Vaccine (Vero cell) in a '1+2' sequential schedule with bivalent oral poliovirus vaccine in 2-month-old infants

This study is a randomized, double-blind, active-controlled phrase III clinical trial. The purpose of this study is to evaluate the immunogenicity and safety of sIPV manufactured by Sinovac Vaccine Technology Co., Ltd in a '1+2' sequential schedule with bOPV in 2-month-old infants. 240 infants aged between 60-90 days will be randomly assigned into experimental group or control group in the ratio 1:1. The experimental group received sIPV-bOPV-bOPV vaccination schedule at one month doses interval (i.e., month 0, 1, 2), and the control group received wIPV-bOPV-bOPV vaccination schedule at one month doses interval (i.e., month 0, 1, 2). The control wIPV was manufactured by SANOFI PASTEUR S.A.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteer between 60-90 days old;
* Healthy volunteers who fulfill all the required conditions for receiving the investigational vaccine as established by medical history and clinical examination and determined by investigators;
* Proven legal identity;
* Participants or guardians of the participants should be capable of understanding the written consent form, and such form should be signed prior to enrolment;
* Complying with the requirement of the study protocol;

Exclusion Criteria:

* Prior vaccination with Poliovirus Vaccine;
* History of allergy to any vaccine, or any ingredient, excipients and Gentamycin Sulfate of the vaccine, or serious adverse reaction(s) to vaccination, such as urticaria, dyspnea, angioneurotic edema, abdominal pain, etc;
* Congenital malformation, developmental disorders, genetic defects, or severe malnutrition;
* Autoimmune disease or immunodeficiency/immunosuppressive;
* Severe/uncontrollable nervous system disease (epilepsy, seizures or convulsions) or mental illness;
* Diagnosed coagulation function abnormal (e.g., coagulation factor deficiency, coagulation disorder, or platelet abnormalities) , or obvious bruising or coagulation disorders;
* Any immunosuppressant, cytotoxic medicine, or inhaled corticosteroids (except corticosteroid spray for treatment of allergic rhinitis or corticosteroid treatment on surface for acute non-complicated dermatitis) prior to study entry;
* Blood product prior to study entry;
* Any other investigational medicine(s) within 30 days prior to study entry;
* Any live attenuated vaccine within 14 days prior to study entry;
* Any subunit vaccine or inactivated vaccine within 7 days prior to study entry;
* Acute disease or acute stage of chronic disease within 7 days prior to study entry;
* Axillary temperature \> 37.0 °C;
* Any other factor that suggesting the volunteer is unsuitable for this study based on the opinions of investigators;
A Study of BBT001 in Healthy Volunteers (HVs) and in Adult Patients With Atopic Dermatitis (AD)

This is a Phase 1, randomized, blinded, placebo controlled, single ascending dose (SAD) and multiple ascending dose (MAD) study of BBT001 in healthy volunteers (HVs) and adult patients with moderate to severe Atopic Dermatitis (AD).

The study consists of three parts:

* Part A (single dose in HVs in sequential ascending dose cohorts, SAD in HVs part)
* Part B (three repeated doses in HVs in sequential ascending dose cohorts, MAD in HVs part)
* Part C (three repeated doses in patients with moderate to severe AD, MAD in patients part)

Eligibility Criteria:
Key Inclusion Criteria (Part A, B, C)

1. Age of 18-65 years.
2. Body mass index between 18-32 kg/m², capped at 120 kg.
3. Negative pregnancy tests for women of childbearing potential.
4. Willingness to refrain from alcohol consumption for 24 hours prior to each study visit.
5. Non-smokers, healthy current smokers (≤5 cigarettes/day), or ex-smokers.
6. Adequate contraception use (for men and women of childbearing potential).
7. No clinically significant abnormalities or history of relevant diseases.

Key Inclusion Criteria (Part C only)

1. Must have dermatologist-confirmed chronic atopic dermatitis (≥12 months). Inadequate response to topical treatments or where they are medically inadvisable.
2. Moderate to severe atopic dermatitis
3. Validated investigator's global assessment for atopic dermatitis (vIGA-ADTM) score ≥3
4. Atopic lesions cover ≥10% of body surface area (BSA)
5. Average peak pruritus numeric rating scale (PP-NRS) score ≥4 in the 7 days before randomization.

Key Exclusion Criteria for (Part A, B, C)

1. Significant health issues, such as: diabetes, positive tests for human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B surface antigen (HBsAg), immunodeficiencies, autoimmune diseases, or cancer, history of conditions predisposing to infections.
2. History of major metabolic, dermatological, liver, kidney, hematological, or other significant disorders.
3. Clinically relevant abnormal lab results, including low blood counts, liver issues, or abnormal kidney function.
4. Positive drug/alcohol tests or abnormal vital signs at screening or Day -1.
5. Abnormal Electrocardiogram (ECG) findings
6. History of drug/alcohol abuse in the past 2 years.
7. Donated \>500mL blood within 2 months of screening.
8. History of severe allergic reactions or hypersensitivity.

Key Exclusion Criteria for (Part C only)

1. Skin diseases other than atopic dermatitis, significant tattoos, or scarring.
2. Receipt of immunoglobulin or blood products within 30 days.
3. Atopic dermatitis with ocular symptoms or chronic ocular steroid use.
4. Chronic pruritus from conditions other than atopic dermatitis.
5. Acute/treated infections or chronic skin infections.
6. Current use of sedating antihistamines or corticosteroids.
Evaluation of HEMO2Life® for Kidney Graft Preservation (OXYOP): 4 Years Follow-up

4 years follow-up of the oxyop study.

Oxyop (NCT02652520 PHRC) was a safety study evaluating the use of an oxygen carrier HEMO2life® as an additive in organ preservation solution in 60 transplanted kidneys. This was a national multicenter (6 centers) open-labeled safety study on HEMO2life® that included 58 recipients. The first patient was included on March 24th, 2016 and the study was completed on February 23th, 2018 (1 year of recruitment and 1 year of follow-up). We also analyzed some efficacy secondary end points using a paired analysis (local kidney receiving HEMO2life® versus contralateral kidney transplanted elsewhere in France). Oxyop4 aims to analyse 4 years results.

Eligibility Criteria:
Inclusion Criteria:

* informed patients participating to the oxyop study

Exclusion Criteria:

* patients refusing to participate