cyrilzakka/clinical-trials huggingface dataset:
A Safety and Efficacy Study of a Recombinant Factor IX in Patients With Severe Hemophilia B

This study will examine the safety and efficacy of a Recombinant Coagulation Factor IX Albumin Fusion Protein (rIX-FP) for the control and prevention of bleeding episodes in subjects who have previously received factor replacement therapy for hemophilia B. The study consists of a screening period, a pharmacokinetic (PK) period, followed by approximately a 5 month treatment period. Subjects will receive weekly routine prophylactic therapy and on-demand treatment for bleeding episodes. In addition, subjects who are not on routine factor replacement therapy prior to the study will receive only on-demand treatment for bleeding episodes.


Eligibility Criteria:
Inclusion Criteria:

* Male subjects, 12 to 65 years old
* Severe hemophilia B (FIX activity of ≤ 2%)
* Subjects who have received FIX products (plasma-derived and/or recombinant FIX) for \> 150 exposure days (EDs)
* No history of FIX inhibitor formation, no detectable inhibitors at Screening and no family history of inhibitors against FIX
* Written informed consent for study participation obtained before undergoing any study specific procedures

Exclusion Criteria:

* Known hypersensitivity to any FIX product or hamster protein
* Known congenital or acquired coagulation disorder other than congenital FIX deficiency
* HIV positive subjects with a CD4 count \< 200/mm3
* Low platelet count, abnormal kidney function, or liver disease
* On-demand subjects experiencing less than 12 or 6 non-trauma induced bleeding episodes requiring treatment with a FIX product during the previous 6 or 3 months, respectively
* Planned major surgical intervention during the study period
Impact of a Ketogenic Diet Intervention During Radiotherapy on Body Composition

Type of study: Pilot / phase I trial

Study purpose To assess the impact of a dietary intervention during radio(chemo)therapy (RCT) on body composition changes

Trial Treatment Patients will be split into a control group and intervention group 1. If willing to undertake a ketogenic diet for the duration of radiotherapy, patients are entered into intervention group 2.

* Group 1: On irradiation days irradiation after overnight fast + ketogenic breakfast consisting of 50-250 ml betaquik® (vitaflo, Bad Homburg, Germany) and 10g MyAmino (dr. reinwald healthcare gmbh + co kg, Altdorf, Germany).
* Group 2: Complete ketogenic diet plus 10g MyAmino/day
* Control: No dietary intervention.
* All groups: Weight measurements and bioimpedance analysis (BIA) once per week, routine blood parameters and quality of life (QoL) questionnaire before, during and after RCT

Endpoints

Primary:

* Feasibility of the dietary intervention during RCT, measured by dropout rates
* Changes in body weight
* BIA phase angle and quantities derived from BIA variables

Secondary:

* QoL
* Toxicities
* Blood parameters
* Grade of regression at time of surgery in case of rectum carcinomas

Inclusion criteria

* One of the following tumor entities:

  * Breast carcinoma
  * Rectum carcinoma
  * Head \& Neck Cancer
* Histological confirmation of malignancy
* Signed written informed consent
* Karnofsky index ≥ 70
* Age between 18 and 75 years
* BMI between 18 and 34 kg/m\^2

Exclusion criteria

* Palliative patients, in particular with metastasis
* Type I diabetes
* Pregnancy
* Pacemaker and other metallic parts within the body
* Known defects in enzymes necessary for ketogenesis, ketolysis, fatty acid oxidation or gluconeogenesis
* Unable to speak or understand German
* Cognitive impairments or psychological disorders
* Renal insufficiency

Planned accrual

* 15 patients with colorectal and mammary tumor plus 5 patients with H\&N cancer in intervention group 1
* 15 patients with colorectal and mammary tumor plus 5 patients with H\&N cancer in control group
* Minimum 5 patients of each tumor entity in intervantion group 2 Total: n ≥ 85 patients

Study procedure

1. Inclusion and full written informed consent.
2. Baseline BIA measurement and blood work
3. RCT with weekly BIA assessments; at least one blood withdrawal ± concurrent dietary intervention
4. Final BIA measurement and blood work after radiotherapy

Follow up For rectal carcinoma: Regression at time of surgery (c and p)


Eligibility Criteria:
Inclusion Criteria:

* RT of one of the following tumor entities: Mammary carcinoma, colorectal carcinoma, head and neck carcinoma
* Histologicallý confirmed malignant Tumor
* Written informed consent
* Karnofsky index \>= 70
* 18 kg/m\^2 \< BMI \< 34 kg/m\^2

Exclusion Criteria:

* Palliative Treatment
* Type I Diabetes
* Pregnancy
* Pacemaker and othe rmetallic parts that make BIA predictions unreliable
* Unable to understand and speak German
* Cognitive impairments
* Renal insufficiency
* intake of carboanhydrase-inhibitors
* Rare metabolic disorders that speak against a ketogenic diet
Rituximab in Primary Lymphocyte Predominant Hodgkin´s Disease(RIPL)

First line therapy for patients with Lymphocyte predominant Hodgkin´s Disease (LPHD) in clinical stage IA using the monoclonal anti-CD20 antibody rituximab


Eligibility Criteria:
Inclusion Criteria:

* lymphocyte predominant Hodgkin´s lymphoma (histologically proven)
* clinical stage IA (without risk factors: large mediastinal mass, extranodal involvement, ESR \> 50mm/h)
* age 18 - 75
* WHO performance status 0-3
* normal organ function
* written informed consent

Exclusion Criteria:

* classical Hodgkin´s lymphoma
* composite lymphoma
* leucocytes \< 3000/µl
* thrombocytes \< 100.000/µl
Dextran Use for Primary Angioplasty Protection in Acute Myocardial Infarction

Reperfusion therapy in acute myocardial infarction saves viable myocardium, but paradoxically reestablishment of coronary artery flow also induces damage and cell death, decreasing the full benefit of reperfusion in terms of reduction of infarct size and preservation of ventricular function . Myocardial reperfusion can in itself produce more damage and cell death, this process defines the phenomenon of reperfusion injury, which could be prevented by applying additional therapies.

During myocardial ischemia, due to lack of O2, the myocyte leaves energy production from the aerobic metabolism of lipids and the production of energy in the form of phosphates will depend, in this situation, on the anaerobic metabolism of glucose. As a result they are consumed muscle glycogen stores that produce little ATP, and also generating acidosis. The cell membrane loses its ability to maintain the fluid's electrolyte balance. Cellular edema is generated by the entry of sodium and water, leading to cell rupture. During ischemia and reperfusion free radicals are produced that stimulate inflammation and consequently release prothrombotic and cytotoxic substances that also produce cellular damage. Due to its osmotic, antithrombotic, anti-inflammatory and rheological effects, dextran could be useful in this scenario.

The administration of a solution in the distal bed, for the protection of the myocardium, before opening the epicardial artery is called by us "controlled reperfusion". The researchers think, using a solution with venous blood, containing less O2 but retaining buffer properties; enriched with Dextran, which has onctic power, anti-inflammatory and anticoagulant properties, and molecules similar to glucose; results in a potentially useful solution for myocardial protection in this scenario.

The group of investigators expect that controlled reperfusion treatment will reduce the incidence of ST correction and infarct size by 20-30%, improving the prognosis in terms of mortality and heart failure.

Eligibility Criteria:
Inclusion Criteria:

* Women and men over 18 years of age
* First acute myocardial infarction with ST elevation, within 6 hours of the initial symptoms, that are admitted for primary PCI at the Hospital San Bernardo.
* TIMI 0 or 1 flow in the culprit artery.

Exclusion Criteria:

* Not able or willing to give informed consent.
* Participate in another protocol.
* Pregnancy.
* History of any of the diseases listed: cardiomyopathy, valvular disease severe, any disease with a life expectancy of less than 1 year.
* Contraindication for protocol drugs (Dextran).
* LBBB or pacemaker.
* Prolonged cardiopulmonary resuscitation.
* Cardiogenic shock.
* Left main coronary lesion or culprit lesion in venous graft.
* Large artery not feasible for PCI, guilty vessel of small caliber or very distal lesion.
Efficacy of DNK333 in Patients With COPD and Cough

This study evaluates the efficacy and safety of two weeks treatment of DNK333 in patients with COPD and cough.


Eligibility Criteria:
Inclusion Criteria:

* Mild to moderate COPD
* Forced expiratory volume in 1 second (FEV1) ≥30% predicted
* FEV1/FVC (forced vital capacity) \<70%
* Significant amount of cough and minimal amount of sputum production, both as judged by self reporting

Exclusion criteria:

* Upper or lower airway infection within 4 weeks prior to screening
* COPD exacerbation within 4 weeks prior to screening
* Past history or current diagnosis of congestive heart failure, cirrhosis or hepatic failure
* History of lung cancer or pulmonary resection/thoracic radiotherapy

Other protocol-defined inclusion/exclusion criteria may apply
VNRX-9945 Safety and Pharmacokinetics in Healthy Adult Volunteers

This is a 2-part first-in-human dose-ranging study to evaluate the safety and pharmacokinetics of escalating doses of VNRX-9945.

In Part 1, subjects will receive a single dose of VNRX-9945 or placebo. Subjects enrolled in the food effect cohort will receive a dose in a fasted and fed state (total 2 doses) of VNRX-9945 or placebo following an appropriate washout period between the doses. In Part 2, subjects will receive doses of VNRX-9945 or placebo daily for 14 days.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy adults 18-55 years
2. Males or non-pregnant, non-lactating females
3. Body mass index (BMI) between 18 and 32.0 kg/m2 and total body weight \>50 kg (110 lbs)
4. Normal blood pressure
5. Normal lab tests

Exclusion Criteria:

1. Current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, autoimmune, hematologic, neoplastic, or neurological disorder
2. History of severe allergic or anaphylactic reaction
3. Abnormal ECG or history of clinically significant abnormal rhythm disorder
4. Positive alcohol, drug, or tobacco use/test
The Effects of Music Therapy and Aromatherapy Interventions on Pulse Rate, Blood Pressure, Anxiety, and Self-Esteem

Appropriate intervention methods should be investigated to reduce stress and fatigue of students in psychomotor skills. The aim of this study is to reveal the effects of music therapy and aromatherapy interventions on pulse, blood pressure, anxiety and self-esteem levels of nursing students during injection application to the ventrogluteal region on a mannequin.

Hypotheses:

H1a= During the ventrogluteal injection application of nursing students on a mannequin, Aromatherapy and Music therapy and Aromatherapy application have an effect on pulse rate.

H1b= During the ventrogluteal injection application of nursing students on a mannequin, Aromatherapy and Music therapy and Aromatherapy application have an effect on blood pressure level.

H1c= During the ventrogluteal injection application of nursing students on a mannequin, Aromatherapy and Music therapy and Aromatherapy application have an effect on anxiety level.

H1d= During the ventrogluteal injection application of nursing students on a mannequin, Aromatherapy and Music therapy and Aromatherapy application have an effect on self-esteem level.

Appropriate intervention methods should be investigated to reduce stress and relieve fatigue of students in psychomotor skills. The aim of this study is to reveal the effects of Music therapy and Aromatherapy interventions on pulse, blood pressure, fatigue and self-esteem levels of nursing students during ventrogluteal injection application. For this purpose, the investigators tried to provide more information to the literature for Music therapy and Aromatherapy interventions in this single-blind randomized controlled study.

Eligibility Criteria:
Inclusion Criteria:

* Students who are first year students, and
* Volunteer to participate in the research will be included.

Exclusion Criteria:

* Volunteer to participate in the research will not be included.
A Genetic Study for Alzheimer Dementia: Case-control Study

The purpose of this study is to find out the difference in genetic test results between Alzheimer's dementia patients and healthy subjects.

The investigators want to identify genes that are importantly related to Alzheimer's dementia.


Eligibility Criteria:
1. Inclusion Criteria: Alzheimer's dementia patient

   * Adult patients over 60 years old
   * Patients with a Alzheimer's dementia patient
   * Total Korean version of mini-mental state examination (K-MMSE) score less than 24
   * Total Clinical Dementia Rating (CDR) over 0.5
2. Inclusion Criteria: healthy subjects

   * Adult healthy over 60 years old
   * Total Korean version of mini-mental state examination (K-MMSE) over 24
   * Total Clinical Dementia Rating (CDR) is 0
3. Exclusion Criteria:

   * Those with severe medical conditions such as unstable conditions of the cardiovascular system, digestive system, respiratory system, endocrine system, etc., who are in poor general condition
   * In the case of a person with impaired consent (MMSE less than 10 points), if not accompanied by a guardian
   * Other cases where the researcher determines that participation in this clinical trial is not appropriate (Patients who are participating in other studies or have participated in other studies within the past 30 days can also participate in this study.)
A Study of ABT-888 in Combination With Carboplatin and Gemcitabine in Subjects With Advanced Solid Tumors

The purpose of this study is to determine the maximum tolerated dose of veliparib (ABT-888)and to establish the recommended Phase 2 dose of veliparib (ABT-888) when administered in combination with carboplatin and gemcitabine in subjects with advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed solid tumors that are metastatic or unrespectable for which carboplatin/gemcitabine is a treatment option.
* Eastern Cooperative Group performance score of 0 to 2.
* Adequate hematologic, hepatic and renal function
* Subject has received up to 2 DNA damaging or cytotoxic regimens in the past five years

Exclusion Criteria:

* Subject has received any anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy, biologic or any investigational therapy within 28 days prior to study administration.
* Subjects with known history of brain metastases and primary CNS tumors.
* Hypersensitivity reactions to platinum compounds or gemcitabine.
* Clinically significant and uncontrolled major medical conditions
* Active malignancy within the past 5 years except for any cancer in situ cured or non-melanoma carcinoma of the skin.
A Study to Assess Any Potential Interaction Between Colesevelam and Ciclosporin in Healthy Volunteers

This study is designed to assess any potential interaction between colesevelam and ciclosporin in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Subject must have a body mass index (BMI) between 19 and 25 inclusive
* Medically healthy subjects with clinically normal laboratory profiles, physical exams, vital signs and ECGs.
* Give voluntary written informed consent to participate in the study

Exclusion Criteria:

* History or presence of significant cardiovascular, pulmonary, hepatic renal, hematologic, gastrointestinal (inclusive of dysphagia, swallowing disorders, severe gastrointestinal motility disorders), endocrine, immunologic, dermatologic, neurologic, infectious, or psychiatric disease.
* In addition, history or presence of: Alcoholism or drug abuse within the past year; OR hypersensitivity or idiosyncratic reaction to ciclosporin or other immunosuppressive agents; OR Chronic infection
* Subjects who ere tested positive at screening for HIV, HBsAg or HCV
* Subjects who received injectable corticosteroids in the 12 weeks preceding the first dose.
* Subjects who are allergic to castor oil or corn oil
* Subjects whose sitting blood pressure is less than 110/60 mmHg at screening or 100/55 mmHg before dosing
* Subjects who have used any medications or substances known to be strong inhibitors of CYP3A enzymes within 10 days prior to the first dose.
* Subjects who have used any medications or substances known to be strong inducers of CYP3A enzymes within 28 days prior to the first dose.
* Subjects who have used antibiotics within 14 days prior to the first dose.
* Subjects who have used other medication (including over-the-counter products) vitamins and herbal products within 7 days prior to the first dose.
* Subjects who have used any live attenuated vaccine within 7 days prior to the first dose or are planning to use within 14 days after the end of the study.
* Subjects who, prior to informed consent, would have donated in excess of: 500mL of blood in 14 days;1500mL of blood in 180 days; OR 2500mL of blood in 1 year.
* Subjects who have participated in another clinical trial: within a period less or equal to 2 half live (t1/2) of the previous investigational product used OR within 60 days prior to first dose.
Knee Nerve Cryoneurolysis and Impact on Pain After Prosthetic Surgery

Interventional, comparative, randomized, controlled study versus standard treatment, in 3 parallel groups, monocentric, aiming to demonstrate the superiority of preoperative cryoneurolysis versus no procedure, in patients operated on for knee arthroplasty and receiving standard analgesia.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years and ≤ 80 years;
* Patient to undergo prosthetic knee surgery;
* Patient in good health (ASA score 1 to 3);
* Patient able to understand the information related to the study, read the information leaflet and agree to sign the consent form.

Exclusion Criteria:

* Known intolerance to any of the products administered during surgery or cryoneurolysis;
* Patient with an electric implant;
* Patient with a contraindication to cryoanalgesia (coagulation disorders, infections, nerve damage);
* Drug addict patient;
* Intervention on septic bone;
* Chronic renal failure (creatinine clearance \<30 mL / min);
* History of cryoglobulinemia, cold urticaria or Raynaud's syndrome;
* Pregnant or breastfeeding woman;
* Patient under guardianship or curatorship, or under a regime of deprivation of liberty;
* Patient participating in another clinical trial, or in a period of exclusion from another clinical trial;
* Patient not beneficiary of a social security scheme.
Dosing of Intra-articular Triamcinolone Hexacetonide for Knee Synovitis in Chronic Polyarthritis

This prospective randomised controlled single blind trial comparing the relapse rate in 6 months for 20 mg versus 40 mg intraarticular triamcinolone hexacetonide (Lederspan®) for knee synovitis in patients with rheumatoid arthritis (RA) and psoriatic artritis (PsoA) is performed to find the optimal dose to use.

Background:

Triamcinolone hecacetonide (THA) has been used for local intraarticular injecton treatment for knee synovitis in decades, but no dose finding studies have been performed. In the literature the doses for knee injections vary between 20 mg and 80 mg, depending on local traditions.

The aim of the present study is to find the optimal THA dosing, comparing the relapse rate during a 6 month observation period for the two most used dosages .

Methods:

Adult patients with RA or PsoA with treatment demands for ongoing knee synovitis are recruited at the Rheumatology Departments in Gävle and Falun. After informed consent patient characteristics,(age, sex, medical treatment), clinical and laboratory parameters of disease activity (DAS28, CRP), as well as degree of functional impairment (HAQ) are collected. A radiographic examination of the knee is performed and assessed (using Larsen Dale index) by an independent radiologist. The patients are allocated to either 20 mg or 40 mg THA using the randomisation dose which is hidden in prepared closed envelopes. After complete synovial fluid aspiration the THA dose is injected . The patients are told to contact the rheumatology department if no treatment response or if symtoms from the treated knee recurr. If so, the knee is examined again and if synovitis is confirmed a relapse is registered. Time from injection to relapse is calculated. Patients without relapse are called after 6 months to confirm they still are well and that no unknown relapse have occurred. When the observation period for the last included patient is finished the relapse rate between the 20 mg THA group is compared with the 40 mg THA Group.

Eligibility Criteria:
Inclusion Criteria: synovitis of the knee, rheumatoid arthritis or psoriatic arthrthritis, written informed consent

-

Exclusion Criteria:

* inability to understand study information, function class 4 according to Steinbrocker, planning knee surgery, , joint infection, intraarticular glucocorticoid injection in this joint the past 3 months, oral glucocortoid treatment corresponding to \>10 mg prednisolone
Gynecologic Cancer Lymphedema Questionnaire as a Clinical Care Tool to Identify Lower Extremity Lymphedema

The purpose of this study is to evaluate if the Gynecologic Cancer Lymphedema Questionnaire (GCLQ) truly detects symptoms or signs of lower extremity lymphedema in patients with diagnosed lower extremity lymphedema. Lymphedema is a chronic condition in which fluid accumulates in the tissues of the body. Many cancer survivors are living with discomfort and changes in their activities due to limb swelling following cancer treatment. If the GCLQ is able to do detect signs and symptoms of lymphedema, the investigators hope to use it as a tool in the clinical care setting to help identify women at risk for or with lymphedema. In the future, this could improve clinical care through the use of a more simple and feasible way to identify lower extremity lymphedema than measuring limbs.


Eligibility Criteria:
Inclusion Criteria:

* Study group of Gynecologic cancer survivors with Lymphedema
* Documented lower extremity lymphedema
* History of a primary diagnosis of gynecologic cancer (vulvar, cervical and uterine only)
* History of surgery for gynecologic cancer including lymph node removal
* No evidence of disease or active treatment
* At least 21 years of age
* Able and willing to provide informed consent
* English fluency Comparison Group of Gynecologic Cancer Survivors without Lymphedema
* No history of lower extremity lymphedema or presence of lymphedema confirmed by limb volume measurements at the time of study participation
* History of a primary diagnosis of gynecologic cancer (vulvar, cervical and uterine only)
* History of surgery for gynecologic cancer including lymph node removal
* No evidence of disease or active treatment
* At least 21 years of age
* Able and willing to provide informed consent
* English fluency

Exclusion Criteria:

* Inability to participate in an informed consent process
* Patients with a psychiatric disorder precluding response to the survey