cyrilzakka/clinical-trials huggingface dataset:
Study of Hydroxyurea to Treat Sickle Cell Disease

The aim of this single-center observational study was to evaluate quality of life, clinical effectiveness, and satisfaction in pediatric and young adult patients with sickle cell disease receiving hydroxyurea.

In this study, 34 pediatric (HbSS: n= 5; HbSβ0: n= 29) and 16 (HbSS: n=5; HbSβ0: n= 11) young adult adult patients with sickle cell disease receiving hydroxyurea for at least a year were participated. Upon receipt of Informed Consent Form, Case Report Form, Demographic Data Collection Form, Child Health Questionnaire-Parent Form, Life Quality Survey Short Form-36, and Hydroxyurea Therapy Satisfaction Survey were used to obtain data for effectiveness of hydroxyurea therapy and parameters that may affect compliance to treatment and life quality of the participants.

Regarding the normal ranges, ferritin, hemoglobin A, A2, F, and S, platelet, mean corpuscular volume, erythrocyte distribution width, basophil percentage, monocyte, monocyte percentage, total bilirubin, direct bilirubin, and C-reactive protein values were higher while hemoglobin, hematocrit, and erythrocyte values were lower in these patients. Our findings regarding quality of life and satisfaction with hydroxyurea therapy indicated that the patients with sickle cell disease had lower scores.

Demographic, clinical, and therapeutic variables as well as comorbid diseases and concomitant drug use when considered together, these findings suggest that the health quality and compliance of the pediatric and young adult patients to therapy might be low due to not sufficiently effective hydroxyurea therapy in addition to comorbidities, concomitant drug use, and side effects.

Eligibility Criteria:
Inclusion Criteria:

1. Patients willing to participate in the study
2. Pediatric and young adult patients
3. Patients diagnosed with HbSS or HbSβ0 sickle cell disease
4. Patients receiving hydroxyurea for at least a year.

Exclusion Criteria:

1. Patients not meeting the inclusion criteria
2. Patients not willing to participate in the study
3. Patients diagnosed with other types of anemia except HbSS or HbSβ0 sickle cell disease
4. Patients not receiving hydroxyurea for at least a year
5. Patients having other conditions such as physical and/or mental difficulties which may affect their quality of life
6. Patients having any contrindication against hydroxyurea
The Effect of Small Changes in Hydration on Cognition

The aim of this study is to determine whether drinking plain water when mildly dehydrated benefits cognitive performance and mood. Volunteers undergo a dehydration protocol designed to result in minor dehydration. While some participants receive two 150ml drinks of water others do not. Differences in cognitive functioning are assessed.

As an essential nutrient, an inadequate intake of water has negative consequences: without a source of water death will occur in days. When Benton and Young (2015) reviewed the topic they concluded that in healthy adults, mild dehydration (in the range of a loss of 2% body mass) had been found to adversely influence mood and cognition. However, it is unclear at what degree of hypohydration these effects begin to emerge.

This study was designed to determine whether small changes in hydration, of the level that might occur on a day to day basis, influence cognition and mood. During a dehydration protocol (sitting in a room heated to 30 degrees for four hours) young adult participants receive either drink two 150ml cups of water or nothing. Effects on memory, attention and mood are monitored.

Eligibility Criteria:
Inclusion Criteria:

* In good general health i.e. no major health condition such as diabetes
* BMI \< 30

Exclusion Criteria:

* Not on blood pressure medication or blood thinning medication such as aspirin - No learning difficulty such as dyslexia
* Diabetes
* Gastro-intestinal disease
* High BMI
* Cholesterol and BP
* Smoker
* Dyslexic/dyspraxic
* Depression or history of depression or other psychiatric disorder
Intermedius Genicular Nerve in the Treatment of Patients With Chondromalacia Patella

Radiofrequency application is a treatment method that temporarily prevents the transmission of pain in the nerve where the application is made through the heat emitted by radio waves.Partial inhibition of the functions of the nerves carrying the joint pain sensation with this method is the basis of the treatment.The intermedius genicular nerve carries the sensation of subpatellar pain due to chondromalacia.In this study,investigators aim is to investigate the effect of radiofrequency neurotomy applied to the intermedius genicular nerve, which receives the sensation of the patella, on pain and knee function in patients with a diagnosis of chondromalacia patella who have anterior knee pain that does not resolve despite conservative treatment, under the guidance of ultrasonography.

The study was designed as prospective, randomized, controlled trial. 46 people who met the inclusion criteria were randomized into two groups of 23 people. The first group will be designated as Nerve blockage group and nerve blocking program will be applied to these patients. Patients in the second group will be designated as the Radiofrequency group and radiofrequency ablation after the blockade program will be applied in accordance with the radiofrequency ablation protocol.Participants were evaluated with Visual Analogue Scale (VAS), Patello Femoral Pain Severity Scale (PFPSS), Kuala's Patellofemoral Scoring System (KPSS).

Eligibility Criteria:
Inclusion Criteria:

* Male/female aged \>18 years
* Diagnosis of chondromalacia patella after physical examination and MR imaging
* Those whose symptoms persist for \>3 months
* Participating in the study voluntarily

Exclusion Criteria:

* Pregnant patients
* History of previous knee surgery
* To have received physical therapy from the knee area in the last 6 months
* Previous RF treatment or any therapeutic injection of the knee such as steroid, hyaluronic acid within 3 months
* Those with pain radiating from the waist or hip
* Patients with neuropathic pain
* History of tumor, infectious, psychiatric disease, bleeding diathesis
* History of knee trauma in the last 6 months
* Those with systemic diseases such as hepatitis, coagulopathy
* Patients with BMI \>40
* Finding a leg length difference
Successful Treatment of Maternal Listeria Monocytogenes Bacteremia in the First Trimester

Successful Treatment of Maternal Listeria Monocytogenes Bacteremia in the First Trimester of Pregnancy

A 34-year-old nulliparous woman with 11 gestational weeks with flu-like illness was proved to be infection by Listeria monocytogenes, and then treated by intravenous ampicillin 2 g every 4 hours for 3 weeks. A healthy unaffected male baby was delivered at 41 weeks' gestation.

Eligibility Criteria:
Inclusion Criteria:

* One pregnant woman with listeria monocytogenes bacteremia in the first trimester
Preoperative IMRT With Concurrent Apatinib for Localised Extremity or Trunk Sarcoma

To investigate the safety and efficacy of preoperative IMRT and concurrent Apatinib for primary truncal or extremity soft tissue sarcoma; To investigate the Quality of life and extremity function post-combination treatment; To study the mechanism of radio-sensitizing effects of Apatinib for primary truncal or extremity soft tissue sarcoma; To assess the relationship between the MRI imaging, pathological findings and local control.


Eligibility Criteria:
Inclusion Criteria:

* Age older than 18-yo.
* Histology proven soft tissue sarcoma of truncal or extremity, deemed appropriate for preoperative radiotherapy and conservative surgery by multidisciplinary discussion.
* ECOG 0-3
* Histology reviewed by reference pathologist
* Lesion can be assessed
* Can tolerate radiotherapy and Apatinib
* Agree contraception.
* Informed consent: All patients must sign a document of informed consent indicating their understanding of the investigational nature and risks of the study before any protocol related studies are performed

Exclusion Criteria:

* No gross tumor post-resection in other center.
* Contraindications to Apatinib, including allergic to Apatinib, active bleeding, ulcer, enteric perforation, enteric obstruction, uncontrolled hypertension, Grade 3 to 4 cardiac insufficiency (per NYHA criteria), and severe hepatic or renal insufficiency (Grade 4), etc.
* Dermatofibrosarcoma protuberans(DFSP), Desmoids, etc.
* Benign histology
* Secondary cancer within 5 years (except cervical carcinoma in situ or early-stage skin basal cell carcinoma)
* STS can be cured by extensive operation alone.
* Previous irradiation to the same area
* radiological evidence of distant metastases
* Other contraindications, can't tolerate operation or other treatment needed in this study.
* Neoadjuvant chemotherapy given or planned.
Feasibility Study of Sentinel Navigation Surgery in Early Gastric Cancer Using Fluorescence (SENORITA4)

SENORITA 1 trial showed laparoscopic sentinel lymph node biopsy and stomach preserving surgery in early gastric cancer can increase the quality of life. (Ryu KW et al. JCO 2022) The radioactive isotope is difficult to use because of the hazard of radiation and shortage of materials. The aim of this study is to investigate whether laparoscopic sentinel lymph node biopsy and stomach-preserving surgery using only fluorescence is feasible.

1. Injection of Indocyanine Green (ICG)

   * Endoscopic injection of 0.25mg/ml of ICG on 4 sites around gastric cancer
   * Identification of sentinel basin using fluorescence laparoscopy
   * Laparoscopic sentinel basin dissection and identification of sentinel node at the back table
2. Surgical considerations

   * Conventional gastrectomy is performed if positive sentinel nodes are diagnosed in the frozen section.
   * If micrometastasis or isolated tumor cells in sentinel basin lymph nodes were diagnosed in permanent pathology, re-operation of conventional gastrectomy is not performed.
   * However, re-operation of conventional gastrectomy should be performed in case of macrometastasis, deep and lateral margin positive, more than pT2 lesion in the permanent pathology.

Eligibility Criteria:
Inclusion Criteria:

* single lesion of adenocarcinoma in preoperative endoscopic biopsy clinical stage T1N0 in the preoperative evaluation of endoscopy and computed tomography
* tumor size: less than 3cm
* location: 2cm far from the pylorus or cardia
* aged 20 to 80
* ECOG 0 or 1
* patient who signed the agreement
* patient who is suspected to underwent laparoscopic or robotic gastrectomy

Exclusion Criteria:

* indication of endoscopic submucosal resection
* inoperable due to poor cardiac, and pulmonary function
* pregnant
* having allergic reaction, previous upper abdominal surgery except laparoscopic cholecystectomy, previous radiation therapy to upper abdomen
* diagnosed as malignancy within 5 years except carcinoma in situ of cervix cancer and thyroid cancer
Cervical Foraminal Stenosis and Radiculopathy - ACDF Versus Minimal Invasive Posterior Cervical Foraminotomy.

A prospective randomized clinical trial. Cervical spondylotic foraminal stenosis with radiculopahty. Comparison results between 2 treatment options: ACDF and minimal invasive posterior cervical foraminiotomy.

80 patients to be followed for 2 years. Parameters to study: NDI, VAS, EQ-5D, complications, health economics, recurrens of stenosis, movement of facet joints pre- and postoperatively (foraminotomy group).


Eligibility Criteria:
Inclusion Criteria:

* Cervical radiculopathy on 1 or 2 levels correlated on MRI and CT Arm pain more than 30 (VAS). Duration more than 3 months.

Exclusion Criteria:

* Myelopathy. Soft disc hernia. Previous neck surgery. Tumors, infection, WAD, trauma, generalized pain syndrome.
CBT Versus a Return to Work Intervention for Patients With Common Mental Illness in Primary Care

Background: Common mental illness, such as anxiety disorders and depression, is the main cause for sick leave in Sweden. Cognitive behavior therapy (CBT) has been shown to be effective in alleviating target symptoms of these disorders, but its effect on sick leave rates has not been sufficiently addressed. The investigators have developed an intervention called return to work (RTW), which is based in cognitive behavioral theory, that has a primary aim of helping sick-listed patients with common mental illness return to work. This new treatment has not been evaluated in a randomized controlled trial.

Aims: The aim of this study is to investigate the effect of CBT and RTW for common mental illness in a randomized controlled trial conducted in primary care. Participants will be randomized to diagnosis specific CBT (n=70), RTW (n=70), or a combination of the two treatments (n=70). Main outcomes are days of sick leave and clinician severity rating of psychiatric symptoms. This study could contribute to new knowledge regarding how to best treat patients on sick leave with common mental illness.


Eligibility Criteria:
Inclusion Criteria:

* Have been on sick leave (at least 50%) for at least 1 month and not more than 6 months
* Have an anxiety disorder diagnosis (obsessive compulsive disorder, social phobia, panic disorder, generalized anxiety disorder, post-traumatic stress disorder, specific phobia), or/and major depression, or/and maladaptive stress reaction, or/and primary insomnia

Exclusion Criteria:

* A lower score than 4 on the Clinician severity rating scale
* A higher score than 6 on the Clinician severity rating scale
Benefits Study of Respiratory-gated PET Acquisition in Lung Disease

Fluorodeoxyglucose (FDG) positron emission tomography (PET) is now widely used for cancer imaging purpose, notably for preoperative work-up. It aims at visualizing organs metabolism. In case of cancer, metabolism is, classically, increased and some hot spots are visible on PET images. Because of respiratory motion some lung tumours (especially the smallest ones) can be falsely interpreted by the clinician.

The investigators developed a respiratory-gated PET method in order to reduce the motion issue. The investigators designed a study to investigate its effect on lung cancer (primary or metastasis) to check if it improves the sensitivity/specificity of PET imaging of the lungs.

To that aim, patients presenting a lung nodule on a CT examination can be proposed to participate this study. After the standard PET acquisition (acquired in free-breathing), an additional 10 minutes respiratory-gated PET acquisition is performed without additional injection. After that, a breath-hold (\~10s) CT is performed.


Eligibility Criteria:
Inclusion Criteria:

* patient has one or more lung lesion(s) less than 35 mm visible on a CT image
* age : over 18 years
* patients gave their written informed consent

Exclusion Criteria:

* pregnancy
* patient has at least one lesion more than 35 mm in its great axis
Hearing Screening in Adults Over 50 Years Old

The goal of this single-arm quasi-experimental study is to evaluate the feasibility, effectiveness, and management of three different hearing screening methods in adults aged 50 years and older in the Czech Republic. The main questions it aims to answer are:

Are the selected hearing screening methods effective in detecting hearing loss in the target population? Can these methods be successfully implemented within the national healthcare system to address gaps in current practices?

Participants will:

1. Undergo hearing screening using all three methods, conducted by general practitioners, to assess their performance.
2. Complete follow-up evaluations conducted by ENT specialists to confirm diagnostic results.

This single-arm quasi-experimental study involves a total of 330 participants aged 50 and older. The study evaluates the feasibility and effectiveness of three distinct hearing screening methods, conducted first by general practitioners and subsequently confirmed by ENT specialists, according to a standardized protocol.

Study Population and Interventions

Participants:

A total of 330 adults aged 50 years and older will be enrolled in the study.

Interventions:

The interventions are divided into two stages:

General Practitioners' Offices:

Before the screening:

Explanation of the screening process. Personal medical history review. Otoscopy and patient instruction.

Screening procedures (performed for all participants in the same order according to the standardized protocol):

1. Completion of the screening version of the standardized "HHIA" questionnaire (Czech version).
2. Whisper test conducted following the standardized protocol.
3. Screening pure tone audiometry performed according to the standardized protocol.

ENT Clinics:

Before the evaluation:

Explanation of the evaluation process. ENT-specific medical history review. Otoscopy and patient instruction.

Diagnostic procedures (performed for all participants in the same order according to the standardized protocol):

1. Pure tone audiometry conducted following the standardized protocol.
2. Tympanometry.

The findings will provide evidence for developing a comprehensive, national-scale hearing screening program for the aging population in the Czech Republic.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent (IC) and consent for personal data processing (CPDP).
* Age 50 years or older.

Exclusion Criteria:

* Known diagnosed persistent hearing impairment.
* Inability to sufficiently understand study instructions due to language barriers.
* Medical condition preventing participation in all parts of the study.
* Inability or unwillingness to complete all parts of the study.
Safety and Tolerability, PK, and PD Study of Single and Multiple ALXN2080 Doses in Healthy Participants

This study is designed to evaluate the safety and tolerability, pharmacokinetics and pharmacodynamics of single and multiple doses of ALXN2080 in healthy adult participants.

Participants will be assigned to 10 different cohorts (6 SAD cohorts and 4 MAD cohorts), each with 8 participants on active treatment with ALXN2080 and 2 participants on placebo. ALXN2080 will be administered under fasted conditions throughout this study, except for the last SAD Cohort 6 in which ALXN2080 will be given with food to evaluate the effect of food on the single-dose pharmacokinetics of ALXN2080.

Eligibility Criteria:
Inclusion Criteria:

* Healthy is defined as having no clinically relevant abnormalities identified by a detailed medical history, physical examination, blood pressure and heart rate measurements, 12-lead ECG, and clinical laboratory tests.
* Body mass index (BMI) of 18 to 30 kg/m2 with a minimum body weight of 50 kg. BMI max is 32 kg/m2.
* Male or female; female of childbearing potential and male participants agreed to follow protocol specified contraception guidance.

Exclusion Criteria:

* Significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders.
* History of hypersensitivity to any ingredient contained in the study intervention.
* Evidence of active infections, history of meningococcal infection, unexplained, or recurrent infection.
* Known or suspected history of drug or alcohol abuse or dependence.
* Current tobacco users or smokers.
* Diseases or conditions or previous procedures known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
* For females: pregnant, breastfeeding, or intending to conceive during the course of the study.
Effect of Aprotinin on Transfusion Requirements in Patients Undergoing Elective Spinal Fusion Surgery

The objective of this study is to evaluate the safety and efficacy of aprotinin as compared to placebo, in reducing the need for blood transfusion in adult subjects undergoing elective spinal fusion surgery involving 3 to 7 vertebral levels with instrumentation


Eligibility Criteria:
Inclusion Criteria:

* Subjects requiring elective spinal fusion surgery involving 3 to 7 vertebral levels with instrumentation. One vertebral level is defined as encompassing two vertebral bodies and one inter-vertebral disc space, so that a contiguous spinal fusion involving 3 vertebral levels would include 4 vertebral bodies and 3 inter-vertebral disc spaces.

Exclusion Criteria:

* Subjects with previous exposure to aprotinin in the last 6 months. If the subject has undergone cardiac surgery in the last 6 months, all attempts should be made to ascertain if aprotinin was administered during cardiac surgery. If no records are available, or if the subject received aprotinin, the subject should be excluded.- Subjects with a known or suspected allergy to aprotinin.
* Subjects with sepsis or a known bone infection.- Subjects with known bone malignancy.
* Subjects with a creatinine clearance less than 30mL/min as calculated by the Cockcroft-Gault formula.
* Subjects with a history of bleeding diathesis or known coagulation factor deficiency.
* Subjects with failure of a major organ system or any active significant medical illness that in the opinion of the Investigator is likely to affect the subject's ability to complete the study or precludes the subject's participation in the study
* Subjects who refuse to receive allogenic blood products for religious or other reasons.
* Subjects whose preoperative red blood cell volume is so low that a blood transfusion would be likely to be given perioperatively (preoperative hematocrit or hemoglobin values \<24% or \<8 g/dl, respectively).
* Subjects who have participated in an investigational drug study within the past 30 days
* Subjects with a history of deep vein thrombosis or pulmonary embolism.
* Subjects who are pregnant or breast feeding.
* Women of childbearing potential in whom the possibility of pregnancy cannot be excluded by a negative serum pregnancy test at screening.
* Women of childbearing potential who are not using a reliable method of contraception.
* Planned use of other antifibrinolytic agents.
* Subjects on chronic anticoagulant treatment with Vit K antagonists that cannot be temporarily discontinued for the surgical procedure (as per local practices).
Nutritional Status and Nutrient Supply in Hospitalised Surgical Patients

Prospective single arm, single center observational study to assess the nutritional status and the nutrient supply during hospitalization for elective gastrointestinal surgery.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing elective surgery of the upper or lower gastrointestinal tract
* mental and verbal ability to understand, read and write in German language
* written informed consent for study participation

Exclusion Criteria:

* age \<18 years
* inadequate ability to be compliant with the study protocol or to complete documentation for the Food frequency questionnaires