cyrilzakka/clinical-trials huggingface dataset:
Cardiac Autonomic Modulation in Older Hypertensive Individuals Submitted to Different Types of Physical Training

Sixty-one sedentary older hypertensive individuals were randomized to four groups: continuous aerobic training (CA), interval aerobic training (IA), resistance training (R), and control (C) group. The protocol included 3 sessions of training by week for 12 weeks. C individuals were instructed to continue their usual activities. They were submitted to the passive tilt test before and after the research protocol, evaluating the heart rate (HR), low frequency (LF) and high frequency (HF) bands, detrended fluctuation analysis (DFAα1) and entropy

The individuals were randomized into four groups: continuous aerobic training (CA), interval aerobic training (IA), resistance training (R), and control (C), which performed physical exercises three times a week for twelve weeks, with a total of 36 sessions. The tilt test was performed before and after the research protocol. Individuals in the control group were only encouraged to maintain their usual activities.

For the analysis of HRV, the baseline conditions (resting in the supine position) were determined, followed by the passive postural maneuver, which characterizes the tilt test (table til tat 70 °) in order to determine the following variables:

* HR: heart rate (sympathetic action)
* LF: Low frequency band (Modulated predominantly by the sympathetic system)
* HF: High frequency band (Modulated predominantly by the parasympathetic system)
* Entropy: data complexity or irregularity index showing that, the higher the values, the better the HRV.
* DFAα1 (short term detrended fluctuation analysis)

Eligibility Criteria:
Inclusion Criteria:men and women 60-year-old or older, extensively using prescription antihypertensive drugs, and having no previous experience with physical training -

Exclusion Criteria:

* • Positive treadmill test (TT) for ischemia

  * Related left ventricular systolic dysfunction of any degree
  * Presence of arrhythmias
  * Use of β-blockers
  * Use more than seven doses of ethyl alcohol per week
  * Renal insufficiency
  * Diabetes
  * Hyper- or hypothyroidism
  * Limiting lung disease
  * Osteomioarticular impairment that would limit exercise performance
  * SBP ≥160 and/or DBP ≥ 100 mmHg on baseline
Study of ISM3412 in Participants With Locally Advanced/Metastatic Solid Tumors

The study has consists of two parts, a dose escalation part (Part 1) and a dose selection optimization part (Part 2). The primary objectives of this study are to evaluate the safety and tolerability of ISM3412 in participants with locally advanced/metastatic solid tumors, and to determine the RP2D of ISM3412.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female participants with age ≥18 years at the time of signing the informed consent.
2. Histologically confirmed unresectable locally advanced or metastatic solid tumors with confirmed homozygous MTAP deletion, who have disease progression after standard therapy, intolerable to standard therapy, or for whom no standard therapy exists.
3. Have measurable or evaluable lesions in Part 1 and at least one measurable target lesion in Part 2 as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
4. Participants must provide a documentary evidence of homozygous MTAP deletion; or provide archival formalin-fixed paraffin-embedded (FFPE) tumor tissue blocks or at least 15 FFPE tumor tissue slides, or perform tumor tissue biopsies for a confirmatory genetic test indicating homozygous MTAP deletion.
5. ECOG PS (Eastern Cooperative Oncology Group Performance Status) ≤1.
6. Life expectancy of ≥12 weeks as judged by the investigator.
7. Adequate organ function as determined by medical assessment.
8. Capable of providing signed ICF and complying with the requirements and restrictions listed in the ICF and in this study protocol.

Exclusion Criteria:

1. Prior treated with other MAT2A inhibitors and/or PRMT inhibitors.
2. Participation in other therapeutic clinical studies within 28 days or 5 half-lives (whichever is shorter) prior to first dose of study treatment.
3. Anti-tumor therapy (chemotherapy, immunotherapy, hormonal therapy, targeted therapy, biologic therapy, or other anti-tumor therapy, except for hormones for hypothyroidism or estrogen replacement therapy, anti-estrogen analogues, agonists required to suppress serum testosterone levels) within 28 days or 5 half-lives, whichever is shorter prior to first dose of study treatment.
4. Toxicities of prior therapy have not resolved to Grade ≤1 or to baseline (as evaluated by NCI CTCAE version 5.0)
5. History of another primary tumor that has been diagnosed or required therapy within the past 3 years.
6. Previous history of, or presence of Gilbert's syndrome.
7. Previous history of myelodysplastic syndrome.
8. Prior solid organ or hematopoietic stem cell transplant.
9. Known active central nervous system (CNS) primary tumor or untreated CNS metastases.
10. Have serious cardiovascular or cerebrovascular disease as per protocol.
11. Presence of uncontrolled systemic infection as per protocol.
12. Unwillingness or unable to comply with the requirements of oral drug administration, or presence of a gastro-intestinal condition.

Other protocol inclusion and exclusion criteria may apply.
Study of RNS60 on Pain and Function After Knee Anterior Cruciate Ligament Surgery

The purpose of this study is to see if use of RNS60 during ACL reconstruction surgery decreases pain and improves functional capacity post-operation.


Eligibility Criteria:
IL-35+Breg/Il-35 Effect on T Cell Immune in Patients With CHB

The investigators observed the level of IL-35 secreting B regulatory (IL-35+Bregs) cells in peripheral blood cells in patients with chronic hepatitis B, and analysed the relationship between the IL-35+Bregs level and disease stage, and Th1 and Th2 cells level.

Regulatory B cells (Bregs) are involved in the immune tolerance process through multiple pathways and Bregs are involved in the process of chronic HBV infection.

Here the investigators intended to investigate the regulating role and the mechanism of CD19+ IL-35+ cells on host T cell immune during chronic HBV infection by using in vitro cell sorting, B cell differentiation induction, Transwell cell co-culture system and other methods.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of chronic hepatitis B virus infection
* 17\<age\<70
* Can read, understand and sign patients informed consent

Exclusion Criteria:

* Co-infection with HCV,HIV,HDV etc.
* Have malignancy
* Have uncontrollable extra-hepatic disease
Evaluation of the Efficacy of Cervical Core Exercises in Persons With Temporomandibular Joint Dysfunction

The aim is to reveal to what extent cervical core exercises affect the results of treatment in patients with Temporomandibular Joint Dysfunction caused by Myofascial pain syndrome. Randomization will be carried out by dividing individuals who agree to participate in the study into 3 groups of 20 people.Participants will be divided into three groups, and all three groups will receive treatment in 30-45 minute sessions a day, 2 days a week for 8 weeks.

The aim is to reveal to what extent cervical core exercises affect the results of treatment in patients with Temporomandibular Joint Dysfunction caused by Myofascial pain syndrome. Randomization will be carried out by dividing individuals who agree to participate in the study into 3 groups of 20 people with the "Research Randomizer" program. Randomization, evaluation and treatment of the groups will be done by different researchers.

Participants will be divided into three groups, and all three groups will receive treatment in 30-45 minute sessions a day, 2 days a week for 8 weeks. Evaluation will be made at the beginning and at the eight week to see the short-term effects. Rocabado exercises will be given to the first group, Cervical Core exercises will be given to the second group, and Rocabado and Cervical Core exercises will be given together to the third group. After the initial evaluations, all exercises will be taught to the patients in the first week, they will be planned as home exercises in the following weeks, and online follow-up will be done via tele-rehabilitation.

Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed with Temporomandibular Disorder caused by Myofascial Pain Syndrome
* Female gender aged 18 and over
* Volunteering to participate in the study
* Not having communication difficulties such as speaking and understanding Turkish or not being able to understand the exercises.

Exclusion Criteria:

* Having a history of acute trauma in and around the Temporomandibular Joint
* Having Temporomandibular Joint dysfunction due to neurological disease
* Having a history of surgical/invasive procedures or treatments on the Temporomandibular Joint
* Presence of infection or tumoral structure within intraoral structures
* Having a history of tooth loss or prosthetic tooth use
* Having a history of surgical procedure in the cervical area
Signatures of Immune Reprogramming in Anti-CD52 Therapy of MS: Markers for Risk Stratification and Treatment Response

Alemtuzumab is a highly effective therapy in relapse remitting multiple sclerosis (RRMS). The aim of this study is to elucidate the mechanism of action of the neuroprotective potential of alemtuzumab in RRMS. Therefore, the investigators will semi-annually analyse blood samples of RRMS patients treated with alemtuzumab up to 36 months. Using in vitro/ ex vivo assays the investigators aim to detect and characterize immune cells including their functional activity. Furthermore, the study aims to combine this analysis with clinical data (MRI, EDSS: Expanded Disability Status Scale, MSFC: Multiple Sclerosis Functional Composite) to reveal the underlining mechanism of action of alemtuzumab to further improve its efficacy and safety for present and future patients.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of MS according to the McDonald criteria 2010 and cranial MRI scan demonstrating white matter lesions attributable to MS within 5 years before prior to signing the informed consent form (ICF)
* Age \> 18 years
* Written informed consent to study participation

Exclusion Criteria:

* Medical, psychiatric, cognitive, or other conditions that, in the Investigator's opinion, compromise the patient's ability to understand the patient information, to give informed consent, or to complete the study
* Any progressive form of MS
* Any condition that serves as a contraindication for alemtuzumab treatment
* Any disability acquired from trauma or another illness that could interfere with the evaluation of disability due to MS
* Major systemic disease or other illness that would, in the opinion of the Investigator, compromise patient safety or interfere with the interpretation of study results, e.g., current peptic ulcer disease or other conditions that may predispose to hemorrhage
* Significant autoimmune disease including but not limited to immune cytopenias, rheumatoid arthritis, systemic lupus erythematosus, other connective tissue disorders, vasculitis, inflammatory bowel disease, severe psoriasis
* Inability to undergo MRI with gadolinium administration
ED50 and ED95 of Intrathecal Bupivacaine With or Without Epinephrine for Total Knee Replacement Arthroplasty

This prospective randomized double-blind dose-response study is aimed to investigate the ED50 and ED95 of intrathecal bupivacaine with or without epinephrine 100 mcg for total knee replacement arthroplasty.

Patients undergoing total knee replacement arthroplasty are randomly assigned to six bupivacaine dose group (6, 7, 8, 9, 10, 11 mg). Combined spinal-epidural anesthesia would be performed. The dose would be considered as successful if no epidural supplement was required during surgery. A probit analysis will be performed to calculate the ED50 and ED95 of intrathecal bupivacaine with or without epinephrine for total knee replacement arthroplasty.

After these measurements, ED50 and ED95 of bupivacaine with epinephrine would be compared with those without epinephrine.

Eligibility Criteria:
Inclusion Criteria:

* The patients with ASA class I or II scheduled for total knee replacement surgery

Exclusion Criteria:

* Patients with previous spine surgery, diabetic and other neuropathy, skin infection at the site of injection, allergy to bupivacaine and other common contraindications for spinal anesthesia were excluded from this study.
Post Marketing Surveillance for ADACEL™ in South Korea

This safety surveillance study is being conducted in accordance with Korea Food and Drug Administration (KFDA) Notification No. 2009-46 "Basic standard for reexamination of new drug".

The study objective is to assess within 30 days post-administration, the safety of ADACEL™ administered under the real clinical practice.


Eligibility Criteria:
Inclusion Criteria :

* Subjects who are 11 through 64 years of age (as indicated in the currently approved local product labeling) , who are given a single dose of the study vaccine, during a routine health-care visit, as active booster immunization for the prevention of tetanus, diphtheria and pertussis.
* Written informed consent obtained from the subject. For subjects below the legal age of consent, written informed consent must be obtained from the parent or legal guardian (legally acceptable representative -LAR) of the subject.

Exclusion Criteria :

* None
Antimalarial Drug Susceptibility and Molecular Characterization of Plasmodium Vivax Isolates in Vietnam

This is a study of drug effectiveness for 2 treatments of vivax malaria, which is one of the two main types of malaria in Viet Nam. There are two important drugs used in Viet Nam for treating vivax malaria, Chloroquine and Artemisinin. Sometimes, when medicines are used for many years they become less effective at treating a disease, especially when they are not used at adequate doses according to national guidelines or when counterfeit drugs are available in the market. The purpose of this study is to check that Chloroquine and Artemisinin, are still effective for patients in Viet Nam.

Participants in this study will be treated with either Dihydroartemisinin-Piperaquine (DHA-PPQ) or Chloroquine (CQ) for 3 days. Both drugs are recommended by the national guidelines to treat vivax malaria. The investigators would like to know if both of these treatments are equally effective so half of the patients in the study will be treated with DHA-PPQ and the other half will be treated with CQ. This way the investigators can compare the drugs to find out if one is better than the other.

Participants will be followed for 3 days in hospital, then regularly by follow-up visits until the 63rd day. Tests will be done to determine the amount of drug and malaria parasites in the participant's body and how the blood cells react to the malaria. The parasite will be tested to determine what type it is and how it reacts to the treatment.

The results of the study will be used to inform malaria treatment guidelines in Viet Nam.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 3 years;
* Mono-infection with P. vivax, parasitemia \> 250/µl asexual forms for in vivo and \>8000 asexual parasites/µl blood for in vitro testing;
* Presence of axillary or tympanic temperature ≥ 37.5 °C or history of fever during the past 24 h;
* Ability to swallow oral medication;
* Ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule;
* Informed consent/assent

Exclusion Criteria:

* Presence of general danger signs or severe malaria according to the definitions of WHO (2000);
* Mixed infection with P.falciparum and P.vivax of other plasmodium species;
* Presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhoea with dehydration) or other known underlying chronic or severe diseases (e.g. cardiac, renal and hepatic diseases, HIV/AIDS);
* Regular medication, which may interfere with antimalarial pharmacokinetics;
* Received antimalarial drugs in the previous 48 hours;
* History of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s);
* Splenectomy;
* First trimester of pregnancy.
A Clinical Assessment of Glass Carbomer Cement

This study will evaluate the clinical performance of glass carbomer cement restorations in restoring proximal lesions in primary molars compared to that of resin modified glass ionomer cement and composite resin restorations. Teeth will be randomly assigned to one of the three restoration groups and the restorations will be evaluated clinically and radiographically every six months.

Glass Carbomer is a monomer free; carbomised nano-glass restorative cement developed from traditional glass ionomer cement (GIC) and contains nano-sized powder particles of hydroxyapatite and fluorapatite. These materials claim to have improved mechanical properties and better bonding to dentin, in addition to continues fluoride release.

The study is a randomized controlled clinical trial where teeth will be randomly assigned to one of the three restoration groups.

Following medical and dental history, bilateral bitewing radiographs will be taken for each patient to assess the presence of proximal lesions. Suitable teeth will then be randomly assigned to one of the restoration groups. A single operator using local anesthesia and rubber dam isolation will then prepare standardized Class II cavities and place the designated restorations according to the manufacturer's instructions.

The quality of the 3 types of restorations will be clinically evaluated at baseline and every six months for color match, marginal discoloration, anatomic form, marginal adaptation, and secondary caries using the criteria described by "Cvar and Ryge" (2005). The evaluation will be performed by 2 calibrated examiners.

Following placement of the restorations, bitewing radiographs will be taken to evaluate the restorations and will be repeated every six months for detection of recurrent caries.

Eligibility Criteria:
Inclusion Criteria:

* One proximal lesion in a primary molar.
* Radiographic evidence of caries extending at least into the inner half of the enamel but not the inner half of dentin.
* Proximal contact with adjacent healthy or restored teeth.
* Occlusal contact with opposing healthy or restored teeth.
* No indication for pulp therapy or other restorative treatment.
* A predicted survival until exfoliation of 2 years.

Exclusion Criteria:

* Radiographic evidence of caries extending into the inner half of dentin.
* No proximal contact with adjacent healthy or restored teeth.
* No occlusal contact with opposing healthy or restored teeth.
* Tooth indicated for pulp therapy or other restorative treatment.
* A predicted survival until exfoliation of less than 2 years.
Effectiveness of Paritaprevir/Ritonavir, Ombitasvir, + Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C in Romania

This study seeks to provide evidence of the effectiveness and obtain patient reported outcome (PRO) data for the interferon-free regimen of paritaprevir (PTV)/ritonavir (r) + ombitasvir (OBV), + dasabuvir (DSV), +/- ribavirin (RBV) in participants with chronic hepatitis C (CHC) in a real life setting across clinical practice patient populations in Romania.


Eligibility Criteria:
Inclusion Criteria:

Treatment-naïve or -experienced adult male or female patients with confirmed CHC, genotype 1, receiving combination therapy with the interferon-free paritaprevir/ritonavir and ombitasvir with dasabuvir ± RBV according to standard of care and in line with the current local label

If RBV is co-administered with the paritaprevir/ritonavir and ombitasvir with dasabuvir, it has been prescribed in line with the current local label (with special attention to contraception requirements and contraindication during pregnancy)

Patients must voluntarily sign and date a patient authorization to use and/or disclose his/her anonymized health data prior to inclusion into the study

Patient must not be participating or intending to participate in a concurrent interventional therapeutic trial

Exclusion Criteria:

None
Translation of the "Exercise in Mental Illness Questionnaire (EMIQ)" to German

The "The Exercise in Mental Illness Questionnaire (EMIQ) - Health Practicioners Version" is a questionnaire designed to assess the prescription behaviour of physical activity as well as related knowledge, barriers and exercise behaviour of mental health professionals.

As a lot of research on prescription behaviour is done using unvalidated questionnaires we want to translate this validated questionnaire into German for further use in this research field.

The "The Exercise in Mental Illness Questionnaire (EMIQ) - Health Practicioners Version" is a questionnaire designed to assess the prescription behaviour of physical activity as well as related knowledge, barriers and exercise behaviour of mental health professionals.

As a lot of research on prescription behaviour is done using unvalidated questionnaires we want to translate this validated questionnaire into German for further use in this research field. Therefore we plan to translate the questionnaire in accordance to established questionnaire translation guidelines.

Then we plan to validate the questionnaire in a sample of about 30 mental health professionals (psychiatrists, psychologists, nurses) currently working with patients with mental disorders. We plan to evaluate re-test-reliability using repeated measurement within 7 days.

Eligibility Criteria:
Inclusion Criteria:

* Psychiatrist, Psychologist or Nurse
* Working with patients with mental disorders
* German mother language

Exclusion Criteria:

- None
Safety and Efficacy Study of Recombinant Human Growth Hormone in Adult Growth Hormone Deficiency Patients

The purpose of this study is to assess the safety, tolerability and Pharmacokinetic/ Pharmacodynamic (PK/PD) profile of three doses of HM10560A on an every week (EW) regime and one dose on every other week (EOW) regime administered for a period of 24 weeks initial study.

* To select the optimal dose and dosing regimen of HM10560A for the subsequent phase III study on the basis of the safety and PK/PD profile after 24 weeks of treatment
* To assess the long term safety of HM10560A when administered in optimal dose range and dose frequency for additional 48 weeks (followed with 2 weeks safety follow up)

Eligibility Criteria:
Inclusion Criteria:

* GHDA subjects, males and females, of age between 23 and 60 years as defined in the Consensus Guidelines for the Diagnosis and Treatment of Adults with GH Deficiency II (2007) as well as American Association of Clinical Endocrinologists Medical Guidelines for Clinical Practice for Growth Hormone Use in Growth Hormone-Deficient Adults and Transition Patients (2009);
* r-hGHdrug naïve or any registered or investigational r-hGH replacement therapy was not given for more than 6 months before the screening.
* Body Mass Index (BMI, kg/m2) of both male and female patients must be between 22.0 to 35.0 kg/m2.
* Female patients must have a negative serum pregnancy test at inclusion.
* Confirmed to be negative for anti r-hGH antibodies at the time of screening.
* Willing and able to provide written informed consent prior to performing any study procedures.

Exclusion Criteria:

* Patients with childhood onset of GHD treated with r-hGH before the age of 18.
* Current antitumor therapy.
* Subjects presenting with any clinically significant ECG abnormality.
* Evidence of intracranial hypertension.
* Significant hepatic dysfunction (persistent elevation of alanine transaminase \[ALT\] or aspartate transaminase \[AST\] \>1.5 x upper limit of normal).
* Pregnancy and breastfeeding;