cyrilzakka/clinical-trials huggingface dataset:
Octaplas Adult TTP Trial

To assess and evaluate the safety of octaplas™ in comparison to standard plasma product (e.g., fresh frozen plasma (FFP) and other approved plasma products used within 24 hours of thawing) used in the treatment of TTP, in patients undergoing Therapeutic Plasma Exchange, with a special emphasis on the occurrence of thromboembolic events (TEEs).


Eligibility Criteria:
Inclusion Criteria:

1. Patient is a male or female at least 18 years of age or older.
2. Patient has a diagnosis of TTP or suspicion of TTP that is planned on being treated with TPE within 3 days of study entry.
3. Patient has thrombocytopenia (platelets \< 100 x 10P9P/L).
4. Patient is willing to give voluntary written informed consent before any study-related procedure is to be performed that is not part of standard medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.

Exclusion Criteria:

1. Patient has a history of severe hypersensitivity reaction to plasma-derived products or to FFP.
2. Patient has an already known IgA deficiency with documented antibodies against IgA.
3. Patient is currently participating in an interventional clinical study or has participated during the past 1 month prior to study inclusion.
4. Patient has severe deficiencies of Protein S.
5. Patient received more than 1 treatment of plasma exchange or plasma infusion for current episode of TTP prior to randomization.
6. Patient is currently taking ACE-inhibitors; in case patient is under ACE-inhibitor treatment a wash-out period of at least 24 hours has to elapse prior the first plasma infusion.
Peer Mentors for Adolescents in HIV Affected Families

This study will evaluate the effectiveness of a peer mentoring program designed for youths ages 9 to 15 whose parents or guardians are HIV infected. The program will focus on the youths' mental health, school performance, alcohol and drug use, personal and social behaviors, and behaviors that might expose them to HIV. The study is expected to enroll predominantly minority youth.

This study will conduct an efficacy trial of peer mentoring for a high-risk, predominantly minority population of 9- to 15-year-old youths whose parents are HIV infected. The study will also determine mechanisms (mediating variables) through which peer mentoring improves outcomes for the mentees, for example, consistency and continuity of relationship, teaching/role modeling, emotional support/empathy, advocacy, and behavioral reinforcement. After the conclusion of the efficacy trial, the study will continue through naturalistic longitudinal research for an additional 2 years in order to examine the long-term outcomes of peer mentoring.

Participants are randomized to either the peer mentoring program or a control condition (a recreation program). Surveys are conducted at entry into the study, at 6 months, 1 year, and then annually for 2 years. Youths will also participate in focus groups. The surveys and focus groups will assess the youths' psychological functioning, academic adjustment, alcohol and drug use, HIV risk behaviors, delinquent/violent behaviors, peer relationships, prosocial activities, and coping/problem-solving skills. The study will also evaluate family outcomes, including parent/guardian functioning and improved permanency planning.

Eligibility Criteria:
Inclusion Criteria

* HIV infected parent or guardian
* No previous involvement in the mentoring program
* Adolescent assent
* Parental consent
DynaCT in Preoperative Imaging Before Insertion of Stentgraft

Endovascular therapy of Aortic Aneurysms depends on good imaging facilities. A relatively new kind of x-ray equipment makes it possible to create computer tomography (CT) - like slice images in the operating room. The purpose of this study is to verify the clinical usefulness of DynaCT in a preoperative setting. To do so we compare aortic measurements in DynaCT to the same measurements in ordinary CT-images which are regarded the gold standard.


Eligibility Criteria:
Inclusion Criteria:

* Not inserted stent graft before.
* Patiens over 60 Years old.
* Able to give informed consent.

Exclusion Criteria: Not

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Long-term Safety, Tolerability and Effectiveness Study of Ofatumumab in Patients With Relapsing MS

The purpose of this study is to collect long-term safety, tolerability, effectiveness and health outcomes data in eligible subjects who have participated in a Novartis ofatumumab clinical MS study.

Vaccination sub-study The purpose of this research sub-study is to find out the effects of ofatumumab on the development of antibody responses to selected vaccines and keyhole limpet hemocyanin (KLH) neo-antigen in subjects with relapsing multiple sclerosis (RMS).

COVID-19 sub-study:

The purpose of this research sub-study is to explore the immune response following Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) vaccination in a subset of subjects on long-term ofatumumab 20 mg sc. Note: Novartis is not supplying the SARS-CoV-2 vaccine.


Eligibility Criteria:
Inclusion Criteria:

1. Must have completed a selected Novartis MS study which dosed ofatumumab 20 mg sc every 4 weeks
2. Written informed consent

Exclusion Criteria:

* Emergence of any clinically significant condition/disease during the previous ofatumumab study in which study participation might result in safety risk for the subject
* Subjects with active systemic bacterial, viral or fingal infections, or chronic infection (e.g. AIDS)
* Subjects taking medications prohibited by the protocol
* Pregnant or nursing (lactating) women Other protocol-defined inclusion/exclusion criteria may apply

Vaccination sub-study:

Inclusion criteria

1. Informed consent
2. Actively enrolled in the COMB157G2399 Study
3. 12 weeks of continuous treatment within the COMB157G2399 Study
4. prior vaccination history as per protocol-defined

Exclusion criteria

* known hypersensitivity or history of systemic allergic, neurologic or other reactions to vaccines
* allergies to egg or shellfish
* any safety findings including low IgG/IgM requiring ofatumumab interruption within 12 weeks prior to vaccination sub-study start
* any major episode of infection requiring hospitalization or treatment with intravenous antibiotics within 2 weeks of the first vaccination sub-study visit

Other protocol-defined inclusion/exclusion criteria may apply
Comparison of Two Different Techniques of Synovial Biopsy and Resistances of Cutaneous Smears in Suspected PPI

The purpose of this study is to determine whether an undirected synovial biopsy technique has the same accuracy in detecting periprosthetic joint infection in the knee as an arthroscopic assisted directed synovial biopsy technique.

Successful treatment of an infected joint arthroplasty depends on correctly identifying the responsible pathogens. The value of a preoperative biopsy remains controversial. We compared the sensitivity and specificity of two techniques of synovial biopsy of knee joint arthroplasties suspicious for infection and asked whether the results correlate with intraoperative findings at revision.

Eligibility Criteria:
Inclusion Criteria:

* Chronic painful knee prosthesis planned for synovial biopsy to detect infection
* Culture-negative joint aspiration

Exclusion Criteria:

* Co-morbidities: Tumour disease, immune suppression
Trial of Continuous Once Daily Oral Treatment Using BIBW 2992 (Afatinib) Plus Sirolimus (Rapamune®) in Patients With Non-small Cell Lung Cancer Harbouring an EGFR Mutation and/or Disease Progression Following Prior Erlotinib or Gefitinib

The primary objective of this trial is to identify the Maximum Tolerated Dose of BIBW 2992 therapy when given continuously in combination with Sirolimus.

The MTD will be based on the Dose Limiting Toxicity information collected during the first two cycles.

Overall safety, pharmacokinetics and anti-tumour efficacy will be evaluated as secondary objectives.


Eligibility Criteria:
Inclusion criteria:

1. Pathologically or cytologically confirmed diagnosis of Stage IIIB or Stage IV NSCLC
2. Patients who have failed conventional treatment (at least 1 prior treatment line), or for whom no therapy of proven efficacy exists
3. Patients whose tumors:

   * are EGFR mutation-positive or
   * are EGFR mutation-negative or unknown provided they had disease progression after achieving either response or stable disease for at least 6 months from a previous treatment with erlotinib (Tarceva®) or gefitinib (Iressa®)
4. Patients aged 18 years or older
5. Life expectancy of at least three (3) months
6. Eastern Cooperative Oncology Group (ECOG, R01-0787) performance score 0-2
7. Written informed consent that is consistent with ICH-GCP guidelines

Exclusion criteria:

1. Prior major surgery, chemotherapy or radiation therapy within 4 weeks before start of therapy.
2. Prior treatment with an mTOR inhibitor within the past 4 weeks before start of therapy or concomitantly with this study
3. Use of erlotinib (Tarceva®) or gefitinib (Iressa®) within 14 days of run-in treatment with Sirolimus
4. Active CNS metastases (defined as stable for \<4 weeks and/or symptomatic and/or requiring treatment with anticonvulsants or steroids)
5. Severe alteration in serum fasting cholesterol (equal or more than 350 mg/dL) or triglycerides (equal or more than 400 mg/dL). Patients may be allowed to enrol on the trial after initiation of lipid lowering agents.
6. Requirement for treatment with any of the prohibited concomitant medications:

   * Concomitant CYP3A4 inhibitors within the past 7 days before start of therapy or concomitantly with this study.
   * Concomitant CYP3A4 inducers within the past 14 days before start of therapy or concomitantly with this study.
7. Any contraindications for therapy with Sirolimus.
8. Known hypersensitivity to BIBW 2992, Sirolimus or other rapamycin analogues (everolimus, temsirolimus, deforolimus, etc.) or the excipients of any of the trial drugs.
9. Use of any investigational drug within 4 weeks before start of therapy.
OCTA Analysis In Children After Lensectomy

The aim of this study is to quantify and compare the foveal avascular zone (FAZ), the parafoveal and foveal vessel density of superficial (SCP) and deep capillary plexus (DCP) and retinal thickness in deprivation amblyopic eyes, fellow non-amblyopic eyes, and age-matched normal eyes, using optical coherence tomography angiography (OCTA). The FAZ, parafoveal and foveal SCP and DCP, and retinal thickness were measured in normal controls and at least 3 months postoperatively in children with unilateral cataract and compared between groups after adjusting for axial length and spherical equivalents.


Eligibility Criteria:
Inclusion Criteria:

* children after cataract surgery and healthy volunteers

Exclusion Criteria:

* presence of corneal opacity preventing detailed imaging
* nystagmus
* retinal disease,
* persistent fetal vasculature
* intraocular inflammation,
* glaucoma
* vitreoretinal surgery
* premature birth
* neurologic disease
* systemic disease that could alter microvasculature (including diabetes, hypertension, cardiovascular disease and renal disease)
Effects of Autogenous Dentin Graft on Socket Preservation

Various graft materials are used to reconstruct bone defects in the jaws due to tooth loss, trauma, advanced periodontal diseases, pathological lesions and congenital disorders. The main features of an ideal bone graft are osteogenesis, osteoinduction and osteoconduction. Autogenous bone graft is considered as the gold standard among all bone graft materials. Because it has all the features that an ideal bone graft should have. However, there are some disadvantages such as donor site morbidity, obtaining limited amounts and high rates of resorption. Because of these disadvantages, other bone graft materials such as allografts, xenografts and alloplastic bone grafts are frequently used for bone augmentation. In the light of recent studies, the limits of conventional bone graft materials such as limited osteoconduction capacity and disease transmission have been clearly demonstrated. Due to the disadvantages of these materials, studies are directed to develop alternative graft materials. Aim of this study is to analyse the effects of autogenous dentin graft and mixture of autogenous dentin graft and platelet rich fibrin (PRF) applied to the tooth extraction sockets on bone healing process. A total of 57 extraction sockets in 9 patients who were planned to be treated with dental implant after tooth extraction were evaluated in this study. Extraction sockets were divided randomly into 3 groups. In the first group, sockets were filled with autogenous dentin graft (Group D-20 sockets). In the second group, sockets were filled with the mixture of PRF and autogenous dentin graft (Group DP-21 sockets). In the third group, sockets were left empty as control group (Group C-16 sockets). After 3 months, histological and immunohistochemical evaluations were performed on the samples taken during the implant surgery. Additionally, samples obtained from each group were examined by scanning electron microscopy (SEM).


Eligibility Criteria:
Inclusion Criteria:

* Age≥18 years,
* Systemically healthy patients (ASA I and II),
* Adequate restorative space for implant-retained restoration.

Exclusion Criteria:

* Teeth with deep decay or root canal filling,
* Systemically complicated patients (ASA III, IV, V),
* Presence of acute infection,
* Pregnancy or lactation,
* Unwillingness to return for the follow-up periods
Identification of the Sensory Level Block to Cold During Epidural Analgesia for Labor: A Cohort Study to Determine the Influence of the Direction of Testing

Assessment of the upper sensory block level during neuraxial analgesia for labor and delivery is an essential component of clinical management and patient safety. A variety of methods have been used for testing the sensory block such as cold, light touch, sharp touch or prick and transcutaneous electrical stimulation. In addition to the diversity of methods, the endpoints used by investigators have also been variable, considering total or partial responses as endpoints. Not surprisingly, a variable sensory block level could be identified as a result of the different methods and types of question asked by the examiner. Another complicating factor is the lack of standardization of the direction of the testing as it relates to anesthetized and non-anesthetized areas. This lack of standardization may result in a difference of several dermatomes in the level that two different assessors might record for the same patient. Considering a clinical research scenario, it may be difficult to replicate results and implement clinical practices. The objective of this study is to determine the degree of agreement between two methods of assessing the sensory block level to cold in women receiving epidural analgesia for labor (anesthetized to non-anesthetized segments versus non-anesthetized to anesthetized segments).


Eligibility Criteria:
Inclusion Criteria:

* patients who request and have no contraindications to receive epidural analgesia
* capable of understanding and signing the written informed consent
* have no language barrier to respond to the level of sensory block assessment
* have no conditions that could compromise their sensitivity to cold.

Exclusion Criteria:

* patients who refuse to sign consent
* epidural analgesia is contraindicated
Inmediate Effect of the Visualization of Action

The observation of actions and motor imagery has demonstrated the activation of certain mechanisms similar to those that occur during active movement, which could induce immediate changes in the amplitudes of movement and sensorimotor variables in observed and imagined movements. The main aim of the study was test the immediate effect of a protocol of observed actions and motor imagery on cervical range of motion and pain intensity in patients with non-specific chronic neck pain (NSCNP). Randomized double-blind clinical trial in patients with DCCI at a primary health care center in the Community of Madrid. A random distribution of study subjects was made into two groups: a) cervical motion videos were presented at full range of motion and b) the videos presented showed a range of motion limited to 40%. In both groups, visualization tasks of actions were alternated with internal kinesthetic motor imagery, in periods of 1min in 2 consecutive series and with a total of 12 minutes of intervention. Cervical range of motion was assessed with a cervical goniometer and pain intensity immediately following the intervention with an Analog Visual Scale.


Eligibility Criteria:
Inclusion Criteria:

* Nos-Specific Chronic Neck Pain lasting more than 3 months

Exclusion Criteria:

* Systemic Disease diagnosed (i.e. Lupus, Fibrolyalgia or Rheumatoid Arthritis)
* Background of fractures or surgery in the cervical region
* congenital anomalies known
* infectious processes or diagnosis of active cancer at the time of the study
Patient-ventilator Asynchrony in Conventional Ventilation Modes During Short-term Mechanical Ventilation After Cardiac Surgery

This study evaluates the effects of VCV, PCV and PSV ventilatory modes during the immediate postoperative period on the variables resulting from regional and global pulmonary electrical impedance and diaphragmatic mobility, as well as perform ventilator synchrony analysis in PSV mode by mechanical ventilator. Half of the participants will receive VCV followed by PSV for weaning, while the other half will receive PCV followed by PSV for weaning.

In the immediate postoperative period of cardiac surgery, patients are found under mechanical ventilatory support. Commonly, they are ventilated in controlled and assisted-controlled volume (VCV) or pressure (PCV) modes, with weaning at pressure support (PSV).

Systematic reviews indicate that there is no difference between the VCV and PCV ventilatory modes for some clinical outcomes or that the existing evidence is insufficient. The distribution of regional ventilation and diaphragmatic mobility can be measured from the use of electrical impedance tomography (EIT) and diaphragmatic ultrasonography (US) to clarify the physiological changes and / or mechanisms of adaptation of the organism submitted to controlled modes cycled at volume or at pressure and spontaneously flow cycled mode.

Besides EIT and US measures, gasometric, hemodynamic and respiratory data will also be recorded. The statistical analysis will be considered α≤0.05 for a statistically significant difference.

Eligibility Criteria:
Inclusion Criteria:

* IMC 18.5-29.9 kg/m²
* Two thoracic tubes (one mediastinal and one left-sided pleural)
* under mechanical ventilation after surgery
* submitted to intraoperative extracorporeal circulation

Exclusion Criteria:

* Over 2h of cardiopulmonary bypass
* Over 12h of post-operative mechanical ventilation
* Post-operative bleeding above 500 ml in the first hour or above 300 ml in the first two hours
* History of special conditions (neuromuscular and chronic pulmonary disease, thoracic deformity, abdominal distension).
Pharmacokinetic Drug Interaction Between Pregabalin and Thioctic Acid.

A randomized, open-label, six-sequence, three-period, three-treatment, multiple dosing clinical trial to investigate the pharmacokinetic drug interaction between Pregabalin and Thioctic acid after oral administration in healthy male volunteers.


Eligibility Criteria:
Inclusion Criteria:

1. Body weight ae least 50kg and BMI(body mass index) within the range of 18 to 27kg/m2
2. Provision of signed written informed consent
3. Acceptable physical examination and clinical examination, during screening

Exclusion Criteria:

1. A subject with clinical evidence or history of hepatic (including carrier of hepatitis virus), renal, respiratory, endocrine, neurologic, immunologic, hematologic, oncologic, psychiatric, or cardiovascular disease
2. A subject with a history of gastrointestinal disease or surgery (except simple appendectomy or repair of hernia), which can influence the absorption of the study drug
3. A subject with history of allergies including study drug (pregabalin or thioctic acid) or other drug allergies (aspirin, antibiotics, etc.), or history of clinically significant allergies
4. A subject whose lab test results are as follows: AST(SGOT), ALT(SGPT) \> 1.5 x upper limit of reference range
5. Presence or history of drug abuse or positive result in urine drug screening test
6. Use any prescriptive medication, Korean traditional medication not considered acceptable by the clinical investigator during the last 14 days period before first dosing, or use any OTC medication not considered acceptable by the clinical investigator during the last 7 days period before first dosing (if used medication is considered acceptable by investigator, patients can be included)
7. Participation in clinical trials of any drug within 60 days prior to the participation of the study
8. Blood donation during 2 months or apheresis during 1 month before the study
9. Use of alcohol over 21 units/weeks
10. Smoker who smoke more than 10 cigarettes per day or who cannot stop smoking during the study period (from 24 hours before hospitalization to discharge)
11. Use of caffeine drink during the study period(from 24 hours before hospitalization to discharge)
12. A subject who takes grapefruit, grapefruit juice, or grapefruit-containing products during the study
13. Judged to be inappropriate for the study by the investigator after reviewing clinical laboratory results or other reasons.