cyrilzakka/clinical-trials huggingface dataset:
Multicenter Registry Study With Therapeutic Hypothermia After Cardiac Arrest in Japan

Recently, early defibrillation and cardiopulmonary resuscitation (CPR) for sudden onset of cardiac arrest are advancing, however, survival rate is still very low in the world. Furthermore, post-cardiac arrest brain injury is a common cause of morbidity and mortality after successful resuscitation which is urgent issue to be solved. Therapeutic hypothermia is part of a standardized treatment strategy for comatose survivors of cardiac arrest in the metabolic phase usually about 15 minutes after cardiac arrest. However, the evidences of the efficacy of therapeutic hypothermia are still few. The optimal candidates, temperature, the timing of initiation, the therapeutic windows and the rate for rewarming have not been defined clinically and should be established. The purpose of this research is the improvement in the outcomes for patients with coma after resuscitation from out-of-hospital cardiac arrest using therapeutic hypothermia established from the analysis of multicenter registry data.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients who remained unconscious after resuscitation from out-of-hospital or inhospital cardiac arrest
* Presented the stable hemodynamics with drug treatments or mechanical supporting system including IABP or PCPS

Exclusion Criteria:

* Patients with:

  * pregnancy
  * acute aortic dissection
  * pulmonary thromboembolism
  * drug poisoning
  * poor daily activity
Pain Pressure Threshold in Elbow Pain

Although validity and reliability studies have been completed in different patient groups in the literature, the validity and reliability of pressure pain threshold assessment in patients with elbow pain has not been studied. This study aims to study the validity and reliability of pressure pain threshold assessment in patients with elbow pain.

Unidimensional and multidimensional scales based on patient reporting are mostly used in pain assessment. Although determining pain severity based on patient reporting is important, the patient's physiological and psychological characteristics may make it difficult to interpret the responses. Therefore, objective measurement of pain is very valuable in assessing health status. Another approach to assessing variation in pain perception is to define pressure pain threshold. Although validity and reliability studies have been completed in different patient groups in the literature, the validity and reliability of pressure pain threshold assessment in patients with elbow pain has not been studied. This study aims to study the validity and reliability of pressure pain threshold assessment in patients with elbow pain.

Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 18-65 years
* Having non-specific elbow joint pain that has been ongoing for the last 3 months
* Having the ability to read and write Turkish
* No vision or hearing problems
* Must have a level of cooperation that can comply with the evaluation

Exclusion Criteria:

* Participated in a physiotherapy program due to elbow problem in the last 6 months
* Presence of neurological or cognitive impairment
* Fractures related to malignant conditions and/or elbow fractures
* Nerve injury, heterotopic ossification or myositis ossificans
* Having elbow arthrosis and/or elbow joint contracture
* Nonunion, malunion and infection problems
* Having complex regional pain syndrome
* Having any known rheumatological, cardiovascular, respiratory or psychiatric disease
* Having a skin disease that will affect the upper extremity evaluation
Platform-based Mild Cognitive Impairment (MCI) Trial

The process of receiving a diagnosis of mild cognitive impairment (MCI) is recognized to induce behavioral responses that can be either adaptive or maladaptive. Five specific areas of concern have been identified, including: 1) failure to plan for future decline, decreased compliance and interaction with medical care providers, 3) decreased confidence and reduced social engagement, 4) increased physical limitations and 5) decreased medication compliance. In this pilot study, participants with MCI and their study partners will participate in behavioral interventions (primarily training workshops and classes) targeting each of these five areas of potential maladaptive behaviors.

Following the approval of an application reviewed by the University's Institutional Review Board, the researcher will evaluate the intervention using a complimentary mixed methods approach. The study will consist of a single-site platform trial examining the intervention group. There are many benefits to using a platform trial approach. First, using a platform trial allows the 18 participants to explore different arms of the intervention. Second, the platform design will allow us to also determine the effects of the interventions on patient help-seeking and adherence behavior in real-world care is critical to estimates of cost-effectiveness. As one of the specific aims of this study is to determine user feedback about modifying behaviors from various interventions, as opposed to determining which intervention is most effective, a platform trial will accomplish this.

Eligibility Criteria:
Inclusion Criteria:

* current subjects of the University of Kentucky Alzheimer's Disease Center (ADC)
* meet consensus guidelines for mild cognitive impairment (MCI) developed by the Second International Working Group on MCI
* have been diagnosed within the last year
* able to provide informed consent
* have a study partner willing to participate

Exclusion Criteria:

* history of stroke
* significant neurological or psychiatric conditions
* brain injury
* residence in institutional setting
Recognition of Heart Failure With Micro Electro-Mechanical Sensors (REFLECS)

The study will test the ability a novel wearable sensor based on a smartphone app (Precordior CardioSignal app) in combination with a sensor device (Suunto Movesense sensor) to non-invasively measure cardiac motion and function.

Heart Failure (HF) is a syndrome where the heart is unable to pump or fill adequately to meet the circulatory needs of the body. The main purpose of this study is to test the ability a novel wearable sensor based on a smartphone app (Precordior CardioSignal app) in combination with a sensor device (Suunto Movesense sensor) to non-invasively measure cardiac motion and function. The phone and sensor are positioned on the chest and echocardiography is used as a gold standard to assess cardiac mechanics including myocardial strain, cardiac torsion, diastolic filling characteristics, hemodynamics including pressure estimates and stroke volume.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 21 years
* Able to consent in English and follow study instructions
* Patients hospitalized or being seen in clinic with heart failure with a diagnosis of HFpEF, HFrEF or PH, as corresponding to each target patient group
* Control patients may include patients that are hospitalized without heart failure, and cardiology patients without heart failure who are seen in outpatient cardiology, who may have suspected CAD and are scheduled for CCTA.

Exclusion Criteria:

* Severe cardiac valvular heart disease
* Previous prosthetic cardiac valve
* Pericardial disease including constrictive pericarditis or moderate or large pericardial effusion
* Mechanical circulatory support (including ECMO, LVADs etc).
* Heart and/or lung transplant recipients
* Major adverse cardiovascular event or surgery within 6 weeks of planned study enrollment
* Patients with pacemaker that has over 1% of beats paced
* Pectus excavatum (severe)
* Pregnant women
* On Dialysis
* Exclude at the clinical discretion of the Principal Investigators
* Not possible to acquire echocardiography with sufficient quality
SOLIRIS® (Eculizumab) Treatment of Participants With COVID-19

This protocol provides access to eculizumab treatment for participants with severe COVID-19.

This is an open label, multicenter, Expanded Access Program (EAP) to allow participants with a confirmed diagnosis of SARS-CoV-2 infection, and a clinical presentation consistent with COVID-19 severe pneumonia, acute lung injury, or ARDS to be treated with eculizumab. Participants admitted to a designated hospital facility who qualify for emergency treatment will be administered eculizumab up to 7 times during their treatment course (5 mandatory doses and up to 2 optional doses, per Investigator assessment).

The EAP consists of a Screening Period of up to 7 days, a 4-week Treatment Period, a final in-hospital assessment on Day 29 or day of discharge, whichever occurs first, and 3 monthly safety follow up visits (to be conducted as a telephone call if the participant has been discharged from the hospital or an in-person visit if the participant is still hospitalized).

For each participant, the total duration of the program is anticipated to be 4.5 months.

Eligibility Criteria:
Inclusion Criteria:

1. Males or females ≥ 18 years of age and ≥ 40 kg at the time of providing informed consent.
2. Confirmed diagnosis of SARS-CoV-2 infection presenting as severe COVID-19 requiring hospitalization
3. Symptomatic, bilateral pulmonary infiltrates confirmed by CT or X-ray at Screening or within the 7 days prior to Screening
4. Severe pneumonia, acute lung injury, or ARDS requiring oxygen supplementation

Exclusion Criteria:

1. Confirmed diagnosis of SARS-CoV-2 infection presenting as mild to moderate COVID-19, even if the participant is hospitalized
2. Participant is not expected to survive more than 24 hours
3. Participant has an unresolved Neisseria meningitidis infection
4. Hypersensitivity to murine proteins or to one of the excipients of Soliris
Impact of Sperm DNA Integrity on In Vitro Cycles

Sperm DNA integrity will be measured via the Toluidine Blue Assay (TBA) for patients undergoing In Vitro Fertilization (IVF); the study will determine correlations, if any, between IVF success and sperm DNA integrity.


Eligibility Criteria:
Inclusion Criteria:

* couple undergoing IVF at the Center for Human Reproduction
* sperm sample given from partner (not a donor)

Exclusion Criteria:

* low sperm concentration (\<5 million/cc)
* using a donor sample
Real-time Identification of the Aberrant Left Hepatic Arterial Territory in the Liver Using Near-infrared Fluorescence Imaging

" Hepatic artery variants are occasionally seen, especially 20-30% of aberrant left hepatic artery. In radical gastrectomy, decision for aberrant left hepatic artery(ALHA) ligation should consider the oncologic safety and liver-related complication. Theoretically, the ALHA preservation is the most ideal in the aspect of liver function protection. However, it is technically difficult which consumes much time. Not only that, oncologic safety could be threatened as some soft tissues, including lymph nodes, could be remained while in preserving the ALHA.

There has been no standardized method to evaluate the ALHA, and to decide whether preserve or ligate it.

This prospective study has been designed to develop the decision algorithm to define the ALHA preservation/ligation, using near-infrared fluorescence imaging during surgery. "


Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed with gastric adenocarcinoma pathologically before surgery
2. Patients aged between 20 to 80
3. Patients with an ECOG 0 or 1
4. Patients who were confirmed the presence of aberrant left hepatic artery before or during surgery

Exclusion Criteria:

1. Patients with abnormal liver function test befor surgery
2. Patients who diagnosed liver cirrhosis or infectious liver disease
3. Patients who underwent liver resection, or chemotherapy for gastric cancer
4. Patients planned for combined liver resection or cholecystectomy during gastrectomy
Impact of the Immune System on Response to Anti-Coronavirus Disease 19 (COVID-19) Vaccine in Allogeneic Stem Cell Recipients (Covid Vaccin Allo)

The present study is a prospective phase IV study. All participants will receive the anti-Coronavirus Disease 2019 (COVID-19) Vaccine (messenger Ribonucleic acid-based vaccine, BNT162b2 or Comirnaty®, commercialized by Pfizer-BioNTech) being authorized in the European Union since December 2020. The vaccine is administered intramuscularly after dilution as a series of two doses at least 21 days apart.

The central question is whether allo-hematopoietic cell transplantation (allo-HCT) recipients can develop protective immunity against COVID-19 upon vaccination. This question needs to be answered urgently and would help the hematologist to provide recommendation / best treatment for these patients. In this pilot project Cov-Allo, this important question will be addressed in a cohort in which allo-HCT recipients will be vaccinated with the mRNA available COVID-19 vaccine according to the Belgian vaccination program. The primary objective is to assess immune response after administration of COVID-19 mRNA Vaccine BNT162b2 (Comirnaty®; Pfizer-BioNTech) in a population of 50 patients allo-HCT recipients. This number is based on the availabilities of vaccines and eligible patients. Moreover, as the study is observational and exploratory, no sample size calculation could be provided for this study.

Eligibility Criteria:
Inclusion Criteria:

* prior allogeneic hematopoietic stem cell transplantation 3 months to 5 years earlier (any donor type)
* age \> or = 18 years at inclusion.
* written informed consent

Exclusion Criteria:

* HIV seropositivity
* Pregnancy
* Active malignant disease at inclusion
* Current grade III-IV acute Graft Versus Host Disease (GVHD)
* In vitro T-cell depletion of the graft if vaccination within the 6 months after transplantation.
* Rituximab administration in the 6 months prior to study inclusion
* Prior documented COVID-19 infection
Psychosocial Factors and Quality of Life in the Effect of Fear of COVID-19 With Cystic Fibrosis

The purpose of this study; The COVID-19 pandemic is to investigate the effects of COVID-19 fear levels of patients with cystic fibrosis on the psychosocial and quality of life levels of individuals.

After individuals were informed about the study, it was administered to individuals who gave written informed consent.This study was carried out on individuals with cystic fibrosis and healthy individuals who meet the eligibility requirements, through online forms.

Eligibility Criteria:
Inclusion Criteria:

* be 16 years of age or older
* Having been diagnosed with Cystic Fibrosis
* Volunteering to participate in the research

Exclusion Criteria:

* Being mentally incapable of successfully applying the scales to be applied for evaluation purposes
* Being treated with sedative and antiepileptic drugs
* Pregnancy
The Safety and Efficacy of Pemetrexed Rechallenge With Bevacizumab

For patients with nonsquamous NSCLC and a good performance status (PS), pemetrexed and cisplatin has been recommended for first-line NSCLC treatment. Recently, results from the PARAMOUNT trial showed that patients with nonsquamous NSCLC who had a good PS and had not progressed after completing four cycles of pemetrexed-cisplatin induction therapy benefitted from pemetrexed continuation maintenance therapy. Furthermore, pemetrexed with bevacizumab continuous maintenance might be better treatment option, considering the results from AVAPEARL trial. Pemetrexed rechallenge has been reported to be effective in some patients. Therefore, in order to investigate the safety and efficacy of pemetrexed rechallenge with bevacizumab,we conducted this study.


Eligibility Criteria:
Inclusion Criteria:

* 20 Years and older
* PS0-2
* Advanced non-squamous non-small cell lung cancer; AND
* Patients who have received more than 4 cycles of pemetrexed therapy before the study

Exclusion Criteria:

* Interstitial pneumonia; AND
* Abnormal blood test
A Randomized-Controlled Lifestyle Intervention to Increase Physical Activity Levels in Adolescents

Students at the age of 14-16 years will be randomized to one intervention arm or one control arm in a 1:1 ratio. Participants of both groups receive a fitness tracker to count the amount of their steps taken. The participants of the intervention arm will commit themselves to a personal goal of steps taken by means of a commitment contract. Achievement of the goal will be rewarded with financial incentives to fulfill the requirements of proper reward medium, according to the Induced Value Theory (Smith, 1976).

The duration of the intervention will be 1 year; incentives are provided for 6 months, the remaining 6 months are the follow-up period.

The hypothesis is that intensified motivational strategies like the provision of commitment contracts and nudges are effective in increasing the number of steps taken per month compared to a control group.

Adolescents age 14 to 16 years visiting schools throughout Tyrol, Austria will be randomized to one intervention arm or a control arm on a class-wise level in a 1:1 ratio. Participants will be invited by the Department of Education in Tyrol and schools will be contacted directly. At the baseline examination cardiovascular risk profiles (including laboratory analysis; anthropometry; a standardized medical interview; and blood pressure, bioelectrical impedance and pulse-wave velocity measurements) are determined and results are communicated in an individual discussion of results.

Afterwards, participants of both groups receive a fitness tracker to count the amount of their steps taken. The participants of the intervention arm will commit themselves to a personal goal of steps taken by means of a commitment contract. Achievement of the goal will be rewarded with financial incentives to fulfill the requirements of proper reward medium, according to the Induced Value Theory (Smith, 1976) and nudges (reminders) will be provided to increase motivation.

The duration of the intervention will be 1 year; incentives are provided for 6 months, the remaining 6 months are the follow-up period. After 1 year a follow-up examination will be conducted. Economic experiments on time and risk preferences are furthermore carried out at baseline.

The hypothesis is that intensified motivational strategies like the provision of commitment contracts and nudges are effective in increasing the number of steps taken per month compared to a control group.

Eligibility Criteria:
Inclusion Criteria:

* Age 14 - 16 years at baseline
* Signed informed consent of subjects and legal guardian

Exclusion Criteria:

* Persons, who are suspended upon a court order or upon other legal processes or are accommodated according to the Hospitalization Act, or for whom a custodian is appointed (or appointment is initiated).
* Persons with impaired power of judgment
* Persons who are currently engaged in military or community service
A Follow-up Study With Children Who Participated in the TEMPO Study in Their First Year of Life

This is a follow-up study of a randomised clinical trial, called TEMPO (a double-blind randomized clinical trial investigating infant formula and human breast milk consumption), in which infants participated in their first year of life. The investigators like to know if these children develop allergies or infections in childhood and whether their feeding pattern in infancy plays a role.


Eligibility Criteria:
Inclusion Criteria:

* Subjects are eligible to participate in the TEMPO Follow-Up study in case:
* they completed the final (12 months) visit in the TEMPO study.
* parents agree that their contact details will be shared with a third party for study purposes.
* parents agree that data collected in the TEMPO study will be used in the TEMPO Follow-Up study.
* parents provide written informed consent for participation in the TEMPO Follow-Up in accordance with local law.

Exclusion Criteria:

* Parents who do not have a smartphone, tablet or personal computer with internet access.
Effect of Manuel Therapy on Tonus, Proprioseption and Balance in Multiple Sclerosis

This study is investigates the effect of cervical mobilization on tonus, position sense and balance in patient with multiple sclerosis. Half of participants will received classic rehabilitation program, while the other half will received servical mobilization in addition to classic rehabilitation program.

Cervical region is rich in terms of muscle spindle and reseptors. When this region is touched by physiotherapists, muscle spindles is activited. Thus position sense of joint and balance is developed. Besides, cervical region is parasympathetic area have common relaxed effect. Thus this part can be benefit to regulation of tonus.

Eligibility Criteria:
Inclusion Criteria:

* Expanded Disability Status Scale (EDSS) score was between 2-5,
* According to the modified Ashworth Scale, spasticity is between 1 and 3,
* EDSS Cerebellar System Sub-Scale, Functional System Score ˃1,
* medical condition is stable and no medication changes were made in the last month,
* Vertebro-basillar test negative,
* Not have any other neurological disorder and orthopedic problem to prevent participation in this study
* A score of at least 24 from the Mini Mental Test,

Exclusion Criteria:

* presence of psychiatric or severe cognitive dysfunction,
* pregnancy,
* Having a neurological disease other than MS,
* having had an attack in the last 3 months,
* Botulinum toxin application within the last 6 months,
* participating in physiotherapy program in the last 6 months
A Phase 1 Clinical Trial to Explore Systemic Exposure of CTO0101 Eye Drops, Safety and Local Tolerability in Healthy Adults

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetic characteristic of CTO0101


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female volunteers
* Written informed consent to participate in the trial

Exclusion Criteria:

* Those who have a history of ophthalmic diseases and surgery within 5 years
* Smokers with an average daily smoking amount exceeding 10 cigarettes