cyrilzakka/clinical-trials huggingface dataset:
Confirmation of Accuracy of the Tool-in-lesion Technology (TiLT) of the Galaxy System With Integrated TOMO Technology

This study will evaluate the feasibility of performing robotic navigation of peripheral airways in human subjects for the purpose of biopsying peripheral lung lesions.

Successful biopsy of peripheral pulmonary lesions continues to be a challenge due to a number of factors, one of which may be the ability to gain access to peripheral lesions due to the size and maneuverability of conventional bronchoscopes. In this study, investigators will evaluate the feasibility of the Galaxy System, which uses a built-in real-time navigation system called TiLT Technology, to both access and biopsy peripheral pulmonary lesions.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18
2. Patients with a moderate to high risk of lung cancer based on clinical, demographic and radiologic information, determined by the treating physicians based on the site's standard of care
3. Peripheral pulmonary subsolid and solid nodules (PPNs) sized 1-3 cm measured as the largest dimension where all or the majority of the lesion is located in the periphery of the lung
4. Pre-procedural CT is conducted within 90 days of the bronchoscopy procedure
5. PPNs that are accessible bronchoscopically on planning CT reconstruction
6. Informed consent properly obtained per local regulations

Exclusion Criteria:

1. Known pregnancy or breastfeeding
2. Patients with pure ground-glass nodules on pre-procedural chest CT
3. Uncontrolled coagulopathy or bleeding disorders
4. Ongoing systemic infection
5. History of lobectomy or pneumonectomy
6. Patient is participating in another drug or device trial or participated in another drug or device trial in the last 30 days.
7. Moderate-to-severe hypoxia, hypoxemia, or hypercarbia per PI's discretion
8. Patients with pacemakers or defibrillators
9. Unsuitable for bronchoscopy procedure under general anaesthesia as agreed by the treating clinician and anaesthetist
eCare for Moods: An Internet-based Management Program

The study aim is to explore the effect of a comprehensive Internet-based disease management program for bipolar disorder and recurrent or chronic major depression on clinical outcomes and satisfaction with care.

This study is a randomized controlled trial that includes 404 subjects, 300 subjects with bipolar disorder and 104 subjects with recurrent or chronic major depressive disorder. The study subject diagnostic groups (bipolar and depressive) are separately randomized to either usual care or to eCare and the data collected from the two diagnostic groups are analyzed separately.

All subjects randomized to the eCare intervention are assigned an eCare nurse care manager in addition to one year of access to an Internet-delivered care management and patient self-management program. While both diagnostic groups receive similar Internet-delivered services for depression, the subjects with bipolar disorder receive special services for bipolar disorder. All subjects randomized to usual care will receive their normal psychiatric care and do not have access to the website.

Study subjects are followed for 24 months and outcome measurements are taken every six months by telephone interviewers blinded to treatment assignment. Specific measures include depression and mania symptoms, severity, adherence with medication, general health, functioning at work and at home, satisfaction with care, and confidence in coping with their disorder. The primary outcomes for patients with bipolar disorder are the severity of depression and the severity of mania over time. The primary outcome for patients with recurrent or chronic depression is the severity of depression over time. The hypothesis is that Internet-based care management will have a favorable effect on the burden of bipolar disorder and/or on recurrent/chronic depression over time.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of bipolar or recurrent major depressive disorder and access to a computer

Exclusion Criteria:

* No diagnosis of bipolar or recurrent major depressive disorder, no computer access
Targeted Temperature Management After In-Hospital Cardiac Arrest

The purpose of this study is to determine whether targeted temperature management at 36.0˚C(TTM-36) in patients who remain unconscious after resuscitation from in-hospital cardiac arrest(IHCA) will reduce death and disability compared with fever control. For this purpose, the current pilot study will be undertaken to establish the feasibility, safety, and surrogate outcomes of hypoxic-ischemic brain injury in 60 patients who remain unconscious after resuscitation from IHCA.

Eligible patients will be randomly assigned in a 2:1 ratio to either TTM-36(n=40) or conventional treatment group(n=20). Randomization will be performed with stratification according to initial rhythm (shockable vs. non-shockable).


Eligibility Criteria:
Inclusion Criteria:

* Age 18-80 years
* In-hospital cardiac arrest requiring chest compression for \> 2 minutes
* Sustained restoration of spontaneous circulation(ROSC) for \> 20 minutes after cardiopulmonary resuscitation(CPR)
* Unresponsive state(lack of meaningful response to verbal commands) for \> 20 minutes after sustained ROSC
* Informed consents from a patient's family member

Exclusion Criteria:

* Unavailable TTM within 2 hours after ROSC
* CPR duration \> 30 minutes
* Unwitnessed arrest with initial rhythm asystole
* Under or planned for extracorporeal membrane oxygenation(ECMO)
* Initial body temperature \< 33 °C
* Preexisting terminal illness with life expectancy \<6 months
* Pre-admission CPC score of 3-5
* Pre-admission mRS score 4-6
* Unresponsive(stupor or coma) before cardiac arrest
* Suspected or confirmed cause of cardiac arrest is diseases of the central nervous system, such as stroke, brain tumor, or amyotrophic lateral sclerosis
* Any condition in which direct skin surface cooling would be contraindicated, such as large burns, unhealed surgical wounds, decubitus ulcers, cellulitis, or other conditions with disrupted skin integrity
* Active massive bleeding
* Major surgery within last 48 hours
* Cardiothoracic surgery within 14 days
* Planned surgery within next 72 hours after ROSC
* Enrolled in other clinical trials
* Pregnant women
* Do-not-resuscitate(DNR) state
* Patients whose family or treating physicians refuse to join this study
Link Between the Peripheral Mononuclear Cells' Capacity to Induce Insulin Resistance and Hyperinsulinemia

This is a two-center proof-of-concept study, ancillary to the MetACTIV study, whose objective is to define immune activation profiles from the data of individuals followed by the Caisse Primaire d'Assurance Maladie du Gard (health insurance fund).

The IRACTIV study will include a subset of volunteers from the MetACTIV study for whom a blood sample will be taken as part of the IRACTIV study.

The local health insurance fund regularly offers people who have already had a free health check-up the opportunity to re-do a check-up. This invitation will be made as part of the routine, by mail. People who have participated in the MetACTIV study will be asked to participate in the present IRACTIV study ( they will be sent an information note). That way, up to 30 volunteers who previously participated in the MetACTIV study, including 10 for whom a particular profile has been identified will be recruited again in sequence.

On the day of consultation at the Gard health insurance fund, consent will be collected from subjects who have agreed to participate. The participation of the volunteers will be reduced to this single visit and 16 mL of blood will be collected on EDTA for the purpose of this study. As in the previous MetACTIV study, this blood will be transported to the Biological Resource Center at Nîmes University Hospital. From this blood, the plasma will be frozen and stored at -80°C for subsequent determination of insulin levels under the same conditions as for the MetACTIV study. Peripheral blood mononuclear cells will be frozen and, later, cultured at the Institute of Human Genetics in complete medium for 48 hours. The effect of the supernatants of these cultures on Akt phosphorylation in HepG2 cells exposed to 10nM of insulin will then be quantified by two different techniques (Western Blot and ELISA). This effect will be expressed as a percentage of inhibition compared to the phosphorylation of Akt induced by insulin alone. The insulin slope between the measurement performed in the MetACTIV study and this IRACTIV study will also be calculated and compared to the peripheral blood mononuclear cells ability to induce insulin resistance in vitro.

Eligibility Criteria:
Inclusion Criteria:

* Individuals who participated in the MetACTIV study.
* Profile 2 subgroup-specific inclusion criteria:
* MetACTIV study individual with a Profile 2.
* Persons who have given free informed consent.
* Persons who have signed the consent form.
* Persons affiliated to or benefiting from a health insurance plan.
* Adults (≥18 years of age).

Exclusion Criteria:

* Persons participating in Category 1 research involving human subjects
* Persons in an exclusion period as determined by another study.
* Persons under court protection, guardianship or trusteeship.
* Persons who are incapable of giving consent.
* Persons for whom it is impossible to give clear information.
* Pregnant, parturient or breastfeeding woman.
Switching to Duloxetine From Other Antidepressants

A multicentre, randomised, open label study of out-patients with major depression who have failed to respond adequately to antidepressant treatment for their current episode of depression. The study compares outcomes associated with two methods of switching from current antidepressant to duloxetine


Eligibility Criteria:
Inclusion Criteria:

* Male and female outpatients of at least 18 years of age, who meet criteria for Major Depressive Disorder (MDD)
* Currently non- or only partially-responsive to an SSRI antidepressant after at least 5 weeks of treatment

Exclusion Criteria include:

* Current primary Axis I disorder other than MDD
* Previous diagnosis of bipolar disorder, schizophrenia, or other psychotic disorders
* Patients judged to be at serious suicidal risk.
* Serious medical illness
The Volume Effect of Hydrodissection for Carpal Tunnel Syndrome

The investigators investigated the volume effect of hydrodissection for Injection therapies in patients with Carpal Tunnel Syndrome. The investigators evaluated participants by Shear Wave Ultrasound Elastography and Artificial Intelligence Imaging Analysis

The investigators investigated the volume effect of hydrodissection for Injection therapies in patients with Carpal Tunnel Syndrome. The investigators evaluated participants by Shear Wave Ultrasound Elastography and Artificial Intelligence Imaging Analysis

Eligibility Criteria:
Inclusion Criteria:

* Age 20-80
* Electrophysiological diagnosis of carpal tunnel syndrome
* At least one of the following two:

  1. Tenderness or numbness over median nerve innervated dermatome over 2 months
  2. Phalen test or Tinel sign or flick sign positive

Exclusion Criteria:

* History of wrist surgery
* Wrist trauma in recent two years
* Received wrist injection in recent three months
* History of brachial plexopathy, cervical radiculopathy or thoracic outlet syndrome
* History of DM, thyroid disorder or autoimmune disease
* Unable to cooperate with interview, examination or injection
Effect of Audiovisual Education on Breast Cancer

This study was conducted as a double-blind randomised controlled trial to determine the effect of education using audio-visual methods and simulation techniques on breast cancer screening and breast cancer fears in illiterate women. The study was conducted in the villages of a district in the south of Turkey with a distance of over 100 km to health institutions. The sample size of the study was calculated with the G\*Power 3.1 programme based on the mean breast cancer fear scores (22.42±8.30 for those without family history and 28.14±6.23 for those with family history) in a study, with a 95% confidence interval, 5% margin of error, 0.92 effect size and 95% power. As a result of this analysis, the minimum sample size required was determined as 64 people in total. However, a total of 120 women were included in the study in order to increase the power of the research, to prevent possible data loss and to make the results more reliable. Participants were divided into intervention (n=60) and control (n=60) groups by simple random sampling method.


Eligibility Criteria:
Inclusion Criteria:

1. Being between the ages of 40-69 (Republic of Turkey Ministry of Health, 2020a).
2. Being a woman living in rural areas.
3. Being an illiterate woman.
4. Not being diagnosed with breast cancer.
5. Not being pregnant, breastfeeding or puerperant.
6. Accepting to participate in the study.
7. Absence of a mental illness.
8. No communication barriers

Exclusion Criteria:

1. Not having completed the given training sessions
2. Having had problems with breast cancer before.
3. Having breast conserving surgery for any reason.
Prospective Chart-Review: Impact of Combination - Digital Breast Tomosynthesis + Digital Mammography

Digital Breast Tomosynthesis (DBT) is a technology that has been developed to improve lesion detection in dense breasted women. Even though DBT has been regarded as a study for dense breasted women, it may also improve lesion detection at an earlier stage and smaller size in women with less dense breast tissue. The overlapping of tissue on a standard of care 2D mammogram leads to decreased cancer detection, it also contributes to pseudo lesions that mimic cancers. This leads to patients being asked to come back for additional imaging including mammogram and/or ultrasound images. DBT has shown to decrease call back rates by up to 43% in reader studies. Even though these results are promising they were not done in a realistic clinical setting.The purpose of this study is to evaluate the FDA-approved combination standard digital mammography (DM) and DBT technology and its impact on our clinical practice.

The investigators would like to prospectively measure the impact on recall rates, comparing DM (digital mammography) and DM+DBT, in our practice and the impact on cancer detection in our screening population. This is a two-site study in which all asymptomatic subjects undergoing the FDA-approved combination standard of care Digital Mammogram and Digital Breast Tomosynthesis (DM+DBT) exam will be eligible for the trial. Each subject will be her own control.Only radiologists who have gone through 8 hours of Tomosynthesis training will interpret the DM and DBT images. These radiologists will categorize each case as either dense (BI-RADS density score of 3 or 4) or fatty (BI-RADS density score of 1 or 2). The radiologist will initially read the standard of care DM part of the study first and record their interpretation and final BIRADs category. The same radiologist will then interpret the DM+DBT combination study and record their final interpretation and BIRADs category. Prior mammogram studies will be used for comparison when reading the DM and DM+DBT studies.

Eligibility Criteria:
Inclusion Criteria:

* Female ages 30 and over
* Asymptomatic
* Any ethnic origin
* No contraindication for routine bilateral mammogram

Exclusion Criteria:

* Pregnancy
* Lactating patients
* Breast implants
* Unable to understand and execute written informed consent
* Patient unable to obtain a mammogram while standing without assistance
Transmission of Mother-Infant Stress Communication

The central aim of this study is to assess mother-infant communication via behavioral, physiological, and affective indices under conditions where distal stressors may not be directly detectable by the infant.

This investigation examines a distal maternal stressor on the quality of interaction in mother-infant dyadic communication. Assessments include behavioral, physiological, and affective indices under conditions where distal stressors may not be directly detectable by the infant. The present research examines mother-infant interactions to test the hypothesis of whether maternal stress may be transduced to their infants via multiple pathways. The secondary aim is to explore effective emotion regulation strategies for the mother as potential buffers to stress and additionally reducing early life stress effects on the infant's regulatory development.

While the emotion regulation literature posits that reappraisal may be associated with decreased in physiological and psychological stress, this type of regulation strategy may be ineffective when interfacing with discrimination. The regulation strategy needs to be titrated to the stressor in order to be effective. These findings will have notable social, clinical, and psychological significance,

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers

Exclusion Criteria:

* No presence of heart murmur or wear a pacemaker
* No medication for hypertensive or cardiovascular disease
* Not using beta blockers
Study for Patients Previously Treated in Avapritinib Clinical Trials

This is an open-label extension study to provide long term safety data for GIST patients who are deriving clinical benefit from avapritinib upon the completion of avapritinib clinical trials.


Eligibility Criteria:
Inclusion Criteria:

1. Patient has histologically confirmed metastatic or unresectable GIST as established by entry in a previous avapritinib clinical trial and has been receiving treatment with avapritinib on one of these trials.
2. Patient continues to receive clinical benefit from avapritinib treatment, as assessed by the investigator.
3. Patient or legal guardian, if permitted by local regulatory authorities, provides informed consent.

Exclusion Criteria:

1. Patient requires therapy with a concomitant medication that is a strong inhibitor or strong inducer of cytochrome P450 (CYP) 3A4
2. Patient has a history of intracranial bleeding either prior to or during avapritinib treatment
3. Patients who have poor organ function, defined as Adverse Events of NCI CTCAE version 5.0 Grade 3 or higher at the time of enrollment must delay start of treatment until symptoms return to Grade 2 or baseline, or the start of treatment has been approved by the Sponsor.
4. Patients who have ongoing cognitive or mood effects Adverse Events of NCI CTCAE version 5.0 higher than Grade 1 must delay start of treatment until symptoms return to Grade 1 or baseline.
5. Women who are unwilling, if not postmenopausal or surgically sterile, to abstain from sexual intercourse or employ highly effective contraception from the time of enrollment and for at least 30 days after the last dose of avapritinib. Men who are unwilling, if not surgically sterile, to abstain from sexual intercourse or employ highly effective contraception from the time of first dose and for at least 90 days after the last dose of avapritinib.
6. Women who are pregnant.
7. Women who are breast feeding.
Measure the Serum Level of Homocysteine in Acne Patients Before and After Oral Isotretinoin.

Serum homocysteine level in Acne patients before and after oral Isotretinoin and Correlation between serum level of homocysteine in acne patients before and after Oral isotretinoin treatment

Acne vulgaris is a common chronic inflammatory disease of the skin. It is found in about 80% of young adults and adolescents. It is a disease that affects the pilosebaceous units of the skin and may result in inflammatory or non-inflammatory lesions,Oral isotretinoin (13-cis-retinoic acid) is the only drug that counteracts all the pathogenetic mechanisms that contribute to the development of acne The standard dose of isotretinoin is 0.5 to 1 mg/kg per day for 4 months to a cumulative dose of 120-140 mg/kg is effective in the management of acne vulgaris The scope of our study is to detect serum homocysteine level in acne patient befor and after oral isotrtinoin treatment

Eligibility Criteria:
Inclusion Criteria:

* Patients of both sexes with acne vulgaris

Exclusion Criteria:

* Patients with history of malignancies.
* Patients with renal and hepatic dysfunction.
* Cardiac patient.
* Pregnant, lactating and female welling to have pregnancy in the period of study.
* Patient with absorption disorder.
* Patient with history of favism.
* Patient has already been treated with isotretinoin.
A Study Evaluating Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of Single IV Dose of HSK3486 Injectable Emulsion in Healthy Subjects.

his single-center, open-label, uncontrolled, and dose-escalation study evaluated the safety, tolerability, and pharmacokinetics/pharmacodynamics of single IV dose of HSK3486 injectable emulsion in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy males or females with full capacity for civil conduct, between 18 and 49 years old (inclusive);
2. Body weight \> 45 kg, and body mass index (BMI) ≥ 19 and ≤24 kg/m2;
3. Blood pressure between 90-140/60-90 mmHg; heart rate between 60-99 bpm; body temperature between 35.8-37.5 ºC; respiration rate between 12-24 breaths per minute; SpO2 when inhaling \> 95%;
4. Normal physical examination, laboratory tests (blood routine, blood biochemistry, and urine routine), 12-Led ECG, posteroanterior and lateral chest x-ray, and or abnormal but without clinical significance (determined by investigator); no potential difficult airway;
5. Subjects must understand the procedures and methods of this study, and be willing to provide informed consent and to complete the trial in strict accordance with clinical trial protocol.

Exclusion Criteria:

1. Known sensitivity to propofol, excipient in propofol medium and long chain fat emulsion injection, excipient in HSK3486 injectable emulsion;
2. contraindicated in general anesthesia;
3. Received any one of the following medications or treatments prior to screening/enrollment:

   1. History of medication abuse or any signs of chronic benzodiazepines use (such as insomnia, anxiety, spasms) within 3 months prior to screening, or a positive urine medication test (during screening or at baseline);
   2. Participated in clinical trials involving any medications or medical devices within 3 months prior to screening, or participated in 3 or more drug clinical trials within the past year;
4. History or evidence of increased risk of sedation or anesthesia, such as cardiovascular disease, respiratory disease, cerebrovascular disease, gastrodintestinal disease and other system disease prior to the screening and/or baseline period;
5. Laboratory results that meet any of the following during screening/enrollment:

   1. Positive for HBsAg, HCV, or HIV;
   2. Abnormal hepatic or renal function confirmed after re-examination;

      * ALT or AST \> ULN;
      * Creatinine \> ULN;
6. History of smoking for more than 3 weeks and/or respiratory irritation caused by smoking within 3 months prior to screening;
7. History of alcohol abuse within 3 months prior to screening or a positive alcohol test (baseline);
8. Women who are pregnant or breastfeeding; women of child-bearing potential or men who are unwilling to use contraception during the trial;
9. Subjects judged by the investigator to be unsuitable for participating in this trial for any reason.