cyrilzakka/clinical-trials huggingface dataset:
A Finnish Community Randomized Psychotherapy Effectiveness Study for Major Depression

Lohja Depression Treatment Study is a randomized treatment trial which compares three approaches for treatment of depression:1) Interpersonal Psychotherapy (IPT), 2) Psychoeducational Group Treatment ( PeGT) and 3) Treatment as Usual (TAU). This Trial aims to test and adapt known short term treatment models for Finnish patients and circumstances.

Patients having signs of depression referred to Lohja area secondary level psychiatric clinics were assessed to the trial. After verification the diagnosis of Major Depressive Disorder (MDD) they were informed of the study. Consented patients were randomized to three study arms.

Baseline clinical demographics was collected. Psychotherapeutic treatment was implemented by specially trained therapists and the study data was collected by trained psychiatrists who were blinded to the therapy model patients has received.Primary outcome measure was 17-item Hamilton Depression Rating Scale (HAMD) and secondary outcome measures were Clinical Global Impression scale (CGI), Social and Occupational Functioning Assessment Scale ( SOFAS), Social Adaptation Scale ( Finnish translation JES) and Quality of Life assessment ( a Finnish validated questionnaire 15-D).The total of sick leave days and number of possible disability pensions in a year were assessed as well.

Assessments were implemented at the beginning, at 1,5 month, at 3 months ( which was the end of active treatment of short-term psychotherapies), at 6 months and at 12 months.

The primary assessment was planned to carry out using tests of group comparison. Sample size of 32 and 32 achieve 91% power to detect a clinically meaningful difference with a significance level (alpha) of 0.01 using two-sided two-sample t-test. Baseline differences in demographic variables and the depression measurement across the three treatment groups were tested using chi-square tests and analysis of variance.Likelihood-based inference using linear mixed models were employed to analyze treatment effects, focusing on the time x treatment interaction. Separate analyses assessed IPT-TAU and PeGT-TAU comparisons. All statistical analyses were performed using R. The aim of this study was to get a total of 140-160 patients, about 50 patients on one group.The final number of patients showed to be 134.

The statistical calculation was intent-to-treat model with consideration to missing data, because in this kind of natural setting notable attrition was assumed. The training of the therapists and researchers and quality control during assessments was considered and personnel was supervised throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Major Depressive Disorder - diagnosed
* Comorbid anxiety disorders

Exclusion Criteria:

* Psychosis
* Suicidal patients
* Serious acute somatic illness
* Inability to read and write
* alcohol dependence or use of illicit drugs
Sevoflurane Human Biomonitoring in Operating Room Personnel

Sevoflurane is a widely used volatile agent for induction and maintenance of anaesthesia. The administration of sevoflurane involves the risk of occupational exposure. Possible negative implications of chronic occupational exposure to sevoflurane are not completely refuted. In Germany no maximum workplace concentration for sevoflurane is defined. This study aims to find out if working conditions of physicians and different anaesthesia techniques effect the extent of occupational exposure to sevoflurane.

In this prospective observational trial 7 cohorts of 4 participants each are investigated. The cohorts consist of physicians working at different places in the operating theatre with different occupational exposure to sevoflurane, and one cohort not working in the operating theatre at all. In order to determine the extent of occupational exposure to sevoflurane a human biomonitoring is conducted. Urinary Sevoflurane and its metabolite hexafluoroisopropanol (HFIP) are measured after 3 consecutive working days.

UPDATE: After detecting traces of HFIP in all cohorts even in physicians not working in the operating theatre measurements were repeated, more cohorts were added including a negative control and measurements before the study period of 3 consecutive working days were added.

UPDATE: For comparison one cohort of patients having undergone sevoflurane anaesthesia was added.

Eligibility Criteria:
Inclusion Criteria:

* Occupational exposure to sevoflurane while conducting sevoflurane anaesthesia/being present during sevoflurane anaesthesia
* Possible occupational exposure to sevoflurane while working in the operating room/perioperative anaesthesia care unit
* No occupational exposure to sevoflurane (working outside the operating theatre)

Exclusion Criteria:

* Presence during a mask induction with sevoflurane
Phase 4 Study To Assess The Safety Of Vivotif At Different Release Titers Among Travelers

This is a multicenter (at travel clinics), phase 4 observational prospective cohort study in healthy adult male and female travelers for whom typhoid vaccination with Vivotif is recommended, as per standard practice.

This is a multicenter (at travel clinics), phase 4 observational prospective cohort study in healthy adult male and female travelers for whom typhoid vaccination with Vivotif is recommended, as per standard practice.

The study will enroll 950 subjects who will be randomized at a ratio of 1:1 into two groups, A and B, of 475 subjects each. Group A will receive 6.9-10.0 x109 CFU/capsule and Group B will receive 4.0-6.8 x109 CFU/capsule, respectively.

All subjects will receive four doses of Vivotif. One dose per subject will be administered on Days 1, 3, 5 and 7.

Investigators, subjects and all personnel involved in running the study will not be aware of the actual release titer associated with the distributed lots. Blinding is maintained using the commercial packaging that does not include the actual value of the release titer.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects are male or female aged ≥ 18 years at time of dosing
2. Subjects are travelers attending travelers' vaccination clinics
3. Subjects are eligible for typhoid vaccination, according to standard practice
4. Subjects are expected to be able to provide follow-up information
5. Subjects have an expected travel departure date more than 21 days after enrollment (to enhance follow-up by ensuring subjects remain in the US during the AE collection period)
6. Subjects must sign a written informed consent

Exclusion Criteria:

1. Subjects with a known hypersensitivity to any component of the vaccine or the enteric coated capsule
2. Subjects deficient in their ability to mount a humoral or cell-mediated immune response due to either a congenital or acquired immunodeficient state including treatment with immune-suppressive or antimitotic drugs
3. Subjects with an acute febrile illness
4. Subjects with acute gastrointestinal (GI) illness
5. Subjects who are receiving medications with antibacterial activity (including proguanil) at the time of enrollment
6. Subjects with other contraindications as determined by the site investigator
Fatty Acid Metabolism in Carriers of Apolipoprotein E Epsilon 4 Allele: Determining the Blood-to-brain Link

In Canada, \~17 millions of adults between 30-64 y old could benefit from a prevention strategy to lower the risk of Alzheimer's disease (AD). Although a lot of epidemiological studies reported positive cognitive outcomes in populations eating fish, there is skepticism about the link between docosahexaenoic acid (DHA), an omega-3 (OM3) fatty acid in fish and prevention of cognitive decline. This is largely because there is a disconnect between epidemiological, molecular and animal studies which generally favor a link between higher DHA intake and cognition whereas clinical DHA and fish oil trial seem not to support such as link. There are several knowledge gaps in this field that might explain why clinical trials were not successful. This project will focus on two major gaps : OM3 fatty acid metabolism and the blood-to-brain DHA link. OM3 supplements in cardiovascular disease have faced the same issues for decades but the more recent trials have now generated the clinical evidence supporting primary and secondary cardiovascular events reduction and a better risk to benefit balance of OM3 drugs compared to statins, for instance. What if, for cognitive decline, the target was missed because the supplement/drug formulations were not appropriately designed to target the brain? The investigators hypothesize that (i) E4 carriers display a faulty packaging of circulating OM3, leading to reduced bioavailability for brain cells, (ii) The use of new OM3 formulation can direct plasma DHA into brain compartments more readily available for the brain, thereby increasing brain DHA concentrations and improving cognition. Studies in mice and humans will be performed to test OM3 metabolism and the blood-to-brain DHA link. Ultimately the information generated in this research project will help to better design clinical trials in term of fatty acid formulation, expected level to reach in the plasma and the brain.


Eligibility Criteria:
Inclusion Criteria:

- Men and women aged between 30-50 years old.

Exclusion Criteria:

* Tobacco use,
* Malnutrition (assessed from blood albumin, hemoglobin and lipids),
* Diabetes,
* Participants taking an EPA+DHA supplement or consuming more than 2 fish meals per week,
* Uncontrolled thyroid, renal and endocrine disorder disease,
* Chronic immune condition or inflammation (CRP \> 10 mg/l, white cell count),
* Cancer,
* Recent major surgery or cardiac event,
* Pregnant or lactating women,
* Pre-menopause or menopause,
* Dementia,
* Ongoing or past severe drug or alcohol abuse,
* Psychiatric difficulties or major depression
* Ongoing or past intensive physical training.
Endovascular Treatment of Popliteal Artery - Balloon Angioplasty Versus Primary Stenting

1. Does primary stenting have a lower 12-month restenosis rate than PTA alone in the treatment of atherosclerotic lesions of the popliteal artery?

   * Alternative hypothesis: "Primary stenting with the Edwards LifeStent is associated with a lower restenosis rate than PTA alone in patients with atherosclerotic lesions of the popliteal artery at 12 months"
   * Null hypothesis: "Primary stenting with the Edwards LifeStent is not associated with a lower 12-month restenosis rate than PTA alone in patients with atherosclerotic lesions of the popliteal artery""
2. Does comparison of the two intervention groups (PTA alone, stenting) disclose differences in terms of the secondary endpoints?
3. How do the intervention methods compare in terms of safety/incidence of adverse effects?
4. What are the long-term clinical implications of the two treatment methods?


Eligibility Criteria:
Inclusion Criteria:

* The patient is at least 21 years old
* The patient or legal representative provided written informed consent
* The patient agrees to comply with the protocol-mandated follow-up visits and testing regime
* The patient has lifestyle-limiting claudication or critical limb ischemia defined as: Fontaine stage IIa-IV/ Rutherford 1-5 category
* The target lesion located within the popliteal artery has angiographic evidence of stenosis \> 70% or occlusion (by visual estimate)
* At least one vessel runoff to the foot
* The patient has no other relevant inflow or outflow stenosis (\> 50%), however when needed iliac or femoral intervention may be done during study procedure.

Exclusion Criteria:

* The patient is currently participating in a drug or another device study.
* The popliteal artery target lesion has previously been subintimal recanalized
* The patient has a history of bleeding diatheses or coagulopathy
* Female patients that are pregnant
* The patient has a contraindication (including allergic reaction) to platelet aggregation inhibitors or heparin
* The patient is unable to conform to the study protocol follow-up procedures or visits.
* The patient has a life expectancy of \<24 months
* The patient has concomitant renal failure which requires dialysis
* The patient has a contraindication (including allergic reaction) to or a known sensitivity to contrast media
* The duplex ultrasound/angiography of the target lesion must NOT meet the following criteria:

  * The popliteal artery target lesion stenosis/occlusion is also continuously located within the superficial femoral artery and/or tibiofibular tract
  * The popliteal artery target lesion is restenotic
  * The popliteal artery has been subintimal recanalized
Promoting Smoking Cessation in Carpenters

The purpose of this study is to test an innovative and sustainable intervention to increase participation in a union-sponsored smoking cessation program among carpenters and floor layers. The investigators will conduct a randomized controlled trial comparing targeted messaging versus standard messaging. All subjects will receive information about the free, union-sponsored smoking cessation program. Subjects randomized to the intervention group will receive additional targeted materials to encourage enrollment in the union's smoking cessation program. The intervention will include monthly mailed and text messages. The investigators hypothesize that subjects who receive targeted messages will be more likely to enroll in the union-sponsored smoking cessation program, be more likely to show change in readiness to quit smoking, and be more likely to quit smoking compared to subjects who receive only standard messaging.

Specific Aim 1: Develop targeted health messages based on audience segmentation to encourage smokers to enroll in a comprehensive union-sponsored smoking cessation program.

We will craft six specific health messages that appeal to four different audience segments: workers under 30 years old without children, workers under 30 with children, workers 30 years old or older without children, and workers 30 or older with children.

Specific Aim 2: Conduct a randomized controlled trial of targeted messaging based on audience segmentation versus standard smoking cessation messaging.

After conducting baseline surveys with union carpenters and floor layers, we will randomize current smokers (smoked within the last 30 days) into either the intervention or control group.

* Control subjects will receive one standard mailing informing them about the free smoking cessation program available to union members.
* Intervention subjects will receive the standard mailing in addition to six targeted smoking cessation messages delivered monthly by mail to their homes. Messages will be specific to one of four audience segments determined by age and parental status. In addition to a segment-specific anti-smoking message, each mailing will have contact information for the union smoking cessation program. Intervention subjects who consented to text messaging will also receive one booster text message each month with a shortened targeted message.

Eligibility Criteria:
Inclusion Criteria:

* Current smoker (smoked cigarettes within the last 30 days)
* Eligible for union health benefits

Exclusion Criteria:

* None
The Use of Dental Pulp Tissue as an Autogenous Graft for Ridge Augmentation

The purpose of this study is to examine and compare the effects of autogenous dental pulp tissue on bone formation in the extraction sockets as compared to commonly used particulate bone graft. The effects on bone formation will be examined using a wide variety of assays.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) Physical Status Classification System ASA 1 (A normal healthy patient) or ASA 2 (A patient with mild systemic disease)
* never smoker
* patients with planned tooth extraction
* intact extraction sockets
* no medication or antibiotics intake for at least 6 months prior to the procedure
* patients who gave their consent to participate in the study.

Exclusion Criteria:

* vulnerable subjects (children, pregnant and lactating women, patients with learning disabilities, and prisoners)
* inability to obtain pulp tissue (for example, due to previous endodontic therapy, obliterated pulp canals)
Two Different Cataract Surgical Procedures to Prevent Posterior Capsule Opacification

In this study, the investigators introduce a new "capsule-reserved" cataract surgical procedure in which anterior lens capsule is reserved and attached onto posterior lens capsule in the purpose of preventing posterior capsule opacification (PCO). A prospective randomized controlled study is reported to compare the new "capsule-reserved" surgical procedure with conventional one on the effectiveness to prevent posterior capsule opacification in age-related cataract patients.

A prospective, randomized controlled study of 240 eligible patients will been enrolled. Two eyes of each patient were assigned randomly to two groups respectively: Group I; anterior lens capsule is conventionally not reserved after continuous curvilinear capsulorhexis, while in Group II, anterior lens capsule is innovatively reserved and attached onto posterior lens capsule. This novel adjusted surgical procedure, featured by using the reserved anterior lens capsule to protect the peri-capsule microenvironment and prevent PCO, is conceptual different from the traditional cataract surgical procedure. Clinical examinations including posterior capsule opacification grading score, central posterior capsule thickness, central posterior capsule density, best corrected visual acuity, contrast sensitivity were carried out preoperatively and at each postoperative visit.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 50 years or above
2. Both eyes were diagnosed with age-related cataract
3. Both eyes were planed to undergo the "Phacoemulsification and IOL implantation" surgery with 1 month
4. Biocular BCVA improvement post surgery was feasible judged by the ophthalmologists.

Exclusion Criteria:

1. Other ocular diseases
2. ACD\<3CT
3. Combined cataract surgery (trabeculoplasty, keratoplasty)
4. Lens pseudoexfoliation syndrome combined with glaucoma or zonular abnormalities
5. Previous intraocular surgery or trauma (laser not included)
6. Uveitis
7. Recent ocular infection
8. Proliferative diabetic retinopathy
9. Diabetes mellitus
10. Congenital ocular abnormalities (aniridia, congenital cataract)
11. Atrophy of iris
12. Participants with previous clinical trials 30 days before surgery
13. Using prostanoid eye drops
14. Uncontrolled systematic diseases
Open-Label Extension Study of DCCR in PWS Followed by Double-Blind, Placebo-Controlled, Randomized Withdrawal Period

This is a multi-center, multi-period study with an open-label period followed by a double-blind, placebo-controlled, randomized withdrawal period evaluating the safety and efficacy of DCCR treatment.

115 PWS participants who completed clinical study C601 will be enrolled into the OLE Period. All participants in the Open Label Extension (OLE) Period will receive open-label DCCR. The actual number of participants eligible to enroll in the double-blind, placebo-controlled, randomized withdrawal (RW) period will be limited to those participants taking DCCR in the OLE Period at the time of the RW Period Visit 1 (Baseline/Randomization Visit).The treatment groups in the C602 RW Period are those participants randomized to receive DCCR and those participants randomized to receive Placebo. Participants will be randomized in a 1:1 ratio (DCCR:Placebo).

Eligibility Criteria:
OLE Period Key Inclusion Criteria:

* Successful completion of clinical study C601
* Provide voluntary, written informed consent (parent(s) / legal guardian(s) of patient); provide voluntary, written assent (subjects, as appropriate)

OLE Period Key Exclusion Criteria:

* Positive urine pregnancy test (in females of child-bearing potential) or females who are pregnant or breastfeeding, and/or plan to become pregnant or to breast-feed during or within 90 days after study participation
* Any new disease, condition, or circumstance which would prevent, in the opinion of the Investigator, the patient from completing all study visits and assessments required by the protocol (e.g., an anticipated change of care setting)

RW Period Key Inclusion Criteria:

* Provide voluntary, written informed consent (parent\[s\] / legal guardian\[s\] of participant); provide voluntary, written assent (participants, as appropriate); this includes consent for randomization and potential treatment with placebo for up to 16 weeks
* Currently participating in clinical study C602 and complete the OLE End of Treatment Visit procedures

RW Period Key Exclusion Criteria:

* Positive urine pregnancy test (in females of child-bearing potential)
* Females who are pregnant or breastfeeding, and/or plan to become pregnant or to breast-feed during or within 30 days after study participation
Intranasal Fentanyl Versus Oral Morphine Sulfate in the Treatment of Pain in Pediatric Trauma

Acute tramatic pain is one of main reasons for consultation in pediatric emergency departments.

To manage pain quickly and effectively must be a primary outcome of the emergency department. However, pediatric emergency department are sometimes criticized for inadequate and delayed initiation analgesia . Indeed, several studies have shown the inadequacy between the intensity of the pain evaluated by the care team and the therapeutic management of it.

The ideal analgesic must have a rapid onset of action, have a powerful analgesic effect, have few side effects and can be administered quickly and painlessly. That's why, the main outcome of this study is to assess the non inferiority of a treatment by intranasal Fentanyl vs morphine sulfate (oral use) in children with traumatic pain on arrival to pediatric emergency department.


Eligibility Criteria:
Inclusion Criteria:

* Patient aged between 4 years old and 15,3 years old
* Acute pain in traumatic context with a suspicion of fracture for patient \<7years old : feeling Pain \>6/10 defined with a face analogue scale and a visual analogic scale (the difference between the scales is not \<10 points)
* For patients \>7 years old : feeling pain \>6 points and defined thanks to a visual analogic scale
* Informed consent form signed by parents
* Beneficiary of an european health protection

Exclusion Criteria:

* Antalgic ( II or III) within 4 hours before the inclusion
* Allergic or non-indication of fentanyl
* Allergic or contraindication of morphine sulfate
* Pre existing peripheral intravenous catheter
* Traumatic brain injury
* Nasal traumatic
Developing a Novel Digital Therapeutic for the Treatment of Generalized Anxiety Disorder

The investigators propose to develop and adapt Unwinding Anxiety phone app specifically for individuals with generalized anxiety disorder.

The study aims are to (1) develop and refine Unwinding Anxiety for individuals with generalized anxiety disorder, (2) determine user engagement and acceptability as well as measure effect sizes of the program vs. treatment as usual, and (3) preliminarily test mechanisms of action. The knowledge gained will set the stage for a number of future studies related to further elucidating the mechanisms of mindfulness, and the clinical efficacy and utility of this type of training delivered via digital therapeutics in general. Specifically, this study will provide necessary variances for powering larger phase 2 studies.

Eligibility Criteria:
Inclusion Criteria:

* Owns a smart phone
* GAD - 7 is equal to or greater than 10

Exclusion Criteria:

* If using psychotropic medication - not on a stable dosage for at least 6 weeks
* Medical disorder of the severity that would interfere with ability to participate
* Not being fluent in English (due to instructions provided in English)
* As needed use (i.e. prn) of benzodiazepines
* Psychotic disorder,
* Previous MT (e.g. MBSR, other Claritas MindSciences training programs).