cyrilzakka/clinical-trials huggingface dataset:
Replication of the The Multi-Media Social Skills Project for Adolescents With Autism Spectrum Disorders

The objective of this study is to validate a social skills training program manual for adolescents (ages 13-17) with Asperger's Syndrome or high functioning autism. Approximately 150 adolescents with autism spectrum disorders will participate in this study, in groups consisting of 6 adolescents and 6 peer volunteers. Participants will participate in both group therapy and peer generalization sessions (in the form of a photography class) once a week over the course of twelve weeks. Participants and their parents will complete paper and pencil, online, or phone measures and video-recordings to assess the participant's social skills prior to the intervention, at completion of the intervention and three months later.

This study is a pre-test, post-test single group design with post test measures at one week after completion of intervention and follow-up at three months. Approximately 300 adolescents will participate in this study. The study will be conducted in ten cohorts of 12. Each cohort will have 6 participants and 6 adolescent volunteers (peers). Cohorts will be run in a time sequential manner with up to four cohorts running at a time. Participants and their parents will complete pre-test measures including both paper and pencil, online, or phone measures and a video-recording to assess the participant's social interaction skills and fluency. These adolescents will participate in both group therapy and peer generalization sessions once a week over the course of twelve weeks. Upon completion of the intervention, participants and parents will complete paper and pencil, online, or phone measures and video post-test measures. Participants will be encouraged to participate in a follow-up session where the paper and pencil and video measures will be completed again.

Eligibility Criteria:
Inclusion Criteria:

* Between 13 and 17 years of age
* Must be a Pennsylvania resident
* A primary diagnosis of Asperger's Syndrome or high-functioning autism, as confirmed by the Checklist for Autism Spectrum Disorders (CASD; Mayes, 2012)
* English as primary language spoken
* Ability to fluently speak in full sentences
* A verbal IQ of 85 or above on the Kaufman Brief Intelligence Test, Second Edition(KBIT-2; Kaufman \& Kaufman, 1990)

Exclusion Criteria:

* A significant language delay
* Difficulty with aggression directed at peers
* A primary thought disorder
* A secondary disorder of anxiety or depression so severe as to prevent the individual's participation in the treatment
* Low social motivation demonstrated through formalized assessment and/or by responses given to screening interviews assessing treatment goals
A Study Using US Medical and Pharmacy Claim Records to Compare the Resource Use, Cost, and Outcomes of People With COPD Who Take Either Tiotropium + Olodaterol or Fluticasone + Umeclidinium + Vilanterol

The purpose of this study is to estimate disease-related and all-cause burden and clinical outcomes of interest following initiation of chronic obstructive lung disease (COPD) maintenance therapy with Tiotropium Bromide/Olodaterol (TIO/OLO) or Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI).


Eligibility Criteria:
Inclusion Criteria:

* ≥30 consecutive days with Tiotropium Bromide/Olodaterol (TIO/OLO) or Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) initiated during the patient identification period of 01 June 2015 to 30 November 2019. The index date will be the date of the TIO/OLO or FF/UMEC/VI pharmacy claim that starts the ≥30 consecutive days with the medication.
* \>1 facility claim with a diagnosis of chronic obstructive lung disease (COPD) in the primary position or ≥2 professional claims with a diagnosis code for COPD in any position on separate dates of service during the study period
* ≥40 years of age as of the year of the index date
* Continuous enrollment with medical and pharmacy coverage for 12 months prior to and including the index date (baseline period)
* Continuous enrollment with medical and pharmacy coverage for ≥30 days following the index date and without discontinuation of the index medication or switch to a non-index regimen (follow-up period); discontinuation and switch as defined in the protocol.

Exclusion Criteria:

* ≥2 medical claims with a diagnosis code for asthma, cystic fibrosis, lung cancer, or interstitial lung disease in any position on separate dates of service during the baseline period
* Pharmacy claims for both TIO/OLO and FF/UMEC/VI on the index date
* A pharmacy claim for any non-index COPD maintenance medication on the index date, defined as: long-acting muscarinic antagonists (LAMA) monotherapy; long-acting beta2 agonists (LABA) monotherapy; inhaled corticosteroids (ICS) monotherapy; fixed-dose combination (FDC) ICS/LABA, or FDC LAMA/LABA
* Free or fixed dose LAMA+LABA maintenance therapy defined as ≥7 consecutive days of overlapping days' supply with a LAMA and LABA during a 6-month pre-index period, excluding the index date

  -- Flags will be created to identify patients excluded for baseline LAMA/LABA use overall and specifically for each FDC LAMA/LABA medication
* Free or fixed dose triple therapy (TT) defined as ≥7 consecutive days of overlapping days' supply with an ICS, LABA, and LAMA during a 6-month pre-index period, excluding the index date
* ≥1 medical claim with a procedure code for lung volume reduction during the study period
* Unknown age, gender, or business line, or unknown/other geographic region
The Effects of Two Different Orthosis on Pain, Hand Strength and Function in Patients With Thumb Carpometacarpal Osteoarthritis

The investigators aimed to assess the effects of two different hand orthosis on hand functioning, pain, disability and quality of life in patients with thumb osteoarthritis

The investigators will randomized 60 patients with stage 1 or 2 thumb osteoarthritis in two groups. The investigators will prescribe a neoprene CMC orthosis for patients in Group 1 and a thermoplastic CMC orthosis for patients in Group 2. The investigators will recommend these orthosis for six weeks. They will assess pain and disability before and after the treatment.

Eligibility Criteria:
Inclusion Criteria:

* Being aged between 18 and 70
* Grade 1 or 2 thumb osteoarthritis

Exclusion Criteria:

* The other hand disorders such as fracture and carpal tunnel syndrome
* Previous hand surgery
Efficacy Study of CLR3001 in Depression

The purpose of this study is to assess the ability of CLR3001 to reverse depressive symptoms relatively quickly in adult patients with major depressive disorder (MDD).

CLR3001 is thought to work by helping the body's natural responses overcome depression.

Eligibility Criteria:
Inclusion Criteria:

* Male or female out-subjects 18-65 years.
* Single episode or recurrent MDD (to a maximum of 5 prior episodes).
* No current therapy for depression as per washout instructions.
* Able to provide written informed consent.
* Meet criteria for MDD with current MDE through MINI questionnaire.
* Meet criteria for MDD with current MDE, as defined by DSM-IV TR.
* HAMD-17 score ≥ 14 at screening (visit 1) and baseline (Visit 2; Randomization).
* Able to understand and complete questionnaires, and communicate with the investigator and study coordinator.
* Judged to be reliable to keep all appointments and procedures required by the protocol.
* Female subjects of childbearing potential (who are not at least 2 years postmenopausal or surgically sterile or totally abstinent) must be using a reliable, medically acceptable form of contraception and must agree to continue such use throughout the duration of the study. Reliable forms of contraception include oral, implanted, transdermal or injected contraceptives, intrauterine devices, and adequate double barrier methods including use of spermicide. Partner's vasectomy is also an acceptable contraceptive regimen.

Exclusion Criteria:

* Investigators and immediate family members.
* Treatment within the last 90 days with a drug that had not received regulatory approval at the time of study entry.
* Persons who had previously withdrawn from this study or previous study investigating CLR3001.
* A primary diagnosis of Panic Disorder, Social Anxiety Disorder, Obsessive-Compulsive Disorder within the past year.
* The presence of an Axis II disorder, which, in the opinion of the investigator, would interfere with compliance in the study.
* History of active substance dependence within the last half-year, excluding nicotine and coffee, or active substance abuse that may interfere with the outcome of the study.
* Acute suicidal ideation or risk, ≥3 on HAMD-17 suicide item.
* Fall in HAMD-17 score greater than 20% between Visit 1 and Visit 2.
* Serious concomitant diseases such as cancer, serious metabolic (e.g. Insulin dependent diabetes), renal, cardiac, thyroid, immunological, neurological or other significant disease or laboratory abnormality (hematology, blood chemistry, ECG), or treatment for medical conditions which may interact with CLR3001.
* Women who are pregnant or breast-feeding, or men or women who plan to
* Infirmities or living in an area limiting participation in the study or compliance with study procedures.
Prognostic Value of Soluble Urokinase Plasminogen Activation Receptor (SUPAR) to Rule Out Complications in Patients Admitted in Emergency Department for Acute Abdominal Pain.

Soluble Urokinase Plasminogen Activation Receptor (SUPAR) is a validated biomarker with applications in the study of inflammation and infection.

Elevated levels of SUPAR have recently been linked to a higher mortality in patients suffering from undifferentiated sepsis, pneumonia, and more recently, COVID-19 infection.

Large randomized controlled trials have been conducted on patients admitted to the emergency department (ER), regardless of the reason for admittance.

These studies have stratified risk based on three cutoffs at initial measurement:

* Low risk : \< 3 ng/mL
* Intermediate risk : entre 3 et 6 ng/mL
* High risk : \> 6 ng/mL Low levels of SUPAR are associated with low risk of mortality in the short and long term in patients presenting to the ED, no matter the reason for admittance. Risk stratification could be an added decision-making tool for clinicians to comfort hospital discharge.

To the best of our knowledge, there is no available data on the added value of SUPAR for predicting mortality in abdominal sepsis and abdominal pain.

Abdominal pain is responsible for 10 to 30 % of ER admissions. Consequently, abdominal pain is then responsible for roughly 10 % of admissions into medical and surgical wards. Mortality varies depending on patient factors. Mortality is usually stratified on age. In patients under 50 years of age, it is near 8%, but it reaches 19 % in patients over 50.

Diagnostic accuracy also decreases drastically with age, reaching approximately 30 % patients over 75.

Taking this into account, integrating a measure of SUPAR levels into the current standard of care could stratify the risk of complications in patients admitted to the ER with abdominal pain.


Eligibility Criteria:
Inclusion Criteria:

Patients :

* Over 18 years of age
* Presenting to the ED with abdominal pain for over an hour
* Classified as category 2 or above on the CIMU or FRENCH severity scale
* Necessitating bloodwork at the discretion of the consulting physician
* Who gave his Non-opposition after clear and fair information on the study

Exclusion Criteria:

Patients :

* With pain evocative of kidney stones
* With a chronic inflammatory disease: HIV infection, inflammatory bowel disease, rheumatoid arthritis, cancer
* Chronic renal disease
* Under hospice care
* Intubated
* Unstable hemodynamically
* Transferred from a secondary care facility and having undergone previous bloodwork
* Patient unable to understand the information and to give his non-objection
* under guardianship, curatorship or subordination;
* benefiting from enhanced protection, namely: minors, persons deprived of their liberty by a judicial or administrative decision, persons staying in an establishment health or social, adults under legal protection
Efficacy of Ketorolac Buccal Infiltration on Success Rate of Inferior Alveolar Nerve Block

The aim of this study was to determine whether combining an intraoral injection of a non steroidal anti-inflammatory drug (Ketorolac), in association with conventional inferior alveolar nerve block, would improve the success rate in teeth with irreversible pulpitis. Forty adult volunteers with including criteria has been randomly divided into two groups (n=20). All patients received standard inferior alveolar nerve block injection. After achieving the lip numbness, one group received a buccal infiltration of Ketorolac and the other one received a buccal infiltration of Normal Saline as placebo. Any pain during root canal treatment has been recorded using analog visual scale. The success was considered as none or mild pain during treatment. The data have been analyzed using Mann-U-Whitney and chi-squared tests.

Objectives:

The aim of this study was to determine whether combining an intraoral injection of a non steroidal anti-inflammatory drug (Ketorolac), in association with conventional inferior alveolar nerve block, would improve the success rate in teeth with irreversible pulpitis.

Design: Randomized double blind clinical trial

Setting and conduct: Forty adult volunteers will randomly divide into two groups (n=20). All patients will receive standard inferior alveolar nerve block injection of 4% Articaine with 1:100000 epinephrine and supplemental buccal infiltration of 0.9 mL 4% Articaine with 1:100000 epinephrine. After five minutes when the lip numbness was achieved, one group received supplemental buccal infiltration of 30 mg/mL of Ketorolac Tromethamine and other group received buccal infiltration of normal saline. Endodontic access preparation initiated after 15 minutes of initial IANB with two negative responses to the electric pulp test. Pain during caries and dentin removal, access cavity preparation and canal length measurements has been recorded using visual analog scale (VAS). The success was considered as none or mild pain during the treatment. The data have been analyzed using Mann-U-Whitney and chi-squared tests.

Participants including major eligibility criteria: all patients with symptomatic irreversible pulpitis (Heft Parker VAS ≥54) of a mandibular molar tooth without systemic diseases; non smoking; without any medicine consumption or analgesic and sedation Intervention: Ketorolac infiltration

Main outcome measures : Pain during caries and dentin removal , access cavity preparation and canals length measurements using VAS.

Eligibility Criteria:
Inclusion Criteria:

* patients with age ranged 18-65;
* without systemic diseases;
* without any medicine consumption;
* non smoking;
* non pregnant;
* non breast feeding;
* with symptomatic irreversible pulpitis (Visual Analog Scale ≥ 54) in one mandibular molar that needs root canal treatment

Exclusion Criteria:

-
Vis-Rx Prime Micro-Imaging Catheter Study

To study the performance of the Gentuity® HF-OCT Imaging System and Vis-Rx Prime® Micro-Imaging Catheter when used to obtain images of coronary arteries in patients who are undergoing cardiac catheterization and are candidates for interventional procedures. The study will evaluate ease of catheter use by physicians using the catheters, image quality and overall performance. The patient's involvement in the study ends when the cardiac catheterization/interventional procedure is completed.

This is a single arm, unblinded, multi-center, clinical evaluation that will be performed at 3 to 5 investigational sites in the United States with subjects who undergo HF-OCT imaging as part of their cardiac catheterization procedure. This study will evaluate a range of device operators (interventional cardiologists) as well as patients and vessels consistent with the product labeling. The operator evaluation will be determined post use of the device using a Likert Grading Scale. Clear Image Length of the acquired HF-OCT image will be measured by an independent core lab. Safety will be monitored through the interventional procedure and Adverse Events that are potentially related to either the device or the procedure will be recorded, evaluated and analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years of age or older
* Patients willing and able to provide written informed consent to participate in evaluation
* Patients who are candidates for transluminal interventional procedures for their coronary arteries (also known as PCI)

Exclusion Criteria:

* Bacteremia or sepsis
* Major coagulation system abnormalities
* Severe hemodynamic instability or shock
* Acute renal failure
* Disqualified for Coronary Artery Bypass Graft surgery
* Disqualified for Percutaneous Coronary Intervention
* Patients currently enrolled in another study to evaluate an investigational device or medication
* Any target vessel which has undergone a bypass procedure

The lesion-specific exclusion criteria assessed from angiography are:

* Total occlusion
* Coronary artery spasm
* Large thrombus (as visible under angiography)
Investigation of 9 Consecutive Infusions of Remicade for Psoriatic Arthritis in Austria (Study P04264)

This is a prospective, open-label, 1-arm, multicenter observational study to determine the dose and time interval of Remicade (Infliximab) infusions in psoriatic arthritis (PsA).

This study population was chosen from a non-probability sample.

Eligibility Criteria:
Inclusion Criteria:

* Participants with active and progressive psoriatic arthritis who have responded inadequately to disease-modifying anti-rheumatic drugs.

Exclusion Criteria:

* All according to contraindications in the label especially:

  * Participants with tuberculosis or other severe infections such as sepsis, abscesses, and opportunistic infections.
  * Participants with moderate or severe heart failure (NYHA class III/IV).
  * Participants with a history of hypersensitivity to infliximab or to other murine proteins, or to any of the excipients.
Femoral Blockade and Low-dose Spinal Anesthesia in Outpatient Knee Arthroscopy

The investigators of the current study aimed to evaluate the effect of spinal anesthesia with low dose bupivacaine combined with femoral blockade on duration of anesthesia and time of first analgesic requirement during postoperative period

Fifty patients undergoing arthroscopic meniscus repair were included to the current study.

The patients were allocated to two groups as the spinal anesthesia with conventional dose of heavy bupivacaine or spinal anesthesia with low dose heavy bupivacaine combined with femoral blockade.

Blood pressures and heart rates were recorded at the beginning, at the 0th minute following femoral block, at the 0th minute and in two-minute intervals following spinal anesthesia for 20 minutes and in five-minute intervals till the end of surgery.

The sensorial block and motor block in both extremities were recorded in two-minute intervals following spinal anesthesia and in five-minute intervals till the end of surgery The time of sensorial blockade to reach T12, maximum level of sensorial blockade level and the time to reach maximum level of sensorial blockade and the time for regression of sensorial blockade to L2, the time for regression of motor blockade were recorded.

Eligibility Criteria:
Inclusion Criteria:

* ASA I-II patients aged between 25-65 undergoing arthroscopic meniscus repair

Exclusion Criteria:

* Contraindications to regional anesthesia (coagulopathy, severe aortic stenosis, sever mitral stenosis, increased intracranial pressure, severe hypovolemia, presence of infection on the site of injection)
* Presence of previous spinal surgery
* Presence of diabetes mellitus
* Presence of neurological disturbance
* Uncooperated patients, patients not accepting to participate the study
* Allergy to study drugs
* ASA II-IV patients, BMI \>38, Height \< 150 cm and \>190 cm
Expression of CD44, PCNA and E-cadherin in Pterygium Tissue

Purpose: Pterygium is a common ocular surface disease defined by fibrovascular conjunctival growth extending onto the cornea. Its pathogenesis remains unclear. In severe cases, it may extend into the central cornea, inducing irregular corneal astigmatism and causing loss of vision. CD44( phagocytic glycoprotein-1 ) is involved in the organization of certain cellular processes, for instance, cell adhesion, division, and migration, by binding with its main ligand, hyaluronic acid. Proliferating cell nuclear antigen (PCNA) is a proliferation marker in the nucleus. E-cadherin is a calcium-dependent transmembrane glycoprotein that plays a significant role in the protection of tissue integrity and cell-to-cell adhesion. This study aimed to determine the role of CD44, proliferating cell nuclear antigen (PCNA), and E-cadherin in pterygium formation and recurrence.

Methods:60 patients with pterygium will be enrolled in the study and conjunctival samples will be collected from 30 patients to form the control group. CD44, PCNA and E-cadherin expressions in surgically removed pterygium will be compared with tissue samples from normal control group.

IBM SPSS (statistical software) version 26.0 will be used for statistical analyses.

Eligibility Criteria:
Inclusion Criteria: patient with pterygium -

Exclusion Criteria: patient with pseudopterygium

-
Positive Emotions Training (PoET) as an Online Intervention to Improve Mental Health: a Feasibility Study

Positive psychology interventions are known to have an impact on mental health as well as on a number of beneficial characteristics like optimism, gratitude and self-efficacy. The new developed Positive Emotions Training (PoET) is one of the first holistic training programs covering eleven positive psychology constructs. The goal of this study was to test PoET's feasibility in the general population and to assess possible effects on positive and negative mental health factors. Additionally, possible effects on optimism, gratitude, happiness, resilience, and self-efficacy were examined.

Hypotheses:

1. It was hypothesized that participants receiving PoET would show a significant increase in positive mental health factors one month after the second training day.
2. It was expected to find a significant decrease in depression, anxiety, and stress symptoms one month after the second training day.
3. It was hypothesized that participants in a control group would not show any significant changes in this regard.

Methods:

The sample (n = 101) was allocated to PoET (n = 55) or control (n = 46) which did not receive any treatment. The allocation was neither randomized nor matched. Participants in the PoET group completed a whole of two training sessions (3.5 hours each) that were conducted in an online format (via Zoom) with groups of about 30 people. These sessions included the following positive psychology constructs: happiness, hope, humour, optimism, gratitude, self-efficacy, flow, meaningfulness, forgiveness, spirituality, resilience.

All participants completed positive and negative mental health measures at the beginning of the first training session and at the beginning of the second one as well as 30 days after the second session. Additionally, they had to complete two short items regarding stress and mood after each training session. They were given an exercise booklet with descriptions and explanations for all exercises during the training and at home. The week between the two sessions was called "7-day-challenge" to motivate the participants to try out several exercises at home.

Data was collected pseudonymised via Socisurvey. Data analysis was conducted with RStudio. Two-factorial repeated measures ANOVAs were conducted to test for possible effects of PoET on mental health.


Eligibility Criteria:
Inclusion Criteria:

* legal age (18)
* ability to use Zoom and all associated technology

Exclusion Criteria:

* none