cyrilzakka/clinical-trials huggingface dataset:
Enhancing Prospective Thinking in Early Recovery (HOME)

The goal of this clinical trial is to use a novel virtual reality intervention to test for efficacy in reducing alcohol use and increasing abstinence, with concomitant increases in future self-identification, future time perspective, and delay-of-reward, in early recovering alcohol use disorder (AUD) persons. The main question\[s\] this trial aims to answer are:

Will the Virtual Reality (VR) intervention decrease the number of stimulant use days? Will the VR intervention produce longer abstinence periods during follow-up visits? Will the VR intervention increase alcohol abstinence rates? Will the VR intervention increase future self-identification? Will the VR intervention increase self-reported future time perspective? Will the VR intervention increase preference for delayed rewards in a laboratory delay discounting task on the study day? Will the VR intervention produce gains in the behavioral effects of future self-identification, future time perspective, and delayed rewards at the 30-day and 6-month follow-ups? Researchers will compare the experimental and control groups to see if there are differences in the results for the questions outlined above.


Eligibility Criteria:
Inclusion Criteria:

* Abstinence between ≥14 days and ≤1 year
* Verbal endorsement of commitment to recovery
* Outpatient
* Psychotropic drugs for SUD-comorbidity
* Drug/alcohol abstinence ≥ 24 hours at the time of the study day visit
* English comprehension

Exclusion Criteria:

* Unstable medical disorders
* Habitual drug use
* Mu-opioid drugs
* Smell/taste disorders
* Unstable psychiatric conditions
* Extravagant/elaborate face tattoos
Educational Intervention in the Fear-Avoidance Delivery

The aim of this research is to study the responsiveness of the Spanish Version of Wijma Delivery Expectancy/Experience Questionnaire, Version A (WDEQ-A) in pregnant women after an educational intervention.

The Wijma Delivery Expectancy/Experience Questionnaire is a self-report instrument designed to measure the fear of childbirth in terms of the woman's cognitive appraisal of childbirth, which is now the most commonly used measure of fear of childbirth. The version A, measures the fear before a delivery (WDEQ-A). It consists of 33 items on a 6-point Likert scale (0 = do not agree; 5 = totally agree). The total score ranges from 0 to 165; the higher the score, the greater the fear the pregnant women experience. A higher score (over 85) indicates a more intense fear of childbirth, and a score of over 100 is considered as a phobia; thus, the scale can measure individual degrees of fear among women before and after their deliveries In Spain, there is no specific instrument to test the effectiveness of different practices that are commonly used to reduce the fear of childbirth as the maternal education. Hence, after cross-cultural adaptation into Spanish of the questionnaire (WDEQ-A-Sp), the responsiveness after and educational intervention will be analysed.

Descriptive analyses will be applied to calculate means and standard deviations of the demographic variables. Distribution and normality will be determined by the one-sample Kolmogorov-Smirnov tests (significance \>0.05). Responsiveness will calculated following COSMIN requirements.

Eligibility Criteria:
Inclusion Criteria:

* Spanish women living in Málaga, \> 18 years old, 26-30 weeks pregnant, to fill all the items of the questionnaires, to perform sessions the Maternal Education Protocol in Malaga

Exclusion Criteria:

* No performin inclusion criteria. No voluntary participation.
Myo-kinetic Stretching Versus Post-isometrics Relaxation Exercise With Traction in Patients of Cervical Radiculopathy

The goal of this clinical trial is to examine the effectiveness of Myo-kinetic stretching exercises versus post-isometric relaxation exercise in patients with cervical radiculopathy. Convenient sampling technique will be used to enroll the patients. Patients will be screened on the basis of pre formulated eligibility criteria. Written Consent will be taken from each patient for participation in the trial. The calculated Sample size of this study will be 68 calculated through Epitool. Group A will receive conservative baseline treatment consisted of hot pack therapy for 10 minutes and traction for 8 minutes. Myo-kinetic stretching exercises and group B will receive conservative baseline treatment and post-isometric relaxation exercise. The assessment of patients will be done at baseline, 4th and 8th week. The outcomes from patients will be calculated by using Numeric Pain Rating Scale (NPRS), Goniometer and Neck Disability Index. The comparison between pre-treatment and post-treatment data will be done after 8th week. Data will be analyzed through SPSS 25.


Eligibility Criteria:
Inclusion Criteria:

* Duration of cervical pain more than 4 weeks.
* History of positive Spurling test

Exclusion Criteria:

* History of previous cervical surgery
* Cervical spine tumor.
* Rheumatoid arthritis, prolong steroid use and osteoporosis in cervical region.
* Cervical spine fracture.
Diabetes Adolescent and Family Group Therapy

In this research study the investigators want more about how being in a group about diabetes helps your family versus individual treatment. The investigators are now asking youth with recently diagnosed (\<1 year) diabetes and their parents to be in the research, because the investigators want to see if this diabetes group and/or individual therapy is helpful to your coping, adjustment, and family communication about diabetes.

The purpose of this research study is to find out what effects the Group Therapy Project has on parents and child's management of Type 1 Diabetes Mellitus (T1DM) from both a group versus an individual therapy modality. We want to start a group and individual therapy program that looks at youth and family adjustment and coping at the Cincinnati Children's Hospital with patients who have T1DM. There has been research before on this group therapy and we want to look at it in a "typical" clinical setting at Cincinnati Children's Hospital for both group and individual therapy, including recently diagnosed patients (\<1 year). This research is being done to understand how a peer and family-based group versus individual therapy can be helpful by looking at survey data as well as medical data before and after participating in the diabetes therapy program. This information will help us further develop prevention and intervention programs for other youth with T1DM and their families.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Type 1 Diabetes,
* Aged 10.0 - 17.9 years of age,
* At least one parent/caregiver to participate with them,
* Diagnosed for at least 6 months for the Group and the Individual Arms.
* Diagnosed for \<1 year for the Recently Diagnosed Arm

Exclusion Criteria:

* Potential participants will be excluded if:

  * They have a co-existing diagnosis of mental retardation, pervasive developmental disorder, substance abuse, eating disorders, psychosis, or other acute psychiatric or medical needs, such as suicidality
  * They are not fluent in the English language.
Brinzolamide/Brimonidine Twice a Day (BID) Fixed Combination (FC) vs Brinzolamide BID Plus Brimonidine BID in Patients With Open Angle Glaucoma or Ocular Hypertension

The purpose of this study was to evaluate the safety and efficacy of Brinzolamide/Brimonidine fixed combination in lowering intraocular pressure (IOP) relative to each of its individual active constituents instilled concomitantly (Brinzolamide+Brimonidine) in patients with open-angle glaucoma or ocular hypertension.

This study consisted of 7 visits conducted during 2 sequential phases: the screening/eligibility phase, which included a screening visit and 2 eligibility visits, and a treatment phase, which included 4 on-therapy visits conducted at Week 2, Week 6, Month 3, and Month 6 (or early exit). Following washout of any IOP-lowering medication, subjects who met all inclusion/exclusion criteria at both eligibility visits and who had IOP measurements within the specified range during this period were randomized to 1 of 2 study drug groups: Brinz/Brim or Brinz+Brim.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with open-angle glaucoma or ocular hypertension and, in the opinion of the Investigator, are insufficiently controlled on monotherapy or are currently on multiple IOP-lowering medications.
* Meet qualifying IOP entry criteria.
* Able to understand and sign an informed consent form.
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Women of childbearing potential if pregnant, test positive for pregnancy at Screening visit, breastfeeding, or not in agreement to use adequate birth control methods to prevent pregnancy throughout the study.
* Severe central visual field loss.
* Can not safely undergo the initial washout period and discontinue use of all IOP-lowering ocular medication(s) for the minimum specified period prior to Eligibility Visit 1.
* Best corrected visual acuity (BCVA) score worse than 55 ETDRS letters (20/80 Snellen equivalent).
* Chronic, recurrent or severe inflammatory eye disease.
* Ocular trauma within the preceding 6 months.
* Ocular infection or inflammation within the preceding 3 months.
* Clinically significant or progressive retinal disease.
* Other ocular pathology.
* Intraocular surgery within the 6 months prior to entry.
* Ocular laser surgery within the 3 months prior to entry.
* Any abnormality preventing reliable applanation tonometry.
* Any other conditions which would make the patient, in the opinion of the Investigator, unsuitable for the study.
* Recent use of high-dose (\>1 gram daily) salicylate therapy.
* Recent, current, or anticipated treatment with any medication that augments adrenergic responses, or precludes use of an alpha-adrenergic agonist.
* Other protocol-specified exclusion criteria may apply.
Tick-borne Encephalitis and Borrelial Antibodies in Serum

In Slovenia, tick-borne encephalitis and Lyme borreliosis are both endemic diseases with high incidence rates and they are both transmitted by a bite of infected Ixodes ricinus tick. In clinical practice, tick-borne encephalitis is confirmed by demonstration of tick-borne encephalitis antibodies in serum of a patient with compatible clinical presentation and cerebrospinal pleocytosis. Patients with Lyme meningitis or meningoradiculitis also have cerebrospinal pleocytosis, however the presence of borrelial antibodies in serum does not attest Lyme neuroborreliosis. Patients with tick-borne encephalitis and positive borrelial antibodies in serum, but not fulfilling criteria for Lyme neuroborreliosis, are often being treated with antibiotics in several European countries due to the possibility of double infection. The investigators hypothesise that such patients do not benefit from antibiotics. Such an approach may appear safe regarding the possibility of borrelial infection, however it can also be associated with detrimental consequences such as antibiotic related adverse reactions, negative epidemiological impact on bacterial resistance, and intravenous catheter related complications.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* clinical picture compatible with tick-borne encephalitis,
* clear cerebrospinal fluid,
* cerebrospinal pleocytosis (leucocytes in cerebrospinal fluid \>5 x 106/)L,
* positive serum immunoglobulin M (IgM) and immunoglobulin G (IgG) antibodies against tick-borne encephalitis virus,
* positive serum IgG antibodies against Lyme borreliae.

Exclusion Criteria:

* isolation of B.burgdorferi sensu lato from cerebrospinal fluid,
* positive intrathecal borrelial antibody production index,
* seroconversion of borrelial IgG antibodies,
* presence of erythema migrans and/or borrelial lymphocytoma in the last month,
* Bannwarth syndrome.
Transverse Abdominis Plane Block Versus Ilioinguinal-iliohypogastric Block For Analgesia Following Hysterectomy

The investigators hypothesis that ilioinguinal iliohypogastric nerves block could provide a potent modality of postoperative pain control as compared to Transverse Abdominis Plane block in open abdominal hysterectomy

Aim of the work

the aim of the study is to compare between the analgesic effect of Transverse Abdominis Plane Block and Ilioinguinal-iliohypogastric block following open abdominal hysterectomy Objectives

* to compare between the analgesic effect of Transverse Abdominis Plane Block and Ilioinguinal-iliohypogastric block For Postoperative Analgesia following open abdominal hysterectomy
* to measure the incidence of complications following both blocks as hematoma, block failure, infection at injection site

Sample size:

Our primary outcome is the time to first rescue analgesia request. In a previous study, the meantime to first rescue analgesia was 10.58 ± 2.35 hours (6). The investigators calculated a sample size that could detect a mean difference of 20% between both study groups. MedCalc Software version 14 (MedCalc Software bvba, Ostend, Belgium) was used to calculate the sample size.38 patients( 19 patients per group) at least were estimated to have a study power of 80% and an alpha error of 0.05. This number will be increased to 42 patients (21 patients per group) to compensate for possible dropouts.

Sample size calculation was performed guided by the power of 80%, confidence level of 95%.

Statistical analysis:

For data analysis, the Statistical Package for Social Science (SPSS) software, version 26 for Microsoft Windows (SPSS Inc., Chicago, IL, USA) will be used. The Chi-squared test will be used to examine categorical data, which will be given as frequency (percent). The Shapiro-Wilk test will be used to verify for normality in continuous data, and the results will be provided as mean (standard deviation) or median (interquartile range) as appropriate. Depending on the data's normality, the unpaired t-test or the Mann Whitney test will be used to assess it. Repeated measures will be examined using analysis of variance (ANOVA), with posthoc pairwise comparisons using the Bonferroni tests. A P value less than 0.05 will be considered statistically significant.

Eligibility Criteria:
Inclusion Criteria:

* Participants will be adult patients (18-65 years)
* ASA I-II
* Scheduled for elective open TAH

Exclusion Criteria:

* Patient refusal
* Any known allergy to local anesthetic
* Patients with neurological, psychological disorders or those lacking cooperation
* Patients with anatomic abnormalities at site of injection, skin lesions or wounds at site of proposed needle insertion.
* Patients with bleeding disorders defined as (INR \>2) and/ or (platelet count \<100,000/µL)
* Patients with hepatic disease e.g. liver cell failure or hepatic malignancy or hepatic enlargement
A Study of Peginterferon Alfa-2a (Pegasys) in Participants With Hepatitis B E-Antigen (HBeAg)-Positive Chronic Hepatitis B Virus (HBV)

This is a study of the efficacy and safety of peginterferon alfa-2a (Pegasys) in naive, interferon- or lamivudine-pretreated participants with HBeAg-positive chronic HBV. Following 48 weeks treatment, there will be a 24 week period of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* Adult participants between 18 to 65 years of age
* HBeAg-positive chronic HBV
* Treatment-naive, or have received and have not responded to or have relapsed on either conventional interferon or lamivudine therapy.

Exclusion Criteria:

* Antiviral or interferon-based therapy for chronic HBV within 6 months of enrollment
* Co-infection with active hepatitis A, C or D virus or with human immunodeficiency virus (HIV)
* Evidence of decompensated liver disease
* Medical condition associated with chronic liver disease other than viral hepatitis.
The Validation of the FibriCheck Application for the Detection of Atrial Fibrillation

Optical sensing technologies have the potential to enable long-term heart rhythm monitoring. The medically certified and clinically validated FibriCheck technology has proven its value for spot-check measurements to detect AF. However, further validation and verification of this technology is necessary to evaluate the performance of the FibriCheck technology on different tools (smartphones and smartwatches). During this study the performance of various optical sensors, ranging from the camera in smartphones to the photodetector in smartwatches, will be explored and device and form-factor variability will be investigated. The objective is to define the accuracy of optical sensing systems in the detection of atrial fibrillation versus a reference traditional 12-lead ECG signal.

During this study the performance of various optical sensors, ranging from the camera in smartphones to the photodetector in smartwatches, will be explored and device and form-factor variability will be investigated. The objective is to define the accuracy of optical sensing systems in the detection of atrial fibrillation versus a reference traditional 12-lead ECG signal. Therefore, 2 groups will be created where different technologies will be investigated i.e. Group 1 will use various mobile devices and Group 2 will use various wearable devices. The recruitment of patients will be carried out in the framework of the usual care practice, where patients can be recruited at different moments throughout their current care-cycle.

Group 1: Smartphone based sensor: Here, the user needs to place the finger on the smartphone camera for 60 seconds to obtain high quality PPG waveforms. These waveforms are analysed using automated algorithms and stored under a unique anonymized study ID.

Group 2: Smartwatch based sensor: Here, a wearable device is used that is placed on the wrist and will record a PPG signal, similar as the smartphone camera, but with a specific PPG sensor. The data is extracted and processed by the FibriCheck software and the algorithms generate a diagnostic output which is stored under a unique anonymized study ID.

The hardware involved originates from different providers. Since FibriCheck is certified as stand-alone software, it is expected that it functions independently from different hardware sources. This hypothesis will be addressed in this study.

Smartphone devices that will be used in this research: Samsung, Huawei, Xiaomi, Apple, LGE, Lenovo and ZTE devices. Wearable devices that will be used in this research: Apple and Fitbit smartwatch devices.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older

Exclusion Criteria:

* Pacemaker dependent heart rhythm
* Tremor or Parkinson's disease
* Barriers for communication and lack of capability to execute the handlings required for this study
Effect of Intravenous Dexmedetomidine Versus Dexamethasone for Management of Repound Pain After Supraclavicular Brachial Plexus Block

Effect of intravenous dexmedetomidine versus dexamethasone for management of repound pain after supraclavicular brachial plexus block.


Eligibility Criteria:
Inclusion Criteria:

* Patients between 20_60 years old

  * Patients with ASA clinical status I/II
  * Patients scheduled for peripheral nerve block for upper extremity surgery

Exclusion Criteria:

* 1) they refused to participate 2) had preexisting neuropathy of the surgical limb 3) hypersensitivity to amide anesthetic 4) significant pulmonary disease 5) coagulopathy 6) sepsis 7) infection at the block site 8) hypersensitivity to dexmedetomidine \& dexamethasone
Meaning Centered Psychotherapy for Palliative Care Patients (MCP-PC)

This randomized, controlled trial evaluates the effectiveness of an adaptation of a well-established brief, structured existential psychotherapy (Meaning Centered Psychotherapy) specifically tailored to the needs of palliative care patients (MCP-PC). Terminally ill patients with cancer who have been hospitalized in a palliative care hospital will be randomly assigned to either MCP-PC or enhanced usual care. Patients will complete a very short battery of self-report measures before the 3-session intervention, and again 2 and 4 weeks later to determine whether treatment has bolstered spiritual and psychological well-being and improved quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Terminal illness with life expectancy of less than 6 months; hospitalized at a palliative care facility in Bronx NY, English speaking

Exclusion Criteria:

* Cognitive impairment or severe psychiatric symptoms that preclude informed consent or participation in treatment.
Outcome of Pulpotomy Versus Root Canal Therapy

Root canal therapy (RCT) is indicated once the pulp is diagnosed with irreversible pulpitis. Despite favorable success rate reported for RCT in vital cases, it is time consuming, and might increases fracture susceptibility of teeth. With the advancement of materials and better understanding of pulpal healing, vital pulp therapy is practiced as an alternative treatment with high success rate. The aim of this study is to explore the outcome, quality of life and patient satisfaction after full pulpotomy compared to RCT.

Permanent molar teeth with carious pulp exposure and mature roots as evident on the preoperative periapical radiograph will be included in the study. The teeth will be randomly divided into 2 groups (n=30). The first group will be treated with Biodentine full pulpotomy and the second group will be endodontically treated. Based on a previously validated questionnaire. The quality of life and satisfaction of patients after pulpotomy treatment will be evaluated compared to those after endodontic treatment. Clinical and radiographic assessment of the treated teeth will be done 3, 6 and 12 months postoperatively. Pain level will be recorded preoperatively and 1, 2, 3, 5 and 7 days after treatment.

The questionnaire consists of five components:

1. Characteristics of the patient; including age, gender, socioeconomic status, smoking, oral hygiene practices, frequency of dental visits, and dental history.
2. Postoperative complications including postoperative pain, discomfort,or swelling.

   These symptoms will be evaluated after 1, 2, 3,5 and 7 days by contacting the patient on the phone and at follow up visits at 3, 6, and 12 months.
3. Quality of life instruments designed
4. Semantic scales designed to evaluate patient satisfaction with the treatment received.

Clinical and radiographic assessment of the treated teeth will be recorded. Success will be defined as clinically asymptomatic tooth with no sinus tract or swelling or periapical lesion.

Data will be analysed statistically using appropriate tests based on the distribution of the results.

Eligibility Criteria:
Inclusion Criteria:

* Medically fit patient
* mature permanent tooth with deep caries
* diagnosis of irreversible pulpits.
* tooth is restored with a direct restoration

Exclusion Criteria:

* immature teeth
* teeth were hemostasis cannot be achieved after pulpotomy
* necrotic teeth
* lack of response to cold test
Erector Spinae Plane (ESP) Block for Renal Colic

Comparing standard of care to erector spinae plane block for acute renal colic pain.

Will compare at times 0, 10 minute, 20 minute, 40 minute and 60 minutes after local nerve block given.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 65 years old
* ASA Level I and II
* flank pain concerning for renal colic in ED

Exclusion Criteria:

* pregnant women
* subjects unable to appreciate ESP block landmarks under ultrasound
* skin infection over needle site insertion
* Allergy to local anesthesia (lidocaine/Ropivacaine)
* bleeding disorders
* serious cardiac, lung, liver or kidney dysfunction
* history of spine surgery
* history of spinal infection
* history of epidural injection within 6 months
* acute exacerbation of serious mental disease
* unable to consent
* unable to communicate pain level