cyrilzakka/clinical-trials huggingface dataset:
Effect of #LIFEGOALS on Adolescents' Mental Health

The aim of this study is to evaluate the effectiveness of the #LIFEGOALS intervention for promoting mental health in early adolescents.

The aim of the MOV-E-STAR project is to promote mental health in early adolescents (12-15 years) by motivating them to adopt a healthy lifestyle. Adolescents can protect their mental health by increasing physical activity, reducing sitting time, getting sufficient sleep, and taking a daily breakfast. Targeting these healthy lifestyle behaviours in young adolescents is an empowering, low-threshold approach that can create large public health effects. The MOV-E-STAR project aims to meet the need for an intervention targeting these behaviors in the adolescent population. Therefore, the mobile intervention '#LIFEGOALS' was developed in collaboration with stakeholders and users. The theory-based intervention consists of an application that includes (a) a self-regulation component for goal setting, self-monitoring and feedback, (b) a narrative in the form of short episodes from a youth daily drama for modelling, attitude change and increased engagement, and (c) an automated chat-function for social support and sustained engagement with the intervention.

The current study will test the intervention in a group-randomized controlled trial for its effects on mental well-being. Participants in the intervention group will have the #LIFEGOALS intervention installed on their phone and will be asked to use the intervention for 12 consecutive weeks. Participants in the control group will not receive an intervention but will only participate in the measurements. Outcomes will be assessed at baseline, intermittent (7 weeks after baseline) and post (13 weeks after baseline). Measures will include smart wearables and surveys.

Eligibility Criteria:
Inclusion Criteria:

* General adolescent population in first, second and third year of Belgian secondary education
* Attending regular secondary education in a school in Flanders, Belgium, at time of data collection
* Good understanding of Dutch

Exclusion Criteria:

* Attending special needs education schools;
* Attending education for non-Dutch speakers.
Perimodiolar Implant Performance in Adults With Low-Frequency Residual Hearing

The purpose of the feasibility study is to investigate hearing performance (audiometry and speech perception) using the CI632 in a group of adults (n=15) with low-frequency residual hearing who meet inclusion criteria.


Eligibility Criteria:
Inclusion Criteria:

1. 18 years-of-age or older at the time of surgery.
2. Low-frequency threshold at 500 Hz ≤ 50 dB HL and high-frequency pure-tone average (PTA), 2000-8000 Hz ≥ 65 dB HL in the ear to be implanted.
3. Pure-tone average (PTA) (0.5k, 1k, 2k Hz) \> 30 dB HL in the contralateral ear.
4. CNC word recognition scores (mean of two lists) ≤ 60% in the ear to be implanted and ≤ 80% in the contralateral ear.
5. English spoken as a primary language.
6. Willing and able to provide written informed consent.

Exclusion Criteria:

1. Individuals greater than or equal to 70 years at the time of surgery.
2. Duration of severe to profound sensorineural hearing loss \> 20 years per self-report.
3. Onset of sensorineural hearing loss, for the purpose of this study, prior to 5 years-of-age.
4. Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array.
5. Conductive overlay of 15 dB or greater at two or more frequencies, in the range of 250 through 1000 Hz in the ear to be implanted.
6. Hearing loss of neural or central origin.
7. Diagnosis of Auditory Neuropathy.
8. Active middle-ear infection.
9. Medical or psychological conditions that contraindicate undergoing surgery as determined by the Investigator.
10. Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations that are inherent to the device and/or procedure, as determined by the Investigator.
11. Additional handicaps that would prevent or restrict participation in the audiological evaluations as determined by the Investigator.
12. Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator.
13. Investigator site personnel directly affiliated with this study and/or their immediate family (spouse, parent, child, or sibling).
14. Cochlear employees or employees of a Contract Research Organization (CRO) or contractors engaged by Cochlear for the purposes of this investigation.
15. Currently participating, or has participated in the last 30 days, in another interventional clinical investigation/trial involving an investigational drug or device.
The Safety and Efficiency of Stent-based Diverting Technique Versus Ileostomy in Rectal Cancer Patients

The goal of this clinical trial is to evaluate the safety and efficiency of stent-based tiverting technique (SDT) versus ileostomy in rectal cancer patients. After the removal of the rectal tumor, participants who are at high risk for anastomotic leakage will either undergo SDT or ileostomies. Researchers will compare SDT to see if SDT could help patients save hospital stays, lower medical costs, and enhance their quality of life, and not alternatively avoid defunction stoma.

In patients with rectal cancer who have a high risk of anastomotic leakage, we aim to compare the safety and effectiveness of SDT versus ileostomy in this study. The primary endpoint of the study was severe complications that occurred within 90 days of the surgery. The secondary endpoints included total complications, the incidence of coloanal anastomotic leakage (Grade B/C), postoperative hospital stay and cost, and postoperative quality of life evaluation.

Eligibility Criteria:
Inclusion Criteria:

1. Rectal adenocarcinoma confirmed pathologically.
2. Rectal cancer patients with high-risk of anastomotic leakage(AL).
3. Age from over 18 to under 80 years.
4. Performance status of 0/1 on ECOG (Eastern Cooperative Oncology Group) scale.
5. ASA (American Society of Anesthesiology) score class I, II, or III.
6. Written informed consent.

Definition of high-risk of AL (one of them):

1. Preoperative body mass index (BMI) ≥30 kg/m2;
2. Long-term use of glucocorticoids before surgery (≥2 weeks);
3. Poor general condition: Preoperative serum albumin was less than 30.0g/L after supportive treatment; or Preoperative renal replacement therapy (blood purification/hemodialysis) is required; or diabetes;
4. Preoperative neoadjuvant radiotherapy;
5. Distance between tumor and anal anus (baseline MRI) ≤7cm
6. The number of stapler used to cut the rectum during the operation ≥3; or the defect of anastomosis is observed; or Intraoperative leak test was positive.

Exclusion Criteria:

1. History of previous rectectomy, except endoscopic mucosal resection or endoscopic submucosal dissection.
2. Familial Adenomatosis Polyposis Coli (FAP), Hereditary Non-Polyposis Colorectal Cancer (HNPCC), active Crohn's disease or active colitis ulcerosa.
3. History of unstable angina, myocardial infarction, cerebrovascular accident within the past six months.
4. Groups who are particularly vulnerable include those who suffer from mental disease, cognitive impairment, severe illness, adolescents, illiterates, women during pregnancy or breast-feeding, etc.
5. Patients with severe complications who do not tolerate surgery or need emergency surgery due to complication (bleeding, obstruction or perforation)
6. Unable ot radical resection, or underwent Miles or Hartmann or TaTME procedure, or requirement of simultaneous surgery for other disease (except the gallblader or appendix due to benign lesion).
Pivotal Bioequivalence FDC Nifedipine / Candesartan vs. Loose Combination of Single Components, Fed

Randomized, open label, single dose, 2-way crossover study to investigate the bioequivalence of a new fixed dose combination (FDC) tablet of nifedipine GITS and candesartan with the corresponding loose combination under fed conditions.

Clinical pharmacology

Eligibility Criteria:
Inclusion Criteria:

* The informed consent form must be signed before any study specific tests or procedures are done
* Confirmation of the subject's health insurance coverage prior to the first screening visit
* Healthy male subject
* Ethnicity: Caucasian
* Age: 18 to 45 years (inclusive) at the first screening visit
* Body mass index (BMI) above or equal 18, and below or equal 29.9 kg / m²
* Ability to understand and follow study-related instructions

Exclusion Criteria:

* Suspicion of drug or alcohol abuse
* Regular daily consumption of more than 1 L of xanthin-containing beverages
* Intake of foods or beverages containing grapefruit within 2 weeks prior to the first study drug administration (the same applies to pomelos and St. John's Wort)
* Use of medication within 4 weeks prior to the first study drug administration which could interfere with the investigational products (e.g. CYP3A inhibitors or CYP3A inducers)

  * examples for CYP3A inhibitors: erythromycin, inhibitors of human HIV protease (e.g. ritonavir, saquinavir), amiodarone, diltiazem, verapamil, fluconazole, itraconazole, ketoconazole, clarithromycin, telithromycin, nefazodon, cimetidine;
  * examples for CYP3A inducers: rifampicin, carbamazepin, phenytoin, phenobarbital, or products containing St. John's Wort;
* Systolic blood pressure below 116 or above 145 mmHg (after at least 15 min supine)
* At the first screening visit

  * Diastolic blood pressure above 95 mmHg (after at least 15 min supine)
  * Heart rate below 45 or above 95 beats / min (after at least 15 min supine) at the first screening visit
  * Clinically relevant findings in the physical examination
  * Positive urine drug screening or alcohol breath test
* Exclusion periods from other studies or simultaneous participation in other clinical studies
Study on Gynecological Laparoscopy Under Total Intravenous Anesthesia

To investigate the effect of preemptive analgesia with tartaric acid butorphanol on postoperative pain in gynecological laparoscopy under total intravenous anesthesia with remifentanil.This randomised, double-blind, placebo-controlled trial enrolled 60 patients undergoing elective gynaecological laparoscopy. The patients were divided into two groups: the butorphanol group (n = 30) and the control group (n = 29). Both groups received TIVA with propofol and remifentanil. Observing two groups of patients on the visual analog scale, the total consumption of rescue analogies, and the confidence of postoperative nausea and vomiting (PONV), and the patient satisfaction score.

To investigate the effect of preemptive analgesia with tartaric acid butorphanol on postoperative pain in gynecological laparoscopy under total intravenous anesthesia with remifentanil.This randomised, double-blind, placebo-controlled trial enrolled 60 patients undergoing elective gynaecological laparoscopy. The patients were divided into two groups: the butorphanol group (n = 30), who received 0.02 mg/kg of tartaric acid butorphanol intravenously 30 minutes prior to anaesthesia induction, and the control group (n = 29), who received the same volume of normal saline. Both groups received TIVA with propofol and remifentanil. The primary outcome was the visual analogue scale (VAS) score for pain at rest and on movement at 1, 2, 4, 6, 12 and 24 hours after surgery. The secondary outcomes were the total consumption of rescue analgesics, the incidence and severity of postoperative nausea and vomiting (PONV), and the patient satisfaction score.

Eligibility Criteria:
Inclusion Criteria:

* women patients, aged 18-65 years, with an American Society of Anesthesiologists physical status of I or II
* undergoing elective gynaecological laparoscopy for benign diseases

Exclusion Criteria:

* patients who had an allergy or contraindication to any study drug
* had chronic pain or opioid use
* had a history of substance abuse or psychiatric disorders
* were pregnant or lactating
* had a severe cardiovascular, respiratory, renal, hepatic or haematological disease
* had a body mass index \>30 kg/m2
* had an inability to understand or cooperate with study procedures
Investigation of Efficacy and Safety of EPOGAM

In this study it will be investigated if patients with atopic dermatitis responding to EPOGAM treatment, show a significant increase of dihomo-gamma-linolic acid in the blood.

Patients with atopic dermatitis will receive EPOGAM 1000 for 12 weeks. Clinical symptoms of the disease will be assessed using the SCORAD score. Dihomo-gamma-linolic acid levels in the blood will be measured with GC-MS.

Eligibility Criteria:
Inclusion Criteria:

* atopic dermatitis since at least 2 months (criteria after Hanifin and Rajka, 1980)
* men or women aged 2 - 45 years
* women of childbearing age using contraception
* informed consent of the patient or of the parents

Exclusion Criteria:

* psychiatric disorder
* abuse of drugs or alcohol
* chronic dermatosis
* glaucoma, cataract or ocular herpes simplex
* Immune deficiency
* Immunological diseases
* clinical relevant changes in laboratory parameters
* congenital diseases
* scabies, infections with dermathophytae, HIV-associated dermatosis
* malignant diseases
* metabolic diseases
* parasites
* patients enrolled in other studies
* progredient, systemic diseases
* pregnancy and lactation
* severe internistic diseases
* organ transplantation in the medical history
* hypersensitivity against an ingredient of the study medication
The Effect of "Mindfulness-Based Compassionate Life Training" for University Students Affected by the Earthquake

In this study, aimed to determine the effect of "Mindfulness Based Compassionate Life Training" given to university students on coping with post-earthquake trauma stress and grief process. According to the experimental design with pre-test and post-test control group, the participants selected from the universe will be assigned to the experimental and control groups impartially. In this study, a priori power analysis will be performed to determine the sample size. For the independent groups, in which the effect of "Mindfulness-Based Compassionate Life Training" on coping with post-earthquake trauma stress and grief will be compared, 80% power will be achieved at a significance level of 0.05 at a 95% confidence interval. A total of 68 participants will be reached by taking into account data losses and including 30% backup sample in the research. Participants included in the study will be numbered from 1 to 68 and 34 experimental and 34 control groups will be created from www.random.org.

Pre-test data will be collected before applying to earthquake survivors in the experimental group and control group. 8 sessions of Mindfulness Based Compassionate Life training will be given to earthquake survivors in the experimental group. Training sessions will be held online. For its effectiveness and continuity, each session will be held between 3 days and 7 days. One week after the Mindfulness-Based Compassionate Living training (after 8 sessions were completed), the "Post-earthquake Trauma Stress Level Determination Scale (NSSTDBÖ)", "The Grief Scale" was administered to the earthquake survivors. The "Self-Compassion Scale Short Form (STS-F)" post-test will be filled in by face-to-face interview. Post-test data from the experimental and control groups will be obtained simultaneously.

Research data will be collected face to face by researchers. 68 earthquake survivors who meet the inclusion criteria (to be studying at a university, to be affected by the earthquake, to be willing to participate in the study, to be open to communication and cooperation) will be included in the study. The descriptive features form consisting of 8 questions for data collection, "Post-earthquake Trauma Stress Level Detection Scale", "Mourning Scale". "Self-Compassion Scale Short Form (STS-F)" will be used. Research data will be collected as a pre-test and post-test for 1 month. Those who do not regularly participate in the Mindfulness-Based Compassionate Living training will be excluded from the study. The research will be carried out with 68 participants, 34 in the experimental group and 34 in the control group.

Eligibility Criteria:
Inclusion Criteria:

* Having a university nursing education
* Being affected by the earthquake
* Willingness to participate in the study
* Being open to communication and cooperation

Exclusion Criteria:

* Not attending sessions regularly
Clinical Pharmacist Intervention on Medication Adherence and Clinical Outcomes in Chronic Kidney Disease Patients

The purpose of this research study is to evaluate the impact of clinical pharmacist interventions on treatment outcomes, health-related quality of life (HRQoL),and medication adherence among chronic kidney disease patients.

Pharmacist's intervention aim to answer:

1. How a clinical pharmacist intervention program impact medication adherence in chronic kidney disease?
2. To assess how patients' counseling and medication adherence impact patient health-related quality of life?
3. How a clinical pharmacist intervention program improves clinical outcomes of chronic kidney disease patients?

This is a randomized, pharmacist-led, two-group, longitudinal descriptive intervention study performed at a private hospital nephrology department. The study included the introduction of clinical pharmacist interventions to improve adherence to prescribed medications, health-related quality of life, and clinical outcomes in patients with Chronic Kidney Disease(CKD).

Recruited patients were randomly divided into two groups; the basic intervention group and the advanced intervention group.

The basic intervention group received routine counseling. An advance intervention group was provided in addition to the usual counseling, education about Chronic Kidney Disease, hypertension or other comorbidity and management, as well as medication adherence, and renal diet (educational infographic for Chronic Kidney Disease patients) at three follow-up intervals after every 2 months. Both groups were followed up for a period of 6 months.

Pre-validated questionnaires will be used for the assessment

1. Medication Adherence Rating Scale (MARS): to evaluate medication adherence
2. MOS 36-Item Short Form Survey Instrument (SF-36): For evaluation of health related quality of life.

For evaluation of clinical outcome Blood pressure, serum creatinine, and hemoglobin will be obtained from medical records (from hospital software or from patient who had done their labs from out sources)during the baseline visit. The same laboratory tests will also be assessed at patients three-time intervals at admission or first visit at the start of treatment, week 8, and week 16.

Eligibility Criteria:
Inclusion Criteria:

* All male and female inpatients and outpatients with chronic kidney disease defined as a creatinine clearance (CrCl) less than 60 ml/min/l, 73 m2
* over the age of 18 years , will be included in study.
* Patient who are on maintenance hemodialysis also included.

Exclusion Criteria:

* Patients with acute renal failure
* Patients who are receiving renal transplants will not be included.
* Patients who will refuse to participate in study will not be included.
Oral Ketorolac for IUD Pain Reduction

To determine if oral ketorolac given at different timepoints prior to intrauterine device (IUD) insertion influences pain experienced during this procedure.

This is a single-site prospective interventional randomized controlled trial to examine the timing of administration of ketorolac for IUD pain control. 108 patients will be recruited to the study and they will be randomized into three study arms in a 1:1:1 ratio. Information including demographics, medical history, and obstetric history will be collected during enrollment. Patients will arrive 3 hours prior to their IUD appointment. Study group "K2" will receive ketorolac 20mg per os (PO) at 2 hours prior to IUD insertion, then they will receive a placebo pill at 1 hour prior to IUD insertion. In contrast, study group "K1" will receive the inverse: they will be given a placebo pill at 2 hours prior to IUD insertion, then they will receive ketorolac 20mg PO at 1 hour prior to IUD insertion. Study group "K0" will receive placebo pills at both timepoints. The patients will then receive a standard IUD insertion by an OBGYN physician. Both patients and providers will be blinded to the study medications received. The standard pain control regimen for IUD insertion includes offering vaginal lidocaine gel self-administered 5 minutes prior to IUD insertion as well as offering lidocaine paracervical block (PCB). All patients will be offered these standard pain control methods including the "K0" group. Patients may utilize one, both, or neither of these offered interventions in addition to the randomized study medication. During the IUD insertion, pain scores at 7 different timepoints will be measured via a visual analog scale (VAS). The VAS is a 100mm visual tool that allows patients to rate the pain they are experiencing at each time interval. The 7 timepoints include: pre-procedure, tenaculum placement, block injection, uterine sounding, IUD deployment, overall (measured immediately post-procedure), and 10 minutes post-procedure. Information on Patient Acceptable Symptom State (PASS) and patient satisfaction will be collected during their appointment. After the 10-minute post-procedure VAS score and questionnaire, patients will be discharged from the study.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Able to consent
* Desires IUD insertion

Exclusion Criteria:

* IUD placement under sedation or oral anxiolytic
* IUD replacement (removal with insertion)
* Daily narcotic or NSAID use
* Contraindications to IUD placement
* Current: pregnancy, genital/pelvic infection
* Lifetime history: uterine anomaly, pelvic inflammatory disease, allergy to levonorgestrel or copper
* Contraindications to ketorolac
* Current: weight under 50 kilograms
* Lifetime history: allergy to NSAIDs, liver disease, renal disease, peptic ulcer disease, cerebrovascular bleeding, gastrointestinal bleeding
Telecare Rehabilitation Program in Chronic Low Back Pain with Psychological Retention and Predominant Sociability

The present study proposes to evaluate the impact of a multidisciplinary biopsychosocial Telecare rehabilitation program at the functional level in people with chronic low back pain with major psycho-behavior maintenance. The hypothesis is that a personalized program combining remote psycho-professional and physical care by digital tools improves functional evaluation in these patients.


Eligibility Criteria:
Inclusion Criteria:

* Chronic low back pain (evolution of more than 3 months)
* Patient treated for this pathology in a multidisciplinary program
* Dallas score \> 50% in anxiety/depression and sociability dimensions
* Patient who has given free and informed consent to participate in the research
* Patient affiliated to a social security scheme or beneficiary of such a scheme.
* Patient with an internet connection at home, allowing videoconferencing and a digital tool with web cam (tablet or computer).

Exclusion Criteria:

* Recent spine surgery (\< 3 months at inclusion visit)
* Cardiovascular risk factor contraindicating sports practice.
* Severe psychiatric pathology
* Low back pain of tumoral or inflammatory origin.
* Associated motor or sensory, neurological impairment.
* Disabling root irradiation
* Pregnant or breastfeeding women
* Patients under legal protection (guardianship, curators or safeguard of justice).