cyrilzakka/clinical-trials huggingface dataset:
Harnessing Mobile Technology to Reduce Mental Health Disorders in College Populations

The prevalence of mental health problems among college populations has risen steadily in recent decades, with one third of today's students struggling with anxiety, depression, or an eating disorder (ED). Yet, only 20-40% of college students with mental disorders receive treatment. Inadequacies in mental health care delivery result in prolonged illness, disease progression, poorer prognosis, and greater likelihood of relapse, highlighting the need for a new approach for detecting mental health problems and engaging college students in services. The investigators have developed a transdiagnostic, low-cost mobile health targeted prevention and intervention platform that uses population-level screening for engaging college students in tailored services that address common mental health problems. This care delivery system represents an ideal model given its use of evidence-based mobile programs, a transdiagnostic approach that addresses comorbid mental health issues, and personalized screening and intervention to increase service uptake, enhance engagement, and improve outcomes. Further, this service delivery model harnesses the expertise of an interdisciplinary team of behavioral scientists, college student mental health scholars, technology researchers, and health economists. This work bridges the study team's collective leadership over the past 25 years in successfully implementing a population-based screening program in more than 160 colleges and demonstrating the effectiveness of Internet-based programs for targeted prevention and intervention for anxiety, depression, and EDs. Through this study, Investigators will test the impact of this mobile mental health platform for service delivery in a large-scale trial across a diverse range of U.S. colleges. Students who screen positive or at high-risk for clinical anxiety, depression, or EDs (excluding anorexia nervosa, for which more intensive medical monitoring is warranted) and who are not currently engaged in mental health services will be randomly assigned to: 1) intervention via the mobile mental health platform; or 2) referral to usual care (i.e., campus health or counseling center).

Participants in the study will be enrolled for 2 years and asked to complete surveys at baseline, 6 weeks, 6 months, and 2 years.


Eligibility Criteria:
Inclusion Criteria:

* Undergraduate students at participating colleges and universities who are 18 years old and older.
* Students who screen has high risk or clinical/subclinical for anxiety, depression, and, eating disorders.
* Students who are not currently in treatment, i.e., in the past month

Exclusion Criteria:

* Students who do not own a smartphone
* Students who are currently engaged in mental health treatment
* Students with anorexia nervosa
Combined CO2 Fractional Laser With Bimatoprost 0.03% Treatment of Alopecia Areata

The goal of this study is to evaluate the efficacy and safety of combined CO2 fractional laser with Bimatoprost 0.03% as novel treatment of alopecia areata.

The main question to study is will the bimatoprost facilitate hair growth if added to fractional CO2 laser treatment in Alopecia areata.

The study included 30 patients who were diagnosed clinically and dermoscopically as alopecia areata with age ranged between 16-55 years. The patients are divided into 2 groups: Group I, received fractional laser sessions with immediate and daily Bimatoprost application and Group II, received only frequent Laser sessions. Laser sessions were given to each patch once every 3 weeks, the procedure was repeated for 3 times.

Eligibility Criteria:
Inclusion Criteria:

* Patients with alopecia areata of the scalp (multilocuolaris or single patch).
* Patient aged from 16- 55 years old in both sex.
* Other treatment wash out period is two months.

Exclusion Criteria:

* Ophiasis pattern and other patterns of alopecia areata.
* Chronic diseases of liver, heart, kidney and blood
* Pregnant women
* Infections of skin in site of intervention
Oral Tramadol Versus Oral Celecoxib for Post-perineal Repair Analgesia

This trial will be performed to compare the effectiveness of oral tramadol versus oral celecoxib for the management of perineal pain following episiotomy or perineal tear repair after spontaneous vaginal birth in obese women

Pain after episiotomy or tear of perineal tissues during childbirth is often inadequately treated and may be severe. Not only did perineal pain negatively affect the physical and mental functioning of the woman, but also it might decrease the success of breastfeeding and reduced her ability to care for her child. The methods of relieving perineal pain included medication and non-medication. When the perineal pain was mild, the most common analgesic used was acetaminophen. Whereas the perineal pain was more severe, other drugs had been chosen such as opioid, non-opioid, and a combination of both opioid and non-opioid analgesics

Eligibility Criteria:
Inclusion Criteria:

* Age:18-35 years
* Obese women with BMI ≥ 30.
* completed full 37-weeks gestation.
* spontaneous vaginal delivery with medio-lateral episiotomy or perineal tear requiring repair.
* Singleton alive fetus.

Exclusion Criteria:

* known allergy to investigated drugs(tramadol or celecoxib).
* regular use of analgesic drugs before or during pregnancy.
* any medical condition known to be potentially exacerbated by opioids, including alimentary canal disorders, hepatic and renal disease.
* instrumental vaginal delivery.
* 3rd or 4th degree perineal tear.
* severe postpartum haemorrhage (\>1,500 ml).
* complicating maternal diseases (pregestational/gestational diabetes mellitus; bleeding disorders; pre-eclampsia and other hypertensive disorders of pregnancy).
* epidural nor combined spinal-epidural analgesia in labour
* a history of peptic ulcer,asthma,thrombocytopaenia.
Use of Nebido® to Assess Tolerability and Treatment Outcomes in Daily Clinical Practice

This is an observational study with a drug called Nebido, a new testosterone replacement therapy, which is available for the treatment of male hypogonadism. The benefit and safety of Nebido have already been thoroughly evaluated through well controlled clinical trials. The main purpose of this observational study is to confirm the established safety profile of Nebido in daily clinical practice.

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany. Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Eligibility Criteria:
Inclusion Criteria:

* Male hypogonadal patients eligible for long-term testosterone therapy who have newly been prescribed Nebido® in accordance with the terms of the marketing authorization

Exclusion Criteria:

* Patients presenting with contraindications as stated in the product information
Validation of a Record-based Frailty Assessment According to the Multidimensional Prognostic Index

Background Various phenotype and cumulative frailty assessment tools have been developed and compared in research. For use in an in-hospital setting, a cumulative and graded frailty assessment method is preferred in order to identify subgroups of patients at risk of adverse events during discharge and transition to primary care. Comprehensive Geriatric Assessment (CGA) is the gold standard to assess frailty. Most medical wards have limited access to specialized geriatric team support capable of performing CGA. Thus in these wards there is a need for a CGA based instrument to identify the frail patients and to quantify the level of frailty. The Multidimensional Prognostic Index (MPI) is based on CGA and is a comprehensive cumulative deficit frailty assessment tool validated in a Danish geriatric department. MPI is fully applicable in the everyday clinical work and supplies useful information to clinicians. It can predict readmission and death, and it is well-suited to assess the degree of frailty. Enabling identification of patients at risk of adverse events facilitates targeting of the interventions in order to improve patient outcomes. The MPI is a bedside assessment. However, in observational record-based research the patient is not accessible for the researcher. To assess and identify hospitalized frail patients retrospectively for clinical research, a valid record-based frailty assessment method is needed. The aim of this study is to compare the accuracy of a record-based MPI assessment with a bedside performed MPI assessment in order to use the record-based MPI when access to bedside MPI is impossible.


Eligibility Criteria:
Inclusion Criteria:

* Acutely admitted to one of the two medical departments listed below
* Aged 75 years or older
* Living within the municipality of Aarhus

Exclusion Criteria:

* Included in any other kind of follow-up schemes
* Already included in this study
* Declared terminally ill or undergoing palliative care at admission
* Admitted from one specific temporary nursing home with geriatric medical assistance (Vikærgården)
* Discharge or transfer to another department, including hospice
* The patient does not want to participate in the MPI-screening process
Evaluation of "PreCut-Papillectomy" in Difficult Biliary Cannulation

To evaluate the effectiveness and sefety of papillectomy to enable bile duct access during endoscopic retrograde cholangiography in patients with difficult biliary cannulation.


Eligibility Criteria:
Inclusion Criteria:

* Difficult cannulation of bile duct

Exclusion Criteria:

* post-surgical upper GI anatomy
* previous endoscopic retrograde cholangiopancreaticography or percutaneous transhepatic cholangiography
* papilla within a diverticulum
* coagulation disorder
Ethnic Lip Augmentation With Hyaluronic Acid Filler

Lip augmentation using hyaluronic acid filler in females with Fitzpatrick skin type V-VI

Using the revised Allergan Lip Fullness Scale (LFS) to improve post injection patient satisfaction in women with Fitzpatrick skin type (FPST) 5 and 6 (examples: Hispanic, African descendants, Indigenous Australians).

Eligibility Criteria:
Inclusion Criteria:

1. Females age 21 and above, with FPST 5 or 6, undergoing lip filler augmentation
2. Subjects will be required not to have had previous lip filler, fat injections, or other lip treatments in the last 12 months.
3. Subjects that understand the purpose and aspects of the study, freely sign the informed consent, complete the required treatment and follow up protocol.

Exclusion Criteria:

1. Females below the age of 21
2. Male patients
3. Subjects with LFS 5
4. Fitzpatrick skin Type 1-4
5. Subjects who have had previous lip filler, fat injections or other surgical lip augmentation in the last 12 months
6. Subjects who are pregnant or nursing
7. Subjects with a known allergy or sensitivity to any component of the study ingredients.
8. Subjects that do not understand the purpose and aspects of the study, do not sign the consent, and do not complete the required treatment and follow up visit will also be excluded.
9. Subjects with a history of bleeding disorders (Vitamin K deficiency, liver disease, renal disease, iatrogenic or otherwise). This includes persons who have undergone therapy with thrombolytics, anticoagulants, or inhibitors of platelet aggregation in the preceding 3 weeks (such as Coumadin, Plavix, heparin analogues)
10. Subjects should not be taking aspirin, nonsteroidal anti-inflammatory medications, St. John's Wort, or high doses of Vitamin E supplements within 7 days prior to the start of the study
11. Subjects with active inflammation or infection in the area of treatment
Post-Market Clinical Investigation Plan- Collagen Dural Regeneration Matrix (DuraMatrix-Onlay Plus)

Monitoring the Use of Collagen Dural Regeneration Matrix (DuraMatrix-Onlay Plus) in the Postmarket Phase.

A prospective, post-market, open label clinical study at a maximum of 8 sites, with an enrollment of 118 subjects. The primary endpoint of the study will be the rate of revision surgery. The presence of adverse events will be evaluated at each follow-up time point i.e. CSF leak, infection and Pseudomeningocele. Patients will have a follow-up evaluation at least at 8 weeks post initial surgery date (which align with the approximate resorption time of the device) where possible and as deemed necessary by a clinician.

No original patient records or personal identifying information will be disclosed to Collagen Matrix.

Eligibility Criteria:
Inclusion Criteria:

* The general population will be included in the study where a dura substitute is required for the repair of dura mater.

Exclusion Criteria:

* Patients that have conditions which are contraindicated per the instructions for use (IFU) would be excluded.
Pudendal Nerve Fluoroscopic Guided Pulsed Radiofrequency for Treatment of Superficial Dyspareunia

Superficial dyspareunia represents a major health problem especially for the newly wed couples. Pulsed radiofrequency for pudendal nerve is a non-neurolytic neuromodulatory method that is effective in relief of this type of pain. Objectives: to evaluate the efficacy of bilateral pudendal nerve fluoroscopic guided pulsed radiofrequency in treatment of intractable non-organic dyspareunia, and compare between trans-gluteal and transvaginal approaches regarding patient comfort and satisfaction.


Eligibility Criteria:
Inclusion Criteria:

* women aged between 16 and 46 years and from a near vicinity to our facility to make her available for follow-up

Exclusion Criteria:

* We had excluded women with any abnormality in the transvaginal US guided imagining, or those with any evidence of local gynecological abnormalities on examination. Meanwhile, we had excluded those women with infection at site of injection, coagulopathy or other bleeding diathesis, pre-existing neurologic deficit in the targeted region, those with history of chronic opioid use and women who refused to participate in the study
Continuous Measurement of the Activity for Clinical Evaluation at Home, for Non-ambulant Neuromuscular Patients

Validation of a measure specifically suitable to evaluate the residual function of upper limbs of non-ambulant neuromuscular patients, especially with Duchenne muscular dystrophy and spinal muscular atrophy.

This approach is of fundamental importance for clinical monitoring and preparing the future therapeutic trials.

The main objective is the continuous measurement of muscle activity in a standardized setting and in the non ambulatory patient's natural environment. This measure uses an innovative technology based on accelerometer and magneto-inertial sensors. The system is intended to measure the physical activity of patients from the extraction of data recorded by the sensors in the three space axes.

The non ambulatory patients will be included and evaluated at baseline and 14 days later. The patients wear the accelerometer device during some standard evaluations and also at home continuously for 14 days.

With this protocol the investigators want to try to find the best variable that characterizes the movement of the upper limbs of non-ambulant neuromuscular patients.

The aim of Pre-Acti is to propose a primary outcome measure that may be used in clinical monitoring of patients.

Eligibility Criteria:
Inclusion Criteria:

* age over 10 years
* neuromuscular disease documented by genetic testing or by muscle biopsy
* not able to walk 10 meters without support
* capable of sitting upright in a wheelchair for at least 3 hours
* subject affiliated to a social security system
* subject who signed an informed consent

Exclusion Criteria:

* severe intellectual impairment limiting the comprehension of the demanded tasks
* acute neurologic, inflammatory, infectious, endocrine, orthopedic disease in the month preceding the inclusion
* surgery scheduled within 3 weeks after enrollment
* surgery at upper limbs in the three months preceding the inclusion
* pregnant or nursing women
Pragmatic Airway Resuscitation Trial

The primary objective of the trial is to determine if 72-hour survival after out-of-hospital cardiac arrest (OHCA) is improved with initial endotracheal intubation (ETI) over initial laryngeal tube (LT) airway management strategies.

The primary objective of the trial is to determine if 72-hour survival after out-of-hospital cardiac arrest (OHCA) is improved with initial endotracheal intubation (ETI) over initial laryngeal tube (LT) airway management strategies.

The null hypothesis is that 72-hour survival is similar between primary Laryngeal Tube (LT) SGA and primary ETI airway management strategies.

Evaluated secondary outcomes will include return of spontaneous circulation, survival to hospital discharge, neurologically intact survival at hospital discharge, airway management performance, and clinical adverse events.

Eligibility Criteria:
Inclusion Criteria:

* Out-of-hospital cardiac arrest (OHCA)
* Adult (age ≥18 years or per local interpretation)
* Non-traumatic etiology
* Initiation of ventilatory support (e.g., bag-valve-mask device, non-rebreather mas, etc.)

Exclusion Criteria:

* Known pregnant women
* Known prisoners
* Major facial trauma (visible major deformity, copious oral bleeding, etc)
* Major bleeding or exsanguination (e.g., major upper or lower GI bleed, visceral perforation, major uncontrolled bleeding from laceration or injury)
* Patient receiving initial care by a non-PART participating EMS agency capable of performing ETI, LT, or other advanced airway management
* Patients with ET tube, LT or other advanced airway device inserted prior to participating EMS agency arrival (e.g., inserted by healthcare facility personnel)
* Patients with a pre-existing tracheostomy
* Obvious asphyxial cardiac arrest (e.g., choking, foreign body aspiration, angioedema, epiglottitis, trauma to mouth and face, etc.)
* Patients with a left ventricular assist device (LVAD) or total artificial heart (TAH)
* Patients with pre-existing written "do-not-attempt-resuscitation" (DNAR) orders
* Inter-facility transports
* Patients with a "do not enroll" bracelet
Impact of Vitamin D Therapies on Chronic Kidney Disease

This investigation will consist of a prospective study utilizing two separate populations of patients with 25(OH)D deficiency, one population with chronic kidney disease (CKD) and one with normal renal function.

Vitamin D helps form and strengthens bones by allowing the body to absorb calcium. Vitamin D helps the immune system fight infection as well as helps keep muscles strong. Without enough vitamin D, bones can become weak, thin and brittle.

Vitamin D is useful in people with all different types of health issues. CKD is the slow loss of kidney function over time. The main function of the kidneys is to remove wastes and excess water from the body. This loss of function usually takes months or years to occur Patients with CKD often have low levels of vitamin D in their blood.

This study will have two groups of patients with CKD and one group of patients that have normal kidney function, but all groups will have low levels of vitamin D. The two groups with CKD (group 1 and group 2) will receive either cholecalciferol or calcitriol. The purpose of having a control group (group 3) without CKD will be to evaluate if any changes that are witnessed in response to vitamin D therapy are specific to patients with kidney disease or apply to all patients with vitamin D deficiency who receive vitamin D supplements.

There are two different drugs in this study. One is called Calcitriol and is approved by the Food and Drug Administration (FDA) as a vitamin D supplement. The other drug is called cholecalciferol and it is approved by the FDA. Unlike calcitriol, cholecalciferol is a nutritional form of vitamin D that can often be found in various types of foods and its chemical structure must be changed by the body to become the active form of vitamin D. It is believed that cholecalciferol may have different effects in the body compared to calcitriol. It is possible that CKD patients would benefit from receiving both of these drugs, but this is currently unclear. While on this study you will receive either one of these study drugs, depending on which group you are assigned to.

Eligibility Criteria:
Inclusion Criteria:

* Chronic kidney disease w/GFR\<35ml/min
* Nutritional vitamin D deficiency, defined as 25(OH)D \< 25ng/ml
* Secondary hyperparathyroidism, PTH\>75pg/mL

Exclusion Criteria:

* Active infection
* Recent hospitalization for acute illness (within last month)
* Refusal to study participation
* History of chronic inflammatory disease process (i.e. inflammatory bowel, rheumatoid arthritis, SLE, etc.)
* Allergy to cholecalciferol or calcitriol
* History of parathyroidectomy
* Functional renal transplant within 5 years
* Current treatment with immunosuppressant medications
* Noncompliance with prescribed medications
Efficacy of Flow Restrictors in Limiting Access of Liquid Medicines by Young Children

This study aimed to assess whether adding flow restrictors, adapters added to the neck of a bottle to limit the release of liquid, affects the proportion of preschool-aged children who can access liquid bottle contents, the amount accessed, and the time required for children to empty the bottles compared with traditional bottles without flow restrictors.

Unsupervised ingestion of medications by young children is an important public health concern, leading to tens of thousands of emergency department visits and many more calls to poison control centers each year. Current knowledge on the specific circumstances in which young children gain access to medications is limited; however, a number of studies have shown that improper replacement of child-resistant packaging (CRP) by a caregiver leads to a substantial number of these incidents. Beginning in 2011, several pharmaceutical manufacturers introduced flow restrictors on over-the-counter (OTC) infants' acetaminophen; however, the efficacy of flow restrictors in limiting accessibility of liquid medicines by young children has not been formally assessed.

This study sought to determine whether adding flow restrictors, adapters added to the neck of a bottle to limit the release of liquid, to liquid medicine bottles can provide additional protection against unsupervised medicine ingestions by young children. A modified version of the standard child test protocol for re-closeable packages outlined in the Poison Prevention Packaging Act (PPPA protocol) was used to assess the efficacy of flow restrictors in limiting children's access to liquid medicines. Preschool-aged children participated in two 10-minute trials in which they were asked to try to "get everything out" of bottles filled with test liquid (a food product with similar flow characteristics to liquid medicine). Randomized block design was used to assign specific bottles to participants. Each child tested an uncapped bottle with a flow restrictor (FR-bottle) for one trial (1 of 3 designs randomly assigned). For the other trial, the child tested a control bottle (a traditional bottle either no cap or an incompletely-closed child-resistant cap). The amount of liquid the child removed from each bottle was measured and the time required to empty bottles was recorded. If flow restrictors limit the amount of liquid a young child can access, even when the outer child-resistant cap is not fully secured, their use could potentially be expanded to other liquid medicines.

Eligibility Criteria:
Inclusion Criteria:

* Attends one of the participating preschools
* Is between 36 - 59 months of age
* Is an English speaker

Exclusion Criteria:

* Has an obvious or overt, temporary or permanent, injury, illness, or physical or mental disability
* Has known allergies/restrictions to ingesting any ingredients in the test liquid