cyrilzakka/clinical-trials huggingface dataset:
Pre-Post Intervention Study to Investigate the Safety, Feasibility, & Efficacy of the NeurGear ZenBud System for the Treatment of Anxiety & Anxiety-Related Symptoms

The goal of this clinical trial is to learn if low intensity fodused ultrasound stiulation delivered to the auricular branch of the vagus nerve works to mitigate symptoms of anxiety disorder in adults. It will also learn about the safety and feasibility of low intensity focused ultrasound stimulation. The main questions it aims to answer are:

Is low intensity ultrasound applied to the auricular branch of the vagus nerve effective for reducing the symptoms of anxiety disorders?

Is low intensity ultrasound applied to the auricular branch of the vagus nerve effective for improving quality of life and sleep for individuals who suffer from anxiety disorders?

Is low intensity ultrasound applied to the auricular branch of the vagus nerve effective for reducing the symptoms of depression for individuals who suffer from anxiety disorders?

Is the Neurgear Zenbud a safe, accessible, and feasible way of treatment for individuals who suffer from anxiety disorders?

Participants will:

Use the ZenBud device, a wearable low intensity focused ultrasound delivery device, for 5 minutes a day, every day for 4 weeks

Complete a weekly Becks Anxiety Inventory, Becks, Depression Inventory, Pittsburgh Sleep Quality Index questionnaire, and PCL-5 weekly

Complete a post study survey asking questions about subjective efficacy and quality of life improvements.


Eligibility Criteria:
Inclusion Criteria:

1. Scoring ≥ 28 on the Beck's Anxiety Inventory
2. Age 18 or older.
3. Ability to independently provide informed consent.
4. Ability to comply with the daily treatment and weekly assessments
5. Ability to communicate in English.

Exclusion Criteria:

1. Scoring below the aforementioned cutoff on the BAI
2. Inability to comply with the treatment and assessment protocol
3. Age less than 18 years.
4. Inability to provide informed consent.
5. Conditions for which ultrasound is contraindicated including cancer, pacemaker, and impaired sensory sensitivity.
6. Conditions for which vagus nerve stimulation is contraindicated including history of vagotomy.
Temporomandibular Joint (TMJ) Positioning Accuracy and Efficiency Using a Dental Compass.

This study is being performed to determine if the use of the Dental Compass Articular and its software will produce therapeutic splints for TMD accurately and successfully, compare favorably with a cohort treated without the Dental Compass (for number of visits, splint modifications, and required CBCTs).

Standard practice in the treatment of temporomandibular dysfunction (TMD) currently involves non-radiographically-assisted manual repositioning of the jaw followed by either an in-office cone beam computerized tomography (CBCT) or tomographic X-ray of both TMJs, and further adjustment as necessary to improve the initial bite impression.\[15\] At follow up visits the therapeutic splint is modified in stages to "walk" the condyle progressively into the ideal position, such as altering side shift, lateral deviation, and rotation. During this process multiple CBCTs or tomographic X-rays, and multiple direct dentist interventions, are required to find the precise joint position, involving significant radiation exposure, and significant chair time for the dentist

The key advantage of using the Dental Compass Articulator in conjunction with its software, is to identify and suggest corrections for the range of orthopedic imbalances present. Software-facilitated identification of imbalances is coupled with manipulation of yaw (anterior, posterior, lateral, or rotational movement of the mandible in a horizontal plane), pitch (rotation of the mandible in a frontal vertical plane), and roll (rotation of the mandible in a lateral vertical plane) to achieve optimal condylar and mandibular position for splint manufacture.

The goals of this study are to:

1. Determine if the use of the Dental Compass Articular and its software will produce therapeutic splints for TMD accurately and successfully, and will compare favorably with a cohort treated without the Dental Compass (for number of visits, splint modifications, and required CBCTs), and
2. Confirm a clinically important reduction in airway constriction and improvement in airway volume with us of the therapeutic splint.

Eligibility Criteria:
Inclusion Criteria for prospective active participants:

* TMJ dysfunction and pain
* CBCT indicates a non-Gelb 4/7 position or \< 1.8 mm bone to bone interval between the mandibular condyle and mandibular fossa anteriorly or posteriorly.

Exclusion Criteria:

* Planning a move within 9 months.
* Unwilling to provide two phone numbers and two email contacts.
* Not willing to express a willingness to come in for 4-6 month follow up if they have marked improvement or improvement in symptoms.
* Not living within 90-minute drive from clinic
* Transportation not reliable
* Involved in any other TMD study
* Life threatening illness or major surgery planned
* Other major life stress that might interfere with completing the study
A Study to Learn About the Effectiveness of Cancer Medicines in Patients With Metastatic Non-small Cell Lung Cancer in Norway.

The main purpose of the study is to learn about the effectiveness and treatment sequence of lung cancer medicines. This study is performed outside of clinical trials in Norway in patients with metastatic non-small cell lung cancer. Non-small cell lung cancer is a group of lung cancers named for the kinds of cells found in the cancer and how the cells look under a microscope. Metastasis is when the cancer cells spread to other parts of the body.

This study includes patient's data from the database who:

* Are 18 years of age or older.
* Are confirmed to have metastatic non-small cell lung cancer between 01 January 2009 and 31 December 2022.

The study is based on data collection from 3 national health registries:

* The Cancer Registry of Norway (CRN),
* The Norwegian Patient Registry (NPR),
* The Norwegian Drug Registry (NDR).

Data from these registries will be linked at an individual patient level to create a single, unified dataset. The information collected includes:

Diagnosis, cancer stage at diagnosis, date of diagnosis, birth year, type of medicinal treatment, date of treatment start and end, treating hospital, age, gender, etc.


Eligibility Criteria:
Inclusion Criteria:

1. Patients ≥ 18 years old with histologically confirmed stage IIIb, IIIc, IVa, or IVb NSCLC at the time of diagnosis
2. Received their first NSCLC diagnosis (stage IIIb, IIIc, IVa, or IVb) between 01 January 2009, and latest available year

Exclusion Criteria:

1. Patients ≥ 18 years old with histologically confirmed stage IIIb, IIIc, IVa, or IVb NSCLC at the time of diagnosis who received radiation therapy with curative intent, defined as a radiation dose larger than 50gy
2. If the data include patients diagnosed after 2021, IIIb patients will be excluded due to changes in the guideline. The updated guidelines for 2022 recommends that patients diagnosed with stage IIIb who have surgery with the intent to cure should not have ''curative'' radiation (i.e.: it is not possible to exclude these from the population from 2022).
Osteopathic Treatment on Motor Development of Hypotonic Infants.

Interventional study involving the human at risk and minimal constraint (RIPH2), randomized single-blind comparing the impact of osteopathic treatment on the axial tone of the hypotonic infant versus simulation

Children referred to the "Center Broussais" clinic for hypotonia are evaluated in terms of psychomotor development by a pediatrician competent in neuro-pediatrics. It is a cabinet for the care of children from 0 to 16 years.

Osteopaths and pediatricians work together in this office of which 50% are children with neurological disorders.

If osteopathic care is indicated, and for children with inclusion / non-inclusion criteria, the study will be offered to parents. In case of parental acceptance, children will be randomized in single blind to receive either an osteopathic treatment (osteo group) or a simulation (simulation group). Neither the parents nor the pediatrician will know the randomization group.

The osteopathic treatment or simulation will be performed in a standardized way according to a previously established protocol.

In both groups, a neurological evaluation of the axial tone will be performed by a pediatrician before randomization, at the end of the first consultation and at the end of the 3rd consultation, ie 3 consultations by a pediatrician.

If the child was drawn in the "simulation" group, three additional consultations will be offered at the end of the study to allow him to benefit from optimal osteopathic care

Eligibility Criteria:
Inclusion Criteria:Age: 8 months-24 months corrected age Axial hypotonia in the neurological examination

* Age (age corrected for prematurity) of motor development evaluated on the Denver II scale below chronological age
* Proposal for osteopathic treatment by the pediatrician or treating physician

Exclusion Criteria:

* • Fever, shock or recent fall (face, skull, spine) not medically investigated, persistent cyanosis, bulging or depressed fontanel, cervical stiffness, fever

  * Neuromuscular diseases without axial hypotonia
  * Not affiliated to a social security scheme
  * Refusal to participate in the study by parents
Effects of a 6-Months Physical Conditioning Program in Patients With Cystic Fibrosis

The purpose of this randomized, controlled trial was to determine whether a (and if so which) physical conditioning program is effective to improve health status, physical activity, and quality of life in patients with cystic fibrosis. A positive effect of physical conditioning was expected.

A high level of physical activity might be beneficial for patients with cystic fibrosis (CF). Several studies have indicated that physical training might improve fitness and lung functions (or, at least, slow the decline in lung functions). However, there are no long-term studies comparing the effects among aerobic training, strength training and no training. Furthermore, motivation to continue a training with little variations between sessions has been shown to decline rapidly. Thus, adherence with such a program may be low. Finally, not all patients feel happy with the same program. Therefore, a home-based individualized sports program might be best suitable to achieve long term benefits. The MUKOTRAIN study is a multicenter randomized controlled trial to determine the effects of a home-based physical training in patients with CF.

Comparisons:

Study A) Patients training aerobically 3 \* 30 min per week (supervised in a sports club near their homes) in addition to their baseline physical activity compared to patients training upper and lower body strength 3 \* 30 min per week (supervised in a sports club near their homes) compared to patients maintaining their physical activity. The supervised intervention lasted 6 months, thereafter patients were followed for an additional 18 months.

Study B) Patients asked to participate in sport activities at least 3 \* 60 min per week (free choice of activities) in addition to their baseline physical activity compared with patients asked to maintain their baseline physical activity.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of cystic fibrosis
* Able to engage in intense physical activities

Exclusion Criteria:

* FEV1 \<35%predicted
* Esophageal varicosis
* Pulmonary bullae
* Drop in arterial oxygen saturation with exercise \<80%
* Non-CF related chronic diseases
* Signs of pulmonary hypertension (ECG and echocardiogram)
Capnographic Monitoring in Gastrointestinal Endoscopy for Elderly Patients

Hypoxia is the most common adverse event in gastrointestinal endoscopes sedated with propofol and sufentanil, especially in elderly people. The aim of this randomized study was to determine whether intervention based on additional capnographic monitoring reduces the incidence of hypoxia in gastrointestinal endoscopes procedures for elderly patients.


Eligibility Criteria:
Inclusion Criteria:

* 65 ≤ Age \<80
* patients undergoing gastrointestinal endoscopes
* patients signed informed consent form
* ASA classification I-II

Exclusion Criteria:

* Coagulation disorders or a tendency of nose bleeding
* An episode/exacerbation of congestive heart failure (CHF) that requires a change in medication, diet or hospitalization from any cause in the last 6 months
* Severe aortic stenosis or mitral stenosis
* Cardiac surgery involving thoracotomy (e.g., coronary artery bypass graft (CABG), valve replacement surgery) in the last 6 months
* Acute myocardial infarction in the last 6 months
* Acute arrhythmia (including any tachycardia - or bradycardia) with the fluid of hemodynamics instability
* Diagnosed chronic obstructive pulmonary disease or current other acute or chronic lung disease requiring supplemental chronic or intermittent oxygen therapy)
* Pre-existing bradycardia (heart rate \< 50 / min), or hypoxia (SaO2\< 90 % )
* Need supplemental oxygen because of pre-existing diseases
* Emergency procedure or surgery
* Multiple trauma
* Upper respiratory tract infection
* Allergy to propofol or tape and adhesives
Comparison of Pre-op and Post-op Pectoralis Nerve Block

The investigators will compare whether patients will have better pain control if they were to receive (PEC I/II block) before surgery or after mastectomy.

The current standard of care at the University of Iowa is to receive a pectoralis nerve block (PEC I/II) prior to surgery for mastectomy and reconstruction cases. The investigators will compare whether patients will have better pain control if they were to receive (PEC I/II block) before surgery or after the mastectomy. Patients undergoing mastectomies at the University of Iowa Hospitals clinics receive general anesthesia and a regional block for pain control. The most commonly employed regional anesthetic technique is a PECS I/II block to anesthetize the pectoral, intercostobrachial, third to sixth intercostal and long thoracic nerves. The PECS I/II blocks are pectoralis field blocks where local anesthetic medication is injected under ultrasound guidance between the tissue planes of pectoralis major and minor muscles (PECS I) and in the plane of the serratus anterior muscle at the level of the third rib (PECS II). The investigators will randomize patients into two groups and blind the patient and the research assistant collecting the data. Group I will have the block performed after induction of general anesthesia and prior to surgical incision by the anesthesiologist. Group II will have the block administered by the surgeon after mastectomy is performed and before reconstruction. On the day of surgery, the investigators will have patients fill out forms to measure pain catastrophizing and depression and anxiety. The investigators would like to measure if there is any difference in postoperative pain scores (visual analogue scale)-immediately post surgery in post-anesthesia care unit (PACU), and then on the admission unit every 4 hours for the first twenty four hours or on discharge (whichever time-point occurs sooner) and will collect the average pain scale of the day on post-op day (POD) 2,3,5 and 7 via patient communication electronic message in RedCap. The investigators will also measure intraoperative and post-operative narcotic use (converted to morphine equivalents), post-operative nausea and vomiting, length of (PACU) stay. In addition the investigators will also collect pain scores and pain catastrophic scale on POD 14 after surgery at their clinic visits to the surgeon. Other data collected will include time taken to perform block, post-operative infection rate and post-operative flap necrosis rate.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Female
* Bilateral mastectomy for breast cancer
* Undergoing breast reconstruction
* Must weigh at least 50 kg

Exclusion Criteria:

* More than 80 years of age
* Male
* Prisoners
* Patients who can't provide their own consent
* Lumpectomy only patients
* Patients having prophylactic mastectomies
* Patient must weigh at least 50 kg
* Allergies to local anesthetics
* Patient refusal
* Patients with a history of bleeding disorders
* Non-English speaking patients
Comparing Acute and Continuous Drug Abuse Treatment: A Randomized Clinical Trial

The purpose of this 2 year study is to conduct a fully powered effectiveness trial comparing recovery trajectories of 200 drug dependent adults (the subjects) who will be randomly assigned to Treatment as Usual (TAU) or TAU + Long-Term Recovery Management (LTRM).

Drug addiction is a chronic illness characterized by problematic drug use, followed by periods of abstinence, reductions in use, or return to problematic drug use. Despite this, substance abuse treatment has traditionally been based on an acute care model. The field needs an addiction management model for drug-dependent patients, which, like disease management for other chronic conditions, provides: 1) initial stabilization; 2) ongoing treatment to maintain clinical gains; 3) monitoring of patient symptoms; and 4) adjustments to the treatment based on the patient's response.

In response to these needs we have developed the Long Term Recovery Management (LTRM) model. LTRM is predicated on initiating long-term addiction management at the onset of substance abuse treatment, extending the length of treatment, expediting the transitions between intensive treatment and maintenance of behavioral change, adapting treatment intensity to patient's response to treatment, and actively facilitating the therapeutic alliance. LTRM combines 3 established treatment techniques (Community Reinforcement Approach, Contingency Management, and Facilitated Therapeutic Alliance), each with demonstrated efficacy, into a chronic disease model. In addition, patient cases are kept open, thereby removing potential obstacles to re-engagement with stepped-up care, when indicated. The LTRM model emphasizes: engagement in continuous long-term treatment and recovery support, therapeutic alliance, and early re-intervention as the main mechanisms for maintenance of behavioral change.

Eligibility Criteria:
Inclusion Criteria:

To be eligible for the study, a subject must:

* At least 18 years of age
* Meet current dependence criteria for stimulants (cocaine/other), opioids (heroin/other), and/or alcohol (if also dependent on cocaine or opioids). Persons who are opioid dependent are eligible if they are not in methadone maintenance therapy; they will be eligible if they are in short-term buprenorphine detoxification
* Self-report use of a primary drug of dependence in the past 60 days; 4) be admitted to outpatient care at Maryhaven
* Willing to participate in the protocol (i.e., to be randomized to treatment condition and agree to attend regular treatment sessions).

Exclusion Criteria:

* Potential subjects will be excluded if they: 1) present with current suicide risk
* Have a current, untreated psychotic disorder
* Plan to relocate outside of the area within 12 months
* Have been sentenced to incarceration of more than 30 days over the next 6 months
* Are alcohol dependent without current dependence on cocaine or opioids.
The Effects of Puberty and Weight on Sugar Metabolism in Children

Our goal is to investigate how hormones that control blood sugar, hunger, and stomach emptying change with puberty and being overweight. These substances change with a meal.

* For this, we need to compare lean and overweight children.
* We need to study them before and during puberty.
* All children in the study will be tested before and after a liquid meal.


Eligibility Criteria:
Inclusion Criteria:

All groups:

Healthy lean and otherwise healthy overweight children and adolescents between the ages of 8 and 17.

Exclusion Criteria:

Same for all groups

The subjects will be excluded if they have:

* a history of chronic disease
* allergy to acetaminophen
* evidence or history of chemical abuse
* abnormal lab values
* pregnancy
Cyclin D1 as a Prognostic Factor in Multiple Myeloma and Its Association With the Immunological Prognostic Factor PDL1 and Clinical and Biochemical Lab Tests

Multiple myeloma (MM) is the most common bone marrow malignancy of terminally differentiated plasma cells. It accounts for about 1% of all malignant diseases and 10% of haematological malignancies and takes the second place after non-Hodgkin lymphoma .

There are some serological and clinical criteria that help to detect the stage of MM and predict the patients' prognosis. These criteria include the level of M protein, calcium, haemoglobin, albumin, creatinine, β2-microglobulin and glomerular filtration rate (GFR).


Eligibility Criteria:
Inclusion Criteria:

1. Patients older than 18 year with newly diagnosed MM.
2. Approval to sign an informed written consent.

Exclusion Criteria:

* 1. Patient younger than 18 years. 2.Refusal to sign an informed written consent.
Effects of ECA on Quality of Life in Head and Neck Cancer Patients Suffering From Cetuximab-induced Rhagades

The SUPPORT trial is an open-label, prospective, randomized, national multicenter intervention study to evaluate the effectiveness of ethyl-2-cyanoacrylate versus the standard treatment of each institution on the pain intensity and QoL in patients with locally advanced head and neck cancer suffering from painful cetuximab-induced rhagades during radioimmunotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Locally advanced squamous cell carcinoma of the head and neck and participation in the HICARE-phase-IV-trial
* Cetuximab-induced painful rhagades, i.e. SUPO Score 2-3 (see Figure 2)
* Compliance to the photo documentation
* Ability of subject to understand character and individual consequences of the clinical trial
* Written informed consent

Exclusion Criteria:

* Cetuximab-induced rhagades without any pain, i.e. SUPO Score 1
* Cetuximab-induced rhagades, SUPO Score 4, i.e. superinfection of the rhagades
* Patients not being enrolled in the HICARE trial
* Substance misuse, psychoactive substance abuse or psychological/social conditions leading to a decreased patients' compliance with possible bad influence to the results of the study
* Known allergic reaction to ethyl-2-cyanoacrylate (ECA)