cyrilzakka/clinical-trials huggingface dataset:
Assessing the Safety and Efficacy of a Novel Subcutaneous Implant Insertion Device on Healthy Adults

The investigators have created a device designed to make it easier to insert pharmaceutical implants under the skin. The device uses a blood pressure cuff to hold the skin on a person's arm in place while a mechanical guide places implants underneath the skin. This device may prevent implants from being embedded too deeply.

The investigators are performing this study to determine the safety and efficacy of the device for use in adult women. The study will determine if the implants are placed accurately under the skin (in the sub-dermal layer). It will also assess if the device causes any discomfort or last pain from use.

Subcutaneous contraceptive implants are one of the preferred methods of long-term contraception by the World health Organization and ministries of health in low- and middle-income countries. These implants offer between three and five years of protection (allowing women to safely space pregnancies and thereby reduce maternal and infant mortality), are 99.95% efficacious, allow women to return to fertility quickly when removed, requires no daily/monthly effort on the part of the woman, and cause minimal side effects in comparison to other methods. However, availability of contraceptive implants in rural areas is limited due to the skill necessary to administer them safely and accurately.

The investigators have created a device designed to make it easier to insert pharmaceutical implants under the skin. The device uses a blood pressure cuff to hold the skin on a person's arm in place while a mechanical guide places implants underneath the skin. This device is designed to prevent implants from being embedded too deeply.

In this trial, the investigators will use the implant insertion device with a placebo sub-cutaneous implant. Implants will be inserted with the device and the accuracy of the placement will be assessed through palpation and ultrasound depth measurements. This data will allow the investigators to assess whether the device ensures accurate insertions of sub-cutaneous implants.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult subjects aged 18 to 49
* Ability to understand study procedure and informed consent document

Exclusion Criteria:

* Patients with a history of keloid scarring
* Pregnancy
* Any rashes or skin conditions around the insertion site
* Known silicone allergies
* Known allergy to lidocaine
* History of bleeding disorders or abnormal bleeding
Music Therapy in Sickle Cell Pain Mixed Methods Study

The purpose of this research study is to:

1. Investigate the effects of a single 20-minute music therapy intervention with a music therapist on the pain intensity, pain relief, and mood of adult patients with sickle cell disease as compared to:

   1. Adult patients with SCD who listen to their preferred music for 20 minutes without the presence of a music therapist (music listening group)
   2. Adult patients with SCD who receive standard care alone (control group)
2. Determine the feasibility (delivery, acceptability, and usefulness) of the music therapy intervention for pain management


Eligibility Criteria:
Inclusion Criteria:

* Subjects who have a diagnosis of sickle cell disease (HbSS, HbSC, HbSbeta+thal, or HbSbeta0thal)
* 18 years or older
* Able to speak and understand English

Exclusion Criteria:

* Patients who have significant hearing impairments and/or significant visual impairments that have not been corrected
Biofeedback Treatment of Anxiety Associated With Chronic Spinal Cord Injury

The purpose of this research is to test the feasibility of an intervention using biofeedback to treat stress and anxiety among individuals with tetraplegia.

The expected duration of participation in this study is about 5 hours over the course of about 5 weeks. Participants will be randomly assigned to either a biofeedback training intervention or a control group. After completing questionnaires, participants will undergo physiological monitoring for the purpose of measuring heart rate and breathing. Those assigned to the biofeedback group will undergo 20 minutes of physiological monitoring while also participating in biofeedback training twice a week for 4 weeks (8 sessions) from home. Those assigned to the control group will undergo 20 minutes of physiological monitoring twice a week for 4 weeks (8 sessions) from home, but will not receive biofeedback training. Each session is expected to last 30 minutes to allow for completion of questionnaires over the the phone prior to and following each training session.

It is hypothesized that the biofeedback intervention will demonstrate high feasibility and compared to those in the control group, participants who receive the biofeedback intervention will attain greater pre-post reductions in both physiological and self-reported stress.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 65
* Diagnosis of tetraplegia with residual sensory or motor impairments
* Discharged from inpatient rehabilitation and living in the community
* Access to high-speed internet at home
* Willingness to download the videoconferencing software Zoom
* Access to a mobile phone and willingness to download HRV software

Exclusion Criteria:

* Does not speak English
* Scores less than 37 on the STAI
* Unable to travel to Craig for an initial assessment
* History of participating in biofeedback training
* Requires mechanical ventilation
* Dependent on diaphragm pacer for respiration
* Currently in treatment for anxiety (e.g., pharmacologic or psychotherapeutic)
* Associated medical condition for which biofeedback is contraindicated (e.g., psychosis, pacemaker, or other implantable electric device)
* Currently hospitalized for medical/rehabilitation treatment
* Unable to commit to the four-week intervention
taVNS for Letter Learning in Dyslexia

This is a pilot study to establish feasibility of transcutaneous auricular vagus nerve stimulation (taVNS) for improving letter-learning in adolescents with dyslexia. The main goals of the study are to 1) evaluate whether children in this age range will tolerate low level stimulation over the course of multiple sessions, 2) determine whether low level taVNS improves novel letter learning in dyslexia, and 3) evaluate the effect of low level taVNS on the brain's response to letters. Participants will complete fMRI before training, immediately after training, and a few weeks after training ends. Training will consist of six 30-minute lessons during which participants will learn novel letter-sound relationships while receiving either active or sham taVNS. Researchers will compare stimulation conditions to determine effect of this device on learning and neural plasticity.


Eligibility Criteria:
Inclusion Criteria:

* Normal non-verbal IQ
* Reading scores above 90 on four single word reading measures (typical reader) OR reading scores below 90 on two or more single word reading measures (dyslexia) with or without ADHD

Exclusion Criteria:

* Neurological diagnoses (e.g., autism, epilepsy, etc.)
* Medications other than those prescribed for ADHD
* Nonverbal IQ below 80
Prevalence of Spasticity in Veterans Living in a Long-term Care Facility

The purpose of the study is to conduct a feasibility survey of the prevalence of spasticity at a single long-term care facility for veterans and their spouses in Murfreesboro, Tennessee. These data will be used to strengthen a future grant application to the Department of Defense in response to their ongoing Traumatic Brain Injury initiative.

The goal of this feasibility survey is to determine the prevalence of spasticity that interferes with care or function at the Tennessee State Veterans Home (TSVH), which is a long-term care facility for veterans and their spouses in Murfreesboro, Tennessee. In order to accomplish this goal, each of the 140 residents will be examined by the principal investigator and a medical record review will be performed; also, each patient and their medical decision-maker (if applicable), direct caregiver, and treating physician will be surveyed in order to further elucidate the barriers to treatment in this population. All consenting residents of the TSVH will be examined, but the data will be separated prior to analysis based on whether the resident is a veteran or a veteran's relative.

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects of any race, aged 18 and above.
* Reside at the Tennessee State Veterans Home

Exclusion Criteria:

* Subjects for whom it is felt that participation in the study would cause medical harm
Gait Analysis in Children With Clubfoot Treated With Tibialis Anterior Tendon Transfer

Patients with clubfoot treated with the Ponseti method and undergoing Tibialis Anterior tendon transfer from a prospective database are evaluated using gait analysis including the Oxford foot model and compared to a group of healthy children.

Children with dynamic clubfoot recurrence after initial Ponseti treatment who underwent TATT between 2014 and 2017 are considered for this study. Exclusion criteria are neurological disease, split transfer of the tendon, additional bone or joint invasive surgery, and initial treatment abroad.

Gait analysis, including the Oxford foot model, will be conducted, and the kinematic and kinetic data of the lower extremity will be compared with a group of age-matched healthy children. To comprise a control group for the purpose of collecting gait analysis data of healthy children, employees of our hospital are asked to allow their children to participate in this study.

Patients will undergo gait analysis, including video recordings with a Vicon motion capture system (Vicon, Oxford, UK) with kinetic data collected from three AMTI force plates (Advanced Mechanical Technology, Inc., Watertown, MA). Placement of markers will be a combination of Cleveland (lower extremity), PlugInGait (upper body), and Oxford Foot (movement within the foot) models.

Eligibility Criteria:
Inclusion Criteria:

* Children with unilateral or bilateral idiopathic clubfoot treated with the Ponseti method
* full TATT

Exclusion Criteria:

* clubfoot associated with syndromes or neurological diseases
* initial Treatment elsewhere with more than 3 casts
* prior joint invasive or bony surgery
* split transfer of the tibialis anterior tendon
A Study of REC-4881 in Participants with Cancers Which Have an AXIN1 or APC Mutation

This is a multi-center, open-label study to investigate the safety, efficacy and pharmacokinetics of REC-4881 (12 mg PO daily doses) for the treatment of participants with unresectable locally advanced or metastatic solid tumors with AXIN1 or APC mutation.

Approximately 60 individuals will be enrolled in this open-label Phase 2 study, allocated 1:1 between the 2 cohorts - AXIN1 mutation or APC mutation. The purpose of the study is to investigate the safety, efficacy, and pharmacokinetics of REC-4881 for the treatment of participants with unresectable locally advanced or metastatic solid tumors with either mutation. Participants will receive treatment with REC-4881 (12mg PO daily) for up to 2 years.

Eligibility Criteria:
Inclusion Criteria:

1. 55 years of age or older with histologically-confirmed unresectable, locally advanced, or metastatic solid tumor with AXIN1 or APC mutation. If a participant has colorectal cancer, then they must be RAS / RAF wild type to enroll into the APC mutant cohort
2. Have experienced progressive disease, relapsed disease, or be intolerant to at least one established standard systemic anti-cancer treatment, or in the opinion of the Investigator have been considered ineligible for standard therapy
3. Measurable disease at baseline per RECIST 1.1 criteria
4. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1

Exclusion Criteria:

1. Received treatment with another mitogen-activated protein kinase (MEK) inhibitor within two months of first dose of REC-4881
2. Left ventricular ejection fraction (LVEF) \<50% as measured by echocardiogram (ECHO) or multigated acquisition (MUGA) scan
Clinical Performance of Short Fiber Reinforced Resin Modified Glass Ionomer Restorations in Cervical Carious Teeth (1y Randomized Clinical Trial)

This research proposal is introduced to clinically test short fiber reinforced glass ionomer material from GC Europe due to gap of knowledge present in this area. It is characterized by higher flexural strength compared to resin modified glass ionomer (RMGIC). Additionally, the short fibers provided effective toughening of the RMGIC matrix by a fiber bridging mechanism.


Eligibility Criteria:
Inclusion Criteria:

* Patients with untreated cervical carious lesions
* Patients with normal occlusion
* Vital teeth with carious cervical lesion with asymptomatic vital pulp.
* Teeth with no or minimum mobility.
* Teeth with normal occlusion.
* Teeth with surrounding healthy gingiva and supporting-structures.

Exclusion Criteria:

* Patients who are unable to return for recall appointments
* Presence of abnormal oral, medical or mental conditions.
* Patients with severe medical diseases.
* Patients with xerostomia
* Patients with parafunctional habits.
* Teeth with signs and symptoms of irreversible pulpitis or pulp necrosis.

  * Severe periodontal problems.
  * Non carious cervical lesions.
A Study of Jaktinib for the Treatment of Steroid-Refractory Acute Graft-Versus-Host Disease.

This is an single-arm, Phase II multi-center study. The purpose of this study is to assess the efficacy and safety of Jaktinib in subjects with Grades II to IV steroid-refractory acute graft-versus-host disease.


Eligibility Criteria:
Inclusion Criteria:

* Have undergone first allogeneic hematopoietic stem cell transplantation (allo-HSCT) from any donor source using bone marrow, peripheral blood stem cells, or cord blood for hematologic malignancies. Recipients of nonmyeloablative and myeloablative conditioning regimens are eligible.
* Clinically suspected Grades II to IV acute GVHD according to NCCN guidelines 2020 V2.0, occurring after allo-HSCT with any conditioning regimen and any anti-GVHD prophylactic program.
* Subjects with steroid-refractory acute GVHD, defined as any of the following:

Subjects with progressive GVHD (ie, increase in stage in any organ system or any new organ involvement) after 3-5 days of primary treatment with methylprednisolone ≥ 2 mg/kg per day (or equivalent) ± Calcineurin inhibitors（CNI）；Subjects with GVHD that has not improved (ie, decrease in stage in at least 1 involved organ system) after 5-7 days of primary treatment with methylprednisolone ≥ 2 mg/kg per day (or equivalent) ± Calcineurin inhibitors（CNI）；Subjects who Corticosteroid dependence（ie, begin corticosteroids at 2.0 mg/kg per day, demonstrate response, but progress before decrease from the initial starting dose of corticosteroids is achieved）.

* ECOG: 0-2；
* Life expectancy \> 4 weeks；
* Ability for oral drug intake；
* Willingness to comply with all study visits and procedures.

Exclusion Criteria:

* Has received more than 2 allo-HSCT.
* Acute GvHD occurring after non-scheduled donor leukocyte infusion (DLI) administered.
* Has received more than 1 systemic treatment in addition to corticosteroids for acute GVHD.
* Presence of an active uncontrolled infection.
* Serum creatinine \> 1.5 ULN or creatinine clearance \< 30 mL/min calculated by Cockcroft-Gault equation.
* Known allergies, hypersensitivity, or intolerance to any of the study medications, excipients, or similar compounds.
Corticosteroid Pulse After Ablation

Radiofrequency ablation is an effective treatment for atrial fibrillation. However, about 20% of the time the atrial fibrillation recurs. Steroids given after the ablation may decrease inflammation caused by the ablation and thus improve healing and decrease the chance of recurrence of atrial fibrillation.

In this study patients will be randomized to receive intravenous steroids or not immediately following the ablation.

Atrial fibrillation, a common arrhythmia, is the source of considerable morbidity. Prevalence of atrial fibrillation in adults is 0.5%, increasing to 10% in those patients over the age of seventy five. Numbers are expected to increase nearly 2.5 fold over the next 50 years. Radiofrequency (RF) ablation to cure atrial fibrillation has become an established and effective therapy in the many atrial fibrillation patients. However, approximately 20% return with recurrent atrial fibrillation after ablation.

RF ablation directly targets the substrate for atrial fibrillation, cauterizing cardiac tissue through the application of radiofrequency energy , causing a myocardial lesion which effectively blocks the errant pathway. This process of RF ablation induces an inflammatory effect. As the lesion heals it often enlarges. This may contribute to recurrence of atrial fibrillation after ablation, as well as increased pain. There is some early evidence that a single dose of corticosteroids after ablation may improve the healing process, thus decreasing pain and incidence of recurrent atrial fibrillation.

The aim of the study is to determine the usefulness of a one time dose of solumedrol following radiofrequency ablation for atrial fibrillation..

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18
* Drug refractory, symptomatic paroxysmal atrial fibrillation

Exclusion Criteria:

* Contraindication to solumedrol
* Persistent or permanent Atrial Fibrillation
* Previous history of radiofrequency ablation for atrial fibrillation
A Study of Avastin With Chemotherapy for Treatment of Metastatic or Advanced and Unresectable Colorectal Adenocarcinoma

This is an observational study designed to follow patients with metastatic or locally advanced and unresectable colorectal cancer who are receiving Avastin in combination with chemotherapy and whose cancer has been either previously untreated or treated \<=4 months prior to enrollment.


Eligibility Criteria:
Inclusion Criteria:

* Signed Informed Consent and Authorization document
* Metastatic, or locally advanced and unresectable, adenocarcinoma of the colon or rectum
* Receiving Avastin as a component of first-line chemotherapy
* First-line chemotherapy plus Avastin initiated \<=4 months prior to enrollment in the study

Exclusion Criteria:

* Patients who have contraindications for treatment with Avastin (see the Avastin Package Insert) or who would incur excessive risks with Avastin treatment are ineligible for this study.
Green Tea Extracts for the Prevention of Colorectal Adenomas and Colorectal Cancer

Experimental studies have shown the chemopreventive properties of green tea extract (GTE) on colorectal cancer. And colorectal adenomas are precursors to colorectal cancers. The aim of this study is to determine the preventive effect of GTE supplements on metachronous colorectal adenomas by giving GTE tablets of which are equivalent of 9 cup-of-green tea per day (0.9 g/day GTE, 0.6 g/day Epigallocatechin gallate (EGCG).

The subjects who had undergone complete removal of colorectal adenomas by endoscopic polypectomy have been enrolled since June 2010. They were then randomized into two groups as follows: supplementation group (0.9 g GTE per day for 12 months) or control group without GTE supplementation. Follow-up colonoscopy was conducted in 12 months. A structured 72-h recall at baseline and the 1-year follow-up was used to assess dietary factors, and to evaluate rectal mucosal proliferation index (RMPI) using known proliferation markers (Ki-67/PCNA), at least 2 random biopsies of rectal mucosa were taken. A sample size of 176 patients (88 per each group) was calculated to give the study 80% power to detect a difference, assuming a two-sided significance test at the 0.05 level.

Eligibility Criteria:
Inclusion Criteria:

- subjects who present one or more adenomatous polyps on colonoscopy.

Exclusion Criteria:

* subjects who denied to participate in this study
* subjects who present inflammatory bowel diseases such as ulcerative colitis or crohn's disease
* subjects who received partial or total colectomy due to colon cancer or other colonic diseases.
* subjects who are pregnant
* subjects who are on aspirin or NSAIDS for any reasons
* subjects who have received a transplant of any major organ or who are on immunosuppressants for any reason
* subjects who are unable to perform a bowel prep or who present poor bowel prep for colonoscopy
Does Autologous Fat Transplantation Improve Results and Reduce Complications in Breast Reconstruction With Implants?

The purpose of this study is to determine if autologous fat transplantation as a pre-treatment gives better results in breast reconstruction with implants after mastectomy and radiotherapy. One group is randomized to conventional reconstruction with implant and one to pre-treatment prior reconstruction with implant.

Our aims are:

1. To study whether lipofilling can decrease the number of reoperations and complications such as postoperative infections or not.
2. Evaluate the aesthetic results and the patients' experiences. For both these aims the hypothesis is that pre-treatment is in favour for the outcomes.

All patients will undergo breast reconstruction with expander implant. Half of the patients will be randomized to pre-treatment with lipofilling before the reconstruction. The randomization will be carried out with block randomization. A certain person that has not met the patients has been assigned to do this.

Fat transplantation: The fat will be harvested manually with dry technique using a Coleman cannula on a 10 ml syringe. There after the syringes and fat are centrifuged at 3000 rpm for 3 minutes. Liquid fat from lysed cells and blood will be separated from the purified fat cells and discarded. The fat graft will then be injected fan-shaped in multiple layers into the subcutaneous tissues of the breast using another blunt cannula with a diameter of 1.29 mm. If necessary to obtain a volume of 100 ml fat injected the procedure will be repeated. All sessions will be performed under general anesthesia in day surgery. Three month later the patients will undergo breast reconstruction with expander prosthesis.

Those patients that are randomized to not undergo pre-treatment will undergo breast reconstruction with expander prosthesis immediately.

After the reconstruction all patients will have as many appointments as necessary for expansion with a breast nurse at our clinic. If necessary the patient will also meet the surgeon. After the month the patients have a routine doctors appointment. After 6, 12 and 24 month the patients will be followed up with objective measurements of breast symmetry and they will fill in quality of life formularies. In this study we are using the validated formulary called Breast Q and a study specific formulary. At 24 month standardized photos of the breasts will be taken.

Eligibility Criteria:
Inclusion Criteria:

* Previously undergone mastectomy and adjuvant radiotherapy.
* Will undergo breast reconstruction with expander prosthesis.
* Mammogram and ultrasound performed maximum three month prior surgery.
* At least one year since last operation or radiotherapy.

Exclusion Criteria:

* Known breast cancer relapse
* Distant metastases except axillary
* Any contraindication for anaesthesia
* Systemic disease such as diabetes mellitus type I.
* BMI \>30 (if the patients lose weight they are eligible)
Gastric pH in Critically Ill Patients

H2-receptor antagonists are the gold standard for stress ulcer prophylaxis in critically ill patients. Various studies demonstrated superiority of proton pump inhibitors over H2-receptor antagonists in increasing gastric pH and in healing gastric acid-dependent diseases. It is unknown, whether proton pump inhibitors are more effective in increasing gastric pH than H2-receptor antagonists in critically ill patients requiring stress ulcer prophylaxis.

Gastric pH is measured continuously for 72 hours with a pipolar microelectrode placed between 7 and 15cm below the lower esophageal sphincter.

Eligibility Criteria:
Inclusion Criteria:

* critically ill patients
* indication for stress ulcer prophylaxis
* gastric pH \< 4

Exclusion Criteria:

* gastrointestinal bleeding
* gastric pH \> 4