cyrilzakka/clinical-trials huggingface dataset:
At-home Auditory Training Clinical Trial

The purpose of this study is to investigate the effectiveness of an auditory training program used at home with the subject's own hearing aids.

The most common communication complaint of older adults with impaired hearing is that they can hear speech, but can't understand it. This is especially true where there are competing sounds in the background. Previous experiments performed under laboratory settings using a novel word-based auditory-training regimen have demonstrated substantial improvements in open-set recognition of words and sentences in noise. The current proposed study will investigate the effectiveness of the training regimen when used in a patient's home setting with their own hearing aids. All testing for the screening, baseline speech testing, training system orientation, and the outcomes portions of this project will be conducted in the Audiology Research Laboratory (ARL) of the Speech and Hearing Center located at 200 South Jordan Avenue. The use of the training program will be done at the subject's home.

Subjects will first come to the ARL for either one session for a hearing aid follow-up and instruction in the use of the training system (Session 1) or for one session for an initial screening to determine eligibility (Screening) followed then by Session 1. Subjects will then take home a training system that includes a tablet computer that has the training program loaded onto it, a portable loudspeaker, and some accessories. There will be three groups of subjects: (1) Hearing aid alone--no training (passive control); (2) Hearing aid plus auditory training (training); and (3) Hearing aid plus audio book use (active control). Total enrollment will be 45 subjects. Those subjects in the training group and active control group will complete a 6-week training period and return to the lab for outcome measures after 6 weeks of training for the primary and secondary outcome measures. The hearing aid alone group will return for the same outcome measures as the training and active control groups, but will have no intervention between these follow-up sessions.

Eligibility Criteria:
Inclusion Criteria:

* •55-79 yrs of age

  * Native English speaker

    * Having corrected vision sufficient to read 18pt font on a computer screen
    * Wearing binaural hearing aids that were fitted within the past 3 years that are the only hearing aids the subject has ever worn

Exclusion Criteria:

* The hearing aids worn by the subject will be evaluated on the subject's ears and must be functioning as required for this study; otherwise, the subject will be excluded from participation until the hearing aids have been adjusted appropriately
* asymmetrical hearing loss
* presence of dementia, Parkinson's disease, or other neurological disorder
Video Consent Form Versus Written Consent Form for ERCP

To prove that video about endoscopic retrograde cholangiopancreatography (ERCP) combined with written informed consent provides participants more information about the procedure, which can make participants understand the procedure well. Investigators advocate the development of institutional and national guidelines to ensure optimal practices of acquiring informed consent.


Eligibility Criteria:
Inclusion Criteria:

* All inpatients who will receive ERCP

Exclusion Criteria:

* under 18 years or more than 70 years
* pregnancy or breast-feeding women
* circulatory and respiratory disorders
* mental illness
Phase 2 Study to Determine if RTB101 Reduces the Severity of COVID-19 in Older Adults Residing in Nursing Homes

The purpose of this study is to determine if prophylaxis with RTB101 decreases the severity of laboratory-confirmed COVID-19 among adults ≥ 65 years who reside in a nursing homes in which one or more residents or staff have laboratory-confirmed COVID-19

RTB101-210 is Placebo-Controlled Study to Determine if Prophylaxis with RTB101 as Compared to Placebo Reduces the Severity of Laboratory-Confirmed COVID-19 in Adults Age ≥65 Years who Reside in a Nursing Home in which One or More Residents or Staff have Laboratory-Confirmed COVID-19. This trial is being conducted in follow up to a Phase 3 trial, in which trends toward a reduction in the severity of laboratory-confirmed RTIs including coronavirus RTIs were again seen. Therefore, RTB101 is a potential pan antiviral immunotherapy that may prevent or ameliorate viral RTIs, including COVID-19, in older adults.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent must be obtained from the subject or health care proxy before any assessment is performed.
* Adults (male and female) aged 65 years and over.
* Residing in a nursing home in which one or more residents or staff has developed laboratory-confirmed symptomatic COVID-19 infection at the time of randomization

Exclusion Criteria:

Subjects will not be eligible if they meet any of the following criteria:

* Any subject who is a current smoker or has a ≥ 10 pack year smoking history.
* Subjects with a medical history of chronic obstructive pulmonary disease (COPD).
* Subjects who are in hospice or receiving comfort care only.
* Subjects who have symptomatic laboratory-confirmed COVID-19 at the time of screening or randomization.
* Subjects with current evidence of an unstable medical disorder including an unstable respiratory disorder, gastrointestinal disorder (including Child-Pugh class B and C hepatic impairment), renal disorder (including subjects with an estimated glomerular filtration rate (eGFR) ≤30 mL/min/1.73m2), or hematologic disorder (including active leukemia).
* Subjects receiving immunosuppressive therapy including chronic use of prednisone \>10 mg daily (however, inhaled corticosteroids and acute use of higher doses of prednisone to treat conditions such as exacerbation of asthma or other acute conditions are allowed).
* Subjects with an immunodeficiency disease, including a positive human immunodeficiency virus (HIV) test result.
* Sexually active males with a partner of child-bearing potential
Comparative Efficiency of Three Regimen, CEFci, CEF and EC as Neoadjuvant Chemotherapy for Primary Breast Cancer

This is a phase IV, prospective, single-center, open-label, randomized, controlled study. Eligible patients are randomly assigned into three groups. The investigators propose to evaluate and compare the efficacy and safety of different neoadjuvant chemotherapies in women with primary breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Female patients, age ≦ 65 years old
* Histologically or cytologically confirmed primary breast cancer by core biopsy
* Disease stage appropriate for neoadjuvant chemotherapy (T2～T3，N0～2，M0)
* No previous treatment for breast cancer
* No history of other malignancies
* No currently uncontrolled diseased (e.g., ongoing cardiac dysrhythmias, unstable diabetes) or active infection
* No history of other malignancies
* No currently uncontrolled diseased or active infection
* Not pregnant or breast feeding, and on appropriate birth control if of child-bearing potential
* Adequate cardiovascular function reserve without a myocardial infarction within the past six month
* Adequate hematologic function with:

  1. Absolute neutrophil count (ANC) ≥ 1500/mm3
  2. Platelets ≥ 100,000/ mm3
  3. Hemoglobin ≥ 10 g/dL
* Adequate hepatic and renal function with:

  1. Serum bilirubin ≤ 1.5×UNL
  2. Alkaline phosphatase and alanine aminotransferase (ALT) ≤ 2.5 x ULN.
  3. Serum creatinine ≤ 1.7 mg/dl
* Knowledge of the investigational nature of the study and Ability to give informed consent
* Ability and willingness to comply with study procedures

Exclusion Criteria:

* Known or suspected distant metastases
* Concurrent malignancy or history of other malignancy
* Uncontrolled diseases or active infection
* Hepatic or renal dysfunction as detailed above
* Geographical, social, or psychological problems that would compromise study compliance
* Known or suspected hypersensitivity to cyclophosphamide, epirubicin and fluorouracil
Cephalometric Evaluation of a Clear Mandibular Advancement Appliance Based on the Twin-block Design

This study evaluates the cephalometric effects of a clear mandibular advancement appliance for the treatment of skeletal class II growing patients suffering from mandibular deficiency.

A Clear mandibular advancement appliance is constructed comprised of a clear dental splint of 1.5 mm thickness adapted on the patient's teeth. This is followed by the construction of acrylic bite ramps bonded over the splints. The bite ramps are constructed as such when the patient bites into occlusion, he/she has to advance the mandible to bring the two parts of the appliance together. Lateral cephalometric radiographs were obtained pre and post-treatment to evaluate the effects on the patient's maxilla, mandible and dentition.

Eligibility Criteria:
Inclusion Criteria:

1. Gender: Female subjects.
2. Chronological age: All recruited subjects were between the ages of 8-12 years.
3. Anteroposterior skeletal relationship: Subjects with skeletal Class II malocclusion with normal maxilla and retrognathic mandible were selected. This was confirmed using lateral cephalometric radiographic analysis with the following parameters: decreased effective mandibular length (Co-Gn) according to McNamara composite , SNB\<78, SNA=82+2.
4. Dental characteristics:

   * Angle Class II molar relationship ranging from edge to edge to full unit Class II.
   * Overjet ranging between 5-10 mm.
   * Absence of posterior crossbite and/or tendency for posterior crossbite.
5. Skeletal maturation stage: The growth stage for all subjects was selected to be before or at the prepubertal growth spurt. This was confirmed by cervical vertebral maturation analysis from the lateral cephalometric radiograph. The cervical vertebrae maturation stage required was Cervical Vertebrae Maturation stage 2-3 according to the cervical vertebrae maturation index by Baccetti et al. allowing sufficient time before the end of the growth spurt.
6. No previous history of orthodontic treatment.
7. Absence of systemic diseases affecting growth or craniofacial development. -

Exclusion Criteria:

-
V-notes Hysterectomy With Regional Anesthesia

Transluminal endoscopic surgery performed through the natural opening via the vagina is a more comfortable, scarless and less complicated method for patients. This method is similar to laparoscopic surgery and is usually performed under general anesthesia. Regional anesthesia is known to be the most comfortable anesthesia type and has less pain, nausea and vomiting during postoperative recovery. Our aim in this study is to evaluate the results by performing the surgery under regional anesthesia.


Eligibility Criteria:
Inclusion Criteria: Female patient between the ages of 30-70 Preoperative anesthesia evaluation will be evaluated as ASA 1-2 according to the American Society of Anesthesiologists (ASA) physical status Patients who are given a hysterectomy indication due to uterus, cervix and/or adnexal condition and will undergo V-NOTES will be included in the study.

Exclusion Criteria:

Patients contraindicated for spinal anesthesia or pneumoperitoneum, those with a history of tubo-ovarian abscess, deep endometriosis or suspected pelvic adhesions
Magnesium for Peroral Endoscopic Myotomy

Postoperative pain after peroral endoscopic myotomy occurs due to involuntary esophageal smooth muscle spasms. Magnesium has antispasmodic properties as a smooth muscle relaxant. This study hypothesizes that among patients having peroral endoscopic myotomy, magnesium will decrease postoperative esophgeal pain as measured by the esophageal symptoms questionnaire, while decreasing perioperative opioid requirements.


Eligibility Criteria:
Inclusion Criteria:

- Planned peroral endoscopic myotomy procedure

Exclusion Criteria:

* cannot give consent
* patients who are clinically unstable and/or require urgent/emergent intervention
* previous esophageal myotomy
* preexisting hypermagnesemia
* end-stage renal disease
* neuromuscular disease, including but not limited to Guillain-Barre syndrome, myasthenia gravis, congenital myopathy, and muscular dystrophy
* preexisting heart failure
* severe ventricular systolic dysfunction (left or right ventricle)
Prevalence and Screening of Abdominal Aortic Aneurysms Among Men With Coronary Artery Disease

The purpose of this study is to investigate the prevalence of abdominal aortic aneurysms (AAA) among male patients with coronary artery disease (CAD) verified in coronary angiography. Ethiology of AAA is known to be common with atherosclerotic arterial diseases (coronary artery disease, peripheral artery disease and carotid artery disease), so the hypothesis is that AAA should be more common among these CAD patients, thus making screening of these patients (for AAA) more cost-efficient.

Study will be carried out as a multi-center prospective screening study. Data will be collected in North Karelia Central Hospital, Kuopio University Hospital and Tampere University Hospital. Data consists of 200 consecutive coronary angiography patients in each hospital, resulting in 600 patients in total. All male patients with diagnosed CAD will be recruited for the study and screened for AAA with ultrasound. Nevertheless, patients with previously known AAA will be excluded from the study.


Eligibility Criteria:
Inclusion Criteria:

* Male patients with coronary artery disease

Exclusion Criteria:

* Patient's denial to participate
* Female Gender
* Already diagnosed or treated abdominal aortic aneurysm
A Study of Pain Relief in Osteoarthritis

The purpose of this study is to compare the safety and pain-relieving ability of Vicodin CR to placebo in subjects with osteoarthritis (OA) of the hip or knee.


Eligibility Criteria:
Inclusion Criteria:

* Males and females ages 21 to 80
* If female, must be of non-child bearing potential or practicing birth control
* Has osteoarthritis of the hip or knee
* Requires therapeutic doses of medication for osteoarthritis pain
* Has sufficient pain to justify the use of around-the-clock opioids

Exclusion Criteria:

* Is associated with any currently ongoing research study, or has previously participated in a Vicodin CR study
* Is allergic to or has had a serious reaction to hydrocodone, other opioids, or acetaminophen
* Cannot discontinue pain medications, even for the short time prior to the study start
* Has any clinically significant illness or recent injury, or has any significant laboratory abnormality, or has recently had major surgery
* Has a history of gastric bypass surgery or preexisting severe gastrointestinal narrowing, or history of diseases that may narrow the gastrointestinal tract
* Has a history of malnutrition or starvation
* Has a history of drug (licit or illicit) or alcohol abuse or addiction, or consumes more than 4 alcoholic drinks per day
* Has a history of a major depressive episode within the past 2 years, or requires treatment with certain drugs for depression, or has a history of major psychiatric disorder
* Pregnant or breastfeeding females
* Is incapacitated, bedridden or confined to a wheelchair
* Has initiated any new therapy or medication for OA within 1 month of screening
* Has had surgery, certain types of procedures, or received certain medications for osteoarthritis within a specified time frame
* Has other conditions that may cause pain, such as rheumatoid arthritis or gout
Comparision of Clinical Efficacy of Immediate Implants With T-PRF and Bone-graft Versus PRF and Bone-graft

The normal architecture of the alveolar process is altered by periodontitis, which also causes the loss of alveolar bone surrounding the teeth. Untreated periodontitis may cause teeth to become mobile and leads to loss of teeth.

In such cases, one of the treatment modalities is extraction of the tooth and placement of immediate implant which reduces the waiting period. And due to the resorption of alveolar ridge the bone graft will be used along with T-PRF and PRF.

So this study aims at the placement of immediate implants along with T-PRF with bone graft and PRF with bone graft.

Dental implants have become more common treatment for replacing missing teeth and aim to improve chewing efficiency, physical health and esthetic. And their will be resorption of alveolar process due to periodontitis . In such compromised cases, to achieve bone augmentation around immediately placed implants a new modality of using platelet rich fibrin (PRF) along with graft material has gained considerable interest.

Successful clinical results have been reported with L-PRF, but some physicians worry about a possible health hazard with glass-evacuated blood collection tubes with silica activators. O'Connell described the unavoidable silica contact. The silica particles in the tube, although dense enough to sediment with the red blood cells, are small enough for a fraction to remain colloidally suspended in the buffy coat, fibrin, and platelet-poor plasma layers therefore, these particles might reach the patient when the product is used for treatment.

Recently use of titanium tubes in the preparation of PRF showed more polymerized fibrin formation with longer resorption in tissues as titanium seems to be more effective in activating platelets than silica and also eliminates the possible silica contamination.

The use of T-PRF(Titanium PRF) along with xenograft creates a block graft with high concentrated growth factors, platelets and leucocytes which enhance development of bone and eliminates the possible silica contamination.

Hence, the aim of the study is to compare the effectiveness of T-PRF with xenograft \[DMBM\] and PRF with xenograft \[DMBM\] around immediate implants.

Eligibility Criteria:
Inclusion Criteria:

1. Patients between 18-55 years of age.
2. Presence of non-restorable teeth (maxillary or mandibular) due to trauma, decayed, mobility, root resorption, root stumps, root fracture, over retained deciduous tooth, endodontic or periodontal failure in whom immediate implants can be placed.
3. Good oral hygiene.
4. Good patient compliance.
5. Class I extraction socket defects according to modified Elian et al 2021.

Exclusion Criteria:

1. Systemic complications (uncontrolled diabetes and severe cardiovascular or infectious diseases).
2. Intravenous and oral bisphosphonate therapy.
3. Patients who are psychologically unable to participate.
4. Pregnant and lactating participants with bone diseases
5. Patients on chemotherapy or radiotherapy
6. Alcohol or drug abuse.
Gait Analysis and Clinical Outcomes of Anterior and Lateral Approach Total Hip Arthroplasty.

The goal of this Prospective Randomized Study is to confirm presence or absence of differences in gait mechanics in direct anterior and lateral approaches for total hip arthroplasty. and to compare the clinical outcomes of both approaches.

The main questions it aims to answer are:

if the anterior approach to the hip is faster recovery than lateral approach? if the anterior approach to the hip has better gait mechanics than lateral approach?

Participants will:

undergo one of the two approaches for total hip arthroplasty. All patients will be followed up at 2 weeks, 6 weeks, 3 months and 18 months. gait analysis will be done at 6wks, 3m, and 18months.


Eligibility Criteria:
Inclusion Criteria:

* Patients with primary osteoarthritis or osteonecrosis of the hip who consented for treatment with a total hip arthroplasty (THA) through an anterior or lateral approach.
* Age between 20 - 60 years of age.
* The participant had to be independent and physically active, which characterized as having the capacity to carry out daily tasks, ascend two flights of stairs, and able to walk for 15 minutes.

Exclusion Criteria:

* Patients with bilateral hip affection.
* Body mass index (BMI) greater than 40.
* Diagnosis other than primary osteoarthritis or osteonecrosis.
* Prior hip or spine surgery.
* chronic uncontrolled comorbidities, psychological disorders.
* American Society of Anaesthesiologists score (ASA) higher than 2
* chronic neurological deficits that influence gait.
* any limb length discrepancy more than 1 cm.
* Any postoperative complication that will lead to delay in weight bearing.
Phase 1 Study of IMP321 (Eftilagimod Alpha) Adjuvant to Anti-PD-1 Therapy in Unresectable or Metastatic Melanoma

The purpose of this study is to determine the safety, tolerability and recommended phase 2 dose of a new drug, known as IMP321, in combination with pembrolizumab when given to patients with unresectable or metastatic melanoma.


Eligibility Criteria:
Main Inclusion Criteria

* Histologically confirmed diagnosis of locally advanced (unresectable Stage III) or metastatic (Stage IV) melanoma
* Currently receiving anti-PD-1 therapy with pembrolizumab and after 3 cycles achieved asymptomatic irPD (slowly progressive, not requiring urgent intervention, and stable performance status) or sub-optimal response (irSD, irPR) as demonstrated in imaging assessments performed within 6 weeks prior to study start
* Female or male 18 years of age or above
* ECOG performance status 0-1
* Evidence of measurable disease as defined by Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 10. Adequate Laboratory criteria

Main Exclusion Criteria

* More than four prior lines of therapies for advanced or metastatic disease.
* Prior PD-1/PDL-1 targeted therapy
* Currently receiving treatment with another investigational drug, or less than 4 weeks since ending treatment on another investigational drug
* Currently receiving systemic chemotherapy, targeted small molecule therapy, radiotherapy, or biological cancer therapy (other than pembrolizumab) or less than 4 weeks since completion of these therapies and first dose of study treatment
* History of irAEs from ipilimumab of CTCAE Grade 4 requiring steroid treatment
* Known cerebral or leptomeningeal metastases
* Serious intercurrent infection within 4 weeks prior to first dose of study treatment
* Active acute or chronic infection
* History or evidence of interstitial lung disease or active non-infectious pneumonitis
* Active auto-immune disease requiring immunosuppressive therapy
* HIV positivity, active hepatitis B or hepatitis C
* Continuous systemic treatment with either corticosteroids or other immunosuppressive medications within 4 weeks prior to first dose of study treatment
Implementation of Mind-Body Practices in an Online Community of Caring (CaringBridge)

CaringBridge (CB) is an online health community for people undergoing challenging health journeys. This platform provides an opportunity for individuals and their caregivers to rally support for a loved-one during a health journey. CaringBridge offers the opportunity for expressive writing through journal entries, wellbeing resources, participant health journey stories, and practical scheduling and communication tools to support community, healing, and wellbeing. Loving Kindness Meditation (LKM) is a systemized mind-body approach developed to increase loving acceptance and has been shown to increase resilience in the face of adversity. The aim of this study is to better understand how mind-body practices, like LKM, impact adult CB users


Eligibility Criteria:
Inclusion Criteria:

* English literacy
* CaringBridge user with an active email address
* Visitor/Caregiver/Patient on a Cancer Journey (for Phase 2 only)

Exclusion Criteria:

* N/A