cyrilzakka/clinical-trials huggingface dataset:
Idiotype Vaccine After Chemotherapy & Stem Cell Transplantation in Lymphoma With Failed Induction Chemotherapy

This is a compassionate use protocol for participants who failed induction chemotherapy + Vaccine on previous trials. These participants then went on to high dose BEAM chemotherapy and transplant, then received idiotype vaccine therapy at 3 months post transplant. Vaccine was given monthly x 4 series, with a fifth series given 12 weeks after the fourth. Participants were then followed annually until progression or death with standard staging.

This trial was made available as a compassionate use protocol for participants who failed induction chemotherapy + Vaccine on trials 0197-99-FB and 0196-99-FB. These follicular NHL participants then went on to high dose BEAM chemotherapy and transplant. Patients received idiotype vaccine therapy at 3 months post transplant. Vaccine was given monthly x 4 series, with a fifth series given 12 weeks after the fourth. Participants are then followed annually until progression or death with standard staging. Immune response testing continues annually on participants who continue to have a response post transplant.

Eligibility Criteria:
Inclusion Criteria:

* histologically confirmed aggressive or indolent, B-cell non-hodgkins lymphoma
* original enrollment in vaccine protocol for newly diagnosed lymphoma and had successful production of idiotype vaccine
* failed to achieve PR or CR with initial induction chemotherapy, received salvage chemotherapy and then stem cell transplant and achieved a CR or good PR following transplantation

  -\>/= 19 years
* signed informed consent
* non-pregnant, non-lactating

Exclusion Criteria:

* serious disease or condition that, in the opinion of the investigator, would compromise the subject's ability to participate in the study.
Measuring Comfort and Clarity With Low Gain Feature in Pediatric Hearing Aid Users

Comfort and clarity of speech will be measured in hearing impaired children age 8-17 using standard speech processing algorithm with a soft speech enhancer feature, referred to as the Adaptive Situational Gain (ASG) feature in study documents.


Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of mild, moderate, or moderate-severe sensorineural hearing loss
* Must use oral mode of communication
* must speak English

Exclusion Criteria:

-
Effect of Cervical Stability Training on Somatosensory Evoked Potential and Cervical Spine in Forward Head Posture

to investigate the effect of cervical stability training on somatosensory evoked potential and cervical spine in forward head posture

The use of electronic tools is increasing in worldwide varieties and the attractiveness of these tools lead to variety of groups of people, especially teenagers, using them for prolonged period of time leading to increased musculoskeletal problems. Excessive use of smartphones for long period of time can lead to decreased postural control and forward head postur (FHP) as phone users maintain an abnormal alignment of the head and neck. The habit of repetitive use of computers, TV, mobile phones, and video games and even back packs forces the body to exhibit bad posture. The overall prevalence of FHP was reported to be 66% in computer based workers.

cervical stability training play a major role in treatment of forward head posture so this study will be conducted to investigate its role on craniovertebral angle, cervical range of motion, pain intensity level, functional disability, neck flexor and extensor muscles endurance, lordotic cervical curvature, somatosensory evoked potential in forward head patient.

Eligibility Criteria:
Inclusion Criteria:

Adult participant (18-to-40years old) with forward head posture, BMI 20-to-25 kg/m², The area of mechanical neck pain will defined to the cervical region, possibly with referred pain into the occipit, nuchal muscles, and shoulders, All patients will have chronic neck pain for more than 3 months, Craniovertebral angle of ˂ 49.

Exclusion Criteria:

Signs of serious pathology (e.g., rheumatoid diseases, ankylosing spondylitis), History of cervical spine surgery, History of trauma or fractures in cervical spine, Signs of cervical radiculopathy or myelopathy, Vascular syndrome such as vertebrobasilar insufficiency.
Clinic-based Intervention to Promote Cervical Cancer Prevention Behaviors

The project is a clinical behavioral research project based at University of Pennsylvania. The goal of this research is to design a brief clinic-based, Nurse Practitioner-guided, and theory-based health promotion intervention to enhance cervical cancer prevention among young women ages 18-26 living in economically disadvantaged urban communities. The investigators will evaluate the intervention for feasibility, acceptability and preliminary efficacy.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-26 years
* Not yet received the HPV vaccine
* Speak, read, and understand 5th grade level of English;
* Had vaginal sex with a male partner in the past 2 months.

Exclusion Criteria:

• Currently pregnant and/or plan to be pregnant in next 6 months
rTMS for Working Memory Deficits in Schizophrenia

In this study, the investigators will be examining the effects of repetitive transcranial magnetic stimulation (rTMS) on memory deficits in individuals with schizophrenia and schizoaffective disorder. Half of the study participants will be chosen by chance to receive active rTMS stimulation while half will be chosen by chance to receive sham rTMS. Sham rTMS will feel the same as active rTMS only there will be no direct brain stimulation. This is necessary to ensure that active rTMS is efficacious in the enhancement of memory in individuals with schizophrenia. Based on results from a recently published pilot study, the investigators propose that active rTMS treatment will result in a significant improvement in working memory performance compared to sham rTMS treatment.

This study is a randomized, double blind, sham controlled study to evaluate the efficacy of repetitive transcranial magnetic stimulation as a treatment for working memory deficits in individuals with schizophrenia or schizoaffective disorder between 18 and 59 years of age. The study duration is approximately 3 months, with the rTMS sessions lasting for 4 weeks, 5 times a week, for about 1 hour each. Several scales will be used to assess symptom severity as part of the clinical assessment. Cognition will be assessed using a validated battery and the N-back task.

This study also involves a type of brain imaging known as magnetic resonance imaging (MRI) at the beginning and at the end of the 4 weeks of daily rTMS to better understand the effects of rTMS on brain structure and function. Investigators will measure the size and connections of different parts of the brain to assess brain structure and blood flow while you are completing some basic tasks to assess brain function. We will also collect two blood samples (before and after rTMS treatment) to see if certain proteins change in response to treatment. Finally, an analysis of genetic material will be conducted to see if genes play a role in differences in how people respond to treatment.

Eligibility Criteria:
Inclusion Criteria:

* Between 18 and 59 years of age
* Current diagnosis of Schizophrenia or Schizoaffective Disorder
* Able to provide written informed consent
* Fluency in the English Language

Exclusion Criteria:

* Have a history of substance abuse or dependence in the last 6 months
* Have a concomitant major and unstable medical or neurologic illness
* Have a history of seizures or have a first degree relative with a history of a seizure disorder
* Current pregnancy or a plan to become pregnant during the duration of the study
* Clinical instability: determined by treating physician
* Have received electroconvulsive therapy (ECT) within the last year
* Have a history of repetitive transcranial magnetic stimulation (rTMS)
* Are taking a benzodiazepine at a dose greater than Lorazepam 2mg or equivalent
* Are taking any non-benzodiazepine anticonvulsant
* Have a cardiac pacemaker, cochlear implant, implanted electronic device or non-electric metallic implant
Investigation of Contralateral Arytenoid Sparing IMRT for T1a & T2a Larynx Cancer & Analysis of Post-treatment Laryngeal Function

The aim of this study is to define a new treatment technique for T1a larynx cancer that maintains excellent local control with less extensive radiation fields. It is thought that this will lead to patients having fewer changes to their voice and a higher quality of life after treatment when compared to the current standard treatment.

Parallel opposed portal external beam radiation is the standard nonsurgical treatment for T1-2N0 glottic cancer. This technique involves treatment of the entire larynx for tumors that are small and limited. Although technological advances now allow radiation oncologists selectively to target and avoid adjacent sub-portions of any organ, these tools have not been applied T1-2N0 glottic cancer due to the perceived low toxicity of standard therapy. However, radiotherapy for early glottic cancer is not without functional side effects and it is not known whether post-treatment function after whole larynx radiation is superior to a more targeted surgical approach.

This is a phase II study to treat unilateral glottic cancer (Stage T1a and T2aN0) with intensity modulated radiation therapy (IMRT). In view of the anticipated small volume of disease at presentation and need to limit the potential for a "marginal miss", treatment will include the entire involved vocal fold, anterior commissure, and the anterior 1/3 of the contralateral vocal fold thus sparing the contralateral arytenoid cartilage and musculature ("contralateral arytenoid sparing IMRT"). In addition, we propose to perform sophisticated objective and patient reported measures regarding speech outcomes for two years after the completion of therapy at specified intervals, to better gain an understanding of the effects of therapy. Our findings will have the potential to dramatically advance the field of early larynx cancer therapy by demonstrating the efficacy of limiting the volume of uninvolved larynx that receives radiation and comprehensively assessing the functional outcomes of said therapy.

Eligibility Criteria:
* Inclusion Criteria:

  * Patients with T1a or T2a squamous cell carcinoma of the glottic larynx (tumor limited to one vocal cord with normal cord mobility).
  * Patients must be able to read and write English to comply with the questionnaire portions of the protocol.
  * ECOG performance status of 0 or 1.
* Exclusion Criteria:

  * Patients with verrucous or adenocarcinoma
  * Patients with T1 tumors on both cords (T1b)
  * Patients with T2b-T4 true larynx tumors
  * Patients with primary supraglottic tumors that involve the true larynx
  * Patients with a prior or concurrent malignancy (other than nonmelanoma skin cancer or carcinoma in-situ of the cervix) are ineligible unless the previous cancer was treated 5 years or more prior to the current tumor and the patient has remained continually disease free
  * Patients who have received prior radiation to the head and neck
  * Pregnant or breastfeeding women
Analysis of Videodermatoscopic Parameters of Ocular, Periocular, Conjunctival and Palpebral Neoformations

ANALYSIS OF VIDEODERMATOSCOPIC PARAMETERS OF OCULAR, PERIOCULAR, CONJUNCTIVAL AND PALPEBRAL NEOFORMATIONS

The analysis of videodermatoscopic parameters of ocular, periocular, conjunctival and eyelid neoformations refers to the use of advanced technology that allows us to examine in detail the lesions or neoformations that appear in and around the eye areas. Through videodermatoscopy, we can evaluate characteristics such as size, shape, color and internal structure of these neoformations, to distinguish benign ones from those that may require further diagnostic investigations or treatments.

Eligibility Criteria:
Inclusion Criteria:

* patients who had been diagnosed with one of the following conditions in the ocular and periocular region: common melanocytic nevus, melanosis, seborrheic keratosis, viral wart, angioma and angiokeratoma, apocrine hydrocystoma, xanthelasma, steatocystoma, actinic keratosis, basal cell carcinoma, squamous cell carcinoma, melanoma.

Exclusion Criteria:

* Patients who presented with one of the following conditions were excluded from the study: concomitant inflammatory processes, including blepharitis, chalazion, pterygium, pinguecula), coexistence of multiple, periocular or ocular lesions, diagnosis of syndromic diseases related to a major risk for cutaneous neoformations.
Effects of Whole Body Vibration (WBV) on Musculoskeletal System of Aged Women

A controlled, non-randomized trial will be carried out in 240 postmenopausal women, aged 55-75 years, over a 18-month period. The group 1 received a physical intervention, consisting of whole body vibration (WBV) over 12 months followed by training arrest during 6 months. The group 2 served as sedentary control. WBV training is performed 2 or 3 times per week, with each session lasting 20 minutes. The training included light squats at 35-50 Hz and ended up by stretching and relaxation exercises at 50 Hz. Bone, muscle and postural evaluations will be performed at the beginning, 6, 12 and 18 months in each group with evaluation of bone micro-architectural trabecular and cortical compartments, at the weight bearing tibia and the non weight bearing radius.

The primary outcome of the project is the pre, mid, and post evaluations of bone. Bone exploration included dual x-ray absorptiometry (DXA) and high resolution peripheral quantitative computed tomography (HR-pQCT). Bone Mass Density (BMD) will be evaluated by DXA at lumbar, femoral levels and humeral, macro and micro-architectures of the cortical and trabecular compartments will be evaluated in distal radius and tibia by HR-pQCT and bone markers will be analyzed longitudinally. The secondary aim is to assess muscle performance and proprioception. Finally will be assessed markers of cartilage degradation and synthesis, no study has been published on this tissue.


Eligibility Criteria:
Inclusion Criteria:

* Be sedentary (less than 2 hours physical activity of low intensity per week)
* Fracture risk Densitometry Risk factors (FRAX) index between 3 and 10%
* Consent form signed

Exclusion Criteria:

* Bone concomitant disease (such as Paget's disease, osteomalacia),
* Endocrinopathy defined on biological criteria (such as Cushing's disease, hyperparathyroidism, hyperthyroidism, hypogonadism),
* Smoking habits (more than 5 cigarettes per day), chronic alcoholism,
* Treatments received in the previous 6 months affecting bone metabolism such as anabolics, anti-osteoporotic treatment, corticosteroids.
* Having a prosthesis (femur and knee),or recently placed metal bouts or plates
* acute thrombotic problems,
* severe heart- and vascular diseases,
* recent injuries due to operation or polyclinical intervention,
* acute hernia, discopathy, spondylolysis,
* epilepsy,
* severe migraine,
* pacemaker,
* every neurodegenerative or neuromuscular disease,
* dementia
Study of Oral High/Low-dose Cepharanthine Compared With Placebo in Non Hospitalized Adults With COVID-19

The purpose of this study is to evaluate the efficacy and safety of high/low-dose cepharanthine for the Treatment of COVID-19 in asymptomatic and non-pneumonia mild adult participants with COVID-19 who do not need to be in the hospital, but in alternate care site.

Screening participants will sign the appropriate informed consent form (ICF) prior to completion of any study procedures.

Patients will be randomized to one of three arms, all participants will receive standardized medical treatment (SMT) according to Scheme for Diagnosis and Treatment of 2019 Novel Coronavirus Pneumonia (The 9th Trial Edition) from health commission of China, including bed rest, adequate energy and nutrition, pay attention to water and electrolyte balance to maintain a stable internal environment, closely monitor and Chinese traditional medicine, etc.

* low-dose experimental arm：cepharanthine 60mg/day + SMT
* high-dose experimental arm：cepharanthine 120mg/day + SMT
* placebo control arm：placebo + SMT

The primary outcome measure is the time to viral clearance which defined as first positive nucleic acid test to the date of the first negative test (in two consecutive point). SARS-CoV-2 viral load was detected and quantified by RT-PCR using nasopharyngeal swabs . Ct value\>35 for both ORF1ab and N gene was considered as negativity.

Eligibility Criteria:
Inclusion Criteria:

* aged over 16 years old with all genders
* SARS-CoV-2 positive（laboratory-confirmed reverse transcription polymerase chain reaction (RT PCR) test)
* patient or immediate adult family member agrees to participate in this study and signs an informed consent form
* asymptomatic or patients with mild covid-19 symptoms
* confirmed SARS-CoV-2 infection within 5 days prior to randomization

Exclusion Criteria:

* Confirmed SARS-CoV-2 infection within \> 5 days prior to randomization
* CT shows pneumonia on admission
* diagnosed as severe or critical COVID-19 before intervention
* has a history of chronic underlying disease and acute exacerbation of that underlying disease at the time of admission
* Females who are pregnant or breastfeeding
Anal Crohn Fistula Surgery

The purpose of this study is to demonstrate, in patients treated with adalimumab, the efficacy of proctological surgery in anoperineal fistula healing after the removal of seton drain.


Eligibility Criteria:
Inclusion Criteria:

* male or female 18 years or older,
* women of childbearing age who use an effective contraception method or women incapable of becoming pregnant \[(i.e. postmenopausal women for 1 year or surgically sterile (hysterectomy and/or bilateral oophorectomy)\],
* Patient with fistulizing anoperineal Crohn's disease. Anoperineal fistulas can be associated with ileal, colic or rectal lesions,
* Patient with at least 1 anoperineal fistula drained with a seton for more than 1 month,
* Patient treated with adalimumab for more than 1 month,
* Patient who agrees to undergo surgery for its drained fistula(s),
* Patient with immunosuppressive therapy (azathioprine, 6-mercaptopurine ou methotrexate) stable for at least 3 months or patients without immunosuppressive therapy,
* Patient who gave signed written informed consent after having received verbal explanation and written information related to the trial.

Exclusion Criteria:

* Pregnant or breastfeeding women,
* Patient having a perineal abscess,
* Patient with a high anovaginal fistula that cannot be treated, according to the investigator ,with fistulotomy, gluing, biodegradable plug or advancement flap,
* Patient treated with a daily dose of corticosteroids of more than 20 mg (a dose of more than 20 mg daily will be authorized during the study),
* Contraindication to proctological surgery on the drained fistula(s),
* Patient presenting with somatic or psychic signs or symptoms that are not compatible with his/her participation in the trial according to the investigator,
* Patient who participate in another clinical trial.
Insulin and Muscle Fat Metabolism

Our objective in this study is to identify the extent to which insulin drives the accumulation of lipids in skeletal muscle of humans. We will test the hypothesis that 4-hours of mild hyperinsulinemia will result in significant muscle lipid accumulation and that such effects will be similar in lean and overweight/obese humans.


Eligibility Criteria:
Inclusion Criteria:

* Age 30-55 years
* Body mass index (BMI) 18-45 kg/m2
* Sedentary (\<1 hour of planned exercise per week)

Exclusion Criteria:

* Regular exercise (\>1 hour of planned exercise per week)
* Smoking, tobacco or nicotine use within the last 1-year
* Fasting glucose \>126mg/dL
* Hypertension (systolic pressure \>140 mmHg or diastolic pressure \>90 mmHg)
* Chronic metabolic or cardiovascular health conditions
* Pregnant, nursing, irregular menses or post-menopausal
* Lidocaine allergy
* Certain medications
* Diminished capacity for consent
A Study of SHR-3821 Injection in Subjects With Advanced Solid Tumors

This is an open label, multi-center, multiple dose Phase I study to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-3821 injection in subjects with advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

1. Voluntary participation and written informed consent.
2. 18-75 years older, no gender limitation.
3. Eastern Cooperative Oncology Group (ECOG) score: 0-1.
4. With a life expectancy ≥ 3 months.
5. Pathologically diagnosed advanced solid tumor.
6. Be able to provide fresh or archived tumour tissue.
7. At least one measurable lesion according to RECIST v1.1.
8. Adequate bone marrow reserve and organ function.
9. Contraception is required during the trial.

Exclusion Criteria:

1. Meningeal metastasis history or clinical symptoms of central nervous system metastasis.
2. Uncontrollable tumor-related pain.
3. Uncontrolled pleural effusion, pericardial effusion, or abdominal effusion with clinical symptoms.
4. Received systemic antitumor therapy before the first dose.
5. Treated with similar target therapy as SHR-3821 before the first dose.
6. Received systemic anticancer treatments 4 weeks prior to the initiation of the study treatment.
7. Unresolved CTCAE 5.0\>=grade 2 toxicities from previous anticancer therapy.
8. Current or History of ILD.
9. Active severe digestive disease.
10. Previous or co-existing malignancies.
11. History of severe hypersensitivity reactions to either the drug substances or inactive ingredients of SHR-3821.
12. Active hepatitis B or active hepatitis C.
13. Other inappropriate situation considered by the investigator.
Validation of the GenePOC Strep A, C/G Assay for Detecting Group A, C and G β-hemolytic Streptococcus From Throat Swabs.

The primary purpose of this clinical investigation is to establish the performance of the GenePOC Strep A, C/G assay on the revogene. This will be achieved by comparing the test to a conventional method for detection of Group A β-hemolytic Streptococcus (GAS) and pyogenic Group C and G β-hemolytic Streptococcus (GCS/GGS) in throat swab samples.

The GenePOC Strep A, C/G assay will be performed using the revogene™ instrument. The revogene instrument, used in conjunction with appropriate reagents, is capable of automated cell lysis, dilution of nucleic acids from multiple sample types as well as automated amplification and detection of target nucleic acid sequences.

A dual swab sample is collected when ICF is signed by patient. One of the swab will be tested on the revogene™, and the second swab will be tested with standard microbiology method at a Reference Center.

Eligibility Criteria:
Inclusion Criteria:

* Samples from patients suspected of having signs and symptoms of a pharyngitis infection
* Patient that signed the approved Informed Consent Form (if applicable)
* Patient older than 2 years of age
* Only one (1) compliant sample per patient is allowed
* Use of dual swab with either liquid Stuart or liquid Amies transport Medium

Exclusion Criteria:

• Patient/sample not meeting inclusion criteria above