cyrilzakka/clinical-trials huggingface dataset:
Measurement of Implant Stability by Resonance Frequency Analysis in Patients Treated for an Upper Aero-digestive Tract Cancer

The primary objective is to describe the evolution of implant stability between the date of implant placement and 3 months later when the implant is implementated in patients treated for cancer of the upper aero-digestive tract

Oral implantology is widely used during prosthetic rehabilitation in healthy patients but also in patients presenting cancers of the upper aero-digestive tract.

Systems for measuring implant stability using resonance frequency analysis exist and are used clinically by some practitioners, such as the Ostell® system from W\&H. These systems make it possible to determine the osseointegration of the implant, and thus the appropriate time to insert the implant, by comparing the value obtained with average values.

Implant survival rates are lower for implants placed in irradiated bone, with an implant stability quotient value identical to implant placement but lower after osseointegration. Only one study shows implant stability quotient values\> 60 with a success rate of 100% at 41 months on implants placed in patients having received radiotherapy. However, no clinical study has investigated the kinetics of osseointegration and the stability of implants placed on a microanastomosis fibula flap as part of aesthetic and prosthetic reconstruction after cancer of the upper aero-digestive tract.

Eligibility Criteria:
Inclusion Criteria:

* Patient with squamous cell carcinoma of the upper aero-digestive tract (oral cavity, oropharynx, hypopharynx
* Patient having been treated by external radiotherapy and/or having benefited from a microanastomosis fibula flap
* Patient going to undergo a surgical intervention with placement of dental implant(s) in an irradiated area or in the microanastomosis fibula flap
* Non-opposition to the study

Exclusion Criteria:

* Patient having difficulties speaking and understanding French
* Patient under tutorship or curatorship
Community Resiliency Collective Efficacy Intervention

This study will evaluate, via a cluster-randomized controlled trial, the effectiveness of a community-centered intervention that promotes thriving and resiliency to reduce community violence.

This study will evaluate, via a cluster-randomized controlled trial, the effectiveness of an innovative community-centered intervention that promotes thriving and resiliency to reduce community violence. In collaboration with community partners, this study will implement a Community Resiliency Collective Efficacy Intervention (CRCEI) to engage community members in dialogue on neighborhood transformation, racial and gender equity, community leadership, and organizing for social change. Facilitating discussion and community organizing within neighborhoods about child and youth thriving is expected to increase individual and neighborhood levels of collective efficacy and reduce community violence. Using a community-partnered participatory approach, this study will use a Community Thriving Matrix tool to engage youth and adult community members in ongoing dialogue on neighborhood transformation, community leadership, and organizing for social change. This focus on envisioning and creating neighborhoods in which children and adolescents can thrive is expected to translate to increased individual and neighborhood levels of collective efficacy as well as violence reduction. Comparison neighborhoods will receive health education sessions as a control intervention. The proposed study involves diverse neighborhoods in the Pittsburgh region and collecting survey data from youth (ages 13-19 years) and adult community participants (both male and female identified). Interviews with a sub-sample of community residents and facilitators and community site leads as well as observations of intervention delivery will provide qualitative information on processes of program implementation. This study will provide the first rigorous evaluation of this community-level prevention approach.

Eligibility Criteria:
Inclusion Criteria:

* youth age 13 years old and up (all genders)
* adults 18 years and older (all genders)
* reside in neighborhoods selected to participate in the study

Exclusion Criteria:

* individuals younger than 13 years old

  * individuals residing outside of participating neighborhoods
Serologic Response to SHINGRIX Vaccine in Patients With CLL and WM Treated With BTK Inhibitors

The primary objective of the study is to assess the capability of a patient with Chronic Lymphocytic Leukemia (CLL) or Waldenström Macroglobulinemia (WM) to generate an immune response to the Shingrix vaccine under first-line BTK inhibitors.

Chronic lymphocytic leukemia (CLL) and Waldenstrom's macroglobulinemia (WM) are known risk factors for zoster reactivation, commonly called shingles. Although a recently FDA-approved recombinant, adjuvanted herpes zoster vaccine (Shingrix) is currently being offered to these populations, no study has specifically evaluated them.

The purpose of the study is to complete a single-arm trial evaluating if patients with CLL or WM, while on treatment with first-line BTK inhibitors, can achieve immunologic response to Shingrix. If effective, this will result in a new, well-tolerated shingles prevention strategy for these patients.

The primary objective is to assess the capability to mount a humoral immune response to Shingrix in patients with CLL or WM under first-line BTK inhibitors.

Eligibility Criteria:
Inclusion Criteria:

* They are at least 50 years of age;
* Have been diagnosed with chronic lymphocytic leukemia (CLL) OR Waldenström's macroglobulinemia (WM)
* Have been on first-line BTK inhibitor (ie ibrutinib or acalabrutinib) for at least 3 months,
* Prior treatment with single agent rituximab is permitted if last dose was administered over one year ago;
* Have at least a one-year life expectancy;
* Have a history of varicella (chicken-pox) OR lived in the US or any endemic country for \> 30 years.
* Prior radiation therapy is allowed

Exclusion Criteria:

* They have a known hypersensitivity to a vaccine component;
* Had herpes zoster reactivation within the past year;
* Had received or were scheduled to receive a live virus vaccine in the period from 4 weeks prior to Dose 1 through 28 days post-second dose;
* Had received or were scheduled to receive an inactivated vaccine in the period ranging from 7 days prior to Dose 1 through 7 days post- second dose;
* Are unable to give informed consent;
* Have absolute lymphocyte counts greater than 20,000 X 109/L;
* Are receiving treatment for CLL or WM with an additional agent other than a BTK inhibitor;
* Had rituximab treatment within a year prior to study start;
* Had prior chemotherapy.
Treatment Success With the CoolLoop Cryoablation System

This clinical study evaluates the safety and efficacy of the treatment with the CoolLoop® cryoablation System (sclerotherapy of muscle tissue of the heart by freezing) in patients with atrial fibrillation (permanent atrial fibrillation excepted) over a follow-up period of 36 months.

A further aim of this study is to evaluate the average duration of procedure and fluoroscopy times.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* atrial fibrillation: permanent AF excepted
* ECG documented AF within the last 6 months
* patients planned for an ablation procedure and suitable and planned for treatment with the CoolLoop® cryoablation system
* signed and dated informed consent documented by the patient, indicating that the patient has been informed of all the pertinent aspects of the trial prior to study enrollment (patient has received a copy of the ICF)

Exclusion Criteria:

* indication that the vascular system is not accessible through the left or right groin.
* indication that a transseptal puncture cannot be performed.
* any previous ablation or surgery due to AF.
* important comorbidities such as cardiovascular events within six months of enrollment or high-risk surgical patients.
* pregnant women at the time of the cryoablation procedure.
* any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the Informed Consent Form.
* participation in interventional trials for cardiovascular devices or drugs.
Nucleoplasty for Contained Herniated Lumbar Discs

This is a prospective randomised double blind comparison trial. Fifty patients will be included, 25 in the nucleoplasty treatment group, 25 in the control group. The nucleoplasty group will undergo the nucleoplasty treatment. Control group will undergo a sham treatment. Both groups will undergo a standardised post-operative care program. The study hypothesis is that nucleoplasty will lead to earlier pain reduction as compared with the sham treatment.

This study will include patients with a contained lumbar hernia of at least 6 weeks existence in whom leg pain is the predominant complaint. Standard treatment for these patients is conservative, as an operation is not without risks and is not always effective. Furthermore, complaints will usually resolve in due time. However, the pain limits the patients in their daily activities, often for a prolonged period.

In this study, nucleoplasty will be compared with a sham treatment and not with conservative treatment, as the discography is thought to have some therapeutic effect.

The primary outcome will be the proportion of patients with at least a 2.5 points decrease on a ten-point Jensen VAS score 3 months after treatment.

Eligibility Criteria:
Inclusion Criteria:

* Mono radicular leg pain for at least 6 weeks as a result from a lumbar contained herniated disc. Leg pain must be of greater impact than concomitant back-pain
* Failing conservative treatment; analgesics and/or physical therapy. Failing means persisting pain leading to problems with daily activities.
* Magnetic resonance imaging (MRI): must be performed \< 6 weeks before start treatment. On MRI signs of contained herniated disc, maximum 33% obliteration of the spinal channel. No signs of other significant spine pathology (see exclusion criteria).
* Neurological investigation by neurologist. Symptoms should be clinically related to the disc herniation level.
* Age \>18 and \< 60 years
* Mean leg pain on visual analogue scale (VAS) \>50 mm (0 -100)

Exclusion Criteria:

* Herniated disc with more than 33% obliteration of the spinal channel.
* Annulus rupture with sequestrated herniated disc.
* Pain on VAS below 50 mm
* Pain existing longer than one year
* Less than 50% preserved disc height
* Conflict with social security/insurance.
* Major motor impairment as a result of the herniation, paresis grade 3 or more using a Medical Research Council (MRC) score
* Other degenerative causes of nerve root compression; ligament flavum or facet joint hypertrophy, degenerative spinal channel stenosis, loss of lumbar kyphosis, discopathy with signs of Schmorls' nodules and loss of nucleus pulposus signal. Other causes of radicular syndrome such as cancer, radiculitis or neural degeneration.
* Spinal instability (spondylolisthesis, spinal fracture or tumor)
* History of back surgery, chemonucleolysis or other intra discal procedures
* Coagulopathies or oral anti-coagulation therapy
* Infection
* Pregnancy
Genome-wide Association Study of Development of Collateral Circulation for Patients With Coronary or Peripheral Artery Disease

The purpose of this study is to evaluate the genome-wide association for the development of collateral circulation for patients with coronary or peripheral artery disease and to develop the molecular genetic treatment model based on genome-wide association data.


Eligibility Criteria:
Inclusion Criteria:

* Age more than 20
* Chronic total occlusive lesion from the coronary or peripheral angiogram

Exclusion Criteria:

* Renal dysfunction
* Hepatic dysfunction
* Thrombocythemia or thrombocythemia
* Planned major surgery in 1 year
* History of gastrointestinal haemorrhage
* Malignant tumor
AlloGen-LI Treatment of Spinal Stenosis

In this pilot study, investigators will test the efficacy of AlloGen-LI, an allograft derived from amniotic fluid, injected into the epidural space at the level of spinal stenosis as an anti-inflammatory treatment to relieve back and leg pain symptoms in patients with spinal stenosis and/or disc herniation. The patients will be followed for 12 weeks. The effect of this treatment will be examined by patient reported changes in pain and disability utilizing validated outcome measures, and MRI imaging evaluating changes in contrast enhancement and T2 signal related to that reflect inflammation and degeneration.

AlloGen-LI contains multiple factors that may serve to ameliorate the detrimental effects of osteorarthritis and degenerative disc disease. Anti-inflammatory components include inhibitors of matrix metalloproteins and pro-inflammatory cytokines, growth factors and interleukins. The product has low immunogenicity and is hypo-osmotic.2 Placental tissues, including amniotic fluid, amniotic membrane and chorion are regulated as human cell and tissue products (HCTP) by the FDA. This regulation allows clinicians to use the allograft materials for human injection. AlloGen-LI is derived from placental tissues obtained from carefully screened healthy mothers at the time of scheduled cesarean section. The mothers have agreed to donate the tissues, which would otherwise be discarded. The experimental treatment would entail an injection of one dose of AlloGen-LI and marcaine into the epidural space under CT guidance, in an identical manner to traditional epidural steroid /marcaine injections.

Eligibility Criteria:
Inclusion Criteria:

1. Low back pain of \> 4-5 weeks but \< 6-7 months
2. Evidence of at least mild lumbar stenosis /disc herniation on MRI
3. Failure of conservative therapy to include physical therapy and pharmacotherapy
4. Patient is at least 18 years of age
5. Patient is willing to be blinded to treatment until after the 12 week post injection visit
6. Patient is willing and able to review and sign the study informed consent form

Exclusion Criteria:

1. No evidence of lumbar stenosis or disc herniation on MRI 2. Patient has had prior lumbar surgery at any level 3. Patient has received epidural steroid injection in the past 6 months 4. Patient currently receives systemic steroids for another medical condition 5. Patient is pregnant 6. Patient has systemic infection at the proposed injection site 7. Patient has a systemic malignancy 8. Current therapy with any immunosuppressive medication 9. History of solid organ or hematologic transplantation 10 History of autoimmune disorder 11. Patient has known allergy to lidocaine, marcaine or steroid 12. Devices and conditions that are contraindications for MRI examination (routinely screened before all MRI examinations).

13. Patient is on anticoagulant medications (other than ASA). 14. Patient has eGFR of \<40 15. Patient has known chronic kidney disease
Data Driven Behavior Intervention and Medical Outcome Evaluation of Patients' Comprehensive Monitoring

During the study, the resuscitation room, general wards and ICU were installed fixed or mobile acquisition devices in the resuscitation room, the emergency department of Peking Union Medical College Hospital, and the collection platform was set up. Patients with acute diseases (infection, diabetes complications, etc.) caused by metabolic syndrome (obesity, diabetes, etc.) were selected after informed consent. All medical intervention behaviors, relevant medical records and medical outcome records within the collection scope of the device platform were collected prospectively . And regular follow-up, guidance of patients with metabolic syndrome control, while collecting all the lifestyle characteristics of patients, some patients with metabolic cabin research, and observe the relevant medical outcomes. After that, all the collected data were coded, and the influence of all lifestyle and medical behavior interventions on patients' medical outcomes was studied by artificial intelligence method.


Eligibility Criteria:
Inclusion Criteria:

* Diabetes and / or obesity (BMI\>=28).
* Emergency room / emergency ward / EICU;
* Be able to understand and agree the research protocol and sign the informed consent

Exclusion Criteria:

* Pregnant women / lactation period;
* The estimated survival time was less than 1 year;
* Long term follow-up is not guaranteed;
* Failure to comply with the protocol or procedure;
* The collection of medical behavior data can not complete the de privacy or label after de privacy;
* Other researchers think that it is not suitable for inclusion
Methods to Improve Preventative Care Uptake

The proposed study examines whether providing patients with information on the incentives for following the preventative care guidelines available through their insurance has an impact on the update of these preventative services.


Eligibility Criteria:
Inclusion Criteria:

* Patients attributed to the New York University Langone Health Clinically Integrated Network and have Medicare or Medicaid coverage (via Healthfirst) who are due for gaps in care

Exclusion Criteria:

* Any patients who do not meet the inclusion criteria
Anesthesia and Cancer Study: Colon Cancer

This study investigates the influence of type of anesthesia on survival and recurrence rate in patients receiving colon cancer surgery. The participants will be allocated to either the TIVA group and the inhalation group.

The effect of anesthesia on cancer recurrence and survival is controversial. According to some retrospective studies and preclinical studies, total intravenous anesthesia (TIVA) is suggested to be more favorable than inhalation anesthesia regarding cancer recurrence and survival after surgery. However, there is no randomized controlled study to determine this difference in colon cancer patients.

Eligibility Criteria:
Inclusion Criteria:

* adults undergoing surgery to remove colon cancer

Exclusion Criteria:

* pregnancy
* colon cancer with invasion to perineum
* palliative surgery
* history of diagnosis or surgery for other cancer
* emergent surgery
* ASA PS classification 4 and 5
* refusion to participate in the study
* allergy to anesthetics
Seroquel- Agitation Associated With Dementia

The purpose of this study is to determine how safe and effective Seroquel (quetiapine fumarate) is compared to placebo (a non-drug tablet) for a period of up to 10 weeks in the treatment of agitation symptoms in nursing home or assisted care residents.

PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must have a diagnosis of dementia compatible with probable or possible Alzheimer's disease (AD)
* Subjects exhibit inappropriate verbal, vocal, or motor activity that requires treatment with an antipsychotic medication in addition to or beyond behavioural modification therapy
* Subject must have a score of at least 14 on the PANSS

Exclusion Criteria:

* Current or past symptoms for schizophrenia, schizoaffective disorder, or bipolar disorder
* Symptoms of agitation that are caused by another general medical condition or direct physiological effects of a substance
* Failure to respond on 2 occasions to an adequate regimen of atypical antipsychotic medications for the treatment of agitation and/or aggression
Treatment of Hypersensitivity Syndrome (DRESS) With Tegeline® (Human Immunoglobulin)

Efficacy and tolerance of Tegeline® treatment in hypersensitivity syndrome. Immunological study of the T cell index phenotype and functionality in hypersensitivity syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18
* Cutaneous and/or mucous eruption
* Polyadenopathy
* Body temperature \> 38°C
* Hematology disorders : Hypereosinophily \> 1.5 G/l, lymphocytosis \> 5G/l, atypical blood lymphocytes
* Consent obtained from patient

Exclusion Criteria:

* Age \< 18
* No consent obtained from patient
* IgV allergy
* Dress with very sérious visceral attack and vital diagnostic (sharp cardiac insufficiency, sharp respiratory insufficiency, hepatic insufficiency, sharp renal insufficiency)
* Oral therapy or immunosuppressive therapy (Methotrexate, cyclosporine, cyclophosphamide, etc.)
* IgA deficiency,
* MCI \>=35
* Sharp renal insufficiency before Dress with creatinaemia \< 60 ml/min (Cockroft)
Sensory Analysis and Taste Modulation of Ketone Esters

Ketone ester (KE) drinks are sold commercially in the USA and elsewhere (the FDA has accepted a GRAS (generally regarded as safe) notification on the KEs we propose to study). KE drinks can have beneficial effects on metabolism. Unfortunately, KE drinks have a strongly unpleasant flavor which can trigger rejection. The current study will generate data to help inform KE drink formulations with improved flavor. First stage, trained subjects will rate the intensity of various sensation qualities (e.g., bitter, sour, metallic, and astringent) from KE drinks to help understand the nature of the unpleasant flavor and the particular sensory systems involved (e.g., taste vs. smell). Then, subjects will taste KE drinks with and without various flavor modifiers. Subjects will be healthy adults (aged 21-45) without known food allergies.


Eligibility Criteria:
Inclusion Criteria:

1. Good general health (self report)
2. Men and women
3. Age from 21 to 45

Exclusion Criteria:

1. Current (or within the last four weeks) acute illness, such as cold or flu
2. Currently active allergies
3. Regular use of medication (over the counter or prescription), except for birth control.
4. Any history of food allergy or sensitivity (particularly to KE drinks or MSG). Any history of sensitivity to 6-Propylthiouracil (bitter compound frequently used to assess individual differences in sensitivity to bitterness).
5. Pregnant, nursing, or trying to become pregnant during the study (pregnancy can affect flavor perception)
6. Chronic illness (any ongoing condition that is serious or required medical monitoring), including kidney problems, liver problems, cardiovascular problems (e.g., heart disease or high blood pressure), diabetes, HIV infection, or other ongoing illness). Diabetes or other metabolic issues could be important for safety as well as quality of data.
7. History of taste problems (absent or abnormal sense of taste)
8. Weigh less than 100 pounds (45.4 kilograms). This is to help ensure that the amount of KE drink consumed remains below the single serving in the GRAS (generally regarded as safe) notice which the FDA has accepted.