cyrilzakka/clinical-trials huggingface dataset:
Toothbrush in the Genesis and Prevention of Dental Recessions

The aim of this research is to evaluate the effect of brushing on gingival recessions and to understand the impact of manual brushing and brushing with mechanical aid on their evolution.

The study involves the recruitment of 90 patients with or without gingival recessions at the Dentistry service of the University of Genoa.

The first phase involves the evaluation of the brushing force on the genesis of gingival recessions. A questionnaire will be filled out and the same toothbrushes and toothpastes will be provided for one month to 30 patients with recessions and 30 patients without recessions. After a month, the "wear" of the manual toothbrush and the gingival health indices will be measured.

In this phase 60 patients with recessions will be divided into two groups according to the oral hygiene method that will be recommended. In the first group a super soft toothbrush will be delivered, in the second group a mechanical toothbrush. Gingival health indices will be taken and an intraoral scan will be done to measure recessions. At 6 months and 12 months the indices will be measured again and compared between the two groups.

This research has two objectives:

1. Evaluate the differences in wear of the manual toothbrush head after one month of use between patients with gum recession and patients without gum recession. In the case of greater wear among patients with recessions it could be assumed that a greater brushing force is able to determine the formation of recessions.
2. Try to understand if there are differences between the super soft manual toothbrush and the mechanical toothbrush regarding the effectiveness of use and the "delicacy" on recession. Both tools are currently recommended for patients with recessions, but there are no studies in the literature comparing the two tools.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-60 years old;
* Fully dentate participants;
* Periodontal health

Exclusion Criteria:

* Patient with periodontitis
* Previous ortho treatment
* Insufficient restorations or prostheses.
* Systemic disease affecting the periodontal tissues (e.g. bleeding disorders, diabetes mellitus etc.)
* Patients under medication associated with gingival enlargement (e.g. calcium channel blockers, immunosuppressants or anticonvulsants).
CBT With Disulfiram and Contingency Management

This is a study of four treatments for chronic cocaine use and may help study participants to control their drug use. All participants will receive weekly individual cognitive behavioral therapy (CBT).

This study will compare four types of treatment involving skills training and incentives for attending sessions or taking study medication. Disulfiram is a widely prescribed deterrent to alcohol use. In addition to weekly cognitive behavioral therapy (CBT), participants will be assigned to one of the following treatments:

1. placebo
2. disulfiram
3. placebo plus incentives for cocaine abstinence and medication compliance (prize CM)
4. disulfiram plus incentives for cocaine abstinence and medication compliance

Eligibility Criteria:
Inclusion Criteria:

* 18-50 year old
* cocaine dependent
* willing to sign consent
* willing to accept randomization to intervention

Exclusion Criteria:

* significant medical conditions
* psychiatric disorder with current use of prescribed psychotropic medication
* lifetime schizophrenia or bipolar disorder
* suicidality or homicidality
* unlikely to be able to complete 1 year follow up
* unable to speak or read English at a third grade level
Mirror Grant - Toward an Understanding of Body Image Adaptation Following Surgical Treatment for Head and Neck Cancer

The goal of this research study is to understand how patients adjust to appearance and body image changes after surgery for head and neck cancer.

If you agree to take part in this study, you will take part in a face-to-face interview with the study staff. It should take about 1 hour to complete. You will also be asked to complete a questionnaire about your demographic information such as age and ethnicity. The interview will be done in a private research area and will be audio-recorded.

The researchers are interested in learning more about your experience of adjusting to the changes in your appearance after your surgery for head and neck cancer. You may be asked to look in a mirror and describe what you see.

If you ask for another interview, or if the interviewer would like your information made more clear, you will be scheduled for a second interview. You will be provided with an early summary of your interview, and you will be able to provide feedback over the phone or in writing on the accuracy of the information and the conclusions.

Identifying information will be removed from all data collected using participant numbers kept separately from consent forms and shared only among approved research staff. Names and other identifying information will be deleted from transcripts (write-ups of the interviews) after the first review for accuracy. Interview transcripts will be kept in locked file cabinets at MD Anderson for 3 years and can be looked at only by the study chair and staff. Recorded interviews will be destroyed 3 years after the study results are published.

This is an investigational study.

Up to 20 patients and 15 healthcare providers will take part in this study. All will be enrolled at MD Anderson.

Eligibility Criteria:
Inclusion Criteria:

1. At least 18 years of age
2. English speaking
3. For patients: Within 6 weeks of undergoing surgical resection for a tumor in the head and neck region, or within 1-3 years from such surgery.
4. For providers: Inpatient clinical staff (i.e. surgeons, nurses, nursing assistants, physical therapists) who care for surgically treated head and neck cancer patients during acute postoperative recovery, and/or outpatient clinical staff (i.e. nurses, physician assistants) who care for these patients throughout active treatment and into the period of survivorship.
5. For providers: Having worked with surgically treated head and neck cancer patients for at least one year.

Exclusion Criteria:

1) For patients: cognitive impairment documented in their medical record (e.g. delirium, dementia) impeding the ability to offer a narrative of his/her experience.
Nd:Yttrium Aluminum Garnet Laser Treatment for Lichen Sclerosus

This study evaluates the efficacy of Nd:Yttrium Aluminum Garnet Laser (Nd:YAG) Treatment of Lichen sclerosus in comparison with topical corticosteroid treatment. Half of participants will receive laser treatment and the other half corticosteroid treatment and the results will be followed for 6 months.

Lichen sclerosus (LS) is a chronic skin disease of unknown cause and very unpleasant symptoms which significantly influences the quality of life of the affected patients. Large majority of LS lesions is located in anogenital region where initial white flat papules usually develop into large, white patches of thin, itchy skin causing fusion of labia minora, narrowing of the introitus and burying of the clitoris. Most common symptoms are itching, pain, soreness, burning, dyspareunia and dysuria all strongly interfering with sexual function and patient's self image. Existing treatment options with systemic and topical medications (oral retinoids, topical steroids) have some drawbacks and recently the use of laser was proposed for treatment of LS. This study evaluates the safety and efficacy of Nd:Yttrium Aluminum Garnet Laser (Nd:YAG) Treatment of Lichen sclerosus in comparison with topical corticosteroid treatment. Half of participants will receive laser treatment and the other half corticosteroid treatment and the results will be followed for 6 months.

Eligibility Criteria:
Inclusion Criteria:

* histologically confirmed Lichen sclerosus
* voluntary signed informed consent

Exclusion Criteria:

* pregnancy
* use of photosensitizing medication
* pathology other than Lichen
* damage of tissues in the treatment area
* other inflammation
* refusal to sign informed consent
Examining the Long-Term Risks of Oophorectomy

At the time of hysterectomy for benign disease, the overall health benefits of preserving ovarian function in a large population of women have not been established.

We are conducting a prospective, observational study of 32,175 women participants of the Nurse's Health Study who had a hysterectomy with or without removal of both ovaries. We are evaluating mortality and morbidity due to the following conditions: coronary heart disease, stroke, breast cancer, ovarian cancer, other cancer, hip fracture and death from all causes.

Eligibility Criteria:
Inclusion Criteria:

* Women who had hysterectomies were classified into simple hysterectomy or hysterectomy with both ovaries removed.

Exclusion Criteria:

* Evidence of cancer, coronary heart disease (MI or Angina Pectoris), stroke, or hip fracture before entering the study were excluded. Cancer as an indication for hysterectomy also excluded.
* Women reporting unilateral oophorectomy, unknown oophorectomy status, unknown age of hysterectomy, or those who had oophorectomy before hysterectomy were excluded.
A Study to Assess the Pharmacokinetics of a Modified-release Tacrolimus Based Immunosuppression Regimen in Stable Kidney Transplant Patients

A study to assess the pharmacokinetics, safety and effectiveness of tacrolimus in stable kidney transplant patients converted from a Prograf® based immunosuppression regimen to a modified release tacrolimus based immunosuppression regimen.

This is a Phase II open-label, multi-center conversion study in stable, adult kidney transplant recipients to assess the pharmacokinetics, safety and effectiveness of tacrolimus in stable kidney transplant patients converted from a Prograf® based immunosuppression regimen to a modified release tacrolimus based immunosuppression regimen.

Eligibility Criteria:
Inclusion Criteria:

* Patient is currently receiving Prograf ® based immunosuppressive therapy for kidney transplantation.
* Patient has stable whole blood trough level concentrations of Prograf® and is clinically stable

Exclusion Criteria:

* Patient has previously received an organ transplant other than a kidney
* Patient is currently receiving sirolimus immunosuppression therapy.
Safety, Tolerability and Pharmacokinetics of BIBW 2948 BS for HandiHaler® in Healthy Male Volunteers

To investigate safety, tolerability, and pharmacokinetics of BIBW 2948 BS after repeated dosing


Eligibility Criteria:
Inclusion Criteria:

* Healthy males based on a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory tests
* Age ≥21 and Age ≤ 50 years
* BMI (Body Mass Index) ≥18.5 and BMI ≤ 29.9 kg/m2
* Signed and dated written informed consent prior to admission to the study in accordance with good clinical practice (GCP) and the local legislation
* Subjects must be current smokers (\<10 cigarettes or \<3 cigars \<3 pipes/day) with a smoking history \>1 year

Exclusion Criteria:

* Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
* Any evidence of a clinically relevant concomitant disease
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
* History of relevant orthostatic hypotension, fainting spells or blackouts
* Chronic or relevant acute infections
* History of relevant allergy/hypersensitivity (including allergy to the drug or its excipients)
* Intake of drugs with a long half-life (\>24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
* Use of drugs which may have reasonably influenced the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
* Participation in another trial with an investigational drug within two months prior to administration or during the trial
* Smoker (\>10 cigarettes or \>3 cigars or \>3 pipes/day)
* Inability to refrain from smoking on trial days
* Alcohol abuse (more than 60 g/day)
* Drug abuse
* Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
* Excessive physical activities (within one week prior to administration or during the trial)
* Any laboratory value outside the reference range that is of clinical relevance
* Inability to comply with dietary regimen of study centre
Single Dose Study Of The Effect Of Cyclosporine On The Pharmacokinetics Of PF-04991532 In Health Volunteers

The primary purpose of this study is to evaluate the pharmacokinetics, safety and tolerability of a single dose of PF-04991532 in healthy adult subjects with and without co-administration of cyclosporine.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female (non-childbearing potential) subjects between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests. Women must be of non childbearing potential as defined in Lifestyle Guidelines. Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).
* An informed consent document signed and dated by the subject or a legally acceptable representative.
* Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, sychiatric, neurologic, or allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease or clinical findings at Screening.
* Subjects with clinically significant infections within the past 3 months (for example, those requiring hospitalization, or as judged by the Investigator), or evidence of any infection within the past 7 days.
* Screening supine blood pressure \>=140 mm Hg (systolic) or \>=90 mm Hg (diastolic), on a single measurement \[confirmed by a single repeat, if necessary\] following at least 5 minutes of rest.
Safety and Immunogenicity of Quadrivalent Influenza mRNA Vaccine MRT5410 in Adult Participants 18 Years of Age and Older

The purpose of this study is to evaluate the safety and immunogenicity of a single intramuscular (IM) injection of up to 3 dose levels of Quadrivalent Influenza mRNA Vaccine MRT5410 compared to an active control (QIV SD, QIV HD \[adults ≥ 65 years of age only\], or RIV4) in adults 18 years of age and older.

Approximately 12 months

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years on the day of inclusion (US) and aged 21 years on the day of inclusion (Puerto Rico)
* A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies:

Is of non-childbearing potential. To be considered of non-childbearing potential, a female must be postmenopausal for at least 1 year, or surgically sterile OR Is of childbearing potential and agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to study intervention administration until at least 12 weeks after study intervention administration.

Exclusion Criteria:

* Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
* Previous history of myocarditis, pericarditis, and / or myopericarditis
* Self-reported thrombocytopenia, contraindicating IM vaccination based on Investigator's judgment
* Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination based on Investigator's judgment
* Moderate or severe acute illness / infection (according to Investigator's judgment) or febrile illness (temperature ≥ 38.0°C \[≥ 100.4°F\]) on the day of vaccination. A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided
* Self-reported or documented seropositivity for human immunodeficiency virus, hepatitis B virus, or hepatitis C virus NOTE: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Cell Therapy for Diabetic Foot Ulcer

Diabetes is a highly prevalent chronic disease that affects a large part of the world's population. Among the most costly complications is the diabetic foot ulcer, where its decompensation can result in limb amputation, a risk 10 to 20 times more frequent for diabetic population. Two underlying pathophysiological mechanisms are mainly identified: neuropathy and problems associated with vasculature and blood supply, in addition to the incidence of infections, which further impairs prognosis. Skin regeneration involves several overlapping and consecutive stages, which in the case of a diabetic patient are altered.

Although healing protocols have been significantly improved at the country level, and there is also a large amount of medical supplies for treatment of these wounds, there are still patients with ulcers refractory to this care that end in amputation. In response to this, new treatments have emerged that use biomaterials and cells of the patient himself, which attempt to emulate the architecture and functionality of normal tissue. Cell therapy has gained strength in recent years, with more and more studies indicating the positive effect of cell application on healing of chronic wounds with underlying pathologies, such as diabetes.

The product to be evaluated corresponds to a combined medical device, which conveys a cellular therapy, known as InbioDerm+C. The purpose of this Phase II clinical study is to determine whether InbioDerm+C treatment plus advanced healing is equal to or superior to advanced healing in a diabetic population with Wagner II grade foot ulcer treated in Villa Alemana primary care family centers, Las Américas, Juan Bautista Bravo Vega and Eduardo Frei.


Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years old and under 75 years old.
* Patient diagnosed with DM type II.
* Patient with negative pregnancy test.
* Ulcer size with area between 1 cm2 and 12 cm2.
* Ulcer with Wagner grade II classification with less than 50% slough and no tendon exposure, validated by an external specialist after ulcer debridement.
* Ulcer age ≥ at one month.
* Patients with palpable posterior tibial and pedial pulse

Exclusion Criteria:

* Patients with non-diabetic ulcers.
* Toe ulcers.
* Patient with grade IV and V renal insufficiency.
* Pregnant or breastfeeding women, or those who are planning to conceive children.
* Clinical evidence of infection.
* Any condition or circumstance that might interfere with adherence to the treatment regimen (compliance with scheduled visits, psychiatric disorders, or drug and/or alcohol abuse)
* History of hepatitis B or hepatitis C and HIV (by internal laboratory biosafety protocols)
* Allergy to penicillin, streptomycin, and gentamicin
* Subjects undergoing treatment with immunosuppressants and corticoids.
* Subjects on anticoagulant treatment with acenocoumarol and warfarin.
* Having received any experimental treatment in the last three months (drug, biological product, medical device or cell therapy), except for the use of vaccines administered against COVID-19 (e.g. mRNA technologies, viral vector or inactivated virus).
Right Lateral Positioning and Its Effect on Induction of General Anesthesia for Children

The quality of induction with sevoflurane, along with its ability to generate optimal conditions for Laryngeal Mask Airway (LMA) insertion without supplemental opioids or muscle relaxants, has also been well documented. An ideal inhalation induction technique besides being rapid and comfortable for the patient should be economical. To achieve rapidity, use of vital capacity breaths with 8% sevoflurane is a more popular method of induction compared with the conventional incremental induction.

100 pediatric patients (age range, 1 to 8 years) scheduled for lower abdominal surgery under anesthesia will be included. All children in both groups will be premedicated with midazolam, 0.5 mg/kg orally, about 30 minutes before the induction of anesthesia. A parent or guardian accompanied the child into the operating room to allow the child to remain calm and cooperative for inhalation induction. Before induction, pulse oximetry and electrocardiogram monitoring will be attached. For each group, inhalation induction was initiated using a face mask using "tidal volume" and "vital capacity" breathing in high sevoflurane concentration (8%).

Eligibility Criteria:
Inclusion Criteria:

* Children aged 1 years to 8 years
* Children with ASA class I/II and their willingness to participate in the study

Exclusion Criteria:

* Known seizure disorder
* Craniofacial abnormalities/difficult airway
* Cardiopulmonary or neuromuscular defects
* Hepatic or renal insufficiency
* Expected difficult intravenous (IV) cannulation (eg, dark complexion, obese)
* Catching colds during the past four weeks
Disposable 7.5Fr Electronic Flexible Ureteroscope Combined 10Fr Ureteral Access Sheath for Treatment of Renal Stone <2cm

Observation efficacy and safety of disposable f7.5 electronic flexible ureteroscope combined f10 ureteral guide sheath for treatment of renal stone \<2cm.

Using disposable 7.5Fr electronic flexible ureteroscope combined 10Fr ureteral guide sheath to treat renal stone \<2cm, and investigating its efficacy and safety.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with kidney stones less than 2cm who choose to perform "Flexible ureteroscopic holmium laser lithotripsy";
2. Over 18 years old, male or female;
3. No hydronephrosis or mild to moderate hydronephrosis (collection system separation is less than 2cm);
4. The subject has no mental illness or language dysfunction, can understand the situation of this study and has signed an informed consent form, and is estimated to be able to cooperate with the completion of the entire study;
5. No urinary tract infection or no clinical manifestations of urinary tract infection;
6. Patients with urinary tract infection, negative urine culture, and no fever need to undergo antibiotic treatment for more than 3 days; urinary routine examination suggests urinary tract infection, positive urine culture, and patients without fever need to undergo antibiotic treatment for more than 7 days, till the urine culture turns negative.

Exclusion Criteria:

1. Patients with a previous history of ureteral stenosis or who have undergone open, laparoscopic ureteral, nephrectomy and lithotripsy;
2. Fever or urinary tract infection is not treated according to the inclusion criteira;
3. Pregnant women and women's menstrual periods;
4. Cannot tolerate anaesthesia or surgery due to serious systemic diseases, heart disease, lung insufficiency and failure of important organs;
5. Anatomical malformations such as polycystic kidneys, horseshoe kidneys, and ectopic kidneys;
6. Patients with high suspicion of ureteral stenosis or diseases that are considered unsuitable to participate in this clinical study;
7. Patients indwelling double J stent preoperatively;
8. Patients who need bilateral upper urinary tract surgery at the same time.