cyrilzakka/clinical-trials huggingface dataset:
CPP-ACPF and Laser's Effect on Dentin Hypersensitivity

The aim of this study was to evaluate the effect of casein phosphopeptide amorphous calcium phosphate fluoride paste (CPP-ACPF) associated with low level laser therapy (LLLT) in the symptomatology and on the quality of life of the individuals with dentin hypersensitivity in a randomized placebo-controlled clinical trial. Volunteers 18 to 50 years old with hypersensitive teeth were randomized into 4 groups: GPlacebo - positioning of the laser tip without light emission + placebo dentifrice; GCPPACPF - positioning of the laser tip without light emission + CPP-ACPF application; GLaser - laser tip positioning with light emission + placebo dentifrice; GLaserCPPACPF - positioning and light emission of the laser beam + CPP-ACPF.

GLaser received the laser application using the infrared light spectrum with wavelength of 808 nm with its active AsGaAl medium in two points of the vestibular face of the hypersensitive teeth. At each point it was applied 60 J / cm², for 16 seconds. Three laser's sessions were applied with a time interval of 24 hours between them. GLaserCPPACPF first received the CPPACPF application and then the laser application according to the manufacturer's recommendations. Before initiating laser therapy, the equipment was calibrated with a tester (MMOptics Ltda®, Brazil).

The GCPPACPF volunteers were submitted to the application of the CPPACPF'S containing tooth paste MI Paste Plus™ (Recaldent™, GC América, USA) on the vestibular surfaces of hypersensitive teeth with the aid of a microbrush applicator (Microbrush, 3M ESPE, Brazil) for 05 minutes. Then, a rubber cup (Unid Microdont, Brazil) mounted on a low speed handpiece (500, Kavo, Germany) was used to scrub the desensitizing gel during 20 seconds on each tooth, according to the manufacturer's specifications. GPlacebo followed the same protocol used in GCPPACPF. In addition to the desensitizing treatments, all GCPPACPF and GPlacebo volunteers received the positioning of the laser tip to mimic the light emission produced in GLaser and GLaserCPPACPF. The noise emitted by the laser device was mimic through the sound reproduction of a smartphone application (HD Voice Recorder - iPhone 6s, Apple®, USA).

Eligibility Criteria:
Inclusion Criteria:

* The presence of at least two hypersensitive teeth;

Exclusion Criteria:

* Milk's proteins allergy;
* Systemic diseases;
* Teeth with carious lesions or pulpitis;
* Teeth with defective restorations;
* Teeth with with cleft enamel;
* Patients with active periodontal disease;
* Patients with analgesic medication;
* Patients with pregnant or lactating women
* Patients who have received professional desensitizing treatment in the last three months.
Pilot Prospective Study: Long-term Health of Living Kidney Donors

Kidney transplantation, a 'miracle' of modern medicine, is the preferred treatment option for End Stage Renal Disease compared to dialysis, patients who receive kidneys have a 70% reduction in risk of death, a dramatically improved quality of life and cost the health care system considerably less. As a result there are over 3000 Canadians, and 57,000 Americans on the waiting list for a kidney. To meet the shortage in cadaveric kidneys, rates of living kidney donation have nearly doubled over the last 10 years, and will continue to rise with growing demand.

Yet despite its advantages for the recipient, living kidney donation remains a complex ethical, moral and medical issue. The premise for accepting living donors is that the "minimal" risk of short and long-term medical harm realized by the donor is outweighed by the definite advantages to the recipient and potential psychosocial benefits of the altruistic gift to the donor. The only benefit for the living donor is psychological - donors experience increased self-esteem, feelings of well-being and improved health related quality of life with their altruistic act of assuming medical risk to help another. The short-term consequences of living donation are well established. On the other hand the long-term implications of living kidney donation are far less certain. This study will look at the long term implications of living kidney donation.


Eligibility Criteria:
Inclusion Criteria:

1. Age greater than 18 years old
2. A predicted Cockcroft-Gault creatinine clearance \> 80 mL/min
3. Average sBP \< 140 and dBP \< 90 based on 3 readings
4. A spot urine protein to creatinine ratio \< 15 mg/mmol

Exclusion Criteria:

1. A medical condition (such as cardiovascular disease, pulmonary disease, active cancer) or psychological condition (such as major affective disorder, personality disorder, a history of chemical dependence) which the local transplant centre deems unfit for donation. Blood group and immunological incompatibility (such as positive cross-match, poor HLA matches) are not reasons for exclusion
2. Evidence of a financial incentive for donation
3. A contraindication to general anaesthesia or surgery
4. A past medical history of hypertension
5. Use of antihypertensive class medications for any reason.(ACE-Is, ARBs, diuretics, beta-blockers, calcium channel blockers)
6. A past history of permanent proteinuria
7. The eligible non-donor is planning to donate their kidney within the next year
8. Unable to give informed consent
9. Unwilling to participate in the follow-up assessments at one, two, three, four and five years, or unwilling or unable to conduct home blood pressure or laboratory measurements
10. The living donor or eligible non-donor is currently pregnant
11. Despite being planned the donor nephrectomy does not take place
12. Enrolled in another clinical study which interferes with the conduct or outcomes of this study
tDCS-Augmented Exposure Therapy for Pathological Fear

This double-blind randomized controlled clinical trial aims to test whether transcranial direct current stimulation (tDCS) can be used to modulate fear extinction learning during exposure therapy for pathological fear, including fear of spiders, snakes, or germs / contamination. Participation takes place over three laboratory visits, including (1) a pre-treatment visit, (2) a treatment and post-treatment visit, and (3) a 1 month follow-up visit. During treatment, participants will receive either 20 minutes of active or sham tDCS, followed by 30 minutes of in vivo exposure therapy.

In a trans-diagnostic sample with marked pathological fear and behavioral avoidance, this study aims to: (1) evaluate whether excitatory tDCS of the mPFC and inhibitory tDCS of right dlPFC enhances exposure therapy relative to sham tDCS; (2) determine whether tDCS effects are moderated by baseline negative prognostic indicators; and (3) determine whether tDCS effects are mediated by pre-post changes in vigilance to threat, in-session fear reduction, and contextual memory for the exposure context. If successful, the project may discover a potentially effective exposure therapy augmentation, and may enhance knowledge of the behavioral, cognitive, affective, and neurobiological factors that moderate and mediate acute treatment response and maintenance of treatment gains. This knowledge may inform treatment development efforts for more debilitating forms of pathological fear.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-65.
2. Fluent in English.
3. A score on at least 1 fear domain-specific prescreen measure \> 2 SDs above the subject pool prescreen mean. These measures include (a) FSQ, and (b) OCI-R.
4. Peak fear ≥ 50 on BATs 1 and 2.

Exclusion Criteria:

1. Currently receiving treatment for the primary fear domain (based on clinical interview).
2. Unstable dose of psychotropic medications within 6 weeks prior to baseline assessment (based on the DMQ; see measures).
3. Medical condition that would contraindicate participation in treatment or assessment activities (e.g., cardiovascular problems; based on the DMQ; see measures).
4. Pregnancy (based on the DMQ; see measures).
5. Current major depressive disorder (based on MINI; see measures).
6. Current, or history of bipolar disorder (based on MINI; see measures).
7. Current, or history of psychotic symptoms (based on MINI; see measures).
8. Serious suicidal risk, as determined by self-report (C-SSRS, BDI-II) and clinical interview (MINI; see measures).
9. Active neurological conditions, including seizures, stroke, unexplained loss of consciousness or concussion (based on DMQ and tDCS Safety Screening Form; see measures)
10. Contraindications for tDCS: Metal in the head or implanted brain medical devices.
DD T2 Daily Disposable Registration Trial

The purpose of this study is to evaluate the performance of the investigational verofilcon A contact lens compared to the commercially available delefilcon A contact lens, by assessing visual acuity as the primary variable.

Enrolled participants will be randomized (2:1) to receive either verofilcon A (test) contact lenses or delefilcon A (control) contact lenses for wear in both eyes and attend 7 office visits: Baseline, Dispense, 1-week follow-up, 2-week follow-up, 1-month follow-up, 2-month follow-up and 3-month follow-up/Exit.

Eligibility Criteria:
Inclusion Criteria:

* Successful wear of spherical soft contact lenses for distance correction in both eyes during the past 3 months for a minimum of 5 days per week and 8 hours per day.
* Best corrected VA 20/25 or better in each eye.
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria

* Any current or prior wear experience with DT1 lenses.
* Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment.
* Other protocol-specified exclusion criteria may apply.
Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) in Gastric Carcinomatosis. Phase II Randomized Study

Peritoneal metastasis is a common pattern in advanced gastric cancer leading to a terminal condition in a very short time. Whatever recent progress regarding systemic chemotherapy using multi drugs association median survival is limited to 6 months with altered quality of life (QoL) after 4 months for all patients. We postulated that a new innovative health technology for delivering intraperitoneal pressurized aerosol of chemotherapy (Doxorubicin and Cisplatin) during laparoscopy can transform that situation offering to double the survival with QoL preservation. Interestingly, PIPAC procedure is made to be applied repeatedly, every 4 to 6 weeks. This therapeutic strategy allows to improved Intra Peritoneal (IP) drugs impregnation and maintained Intra-Veinous (IV) chemotherapy meanwhile. The primary objective of this study is to evaluate and compare 24-month progression free-survival in patients with peritoneal carcinomatosis of gastric cancer treated either with IV chemotherapy and Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) or with IV chemotherapy alone, with preservation of quality of life.


Eligibility Criteria:
Inclusion Criteria:

* 18 \< age ≤ 75 years
* Performance status (WHO) \< 2
* White blood cells \> 3.500 /mm3; neutrophils \> 1.500 /mm3; platelets \> 100.000 /mm3
* Creatinemia \< 1.5 x Normal, Normal ASAT, ALAT and Serum total bilirubin, Normal ionic balance (potassium, calcium, magnesium and phosphorus
* An acceptable nutritional condition with Body Mass Index (BMI) \> 18.5 kg/m2, Albumin \> 30 g/l, pre-albumin \> 110 mg/l
* Effective contraception for patients of childbearing age
* Written consent obtained prior any act of the research
* Patient with social insurance
* Patient having synchronous or metachronous peritoneal metastasis or ovarian metastasis of a gastric adenocarcinoma cancer, including adenocarcinoma with independent cells (ADCI) or linitis
* Patients with or without primary gastric tumor could be included
* Peritoneal Cancer Index (PCI) \> 8

Exclusion Criteria:

* Weight loss \> 20% of total body weight before disease
* Presence of uncontrolled comorbidities including severe chronic disease or organ insufficiency
* Contraindication to any drug contained in the chemotherapy regimen, according to summary of product characteristic's
* Having any form of previous intra-abdominal chemotherapy or intra-abdominal antibody therapy
* Patients with history of allergic reactions to platinum compounds or doxorubicin
* Complete deficiency of the enzyme dihydropyrimidine dehydrogenase.
* Patients are not allowed to undergo any cancer-specific treatment during the trial.
* Secondary debulking surgery is not allowed during PIPAC treatment
* Pregnancy or breastfeeding
* Patient under guardianship
* Other systemic metastases (liver, lung, bone, brain) or lombo-aortic lymph node involvement
* Pleural effusion requiring evacuation for respiratory failure
* Small bowel occlusion with no possible food intake
* Ascites \> 3 liters
* HER2 +++ tumor
Autologous T Cell Vaccine (TCV) for Multiple Sclerosis

This is a 1 year study to evaluate the efficacy, safety, and tolerability of Tovaxin T cell therapy in subjects with a clinically isolated syndrome (CIS) and relapse-remitting multiple sclerosis (RR-MS).

A 2 arm, 52 week parallel-group of Tovaxin versus placebo in subjects with CIS or RR-MS. Subjects who provide written, informed consent will complete screening and procurement assessments and provide blood to be used for vaccine production. Eligible subjects will be enrolled to receive either Tovaxin or placebo and will complete baseline assessments. Randomization and enrolled subjects will receive study treatment by subcutaneous injections at weeks 0, 4, 8, 12, and 24. Subjects will be monitored by CBC, serum chemistries, urinalysis, Expanded Disability Status Scale (EDSS), MSFC, MSQLI, magnetic resonance imaging (MRI), and monitor myelin reactive T cells for safety, efficacy, and tolerability of Tovaxin.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 to 55 years old
* Presence of myelin reactive T cells at screening
* Diagnosis of CIS with screening MRI that fulfils the Barkhof criteria - dissemination in space
* Diagnosis of MS within the past 10 years according to the McDonald criteria (2005)
* Baseline EDSS score between 0 and 5.5 inclusively

Exclusion Criteria:

* Unable to produce T cell vaccine
* Disease-modifying treatment for MS during the last 30 days and 60 days for steroidal treatments
* Diagnosis of progressive-relapsing, secondary progressive, or primary progressive MS
* Planned pregnancy, currently pregnant, or breastfeeding
* Any prior treatment with total lymphoid irradiation, cladribine, T cell or T cell receptor vaccination
HH-120 Nasal Spray for Post-exposure Prevention of SARS-CoV-2

This study will assess the efficacy of HH-120 nasal spray in participants for the post-exposure prevention of SARS-CoV-2.

During this study, participants will receive HH-120 nasal spray treatment for 7 consecutive days, the efficacy and safety of HH-120 nasal spray will be assessed throughout the study period mainly based on the incidence of symptomatic SARS-CoV-2 infection and adverse events, respectively.

Eligibility Criteria:
Inclusion Criteria:

* 12 to 85 years old.
* Participants with potential exposure to index patients (with known positive result of qRT-PCR or rapid antigen test \[RAT\]).
* Participants will be randomized no longer than 48 hours from the onset of the COVID-19 related symptom of the index patients.
* Participants with a negative RAT result within 2 hours prior to randomization.
* Fertile participants must agree to use a highly effective method of contraception.
* Participants being able and willing to provide informed consent prior to any study-specific procedure.

Exclusion Criteria:

* Those with high risk of cardiac events, or severe abnormal functions of liver, kidney, lung, brain and other organs and are deemed as unsuitable to participate in the study (except for those subjects with kidney failure but received regular dialysis, or those with liver dysfunction but stabilized after treatment evaluated by the evaluation of the investigators).
* Those comorbid with asthma.
* Those with a history of SARS-CoV-2 infection within 3 months prior to randomization.
* Those who has received any nasal spray or aerosol inhalation COVID-19 vaccine within 3 months prior to randomization.
* Those who experienced symptom of upper respiratory tract infection within 2 weeks prior to randomization, such as nasal congestion, sore throat, shortness of breath (dyspnea), cough, fatigue, fever, headache, etc.
* Known history of allergy or reaction to any component of the study drug formulation.
* Those who has received other treatment with anti-COVID-19 indication (within 1 month or 5 half-life period prior to randomization, whichever occurs first).
* Participants with nasal disease that is inconvenient or intolerant of nasal spray administration.
* Other reasons considered by the investigator to be unsuitable for the study.
Intranasal Fentanyl in Treatment of Labour Pain

Physiological changes during pregnancy are known to affect the pharmacokinetics of many drugs. Intranasal fentanyl is an interesting option for obstetric analgesia, but its use in pregnant patients has not been established. The investigators studied pharmacokinetics of intranasal fentanyl in labouring women and to subsequently evaluate the maternal and fetal safety after administration.


Eligibility Criteria:
Inclusion Criteria:

* healthy parturients with uncomplicated, single gestation pregnancies, full term (38-42 weeks of gestation) pregnancy, agreed to participate

Exclusion Criteria:

* a disease that might affect hepatic or renal function, contraindications to opioid analgesics, fetal growth retardation, signs of fetal asphyxia by cardiotocography, meconium stained amniotic fluid or placental insufficiency. The subjects should not have received fentanyl during the previous 14 days.

Not agreed to participate
Chronic Plaque Psoriasis (Ps) Registry

The purpose of this study is to evaluate the long-term safety of Humira® in Adult Patients with Chronic Plaque Psoriasis (Ps).

ESPRIT is a 10 year registry of patients taking HUMIRA® for Psoriasis. Patients who volunteer to participate will be asked to provide information about their medical history and experiences with HUMIRA®. No registry specific testing will be performed. Patients will be asked to provide data on their experiences with HUMIRA® approximately every 6 months, or as determined by the study doctor. No drug will be provided as a result of participation in the registry. All treatment decisions are independent of participation in the registry.

Eligibility Criteria:
Inclusion Criteria:

1. An adult patient (18 years of age or older) with chronic plaque psoriasis who has been prescribed HUMIRA® therapy according to the local product labeling and meets one of the following criteria:

   * New initiated (within 4 weeks of registry entry) on HUMIRA® therapy;
   * Initiated HUMIRA® therapy in the past and:

     * Has received continuous (no more than 70 consecutive days off drug) HUMIRA® therapy and the physician can provide source documentation of SAEs, AEs, of Special Interest, and dosing information since initiation of therapy.

   OR
   * Is entering after participation in an AbbVie HUMIRA (adalimumab) sponsored study and has received continuous (no more than 70 consecutive days off drug) HUMIRA® therapy after the completion of AbbVie sponsored study and physician can provide source documentation of SAEs, AEs of Special Interest, and dosing information since initiation of commercial HUMIRA® (defined as a prescribed/non study drug).
2. Patient is willing to consent to data being collected and provided to AbbVie;
3. Patient is capable of and willing to give written informed consent and to comply with the requirements of the registry.

Exclusion Criteria:

- Patient should not be enrolled if he/she cannot be treated in accordance with the local product label.
Transcranial Direct Current Stimulation Combined With Exercise in Low Back Pain

The purpose of this study is to evaluate the effects of transcranial direct current stimulation combined with Pilates based exercise on chronic low back pain. This is a randomized clinical trial composed of two arms.

Chronic low back pain may be associated with pathoanatomical, neurophysiological, physical, psychological and social factors. Treatments that relieve the symptoms of these patients are of great importance to improve the quality of life of these individuals. Thus, this study aims to evaluate the effects of transcranial direct current stimulation combined with Pilates based exercise on chronic low back pain. This is a randomized clinical trial that will be composed of men and women between 18 and 65 years of age, with a history of low back pain for more than 12 weeks and a minimum pain intensity equal to 3 cm on the numerical pain scale. The volunteers will be randomized into two distinct groups: stimulation + exercise group (EG - will perform a Pilates based exercise protocol combined with transcranial direct current stimulation) and sham stimulation + exercise group (SG - will perform the same exercise program combined with sham stimulation). The interventions, regardless of the group, will be carried out three times a week for four weeks. Participants will be submitted to three assessments: the first (T0) will be performed before the treatment protocols; the second (T1) will be performed after the four weeks of intervention; and the third (T2) will be a follow-up one month after the end of the treatment protocol. Pain sensation, functional performance, central sensitization, quality of life, pressure pain threshold, global impression of change, adverse events and medication use will be evaluated. For the statistical analysis, a mixed model ANOVA will be performed for the inter and intragroup comparison, with Tukey's post hoc, considering a significance level of 5%.

Eligibility Criteria:
Inclusion Criteria:

* Men and women with chronic nonspecific low back pain (for more than 12 weeks) and minimum pain intensity of 3 on numerical pain rating scale.

Exclusion Criteria:

* diagnosis of fracture and spine pathologies, fibromyalgia, spine surgery in the last year;
* low cognitive level assessed by the Mini Mental State Examination;
* presence of central neurological diseases (such as Parkinson's and stroke) or psychiatric (such as depression or schizophrenia);
* history of epileptic illness;
* seizure history;
* brain implants;
* pacemaker;
* pregnancy.