cyrilzakka/clinical-trials huggingface dataset:
Home Nasal Pressure for Sleep Apnea Management in Primary Case

Primary objectives: To determine the efficacy and cost-effectiveness of a management program for patients with obstructive sleep apnea syndrome (OSAS) carried out in primary or specialist healthcare. In the primary arm, the diagnosis and therapeutic decision will be made by means of a domiciliary nasal pressure (DNP) channel and oximetry while the specialist healthcare arm will use polysomnography (PSG) in a hospital. Patients with an intermediate-high suspicion of OSAS will be included, taking as primary variables the Epworth scale, for efficacy, and the Epworth scale and EuroQol 5D, for cost-effectiveness.

Secondary objectives: efficacy of the two SAHS management programs according to the following secondary variables: a) quality-of-life tests: FOSQ questionnaire, SF36 and analogical wellbeing scale, b) adherence to and compliance with the treatment.

Design: prospective, randomized, controlled, open, parallel, non-inferiority. A total of 280 patients will be randomized for management on the basis of DNP (primary) or PSG (specialist), thereby giving rise to 4 groups: two treated and two not treated with CPAP. The former will undergo a home auto-titration. The follow-up will last 6 months and include 4 evaluations.

Eligibility Criteria:
Inclusion Criteria:

1. Snoring or apneas objectively observed during sleep by a partner;
2. Symptoms that are potentially secondary to apneas/hypopneas with an intermediate-high probability of being treated with CPAP. In operative terms, Epworth scale ≥12 or previous cardiovascular disease;
3. Age between 18 and 70 years;
4. Absence of any clinical suspicion of any other sleep pathology susceptible to coinciding with daytime sleepiness.

Exclusion Criteria:

1. Psycho-physical incapacity to complete questionnaires;
2. Documented structural or coronary heart disease uncontrolled by any medical treatment;
3. Cheyne-Stokes syndrome;
4. Patients subjected to uvulopalatopharyngoplasty;
5. Significant nasal obstruction impeding the use of CPAP;
6. Pregnancy;
7. Lack of informed consent.
Gardasil Administration

The purpose of the Gardasil study is to increase the rates of Gardasil vaccination at a maternal fetal Care Center. This will be done by reminding patients via text to come for follow up vaccine appointments.

Patients will be screened in center for history of Gardasil vaccination. If the patient has not received the vaccination series they will be counseled/educated (standard of care \[SOC }) and offered the vaccine series. If the patient agrees to the vaccination, they will then be offered participation in this study, (consent will be reviewed and signed) and they will receive the first vaccination at this visit, administered according to standard protocol. The patient will then be scheduled for two follow up vaccination appointments. The second vaccination will be given 2 months after the first vaccine and the third will be given 4 months after the second vaccination in accordance with the Gardasil vaccine guidelines. -SOC

The patients will receive a total of two texts during the study entirety. The two texts will be appointment reminders for the second and third vaccination, sent 1 week prior to the next appointment. This is study related.

Data collection Data will be collected using a data collection sheet. The investigators will record date of first vaccine administration and adherence to follow up.vaccinations.

Eligibility Criteria:
Inclusion criteria

* Patient receiving gynecological or postpartum care at the Maternal Fetal Care Center
* Females age 9-26 years per manufacturer's recommendation
* Having a cell phone that will allow texting
* Willing to accept any texting charges that may occur for receiving the reminder text.

Exclusion criteria

* Allergy to HPV-4 or HPV-9 vaccine
* Prior completion of the HPV-4/9 series,
* Pregnancy
* Patients older than 26 years old
The Influence of Cortical Bone Perforation on Guided Bone Regeneration in Humans

The purpose of this randomized clinical trial was to evaluate the effect of cortical bone decortication on the angiogenesis and osteogenesis of augmented ridge by GBR.

Background: The purpose of the current study was to evaluate the effect of cortical bone perforation on angiogenesis and osteogenesis of augmented ridge by guided bone regeneration.

Methods: Fourteen patients (mean age: 52) who were in need of dental implants at areas with osseous defects in the mandible were selected. In the test group (n=7), alveolar cortical bone at the area of regeneration was perforated using a #2 high speed round bur. No decortication of cortical bone was performed in the control group (n=7). Subsequently, defects were augmented by guided bone regeneration using resorbable membrane and bovine bone. After a healing period of 7 months, implant sites were created and trephine cores harvested for histological and histomorphometric analysis of the grafted areas.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria were presence of atrophic mandibular ridges with bucco-lingual width ranging between 2-5 mm, as measured on serial sections of a computerized axial tomography (CAT) scan.

Exclusion Criteria:

* Exclusion criteria included patients with diabetes, osteoporosis or other metabolic disorders, smokers, pregnant patients and patients who had any systemic or local factors that would inhibit normal wound healing process.
SPP100 Dose Finding Study in Japan

This study will evaluate the efficacy of SPP100 in lowering blood pressure in patients with essential hypertension.


Eligibility Criteria:
Inclusion Criteria:

1. Mild to moderate essential hypertension
2. Age: ≥20 years old and \<80 years old (at time informed consent obtained)
3. Sex: N/A
4. Admission status: Outpatient

Exclusion Criteria:

1. Pregnant women, lactating women, potentially pregnant women, or women who wish to become pregnant
2. Patients having a mean sitting diastolic blood pressure of ≥110 mmHg and/or a mean sitting systolic blood pressure of ≥180 mmHg at either Visit 2 or 3
3. Patients with secondary hypertension as a complication or patients suspected of having secondary hypertension(due to aortic coarctation, primary aldosteronism, coarctation of renal artery, renal hypertension
4. Patients suspected of having malignant hypertension
Experimental Evaluation of Back Braces for the Treatment of Spinal Deformity Produced With 3D Printing Technology

The proposed investigation is a pilot study that involves pediatric patients affected by spinal deformity (Adolescent Idiopathic Scoliosis and Osteogenesis Imperfecta).

The main goal is to evaluate the acceptability, the safety and the overall satisfaction of the patients wearing the back braces produced with an innovative methodology using 3D printers, compared to the current braces manufactured with a production model based on thermoforming, that has well-established clinical efficacy.


Eligibility Criteria:
Inclusion Criteria for Adolescent Idiopathic Scoliosis:

* ages 6 to 17 years;
* lumbar or thoracolumbar scoliosis;
* measured rib hump greater than 5 degrees with scoliometer;
* Cobb angle, measured on frontal X-ray images, within 15 and 30 degrees.

Inclusion Criteria for Osteogenesis Imperfecta:

* ages 3 to 17 years;
* vertebral pain and/or vertebral deformity with typical double-concave lenses shape and/or deformity in frontal or sagittal planes assessed with clinical traction, deflection or derotational tests.

Exclusion Criteria:

* skin allergies;
* behavioural and psychiatric problems (e.g., emotional problems, anxiety, panic);
* chest dimensions beyond printing limits (i.e., maximum diameter 35 cm and maximum height 60 cm).
Vulvodynia Pain Thresholds

Annotated pain maps will be created showing region and size of areas sensitive to mechanical stimulus in both women affected by vulvar pain and unaffected control patients.

The investigators will develop annotated pain maps showing region and size of areas sensitive to mechanical stimulus. The pain maps will be created by combining IR images, photographs, and clinical input, and will be correlated with patient co-morbidities. The IR images will assess for areas of inflammation and increased skin temperature. Pain maps will be created with patient response to mechanical stimulation with a cotton swab and will be overlaid on the thermographic images. Through this combination of measurements, the investigators plan to expand the diagnostic tools used in patient care as well as on the classification of this heterogeneous disorder.

Eligibility Criteria:
Inclusion Criteria:

* women meeting criteria for vulvodynia women seeking care for routine gynecologic exam

Exclusion Criteria:

* women less than 18 years of age current pregnancy women with vulvar or vaginal disorder other than pain
PRF Treatment for Patients With Chronic Lumbosacral Radicular Pain Compared to Conventional Medical Management

The purpose of the study is to evaluate the effect of PRF treatment adjacent to the lumbar dorsal root ganglion (DRG) of L5 or S1 in patients with a chronic lumbosacral radicular syndrome (LRS).

Prospective, single blinded, multicenter clinical trial.


Eligibility Criteria:
Inclusion Criteria:

* Symptoms more than 3 months 18,48
* Optimized conventional medical management at least for 1 month
* Pain radiating into the leg, up to the hallux (big toe) (L5) or little toe (S1)
* The pain in the leg dominates over a possible lumbalgia, the average pain in the leg measured 3 times a day, at predefined time points, over 4 consecutive days prior to inclusion should be more than 5 (NRS 10-point scale) 8
* Pattern of radiation suggestive for L5 or S1 pathology 49,50
* One or more positive neurological tests of nerve root tension or neurological deficit 51 ; straight leg raising test (SLRT), contralateral SLRT, motor reaction during SLRT and passive cervical flexion, motor reaction during passive cervical flexion while bending forward in standing position
* Capable of understanding the information relative to the treatment and procedure and willing to provide informed consent
* Capable of understanding and filling-out the questionnaires necessary for evaluation of the treatments
* Patients having undergone low back surgery like discectomy with or without laminectomy are allowed to participate in the study

Exclusion Criteria:

* Patients younger than 18 years
* Malignant disorder or currently under treatment for a malignant disorder
* Previous lumbar fractures
* Proven myelum lesion or abnormalities in the central neurological structures
* Systemic or connective tissue diseases
* Diabetes mellitus type I
* Multiple sclerosis
* Coagulation disorders
* Pregnancy
* Conventional medical management less then 1 month
* Pain Catastrophizing Scale \> 45. When the patient has a higher score he/she will first be referred to a psychologist for consultation 52
* Leg pain due to localized hip or knee pathology
* Patients with a pacemaker or neurostimulator
* Patients previously treated with RF or PRF of the lumbar DRG
Physical Therapy in Pre-cystectomy Patients

This single-site, non-randomized, study evaluates the impact of a physical therapy consultation for patients with bladder cancer scheduled for radical cystectomy (RC). The purpose of this study is to investigate whether consultation with a physical therapist and the development of a personally tailored exercise program in the pre-cystectomy period for patients with bladder cancer will result in reduced post-operative complications, morbidity, length of inpatient stay, improve readmission 30-day and 90-day and improve 90-day mortality. This study will be partially retrospective (pre-implementation of a physical therapy consultation order) and partially prospective.


Eligibility Criteria:
In order to participate in this study a subject must meet all of the eligibility criteria outlined below:

Inclusion Criteria:

1. Age ≥ 18 years at the time of bladder cancer diagnosis
2. History of bladder cancer
3. Performance of radical cystectomy

Exclusion Criteria:

1. No history of bladder cancer or radical cystectomy
Using National University Cancer Institute of Singapore (NCIS) Registry to Measure Time Trends in Quality of Care for Breast Cancer Patients in a National Cancer Centre

The investigators hypothesise that the research data will enable them to elucidate local clinical practices with regard to breast cancer care and enable them to extrpolate the data to improved local clinical care for their patients through self-regulation and audit.


Eligibility Criteria:
Inclusion Criteria:

* Female
* 21 years old

Exclusion Criteria:

No patient involved
Painful Breastfeeding and Bacterial or Yeast Infection

The aim of this study is to investigate the prevalence of yeast and bacteria in women with breastfeeding pain and to identify signs and symptoms.

Painful breastfeeding is one of the most common reasons for early weaning. Persistent pain associated with breastfeeding can sometimes be difficult to diagnose and is a source of frustration for the breastfeeding women as well as for healthcare providers.

The diagnosis of candida infection in breastfeeding women is generally based on signs and symptoms identified in case reports and without any culture. Breastfeeding pain has been described as superficial or deep in some studies. This deep pain syndrome as caused by candida or bacteria has been questioned. A few studies have cultured breast milk from women with deep breast pain and found Candida albicans infections or bacterial infections usually caused by Staphylococcus aureus. There still remains controversy and lack of evidence for candidiasis affecting the lactating breast as well as bacteria causing the pain. Ensured diagnostic methods are important due to the resistant problem with both antibiotics and antifungals. Only one study has described five key symptoms associated with candida. It was shiny, flaky nipple/areola, burning pain on the nipple/areola, non-stabbing pain or stabbing pain in the breast.

The objective of this study was to investigate the prevalence of candida and bacteria in women with superficial or deep breastfeeding pain and to identify signs and symptoms linked to candida or bacteria in breast milk and nipple/areola.

Eligibility Criteria:
Inclusion Criteria:

* scored pain \> = VAS 4

Exclusion Criteria:

* breastfeeding technique problems
* clinical signs of mastitis
* muscular pain
* breast surgery
* use of antibiotic or antifungal treatment during the last preceding week
* temperature \> = 37 degree Celsius
Intravascular Laser Irradiation of Blood Use in Poor Ovarian Responders

The aim of this study was to investigate the effects of intravascular laser irradiation of blood on outcomes of in vitro fertilization cycles in poor ovarian responders.

Intravascular laser irradiation of blood (ILIB) with He-Ne laser (632.8nm) has been applied on many organs and on the hematologic and immunologic system. Quite a number of both animal and human experiments have demonstrated that ILIB has a wide range of effects, including biostimulation, analgesia, antiallergic effects, immunomodulation, vasodilatation, antihypoxic, anti-oxidant, anti-aging and anti-inflammatory effects.

Poor ovarian responders (PORs) defined as poor or no response to ovarian stimulation had poor prognosis in assisted artificial technique (ART), which is a great challenge in in vitro fertilization (IVF) cycles. Previous studies showed that treatment with anti-oxidants could improve the outcomes of the poor ovarian responders; however, the effect is limited. Since ILIB has anti-aging, anti-oxidant and anti-inflammatory effects, the investigators hypothesize that ILIB may improve ovarian function and oocyte quality in PORs. Therefore, the investigators attempt to explore the effects of ILIB on the IVF outcomes in women with poor ovarian response.

Eligibility Criteria:
Inclusion Criteria:

* Women who undergoes IVF cycles
* BMI:18-30 kg/m2
* Diminished ovarian reserve (AFC\<5, AMH\<1.2 ng/ml)

Exclusion Criteria:

* Primary ovarian insufficiency
* Congenital uterine anomaly
* Severe intrauterine adhesion
* Severe male factor (azoospermia)
* Chromosome anomaly
* Malignancy
* Donor cycles
A Study of Aripiprazole in the Management of Patients With Schizophrenia in the General Psychiatric Practices

The purpose of this clinical research study is to evaluate if Aripiprazole will prove to be effective, safe and well tolerated in the treatment of patients with schizophrenia who are treated in a general psychiatric setting.


Eligibility Criteria:
Inclusion Criteria:

* Clinical DSM-IV diagnosis of schizophrenia
* Patients being managed as outpatients, for whom an alteration in medication is clinically reasonable or initiation of antipsychotics is required

Exclusion Criteria:

* Risk of committing suicide, diagnosis of schizoaffective disorder, bipolar disorder, depression with psychotic syptoms, or organic brain syndromes
* Prisoners or subjects compulsory detained
Evaluation of Fenofibrate on Radiation-induced Skin Injury

Fenofibrate is a specific ligand for PPARα, which has been used for the treatment of hypercholesterolemia, hypertriglyceridemia, diabetes and cardiovascular diseases for long time. Fenofibrate reduces low-density lipoprotein (LDL), very low density lipoprotein (VLDL) and triglyceride levels, while increases high-density lipoprotein (HDL) levels. PPARα has also shown antioxidant and anti-inflammatory properties. Fenofibrate confers cytoprotective effect against myocardial ischemia-reperfusion (I/R) injury in rats by suppressing cell apoptosis and ameliorates age-related renal injury through the activation of AMPK and SIRT1 signaling. However, the safety and effectiveness of fenofibrate on the progression of radiation-induced skin injury remain unknown. The purpose of this study is to determine whether topical application of fenofibrate is safe and effective for radiation-induced skin injury.

Radiation-induced skin injury is a significant side effect of ionizing radiation delivered to the skin during cancer treatment as well as a result of other exposure to radiation. The skin is one of radiosensitive organ systems in human body because it is a continuously renewing organ containing rapidly proliferating and maturing cells. Ionizing radiation promotes reactive nitrogen and oxygen species (RNS/ROS) production due to radiolysis of water and direct ionization of target molecules, which result in oxidative damage and skin injuries. It is considered that \~95 % of cancer patients receiving radiation therapy will develop some form of radiodermatitis, including erythema, dry desquamation, and moist desquamation. Radiation-induced skin injury negatively affects the process of radiotherapy and the quality of patients' life. Despite substantial improvements in radiation technology, radiation-induced skin toxicity is still a concerning problem. The purpose of this study is to determine whether topical application of fenofibrate is safe and effective for radiation-induced skin injury.

Eligibility Criteria:
Inclusion Criteria:

* Eligible patients had to have a pathologically proven cancer with a planned course of radiotherapy.
* Normal haematological function (granulocyte count \> 1.5 X 109 cells per litre, platelet count \> 100 X 109 cells per litre and haemoglobin \> 100 g/L) and organ function (creatinine clearance \> 50 mL/min) and aspartate aminotransferase/alanine aminotransferase \< 2.5 of upper normal limit).

Exclusion Criteria:

* The presence of rash or unhealed wound in the radiation field, known allergy or hypersensitivity to fenofibrate, pregnancy or lactation, history of/current connective tissue disorder and prior radiation to the thorax.
Improving Social Relationships for Adolescents with Central Disorders of Hypersomnolence

The goal of this study is to test a web-based psychoeducational resource for adolescents with central disorders of hypersomnolence and their families. The investigators hope to assess the website's usability, acceptability, and feasibility, as well as its potential effect on social relationship health.

Participants will be asked to review the content of the psychoeducational websites. The participants will then provide feedback on the website, as well as the adolescent's social relationships and social health before and after reviewing the website through online surveys.

The American Academy of Sleep Medicine's clinical practice guideline task force concluded that "reliance on medications alone to treat CNS hypersomnia conditions is likely insufficient." Our stakeholder data demonstrated that this issue is a significant challenge in the domain of social relationship health for children with narcolepsy type 1 and 2 (NT1/NT2) and idiopathic hypersomnia (IH). With one peak for symptom onset in adolescence, a critical period in a child's social development, children with NT1/NT2/IH and their families report significant social sequelae of the disorder and its treatment that have lifelong implications. To address this important, yet consistently overlooked real-life concern for adolescents with CDH, the investigators intend to assess an online psychoeducational website that the investigators designed to provide families with the knowledge and resources to improve the adolescent's social relationship health.

A total of 45 families will participate in a single-arm usability, feasibility, and acceptability trial. Eligible families will be provided with instructions on how to access the website. Participants will be encouraged to return to the website as often as needed to review content. For the purposes of this study, participants will be instructed to review all intervention materials within one month of receiving website access. The participants will then complete feedback questionnaires on the secure online platform REDCap. This study will inform a future randomized controlled trial testing the efficacy of the investigators' intervention. The investigators' stakeholder informed program will be the first of its kind for children with NT1/NT2/IH, with the potential to be widely disseminated.

Eligibility Criteria:
Inclusion Criteria:

* Adolescent from 10-17 years of age and parent of the adolescent
* Adolescent has physician-diagnosed narcolepsy type 1 or type 2, or idiopathic hypersomnia
* English fluency
* Interest in learning more about how to improve social health for adolescents with a CDH