cyrilzakka/clinical-trials huggingface dataset:
Patient-Centered PD Ambulatory Monitoring System

This a usability study of a wearable sensor platform that utilizes a smartwatch to periodically record motion data. That data is processed in a connected smartphone and translated into symptom scores for dyskinesia, slowness, and tremor. The research subjects will use the wearable system over the course of five weeks, during which a change in therapy regimen is prescribed by the physician. Research analysis will be focused on patient and clinician experiences with the app and its reports.


Eligibility Criteria:
Inclusion Criteria:

* Existing Patient of Collaborating Physician (David E. Riley, MD)
* Diagnosed With Parkinson's Disease
* Hoehn \& Yahr Scale I-III
* Ambulatory and capable of using the ParkinPal system
* Able to understand and follow instructions regarding using the device

Exclusion Criteria:

* Any subject that does not meet the subject selection criteria will be excluded from this study. Children will be excluded from this study due to the fact that they are unlikely to have PD. Subjects that are not capable of functioning independently or are so symptomatic as to compromise their safety will also be excluded.
Study of the Effect of Once a Week Risedronate on the Microstructure of Tibia and Radius Using a New Scanning Method

The primary purpose of the protocol is to evaluate the sensitivity of 3D-pQCT (3D-Peripheral Quantitative Computed Tomography) technology to detect minute changes in bone microarchitecture.

The 3D-pQCT equipment allows the evaluation of changes occurring within the bone at "microarchitecture" level, without the need for invasive bone biopsies. The primary objective is to evaluate the sensitivity of the technology to detect a difference between those treated with risedronate 35mg OAW (once a week) or placebo. Early phase postmenopausal women with osteopenia have been chosen because they have a more rapid and higher level of bone loss during the first few years of the menopause.

Eligibility Criteria:
Inclusion Criteria:

* cessation of menstruation (surgical or natural) between 6 and 36 months prior to study enrollment;
* osteopenic
* must have at least 1 evaluable radius and tibia, without history of fracture (traumatic or atraumatic)
* BMI (body mass index) between 18 and 28 kg/m2 inclusive;

Exclusion Criteria:

* history of any generalized bone disease, including hyperparathyroidism, Paget's disease of bone, renal osteodystrophy, or any other acquired or congenital bone disease; or any known condition that would interfere with the assessment of DXA (dual-energy X-ray absorptiometry) at either the lumbar spine (3 non-evaluable lumbar vertebrae at lumbar spine L1 - L4) or the femoral neck.
* clinical or radiological evidence of osteoporosis, such as atraumatic vertebral compression fracture (\* 20% reduction in anterior-to-posterior or middle-to-posterior height ratio; or 20% reduction of the anterior, middle, and/or posterior height as compared with the adjacent vertebrae) documented by spinal X ray or a history of osteoporosis-related atraumatic fracture of the hip or of the wrist;
* glucocorticoid-induced osteopenia;
* previous bisphosphonate therapy;
Evaluating the Efficacy of a Video Based Intervention to Educate Teen Moms About Fetal Alcohol Syndrome (FAS)

Evaluating the efficacy of a video about FAS to determine whether it has an impact on knowledge about FAS and their likelihood to participate in risk taking behavior.

Teenage mothers are asked to participate in the study and then randomized into an intervention or control group. Both groups take a multiple choice survey and then are randomized to either watch a video about FAS or not. After the video (or not for the controls) they then take a post video short answer survey. The survey results are then scored and statistical analysis performed to determine whether the video intervention increased their knowledge about FAS and their likelihood to drink alcohol during pregnancy.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant teens aged 12 to 16 years

Exclusion Criteria:
Comparing Hemodiafiltration with and Without Hemoadsorption

Goals: The aim of the study is to assess the efficacy and safety of the combination of HDF + HA compared to HDF. To do this, we will evaluate the elimination of a wide range of molecular weight molecules, including small protein-bound solutes.

Design: Prospective, single-center study. Each patient underwent two dialysis sessions with routine dialysis parameters in which HDF or HDF + HA treatment modality will be compared.

Study subjects: 20 patients, stable on a thrice-weekly hemodialysis program, will be included. Local Ethics Committee will approve the study and patients will give informed consent.

Interventions: Prospective collection of two dialysis sessions. The only difference among the sessions in each patient will be add or no sorbent cartridge. One session with FX60 Cordiax, helixone, Fresenius Medical Care in postdilution on-line hemodiafiltration and another session with the same dialyzer plus HA 130 cartridge. The order of these treatment sessions was randomly. Blood samples for analyses were taken for each patient in the same dialysis session of the week.


Eligibility Criteria:
Inclusion Criteria

* Adult patients (age \> 18 years)
* More than 6 months on a dialysis program
* Stable in a hemodialysis program
* AV fistula, prosthesis, or tunneled catheter as vascular access
* No residual diuresis (\< 200 ml/day)
* Not enrolled in a living donor transplant program
* No immunosuppressive treatment
* Provide written informed consent

Exclusion Criteria

* Chronic inflammatory diseases
* Neoplasms
* Immunosuppressive treatment or chronic treatment with anti-inflammatory drugs
* Dysfunctional AV fistula or catheter
* Single-needle dialysis
* Kt/V less than 1.3 or PRU \< 70%
* Scheduled living donor kidney transplant
Whole Milk Versus Whey Protein Supplement and Resistance Exercise

The purpose of the study is to examine the effects of consuming protein supplement (whey) compared to whole milk immediately after bouts of resistance training on muscular strength and body composition.


Eligibility Criteria:
Inclusion Criteria:

* healthy
* currently working out at least 3 times per week

Exclusion Criteria:

* taken any ergogenic aid/sport supplements in the last 2 months
Dose-escalation, and Safety Study of LDE225 and Gemcitabine in Locally Advanced or Metastatic Pancreatic Cancer Patients

This phase Ib study includes two phases: dose escalation phase and safety expansion phase.

During the dose escalation phase, successive cohorts of eligible patients (minimum 3 and maximum 6 evaluable patients per cohort) will receive increasing oral doses of LDE225 administered on a continuous once daily (QD) dose in combination of gemcitabine. This phase of the study will determine the maximum tolerated dose (MTD) and/ or recommended dose for expansion (RDE) of LDE225 administered in combination with gemcitabine in locally advanced or metastatic pancreatic adenocarcinoma patients.

During the safety expansion phase, once the MTD of LDE225 is established, additional patients will be enrolled and treated at the MTD of LDE225 in combination with gemcitabine in order to further evaluate its safety, tolerability and explore the potential efficacy of the combined treatments on the patients in locally advanced or metastatic pancreatic adenocarcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Patients with locally advanced or metastatic pancreatic adenocarcinoma that have not been previously treated or have progressed despite chemotherapy
* Performance status of 0 or 1 per WHO classification
* Adequate hematologic , renal and liver function
* Adequate blood creatine kinase value (CK \< 1.5ULN)

Exclusion Criteria:

* Treatment with prior radiotherapy
* Pancreatic cancer that is potentially curable by surgery
* Women of childbearing potential unless they are using highly effective method of contraception Other protocol-defined inclusion/exclusion criteria may apply

Other protocol-defined inclusion/exclusion criteria may apply.
Efficacy and Cost Analysis of Steroids in Treatment of Otitis Media With Effusion

We intend to study the cost of treatment, efficacy and adverse effects for Otitis media with effusion.

Treatment groups would be:

1. Cefpodoxime + oxymetaxoline drops + levocetirizine
2. Fluticasone intranasal spray
3. Short term oral steroids
4. Wait and watch

Eligibility Criteria:
Inclusion Criteria:

* history of mild ear ache or decreased hearing for three or more months, plus
* intact and immobile tympanic membrane by pneumatic otoscopy
* Type B tympanogram

Exclusion Criteria:

* any external ear condition that hampers visualization of tympanic membrane
* lost to follow up
A Phase 1 Clinical Study of NXP900 in Subjects with Advanced Cancers

The purpose of this dose escalation study is to evaluate the safety profile of escalating doses and dose schedules of NXP900.

This is a dose escalation study of NXP900 administered to patients with advanced cancers. The study will propose dose and dose schedules for future studies.

Eligibility Criteria:
Inclusion Criteria:

1. Provide written informed consent.
2. 18 years old or older.
3. Advanced, metastatic, and/or progressive solid tumors for whom there is no authorized or effective therapy available, or for whom such therapies are considered inappropriate by the Investigator.
4. Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.

Exclusion Criteria:

1. Subjects with known human epidermal growth factor receptor 2 (HER2+) overexpressing malignancies.
2. Radiotherapy (except for palliative reasons), endocrine therapy, chemotherapy, or investigational agent within 28 days, (42 days for nitrosoureas, mitomycin-C) of first dose of NXP900. Subjects can continue to receive bisphosphonates due to metastatic bone disease or GnRH agonists if they have prostate cancer.
3. Ongoing toxic manifestations of previous treatments \> Grade 2 with the exception of alopecia and neuropathy.
4. Subjects with treated brain metastases with evidence of progression within 28 days after central nervous system (CNS)-directed treatment, as ascertained by clinical examination and brain imaging (magnetic resonance imaging \[MRI\] or computed tomography \[CT\] scan) during the Screening period.
5. Female subjects who can become pregnant (or are already pregnant or lactating), unless they have a negative serum pregnancy test before enrollment and agree to use at least one highly effective form of contraception .
6. Male subjects with partners of childbearing potential, unless they agree to take measures not to father children by using a barrier method of contraception (condom plus spermicide).
7. Major surgery from which the subject has not yet recovered.
Diagnostic Tests in the Context of Threatened Preterm Labour

The primary purpose of the protocol is to compare the diagnostic accuracy in terms of positive and negative predictive values of Premaquick © (combined detection of IL-6 / IGFBP-1 total / IGFBP-1 native) and Quikcheck fFN ™ (fibronectin detection) tests for prediction of spontaneous delivery within 7 days in women with threatened preterm labor. The study hypothesis is that combined detection of IL-6 / IGFBP-1 total / IGFBP-1 native dice the admission will improve the prediction of delivery compared to the detection of fetal fibronectin alone in women with threatened preterm labor.

The threat of premature labour is the main cause of hospitalization during pregnancy (38% of hospitalizations). To date, the assessment of severity relies mainly on ultrasound measurement of the cervix. The length of the cervix is significantly correlated with the risk of spontaneous premature delivery. A threshold of 25mm is relevant to rule out a delivery within 7 days but the identification of new markers including biological would be interesting to guide the clinician in assessing the risk of preterm birth. Among the biomarkers measured in vaginal secretions, the detection of fetal fibronectin seems to be the most relevant because of a high negative predictive value (NPV) up to 100% to rule out a delivery within 7 days. However, the use of this test is discussed because of its low positive predictive value (PPV) to predict delivery within 7 days (from 11% to 48%). The use of Premaquick © test (Biosynex, Strasbourg, France), which allow the simultaneous quantification of IL-6, total IGFBP-1 and native IGFBP-1 could be more efficient compared to the detection of fibronectin by improving the VPP. The results already obtained on a cohort of 97 patients (Eleje et al., 2016) show a similar NPV and a higher PPV of the Premaquick© test compared to the Quikcheck fFN ™ test (PPV up to 95% when the 3 markers are positive). Investigator wish to conduct a comparative study between these two tests on a larger cohort of patients (n = 220). Results of the tests will be masked for the clinician and the patient in order to assess and compare their ability to predict delivery within 7 days without modify the current medical management.

Eligibility Criteria:
Inclusion Criteria:

* Major pregnant women admitted to Clermont-Ferrand CHU maternity for threatened preterm delivery with intact membranes between 24 and 34 (+6 days) week of amenorrhea, with length of cervix \< 30mm (ultrasound measurement).
* Ability to give informed consent.
* French social security scheme.

Exclusion Criteria:

* - Dilation of the cervix ≥ 4 cm
* Triple pregnancy or more
* Fetal membranes rupture
* Known uterine malformation
* Hydramnios
* Fetal malformation
* Placenta previa
* Abundant metrorrhagia
* Patient who had already participated in the study during the same pregnancy
* Patient under guardianship or curatorship
Warning Signs of Squamous Cell Carcinoma and Prevention of SCC by at Risk Organ Transplant Recipients

Using focus group and cognitive interviews with organ transplant recipients, the investigators developed interactive workbooks: a) prevention by sun protection b) early detection by skin self-examination (SSE). The investigators hypothesis is if the patient learns by acquiring skills in a favorable environment, then the patient may reduce their anxiety, enhance self-efficacy and perform self-management by SSE and sun protection. The investigators also evaluate existing internet sources of primary and secondary prevention of skin cancer for organ transplant recipients.


Eligibility Criteria:
Inclusion Criteria:

* People with a history of solid organ transplantation within the last 2 years
* Speaks English
* Can see to do SSE, capable of seeing to read a newspaper
* Stable health, patients report a general state of well being

Exclusion Criteria:

* Unable to speak English
* Insufficient vision to see their own skin as determined by their ability to read a newspaper
* Comorbid debilitating disease
* Dementia or insufficient cognitive skills to follow instructions provided at a sixth grade language level.
Non-surgical Periodontal Therapy: Efficacy of re Treatment for Non-responding Sites.

The current experimental protocol is a pre-post quasi-experimental design. A cohort of individuals will be enrolled progressively according to a screening record of periodontitis. They were treated with PMPR and Subgingival Instrumentation according to their diagnosis. After 3 months they will be re-evaluated, and non-responding sites (Ppd\>=4mm and bop+) will be scheduled for the second session of PMPR and SI. After 2 months they will be re-evaluated and clinical efficacy will be defined.

The current experimental protocol is a pre-post quasi-experimental design. A cohort of individuals will be enrolled progressively according to a screening record of periodontitis. Once included, individuals will receive, by a calibrated examiner, a full-mouth periodontal chart, and accordingly, they will be treated in a multi-step approach, in accordance with the recent clinical guidelines. The treatment will consist of oral hygiene instruction and motivation, risk factor control, professional mechanical plaque removal (PMPR), and subgingival instrumentation (SI): it will be performed by two experienced operators. Thereafter, after 3 months, patients will be evaluated and a new periodontal chart will be performed. The presence of non-responding sites (Ppd\>4 and bop+) will be treated with the second session of PMPR plus Subgingival Instrumentation. After 2 months patients will be clinically evaluated and a full periodontal chart will be completed.

Eligibility Criteria:
Inclusion Criteria:

* unremarkable general health; age 18-80; minimum of 20 teeth; Periodontitis (Stage 1-4); no antibiotic intake in the previous 6 months;

Exclusion Criteria:

* Subgingival instrumentation in the previous 12 months
* No antibiotic intake in the previous 3 months
* A compromised medical condition requiring prophylactic antibiotic coverage
* Pregnant/nursing
* Ongoing drug therapy that might alter the clinical signs and symptoms of periodontitis
The Effect of Feeding Infant Formula Containing Prebiotics and/or Probiotics

The study is intended to evaluate the microorganisms found in infant stools when consuming study formulas containing prebiotics and/or probiotics compared to infants consuming mother's own breast milk.


Eligibility Criteria:
Inclusion Criteria:

* Singleton, 10-14 days of age at registration/randomization
* Term infant with birth weight of 2500 grams or more from a vaginal birth
* Formula feeding infants must be on formula for at least 3 days
* Human milk fed infants must have received mother's own breast milk from 1 day of age to study registration and mother has intention to exclusively provide mother's own breast milk for the duration of the study
* Signed informed consent

Exclusion Criteria:

* History of underlying metabolic or chronic disease or immune compromised
* Feeding difficulties or formula intolerance
Predicting Treatment Failure in HSIL Patients with Positive Margins After Conization Via Detection of PAX1 Methylation

The goal of this multicenter, observational study is to evaluate whether methylation testing of paired box gene 1 (PAX1) can better predict and diagnose recurrence or persistent disease in patients with positive margins after cervical conization for high-grade squamous intraepithelial lesion (HSIL). The main question it aims to answer is:

Can PAX1 gene methylation testing provide a more accurate and effective prediction and diagnosis of cervical disease recurrence/persistence in addition to existing methods? Participants will be managed according to the latest clinical guidelines, and during follow-up, a non-invasive test, PAX1 gene methylation testing, will be added.

This study is a multicenter, prospective observational study that qualitatively assesses the methylation status of the PAX1 gene in cervical exfoliated cells from patients with HSIL and positive margins after conization. The aim is to evaluate the ability of PAX1 gene methylation testing to predict treatment failure (lesion recurrence or persistence). The first follow-up occurs 6 months post-surgery, including high-risk human papillomavirus (hrHPV) testing and cytology, with referral for colposcopy, including biopsy and/or endocervical curettage (ECC), if necessary. Subsequent management and follow-up are based on examination results, following clinical guidelines, and arranged at intervals of 6-12 months depending on the findings. The follow-up includes routine clinical examinations widely applied in practice, and PAX1 testing will be completed at each follow-up visit. PAX1 testing, like hrHPV testing and cytology, will be performed using cervical exfoliated cells.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than 25 years and less than 55 years;
* First-time cervical conization (cold knife conization or loop electrosurgical excision procedure);
* Postoperative pathology showing HSIL (CIN2 or CIN3);
* Positive margins for HSIL (CIN2 or CIN3) in conization specimen.

Exclusion Criteria:

* The presence of other malignant tumors or precancerous lesions;
* Lack of willingness for follow-up;
* Pregnant or breastfeeding women;
* Unable or unwilling to complete follow-up examinations;
* History of prior cervical disease treatment (surgical or physical therapy);
* Presence of immune system disorders.
Safety and Efficacy of Bimatoprost Solution in Increasing Overall Eyelash Prominence

This study evaluates the safety and effectiveness of topical bimatoprost solution for enhancing eyelash prominence.


Eligibility Criteria:
Inclusion Criteria:

* Dissatisfaction with eyelash prominence,
* Eyelash prominence assessment of minimal or moderate,
* Ability to provide written informed consent

Exclusion Criteria:

* Subjects without visible lashes,
* Asymmetrical (uneven lashes or longer on one side than the other) eyelashes,
* Any eye disease or abnormality,
* Eye surgery,
* Permanent eyeliner,
* Eyelash implants,
* Eyelash extension application,
* Any use of eyelash growth products within 6 months of study entry,
* Treatments that may effect hair growth,
* Subjects requiring eye drop medications for glaucoma,
* Subjects having a situation or condition, which the study doctor feels might put you at risk, may make the study results confusing, or may interfere with the study.
14.0- 3.0- 3.0- η Protein With Rheumatoid Arthritis

Aim of work: to explore the potential association between serum 14.0-3.0-3.0- η protein level with disease activity and bone mineral density (BMD) in Egyptian patients with rheumatoid arthritis (RA).

188 patients with RA and 192 matched controls were enrolled. The RA activity parameters were evaluated in RA patients. BMD was measured. Serum level of 14.0- 3.0- 3.0- η protein and IL_.6 were estimated for all participants by ELISA.

A total of 200 RA patients were invited to be enrolled in this study. Patients were diagnosed as having RA by the 2010 European-league-against-Rheumatism- (EULAR) and American-College-of-rheumatology (ACR) classification criteria for RA. Patients were collected from the outpatient clinic of the Rheumatology and Rehabilitation Department, Mansoura University Hospital.

All participants underwent detailed medical history taking as well as clinical examination. The medical records of all patients were carefully reviewed. Data collection included age, gender, past medical history, current and past drug intake. In RA patients, the disease duration, duration of the morning stiffness, tender joint count (TJC) and swollen joint count (SJC) were reported. The activity of RA was measured by disease activity score 28 (DAS.28) based on the erythrocyte sedimentation rate (ESR) level (DAS28-ESR) \[19\]. The intensity of perceived pain was assessed by the visual analog scale (VAS) 100-mm scale.

Bone mineral density (BMD) was measured using dual energy X-ray absorptiometry (DEXA) at proximal femur for all participants who were categorized into normal, osteopenic, or osteoporotic according to the definition of the World Health Organization (WHO) of the recorded T score A commercially available human IL_.6 ELISA kit (GenProbe, Diaclone, France) was used to measure IL_.6 serum level following the instructions of the manufacturer.

Serum level of 14.0- 3.0- 3.0- η protein was determined by ELISA for all participants,

Eligibility Criteria:
Inclusion Criteria:

* Patients were diagnosed as having RA by the 2010 European-league-against-Rheumatism- (EULAR) and American-College-of-rheumatology (ACR) classification criteria for RA Patients were collected from the outpatient clinic of the Rheumatology and Rehabilitation Department, Mansoura University Hospital

Exclusion Criteria:

* postmenopausal females, patients with other rheumatic autoimmune diseases, severe infection, diabetes mellitus, hypertension, liver or kidney disease, malignancies, endocrinal diseases, pregnant or lactating females. Patients with current intake of glucocorticoids, anticonvulsants, estrogen or anti-coagulant, alcohol users, or other factors that lead to secondary osteoporosis were also excluded from the study