cyrilzakka/clinical-trials huggingface dataset:
Temporally Optimized Patterned Stimulation (TOPS®) Deep Brain Stimulation (DBS) for the Treatment of Parkinson's Disease

This study will test newly developed stimulation settings called Temporally Optimized Patterned Stimulation or TOPS, which can be used with an already implanted deep brain stimulation system. The purpose of this study is to determine if TOPS DBS can improve Parkinson's symptoms compared to Standard DBS.


Eligibility Criteria:
Key Inclusion Criteria:

* Diagnosed with Parkinson's disease
* Implanted with unilateral or bilateral subthalamic DBS System to treat Parkinson's disease at least 6 months prior to the study date
* Responds to DBS by having demonstrated a minimum improvement in motor score

Key Exclusion Criteria:

* Score of \<24 on the Mini Mental Status Exam
* Abuses drugs or alcohol
* Pregnant
* History of significant cardiovascular, pulmonary, musculoskeletal, metabolic, or other neurological disorders (i.e. epilepsy, stroke)
* Prisoners, employees that report to investigators
Effects of Connective Tissue Manipulation Versus Stretching Exercises in Primary Dysmenorrhea

The study will be a randomized clinical trial in which the effect of connective tissue manipulation will be compared with the effect of stretching exercises on pain and severity of symptoms in primary dysmenorrhea. Inclusion criteria will include nulliparous females in the age range of 18-25 years old. Exclusion criteria will be women with irregular menses (\<21 and \>35 days), systemic and gynecological diseases (gastrointestinal, autoimmune, psychiatric diseases, endometriosis, pelvic inflammatory diseases), pregnant women, previous pelvic surgery, traumatic injury. The participants will be allocated to two groups, group A and B. Group A will receive connective tissue manipulation on sacral, lumbar, lower thoracic and anterior pelvic regions with the patient in sitting and supine positions. Group B will receive active stretching exercise regime including forward, backward ad side trunk bending, heel raise, half squatting, knee to chest, hamstring stretching, calf stretching and abdominal contractions.

The study will be a randomized clinical trial in which the effect of connective tissue manipulation will be compared with the effect of stretching exercises on pain and severity of symptoms in primary dysmenorrhea. Inclusion criteria will include nulliparous females in the age range of 18-25 years old. Exclusion criteria will be women with irregular menses (\<21 and \>35 days), systemic and gynecological diseases (gastrointestinal, autoimmune, psychiatric diseases, endometriosis, pelvic inflammatory diseases), pregnant women, previous pelvic surgery, traumatic injury. The participants will be allocated to two groups, group A and B. Group A will receive connective tissue manipulation on sacral, lumbar, lower thoracic and anterior pelvic regions with the patient in sitting and supine positions. Group B will receive active stretching exercise regime including forward, backward ad side trunk bending, heel raise, half squatting, knee to chest, hamstring stretching, calf stretching and abdominal contractions.

All the participants will be informed about the manner of research and will be asked to sign the consent form after they are willing to participate in the study. WaLIDD score and dysmenorrhea severity scoring will be used to determine and assess the dysmenorrhea pain and severity. Treatment sessions will be conducted for 8 weeks, 3 times in a week and each session will be carried out for 20 minutes. At the end of two months, subjects will be assessed for their two menstrual cycles. SPSS 21 will be used for data analysis. After checking normality of data appropriate tests will be applied.

Eligibility Criteria:
Inclusion Criteria:

* Nulliparous women • Age range of 18 to 25 years

Exclusion Criteria:

* Women with irregular menses (\<21 days and \>35 days)
* Systemic and gynecological diseases
* Pregnant women
* Women taking contraceptive pills
* Traumatic injuries
* Previous pelvic surgery
BEhavioral EConomics for Oral Health iNnovation Trial

This Phase II stratified randomized prevention trial will assess the efficacy of a behavioral economic theory-based financial incentive drawing program versus a control regimen to promote early childhood caries (ECC) preventive health behaviors (toothbrushing performance) for young children of predominantly Latino parents/caregivers in Early Head Start (EHS) and day care center programs.


Eligibility Criteria:
Inclusion Criteria:

* Child

  * at least 2 fully erupted teeth
  * enrolled in, or waitlisted for, one of the participating Los Angeles County Early Head Start (EHS) or affiliated day care center or area clinic programs
* Parent/caregiver

  * provide signed and dated informed consent form in English or Spanish
  * agree to comply with all study procedures and be available for the duration of the study
  * aged 18 or older
  * speak either English or Spanish and self-reported ability to read and write either English or Spanish
  * be a parent or caregiver of a child at least 6 months old but less than 4 years (48 months), with at least 2 fully erupted teeth and enrolled in, or waitlisted for, one of the participating Los Angeles County EHS or affiliated day care center or area clinic programs
  * not be planning to move residence for the next 18 months outside the greater Los Angeles area
  * own a smartphone with Google Play or iTunes store app and be willing to download and install the smart powered toothbrush app at the Screening visit and keep it installed for the duration of the project. \[If the app cannot be properly installed by the baseline visit, the participant will not be randomized.\]
  * be willing to be contacted via text-messaging (SMS) for study related notifications, such as incentives earned or reminders to sync the toothbrush
* Stakeholder

  * be a staff member at a participating study site (e.g. EHS or affiliated day care center)
  * verbally agree to participate after being provided a study information sheet

Exclusion Criteria:

* Child

  * known allergic reaction to components of the study product(s)
  * uncooperative or behaviorally unsuited (assessed during a toothbrush prophylaxis, ASTDD Basic Screening Survey caries screening, and photograph of maxillary incisors at the screening visit)
  * more than 2 crowns on maxillary incisor teeth (teeth# D, E, F, G, or equivalently #52, 51, 61, 62).
  * participated in the BEECON pilot trial
  * a sibling of a child enrolled in the study (the family's oldest child in the eligible age range will be the study child)
  * enrolled in foster care
  * anything else that would place him/her at increased health risk or preclude the individual's full compliance with or completion of the study
* Parent/caregiver

  * participated in the BEECON pilot trial
  * unable or unwilling to install and use the smart powered toothbrush app during the run-in period
Prospective Investigation of Cardiovascular Risk Factors in Tumor Patients

In this study, prospective cohort study was used to collect the general information of patients' sex, age, previous history, family history, electrocardiogram, echocardiography, cardiac biomarkers TnT, BNP, biochemical examination, and clinical treatment of the patients who diagnosed cancer by pathology in National Cancer Center/ Cancer Hospital , Chinese Academy of Medical Sciences and Peking Union Medical College from January 2018 to December 2020. This study intends to evaluate and screen the cardiovascular risk of tumor patients during antitumor therapy and to establish a model of cardiovascular risk assessment for tumor patients, providing clinical evidence for the prevention of cardiovascular disease risk associated with cancer patients.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of malignant tumor by pathology or cytology
2. Age 18-80, KPS \> 70
3. Epidemiological information, clinical diagnosis and treatment and key information of medication are not missing.
4. The liver and kidney function were in the normal range.
5. All selected patients signed informed consent.

Exclusion Criteria:

1. patients diagnosed with congenital heart disease, cardiomyopathy, heart failure, arrhythmia, myocardial ischemia and myocardial infarction within 6 months before enrollment.
2. Severe impairment of liver and kidney function.
3. Left ventricular ejection fraction \< 50% by echocardiographic examination.
4. Diagnosis of more than one kind of tumor at the same time.
5. History of surgery and trauma within 3 months before enrollment.
6. Poor compliance
Auriculotherapy During Medication Abortion

This randomized trial will evaluate the effect of adding auriculotherapy (i.e. acupuncture applied to the ear) using either gold beads or Pyonex needles in addition to usual care for the relief of pain and anxiety during medication abortion. The control group will receive placebo auriculotherapy plus usual care. Participants will receive the assigned treatment immediately after they receive their initial abortion medication. The investigators will assess pain and anxiety via text message once daily for four days, and in person at a one-week follow-up visit.

Most women undergoing medication abortion with mifepristone and misoprostol report moderate to severe pain, despite treatment with ibuprofen or opioids. In 2018 National Academies of Sciences, Engineering and Medicine (NASEM) recommended research to improve pain relief. Limited data indicate that acupuncture is valuable for dysmenorrhea and for labor pain, conditions in which pain may be similar to that experienced during medication abortion. This randomized trial will recruit women seeking medication abortion after they have completed their routine clinical assessment and after they have received mifepristone. This study will evaluate two types of auriculotherapy applied to selected acupoints on the external ear. The study treatments are acupuncture using Pyonex needles and acupressure using gold pellets; both are applied to the ear using adhesive disks. A control group will receive the adhesive disks alone. All participants will receive usual medication abortion care, including taking misoprostol 1-3 days after mifepristone and ibuprofen for pain management. The investigators will query the participants regarding pain and anxiety. Follow-up will end at the time of the usual clinical follow-up about one week after mifepristone administration.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant up to 10 weeks (70 days) gestation
* Seeking medication abortion with mifepristone and misoprostol
* Initial clinical care completed and mifepristone administered
* English- or Spanish-speaking
* Able to use a mobile phone for follow-up on days 1-4

Exclusion Criteria:

* Not a candidate for medication abortion for any reason
* Allergy to adhesives
Study of Milk Allergy and Tolerance in Children

The purpose of this study is to determine if children who are allergic to milk can increase tolerance through frequent dose-escalation every 6 months versus 12 months leading to eventual tolerance of less heated milk and ultimately unheated milk.

Milk is among the most common food allergens in infants and children. The majority of children outgrow their milk allergies; however, the exact mechanisms by which food tolerance is achieved are unknown. Strict avoidance of the offending food is currently the only known therapy. However, some have been known to tolerate milk products cooked at high heat such as when baked in foods.

This clinical trial involves a diet containing extensively baked milk protein to investigate the effects of ingestion of heat-denatured milk on development of oral tolerance to non-baked milk.

Eligibility Criteria:
Inclusion Criteria:

One or more of the following inclusion criteria for enrollment in the study have to be met:

* Convincing history of an allergic reaction to milk or a positive double blind placebo controlled milk challenge (DBPCMC) within the past 2 years and either detectable milk immunoglobulin E (IgE) or positive prick skin test to milk OR
* Serum milk-IgE of high predictive value \>14 kUa/L or prick skin test to milk \> 10mm wheal within the past 6 months regardless of past clinical history of reactions OR
* Convincing history of an allergic reaction to milk or a positive DBPCMC more than 2 years ago and either a positive serum milk-IgE \< 14 kUA/L or positive prick skin test to milk \< 10 mm wheal within the past 6 months (eligible only for the active arm of the study and will undergo a reversed sequence of initial baked-milk challenges)

Exclusion Criteria:

* Inability or unwillingness of a participant to give written informed consent or to comply with study protocol
Addressing Individual Variability in Response to Exercise

In this proposal, the investigators challenge the assumption that following the physical activity guidelines implies benefit for ALL adults, and that if benefit is not achieved in response to first line therapy, it will be by simply exercising more. Thus, for improving cardiorespiratory fitness and cardiometabolic risk factors, unanswered questions include: 1) To what extent, regardless of exercise amount or intensity, is exercise not associated with benefit? Demonstration of a resistance to benefit through exercise in a substantial number of adults would be a novel and important finding, would counter the assumptions of many if not most health care practitioners, and could have immediate and direct application in all health care settings. 2) To what extent will non-responders to first line therapy (150 min/wk) be required to increase exercise amount or intensity to achieve benefit? 3) To what extent will failure to improve CRF segregate (be associate with) with cardiometabolic risk factors? The investigators propose that adults who remain exercise resistant for improvement in CRF and cardiometabolic risk despite increasing amount or intensity are at high risk of metabolic disease and consequently, are candidates for alternative treatment strategies. 4) To what extent is biological sex and/or phenotype a determinant of response or non-response to exercise?

The trial has three objectives:

Primary objective: Determine whether alterations in exercise amount and intensity improves the rate of clinically meaningful improvements in aerobic exercise capacity as measured by cardiorespiratory fitness (CRF, VO2peak) among adults.

Secondary objective: Determine whether common cardiometabolic risk factors segregate with respect to variation in CRF to first line therapy in adults, and, whether clinically meaningful improvements in cardiometabolic risk factors segregate with associated improvement in CRF.

Tertiary objective: Identify whether biological sex and/or phenotype are determinants of variation in CRF and cardiometabolic risk factors in response to first line therapy, and, whether they predict variability in CRF response to alterations in exercise dose.

Eligibility Criteria:
Inclusion Criteria:

* Sedentary lifestyle (planned physical activity for one day per week or less).
* Weight stable (± 2 kg) for 6 months prior to the beginning of the study.
* BMI between 20 and 40 kg/m2.

Exclusion Criteria:

* Physical impairment which would make the intervention very difficult or unsafe according to doctor's advice.
* Diabetes, current smokers.
* Plan to move from the area in next 8 months.
Dietary Intake of Tryptophan and Metformin Response

This study will examine the influence of dietary intake of tryptophan on response to metformin. The investigators hypothesize that dietary tryptophan alteration will influence metformin response.


Eligibility Criteria:
Inclusion Criteria:

1. healthy adult male or non-pregnant female volunteers (age 20-40)
2. able and willing to give consent

Exclusion Criteria:

1. Age less than 20 or greater than 40
2. Women who are pregnant, nursing, or at risk of becoming pregnant
3. Body mass index (BMI) less than 20 or greater than 28
4. Changes of more than 5 pounds in weight (increase or decrease) during the month prior to enrollment in the study
5. Participation in more than 300 minutes of exercise per week during the month prior to enrollment in the study
6. Known diabetes or pre-diabetes (based on prior diagnoses, use of medications to lower glucose; or fasting blood glucose \> 100mg/dL at screening)
7. Untreated hypertension (defined as systolic blood pressure \> 140mmHg and diastolic blood pressure \> 90mmHg)
8. Current or past mood disorder, including major depression, anxiety, or bipolar disorder
9. Conditions causing intestinal malabsorption, including celiac disease or a history of intestinal or gastric bypass surgery
10. History of liver disease and/or aspartate aminotransferase (AST) or alanine aminotransferase (ALT) more than 3 times upper limit of normal (ULN)
11. Estimated glomerular filtration rate (eGFR) \< 60 ml/min/1.73 m2 as calculated by the Modification of Diet in Renal Disease equation
12. Currently taking or intending to take during the study duration any medication known to affect glycemic parameters, such as glucocorticoids, growth hormone, or fluoroquinolones
13. Use of medications and herbal or vitamin supplements during the study
14. Contraindications to safe use of metformin, including planned radiologic or angiographic study requiring contrast within one week of the study completion
15. Objection to taking metformin
16. Participation in any other interventional study during the study duration
17. Use of nicotine-containing products, including inhaled, chewed, or patches during the study.
18. Use of drugs of abuse.
19. Restrictions that prevent adherence to standardized meals or unwillingness to adhere to a pre-specified meal plan, including abstinence from alcohol and limitation of caffeine intake to one drink daily.
Epidemiological Observation From a Smartphone Self-monitoring Application for Suspected COVID-19 Patients' Triage

A coronavirus pandemic began on 12/31/2020 with the first Chinese patient. As of 3/16/2020, the epidemic affects more than 100 countries with 169,000 official infections and 6,500 deaths. This virus causes a pathology ranging from simple flu symptoms in 80% of cases to acute respiratory distress syndromes requiring resuscitation in 5% of cases and a death rate of 1.4 to 4% of cases.

The arrival in France on 02/25/2020 with an exponential development of the infection (more than 5,000 cases on 03/15/2020) was accompanied by an unprecedented number of calls to the French emergency service call number (15) of worried patients with overload and sometimes saturation of the service that can impact calls and the care of patients really recovering from an emergency.

We previously developed a Moovcare® web application which showed a 7 months survival benefit by early detection of relapsed lung cancer based on the reporting of patient symptoms analyzed by a validated algorithm in 300 patients and 1 trial randomized. Another application for detecting and monitoring chemo-induced febrile aplasia appears to show a reduction in the number of hospitalizations for sepsis. Finally, Smokecheck, a self-assessment application for symptoms by smokers, has shown that it improves the detection of symptomatic operable bronchial cancers (9 to 24%, p = 0.04).

The web application https://www.maladiecoronavirus.fr/ was developed with a group of physicians from the Institut Pasteur, Hospitals group of Paris, Hospitals of Lille and Rennes and the ILC Jean Bernard in Le Mans. It makes it possible to guide symptomatic patients and patients who wishing to know what to do (call their general practitioner, teleconsultation, or call emergency service) based on symptoms and predictive factors of severity.

Following the availability of this new tool, we want to assess the impact of the application on the number and relevance of calls to emergency service.


Eligibility Criteria:
Inclusion Criteria:

* All users of the https://www.maladiecoronavirus.fr/ application over the age of 18

Exclusion Criteria:

* not applicable
Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination (FDC) With and Without Ribavirin for the Treatment of HCV

The purpose of this study is to evaluate the safety, tolerability, and antiviral efficacy of ledipasvir (LDV)/sofosbuvir (SOF) fixed-dose combination (FDC) tablets with or without ribavirin (RBV) administered for 12 and 24 weeks in treatment-naive subjects with chronic genotype 1 HCV infection.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18, with chronic genotype 1 HCV infection
* HCV treatment-naive
* HCV RNA \> 10,000 IU/mL at screening
* Cirrhosis determination; a liver biopsy may be required
* Screening laboratory values within defined thresholds
* Use of two effective contraception methods if female of childbearing potential or sexually active male

Exclusion Criteria:

* Pregnant or nursing female or male with pregnant female partner
* Co-infection with HIV or hepatitis B virus (HBV)
* Current or prior history of clinical hepatic decompensation
* Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain resolved skin cancers)
* Chronic use of systemic immunosuppressive agents
* History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol
A Pharmacokinetic (PK) Study of Three Types of E0302 Sustained Release (SR) Tablets Compared With E0302 Immediate Release (IR) Tablet Under Fed Conditions in Healthy Participants

To assess the PK and safety after administration of three types of E0302 SR tablets (SR1, SR2, SR3) and E0302 IR tablet.


Eligibility Criteria:
Inclusion Criteria:

Participants must meet all of the following criteria to be included in this study:

1. Body mass index (BMI) of 18 to 30 kilogram per meter square \[kg/m2\], inclusive at Screening

Exclusion Criteria:

Participants who meet any of the following criteria will be excluded from this study:

1. History of drug or alcohol dependency or abuse within the 2 years before Screening, or those who have a positive urine drug test or breath alcohol test at Screening or Baseline
2. Subjects who contravene the restrictions on concomitant medications, food and beverages
3. Currently enrolled in another clinical study or used any investigational drug or device within 3 months preceding informed consent