cyrilzakka/clinical-trials huggingface dataset:
The Measurement of Nocturnal Hypokinesia in Parkinson's Disease (PD) Patient Compared With Spouse by Wearable Sensors

To quantitative measurement of nocturnal hypokinesia of Parkinson's disease patients compares with their spouses by using multisite accelerometers for 1 night at their home. To determine whether the nocturnal movement of Parkinson's disease patients less than normal elderly people or not.

To quantify the severity of nocturnal akinesia, the nocturnal akinesia dystonia and cramp score (NADCS) and Unified Parkinson's Disease Rating Scale (UPDRS) were recorded in the patient group and also details of demographic data, history and physical examinations were included. The patients and spouses wore the 3-axis (x,y,z) accelerometers at bilateral wrists, bilateral ankles, and trunk for 1 night at their home. The 5-minute periods after going to bed and before waking up in the morning were excluded from the analysis. The definition of movement of the trunk is a change of 15 degrees from the previous position and sustained for 5 minutes in any axis. The movement of limbs is defined as a change of 15 degrees from the previous position and sustained for 2 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Parkinson's disease patients who met the criteria diagnosis of United Kingdom Parkinson's Disease Society Brain Bank (UKPDSBB) with their spouses which age difference less than 10 years.

Exclusion Criteria:

* 1) patients and/or spouses who were bed ridden,
* 2) a history of other neurological diseases or other muscle and joint diseases,
* 3) no history of hypnotic drug use
Influence of Obesity on Propofol Pharmacokinetics During Cardiopulmonary Bypass

The primary objective of this study is to develop a descriptive and predictive pharmacokinetics model propofol disposition during cardiopulmonary bypass (CPB) in obese and lean patients.

Anaesthesia maintenance upon initiation of CPB will be achieved by propofol (1%) bolus (1 mg/kg TBW) immediately followed by 2 mg/kg TBW/hr infusion that will be continued till weaning from CPB. During CPB an additional propofol bolus doses can be administered to prevent awareness according to the clinical judgment of the responsible anaesthesiologist. Any additional doses given and their timings will be recorded.

Blood samples of 2 ml each will be collected from the arterial line of CPB machine until the end of CPB then from sub-clavin arterial catheter routinely inserted in such surgeries. Sampling process will follow the following schedule; at baseline prior to dosing, followed by samples at 1, 3, 5,7 min after the propofol bolus dose, then every 20 minutes during propofol infusion, just before discontinuation of the propofol infusion and at 1, 3, 5, 7, 10, 20, 30, 60 minutes after the end of infusion. In addition, just before any rescue propofol dose administration, an unscheduled sample will be withdrawn

Eligibility Criteria:
Inclusion Criteria:

* BMI ≤ 25 kg/m2 or ≥ 30 kg/m2.
* Propofol based maintenance of anaesthesia during CPB.

Exclusion Criteria:

* Pregnant women or lactating mothers.
* Renal (serum creatinine concentration\>1.5 or creatinine Cl ≤ 30 ml/min) or hepatic disorders (total bilirubin \>1.5 or ≥ 2 fold increase in alanine transferase (ALT) or aspartate transferase (AST).
* Systemic infections.
* Hypoalbuminemia (defined as albumin \<3.5 gm/dL).
* Known history of alcohol or drug abuse.
* Administration of aspirin on the day of surgery or warfarin within 7 days preceding surgery
Prospective Registry for Patients With Chest Pain in Emergency Department

monocentric, prospective registry collection of clinical data of all patients with chest pain in emergency department and follow-up after 30 days

An unselected patient-population with chest pain entering through the emergency department participate in a diagnostic survey where a chest pain algorithm based mainly on risk scores (Grace, TIMI, Heart) verifying the diagnostic forecasting power (sensitivity, specificity, negative and positive predictive value) of biomarkers, risk scores and imaging methods for diagnosing of potential life-threatening disease.

Eligibility Criteria:
Inclusion Criteria:

* age \>18 years old chest pain written confirmation of participants or legal representative

Exclusion Criteria:

* thorax trauma
An Exploratory Open-Label Clinical Trial Evaluating the Immunogenicity of the 9-valent 2-dose HPV Vaccination Regimen

The goal of this study is to explore and evaluate whether a 2-dose schedule of Gardasil 9 among young and mid-adult women 16-45 years of age is generally safe and immunogenic, with an antibody response that is not inferior to that observed of a 3-dose schedule of Gardasil 9 among women aged 16-26 years old. The investigators thought that having a 2-dose vaccination regimen for individuals 16 to 45 would provide a more robust dataset than those of 27 to 45 years old.

The investigators will identify potential eligible subjects from the Boston Medical Center (BMC) Clinical Data Warehouse from the following BMC clinics: Pediatrics, Adolescent Medicine, Family Medicine, Obstetric/ Gynecology (OB/GYN), and Women's Health/Adult Primary Care. The research team will mail a recruitment opt-out letter signed by the principal investigator to the participant along with a study flyer. The recruitment letter will inform the participant that a research member may contact them via phone within two week to provide more information regarding the study.

Participants opting-in will be called and interviewed with the study recruitment script and eligibility will be determined. Eligible participants who agree to participate (in-person or over the phone), will be scheduled to come to the Boston University (BU) General Clinical Research Unit (GCRU) to complete the consent process. At the baseline visit participants will be assigned into the appropriate group (control vs. intervention) based on their age.

Eligibility Criteria:
Inclusion Criteria:

* Women receiving care at Boston Medical Center

Exclusion Criteria:

* Currently pregnant
* Prior HPV vaccination
* A history of severe allergic reaction, including known allergy to any vaccine component, specially severe allergic to yeast
* Immunocompromised/previous immunosuppressive therapy
* Thrombocytopenia or other coagulation disorder
* Currently breastfeeding
Effects of CPAP on Cardiovascular Risk in Obstructive Sleep Apnea (OSA) and Metabolic Syndrome

The increased risk of atherosclerotic morbidity and mortality in patients with obstructive sleep apnea (OSA) has been linked to arterial hypertension, insulin resistance, systemic inflammation, and oxidative stress in previous studies.

We aimed to determine the effects of 8-weeks therapy with continuous positive airway pressure (CPAP) on glucose and lipid profile, systemic inflammation, oxidative stress, and the global cardiovascular disease (CVD) risk in patients with severe OSA and metabolic syndrome.

Patients with obstructive sleep apnea (OSA) are at increased risk of atherosclerotic morbidity and mortality.OSA is associated with the development and/or worsening of arterial hypertension, a traditional risk factor of atherosclerosis.Moreover, OSA has been linked to novel factors related to atherogenesis - metabolic syndrome,systemic inflammation,6 and oxidative stress.

Numerous studies have selectively examined the effects of continuous positive airway pressure (CPAP) ventilation, the primary treatment for OSA, on the traditional and novel risk factors of atherosclerosis. A recent metaanalysis of 16 randomized trials indicated that CPAP decreases blood pressure in patients with OSA.9 Furthermore, reductions in serum total cholesterol, C-reactive protein (CRP), tumor necrosis factor-alpha (TNF-alpha), interleukin (IL)-6 and IL-8 were demonstrated after effective CPAP therapy.In addition, CPAP was shown to reduce systemic oxidative stress.Improvements in insulin sensitivity have been reported in some,but not in all studies. Importantly, substantial evidence links the effects of CPAP to compliance with this treatment.

Most observational studies examined the effects of CPAP across a broad-range of OSA severity, and have included patients with and without the metabolic syndrome. Up to now, no study analyzed the effects of CPAP on glucose and lipid metabolism, systemic inflammation, oxidative stress, and the global cardiovascular disease (CVD) risk within the same cohort of subjects with severe OSA and concurrent metabolic syndrome. Importantly, the metabolic syndrome exacerbates CVD risk over and above that attributable to OSA alone. Therefore, reduction of CVD risk in patients with OSA and concurrent metabolic syndrome is of paramount importance.

The primary purpose of the present study was to determine, in patients with severe OSA and metabolic syndrome compliant to CPAP, the effects of 8-weeks therapy on the glucose and lipid profile, systemic inflammation, oxidative stress, and on the global CVD risk. The secondary goal was to analyze factors related to compliance with CPAP.

Eligibility Criteria:
Inclusion Criteria:

* severe OSA (more than 30 obstructive apneas or hypopneas per hour of sleep and excessive daytime sleepiness)
* metabolic syndrome

Exclusion Criteria:

* endocrine or metabolic disorders other than metabolic syndrome
* history of myocardial infarction, angina or stroke
* inflammatory or other chronic disease
* respiratory disorder other than OSA
* neurological lesions
* regular use of sedative medication or alcohol
Low-protein Infant Formula With Partial or Extensive Proteinhydrolysate 4 Year Follow-up

The study is conducted to examine the suitability of partially respectively extensively hydrolyzed low protein infant formulae with and without pro- and prebiotics for healthy, term infants.

Primary hypothesis to be tested is: an infant formula based on a Protein hydrolysate with modified protein content is non inferior compared to a standard infant formula based on a Protein hyrolysate in respect to proper growth of healthy, term infants within the first four month of life.

4-year follow-up (without further Intervention) will focus on body composition and allergic predisposition.

View Section Brief Summary

Eligibility Criteria:
Inclusion Criteria:

* written informed consent (by parents, caregiver)
* Healthy term newborns (gestational age: ≥ 37 weeks)
* Birth weight between 2.500 - 4.500 g
* Age at enrolment: \< 28 days of age
* Infant received no other formula since birth
* Parents / Caregivers are able to speak German

Exclusion Criteria:

* Severe acquired or congenital illness
* preterm infants (gestational age \< 37 weeks)
* Birth weight lower than 2.500 g or higher than 4.500 g
* Feeding a cows milk based formula or any other formula prior to inclusion in this study
* Participation in any other clinical study intervention
* Regular intake of supplementary pre- and probiotics by the child and/or breastfeeding mother
* Mothers with diabetes mellitus or mothers suffered from gestational diabetes
* Founded assumption that it will not be possible for parents / caregivers to be compliant with the study protocol
* Breastfed infants: illness of the mother, that may have an influence on the gastrointestinal tract of the child
* Breastfed infants: mother receives or received antibiotics one week before inclusion in this study or during the first study phase
Internet-based Coaching for Young Adults With Neuropsychiatric Disorders

Purpose: To develop a model for internet-based support and coaching to young adults with neuropsychiatric disorders (NPD). To improve the individual's psychosocial functioning and his/her understanding of how he/she is functioning.

NPD comprise problems with social interaction, attention, impulse control and hyperactivity. The most common NPD diagnoses are ADHD (attention deficit hyperactivity disorder), autism spectrum condition (ASC) and Tourette's disorder (TD). In this study the investigators use Internet-based treatment for young adults with NPD.

Method: Support/coaching by using communication over the Internet (chat and e-mail) with individuals with NPD. Twice every week during 8 weeks, young adults with NPD are offered support and coaching over the Internet by psychologist/educational therapist with great experience from NPD. The individuals are assessed before and after treatment pertaining to quality of life, sense of coherence, self-esteem, depressive and anxiety symptoms, and parents' evaluation of the young adult's situation.

Aims: To develop an internet-based support and coaching model for young people with autism spectrum disorder (ASD) and/or attention-deficit/hyperactivity disorder (ADHD), and to validate the model. Method: A user centred design was applied to develop a model for internet-based support and coaching, where individuals received eight-week support via internet (chat). The model was validated by ten individuals, 15 to 26 years of age, with ASD and/or ADHD. Self-report questionnaires (Sense of Coherence (SOC), the Rosenberg Self Esteem Scale, the Manchester Short Assessment of Quality of Life (MANSA), Montgomery Åsberg Depression Rating Scale (MADRS), and the Hospital Anxiety and Depression Scale (HAD)) were distributed before and after intervention. A structured interview regarding the quality of the model, the Patient perspective of Care and Rehabilitation process (POCR), was used after the intervention. Results: The validation showed significant improvement of SOC, self-esteem and subjective Quality of Life at follow-up and the majority perceived high fulfilment/importance on the POCR. Conclusions: The model can be an important complement to other interventions for young people with ASD and/or ADHD.

Eligibility Criteria:
Inclusion Criteria:

* The individuals had to fulfill a diagnosis of ADHD, Tourette's disorder and/or an ASD (autistic disorder, Asperger's disorder or pervasive developmental disorder not otherwise specified (PDD NOS), according to the DSM-IV (APA, 1994).
* The inclusion age was between 15 and 26 years.

Exclusion Criteria:

* mental retardation,
* current psychosis,
* current major depression,
* current alcohol and/or substance abuse/dependence,
* severe dyslexia and/or severe psychosocial problems (e.g. criminality)
Effect of BMS-986165 on the Pharmacokinetics of Rosuvastatin

The study is to assess the effect of coadministration of multiple doses of BMS-986165 on the systemic exposure of rosuvastatin in healthy participants.


Eligibility Criteria:
Inclusion Criteria:

1. Signed Informed Consent
2. Healthy male and female participants (not of childbearing potential) as determined by no clinically significant deviation from normal in medical history, physical exam, ECGs, and clinical laboratory determinations
3. Subjects with body mass index of 18 to 32 kg/m2, inclusive.
4. Women participants must have documented proof that they are not of childbearing potential.
5. Men who are sexually active with WOCBP must agree to follow instructions for method(s) of highly effective contraception for the duration of study treatment(s) plus 5 half-lives of BMS-986165 (4 days) plus 90 days (duration of sperm turnover) for a total of 94 days of post BMS-986165 treatment. In addition, male participants must be willing to refrain from sperm donation during this time.

Exclusion Criteria:

1. History of allergy to BMS-986165, rosuvastatin, or related compounds, of myalgia or rhabdomyolysis while taking rosuvastatin or related compounds or any other drug allergy
2. Any significant acute or chronic medical illness, active TB requiring treatment or documented latent TB within the previous 3 years, current or recent gastrointestinal disease, current or recent history of nausea, vomiting, constipation or irregular bowel movement
3. History of chronic headaches, syncope, orthostatic instability, or recurrent dizziness, biliary disorders, drug-induced acne or rash, fibromyalgia, neutropenia or thrombocytopenia
4. Smokers who currently smoke, recent drug or alcohol abuse, blood transfusion within 4 weeks of study treatment administration, current skin findings that could interfere with the interpretation of study

Other protocol defined inclusion/exclusion criteria could apply
A Study of QLM2011 in Subjects With Advanced Solid Tumors

This trial is an open-label, single-center, dose-escalation and cohort-expansion Phase I clinical study in patients with advanced solid tumors. The purposeaim of this study is designed to evaluate the safety, tolerability, pharmacokinetics and preliminary antitumor activity of QLM2011 in patients with advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18, ≤80 years, no gender limitation；
* Histologically or cytologically confirmed diagnosis of advanced or metastatic solid tumors, for which standard therapy either does not exist or has proven to be ineffective, intolerable for the patient；
* At least one measurable lesion as per RECIST version 1.1；
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1；
* Life expectancy ≥3 months；
* All subjects of reproductive potential must agree to use an effective method of contraception during the study and for 3 months after the last dose, and women of reproductive age must have a negative blood pregnancy result within 7 days prior to the first dose.

Exclusion Criteria:

* Chemotherapy, radiotherapy, targeted therapy， endocrine therapy, immunotherapy and other anti-tumor treatment within 28 days of the first dose of the study drug, 6 weeks for nitrosoureas or mitomycin C, 2 weeks (or 5 half-lives whichever is longer) for using fluorouracil or small molecule targeted drugs, 2 weeks for using traditional Chinese medicine with anti-tumor indications.
* Uncontrolled or clinically symptomatic serous cavity effusions (e.g., pericardial effusion, pleural effusion, ascites, etc.) requiring repeated puncture drainage or medical intervention.
* Toxicity from prior antitumor therapy has not recovered to ≤ Grade 1 per the Common Terminology Criteria for Adverse Events (CTCAE v5.0) (exceptions include alopecia, peripheral neuropathy, isolated laboratory abnormalities, or other toxicities deemed by the investigator to pose no safety risk).
* Have a history of other malignant tumors within 3 years before signing the informed consent, excluding cervical carcinoma in situ, basal cell carcinoma of the skin, papillary thyroid carcinoma or squamous cell carcinoma of the skin that has received radical treatment;
Chemotherapy Plus Radiation Therapy in Treating Patients With Previously Untreated Thyroid Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients who have previously untreated anaplastic thyroid cancer.

OBJECTIVES: I. Evaluate the activity of chemotherapy with hyperfractionated radiotherapy in terms of complete and overall response rate, time to progression, pattern of failure, incidence of second primary tumors, and overall survival in patients with previously untreated anaplastic thyroid cancer.

OUTLINE: This is a multicenter study. Patients receive oral hydroxyurea every 12 hours on days 0-5, fluorouracil IV and paclitaxel IV continuously over days 1-5, and hyperfractionated radiotherapy twice daily on days 1-5. Patients receive filgrastim (G-CSF) subcutaneously daily on days 6-12. Treatment repeats every 2 weeks for 5 courses. Following completion of concurrent chemoradiotherapy, patients with no prior initial modified neck dissection who have residual macroscopic nodal disease or initially staged nodal disease with no evidence of residual disease undergo neck dissection. Patients with macroscopic residual disease at the primary site undergo complete excision of disease. Patients with any progressive disease or recurrence of disease undergo conventional surgical management. Patients are followed at 4-6 weeks, every 3 months for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: Approximately 16-46 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed anaplastic thyroid cancer Metastatic disease allowed

PATIENT CHARACTERISTICS: Age: 15 to 80 Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Alkaline phosphatase no greater than 2 times normal Transaminases no greater than 2 times normal Renal: Not specified

PRIOR CONCURRENT THERAPY: Prior simple excision (e.g., transoral laser excision) of the primary lesion allowed if organ function preserved Prior modified neck dissection allowed
Real-world Data Regarding Treatment of Ulcerative Colitis Patients With Golimumab

TNF inhibitors have improved treatment options for patients with inflammatory bowel disease (IBD) and three TNF inhibitors, infliximab, adalimumab and golimumab are available for treatment of ulcerative colitis in Switzerland. However, these drugs have been tested under ideal conditions in randomized controlled trials. Real-world data are needed to complement this information. It is the aim of our study to test, whether patients with ulcerative colitis can be effectively treated with golimumab in a real world setting in Switzerland.

The investigators will use data from the Swiss IBD cohort study (SIBDC) in Switzerland. They will identify all SIBDC patients with UC treated with Golimumab and perform a retrospective chart review. The investigators will acquire patient reported outcomes and objective measures for inflammation at baseline, at 6-10 weeks and at 6 and 12 months after golimumab treatment. Primary endpoint will be clinical response (i.e. meaningful improvement) at 6-10 weeks. Secondary endpoints will be clinical response at 6 and 12 months and clinical remission (i.e. free of symptoms of disease).

Ulcerative colitis patients from the Swiss IBD cohort study treated with golimumab will be identified. The investigators will perform a retrospective chart review and assess patient reported outcomes and objective measures of inflammation to assess response and remission.

As clinical response in UC the investigators will define a composite end point of: Marked improvement in partial Mayo score AND improvement in one or more of the following parameters (acquired during chart review):

* Endoscopy data
* ultrasonography
* Calprotectin (cut off 100microg/g)
* CRP
* Anemia resolution

Marked improvement is defined as: Clinical response based on partial Mayo Score (including physician global assessment): decrease in partial Mayo score ≥ 2 points and ≥ 30% from baseline and a decrease in rectal bleeding subscore ≥ 1 point or absolute rectal bleeding score ≤ 1. Improvement in lab work is defined as a reduction of the difference between baseline values and the next limit of normal by ≥ 30%. Improvement in endoscopy/ ultrasonography is defined as a reduction of colitis in the same technique compared to baseline substantiated by images (endoscopy) or measurements of diameter of the bowel wall.

As clinical remission in UC the investigators define normalization (i.e. absence of pathology) of patient reported outcomes (Frequency of stool, blood in stool) AND no evidence of residual disease activity in all of the following parameters:

* endoscopy data
* ultrasonography
* calprotectin (cut off 100microg/g)
* CRP and anemia

Eligibility Criteria:
Inclusion Criteria:

* Patient of the Swiss IBD cohort study
* Diagnosis ulcerative colitis
* Past treatment with golimumab (at least one dose)

Exclusion Criteria:

* none