cyrilzakka/clinical-trials huggingface dataset:
Investigating the Effect of Whole-fruit Coffee Extract on Exercise Performance

Caffeine is a widely used efficacious supplement by both the general public, and athletes, with the goal of improving performance. The effects of caffeine alone are well known, but it is not clear whether a multi-ingredient supplement (containing both caffeine and polyphenols) can affect exercise performance.

This study aims to determine if a low dose of caffeine, in the form of a whole-fruit coffee extract also containing polyphenols, can improve exercise performance compared to a placebo condition, with a secondary objective of identifying if this supplement can improve post exercise refuelling (glycogen resynthesis).

Participants will consume either the supplement or a placebo before engaging in an exercise protocol. Muscle biopsies will then be obtained so as to measure subsequent glycogen resynthesis, with multiple blood samples being taken through the day. The following morning another biopsy will be taken before the exercise protocol will be repeated.

This research will inform us of the efficacy of caffeine and polyphenols on improving exercise performance.


Eligibility Criteria:
Exclusion criteria:

* Allergy to Lidocaine
* Exclusion critera
* Any diagnosed metabolic health condition
* Pregnant
* Non-habitual caffeine intake
* Smoker
* No endurance training
* Diagnosed Cardiovascular disease
* Beta-Blockers
* Recent history of musculoskeletal injury

Inclusion criteria:

* Age 18-40
* Heathy
* Highly trained endurance athletes (V̇O2max: males \>55 and females \>50 mL⋅kg bm-1⋅min-1)
* Both males and females are allowed to participate. If females are on the oral contraceptive pill they are to be tested on consecutive weeks. If they are not on the oral contraceptive pill, then female subjects are to be tested every 4 weeks, at the same point of their menstrual cycle.
Oxytocin and Dyadic Psychotherapy in the Treatment of Post Partum Depression

Rationale and Hypotheses of the Current Research: the investigators speculate that mothers suffering from PPD exhibit high levels of depression and low levels of OXT, hence experiencing the interaction with their child as less rewarding, which in turn promote further depressive symptoms and interfere with child development. While dyadic psychotherapy has been studied in this context, it is unknown which depressed women will respond to this type of therapy, and whether such a response is mediated by the pro-bonding effect of oxytocin.

The aim of this study is three-fold:

1. To study the effect of the administration of a single dose (24IU) of oxytocin on cerebral circuit processing and connectivity of empathy and attachment.
2. To examine whether the clinical response of mothers suffering from postpartum depression to short term dyadic psychotherapy (based on improved mother-child interactions) can be predicted by a unique brain response pattern to oxytocin.
3. To assess the relationship between levels of oxytocin in mother and baby and the effectiveness of psychological dyadic treatment on mothers suffering from postpartum depression.


Eligibility Criteria:
Inclusion Criteria:

* Women of all ages who are 3 to 8 months post-partum.
* Women who have completed a minimum of 12 years of education.
* Women who are willing and able to provide informed consent for their participation and after the study has been explained. Infant participation will be allowed after consent has been obtained from mothers.
* Current DSM-IV-TR diagnosis of PPD disorder as confirmed by SCID (administered as part of the study of protocol number PPD1, proposed to the Helsinki committee on June 2014).
* Symptoms: BDI total score \>9, EPDS total score \>10
* Treatment with antidepressants will be allowed provided that patients have been on the medication for at least 4 weeks prior to entry into the pre-treatment assessment phase of the study.

Exclusion Criteria:

* Unwilling or unable, in the opinion of the investigator, to comply with study instructions.
* Pregnant women.
* Clinically significant medical disease (malignancy, poorly controlled diabetes, active ischemic cardiac disease, or cardiomyopathy, serious pulmonary disease, kidney disease, impaired liver functioning).
* Women with significant risk of committing suicide or harming others in the opinion of the psychiatrist.
* Women with a current DSM-IV-TR substance or alcohol abuse. However, patients with a history of and/or current recreational use of cannabinoids or alcohol, and/or patients who smoke cigarettes can be included.
* Women who suffers from depression due to physical condition.
* Women who suffers from severe major depression (MADRAS\>30)
* Women who suffers from chronic depression (over 6 months)
A Phase 1 Study of SB1518 for the Treatment of Advanced Lymphoid Malignancies

This is a Phase 1 dose escalation study to determine the maximum tolerated dose and the dose limiting toxicities of SB1518 when given alone once daily by mouth to subjects with advanced lymphoid malignancies.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with histologically documented diagnosis of a lymphoid malignancy as defined in the World Health Organization (WHO) classification scheme except for those listed in Exclusion Criteria
* Subject must have received at least 2 prior regimens for their lymphoid malignancy, one of which was an anthracycline-containing combination regimen and have shown disease relapse or did not respond to the prior regimen
* Subjects with classic HL or diffuse large B cell lymphoma must have failed, refused or are ineligible to receive stem cell transplant
* Subjects must have measurable lesions (at least one target lesion measuring 2cm in diameter) by computerized tomography (CT) scan
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* All men of reproductive potential and women of child-bearing potential must agree to practice effective contraception during the entire study period and for one month after the last study treatment unless documentation of infertility exists. Additionally, women of child-bearing potential must have a negative pregnancy test within 14 days prior to the first dose of study drug
* Able to understand and willing to sign the informed consent form

Exclusion Criteria:

* Post-Transplant Lymphoproliferative Disease (PTLD), Burkitt's lymphoma, Burkitt-like lymphoma, lymphoblastic lymphoma/leukemia, multiple myeloma, or HIV-associated lymphoma
* History of or active Central Nervous System (CNS) malignancy
* Have undergone allogeneic stem cell transplant and were treated with immunosuppressing agent within the past 6 months
* Active Graft-versus-host disease (GVHD)
* Uncontrolled inter-current illness including, but not limited to, ongoing active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements as judged by treating physician. Subjects receiving antibiotics for infections that are under control may be included in the study
* Concurrent malignancy, except those subjects with early stage squamous cell carcinoma of the skin, basal cell carcinoma of the skin, or cervical intraepithelial neoplasia are eligible for the study
* Known HIV-positive (such subjects are at increased risk of lethal infections when treated with potentially marrow-suppressive therapy)
* Known active Hepatitis A, B or C
* Women who are pregnant or lactating
Prospective Collection of Female Specimens for Testing With Gen-Probe APTIMA (Registered Trademark) Assays

The objective of this study is to obtain female first-catch urine, vaginal, cervical and endocervical swabs for testing with multiple APTIMA Assays on the Gen-Probe PANTHER® and TIGRIS® Systems.


Eligibility Criteria:
Inclusion Criteria:

* The subject is at least 16 years of age at the time of enrollment and is currently sexually active (has had penile/vaginal intercourse within the past 12 months)
* The subject and/or legally authorized representative is willing to undergo the informed consent process prior to study participation (a minor will need the documented consent of his/her parent or legal guardian, unless the site has an institutional review board \[IRB\]-approved waiver for parental consent for minors)

In addition, the subject must meet at least one of the following criteria:

* The subject reports symptoms consistent with a suspected sexually transmissible infection (STI) such as abnormal discharge, genital itching, pain/discomfort during sexual intercourse or urination, and/or lower abdominal discomfort
* Subject is asymptomatic and known to be partners with, or a contact of, a person with a confirmed or suspected STI(s)
* Subject is asymptomatic and undergoing screening evaluation for possible STIs
* Subject is asymptomatic and undergoing a routine examination with a pelvic examination

Exclusion Criteria:

* The subject took antibiotic medications within the last 21 days
* Subject already participated in this study
* Subject has a history of illness that the principal investigator (PI) or designee considers could interfere with or affect the conduct, results, and/or completion of the clinical trial
* Subject has a history of illness that the PI or designee considers could create an unacceptable risk to the subject if enrolled
The Incidence of Gallstones After Gastrectomy

To provide preventive and therapeutic strategies for participants with gallstones after gastric cancer by comparing the risk of postoperative gallbladder stone formation with two different resection ranges using the Roux-en-Y reconstruction modality in radical gastric cancer surgery.

A large number of clinical studies have found that the incidence of gallstones in patients after radical gastric cancer surgery is higher than that in the normal population. However, the pathogenesis has not been clarified, and the prophylactic removal of the gallbladder in patients with gastric cancer remains controversial. A previous study found a statistically significant incidence of gallbladder stones after Billroth I versus Roux-en-Y in distal gastrectomy for gastric cancer. Therefore, the investigators plan to conduct a retrospected cohort study to collect further participants with gastric cancer who underwent total gastrectomy to answer whether different surgical resection ranges during surgery increase the incidence of gallstones this question.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Gastric Cancer underwent Gastrectomy

Exclusion Criteria:

* Age less than 18 years or age greater than 75 years;
* Not Roux-en-Y reconstruction;
* R0 excision is not achieved;
* Previous history of upper abdominal surgery, such as cholecystectomy, gastrectomy;
* Preoperative gallbladder diseases, such as gallstones, gallbladder polyps, chronic cholecystitis;
* Preoperative neoadjuvant chemotherapy or radiotherapy;
* Previous history of malignant tumours;
* Patients with mental or developmental abnormalities or women during pregnancy or breastfeeding;
* Gastric perforation or bleeding leading to emergency surgery;
* Palliative surgical treatment;
* Incomplete case information.
Overnight Use of Electroacustimulation on Postoperative Nausea and Vomiting in the Outpatient Surgery Population

Postoperative nausea and vomiting after outpatient surgery are significant sources of patient dissatisfaction. The prevention of postoperative nausea and vomiting (PONV) should be equally as important as prevention of pain because both are large sources of patient dissatisfaction and can necessitate admission after routine outpatient procedures.

None of the currently available pharmacological interventions are able to totally abolish PONV. The use of electroacustimulation is a useful adjunct in prevention of PONV, but has yet to be studied when the patient takes the device home with them after leaving an outpatient facility.

The goal of this project is to perform a pilot study to determine if sending patients home with the electroacustimulation device will decrease their PONV and subsequently increase their overall satisfaction.

The primary outcome will be post-operative nausea and vomiting scores on a scale of 1-10 based on surveys which will be performed at 30m, 60m, 120m, and 24h post-op.

Secondary outcomes will be the amount of rescue nausea medications required by the patients, time to discharge, subjective pain assessment and the impact of their symptoms on the activities of daily living since being discharged from the surgery center based on survey, and amount of narcotic received.

This project would also aim to reduce the amount of time patients spend in recovery post-operatively, reduce hospital admissions secondary to persistent nausea and vomiting, and educate students and trainees about alternative methods of treating and preventing postoperative nausea and vomiting.

Eligibility Criteria:
Inclusion Criteria:

• scheduled for outpatient surgery procedure under general anesthesia

Exclusion Criteria:

* pregnancy
* currently experiencing menstrual symptoms
* cardiac pacemaker
* previous experience with acupuncture therapy
* pharmacologic treatment for nausea or vomiting in the 24 hours prior to surgery
OPTmizing Advanced Stage HodgkIn LymphoMa patIentS Therapy

This is a prospective, multi-center, open-label, phase II clinical trial, aims to assess the effectiveness of the combination ACVD (Adriamycin, Cyclophosphamide, Vinblastine and Dacarbazine) and BV (Brentuximab Vedotin) in PET-2 positive advanced-stage HL patients, in order to improve the overall long-term disease control in the entire cohort of advanced-stage HL.

With the aim of reducing Blemoycin pulmonary injury (BPI) , Bleomycin was withdrawn and substituted with Cyclophosphamide (ACVD cycle) in patients with a PET-2 negative. All advanced stage HL patients will receive 2 cycles of the standard treatment ABVD and assessed with PET-2 scan.

Knowing that Cyclophosphamide toxicities include cytopenias, amenorrhea and male infertility. These toxicities are mainly dependent on the total cumulative dose. Doses less than 4 g/m2 are not associated with sterility or major toxicity, doses higher than this can lead to azoospermia which was reversible in many cases therefore the cumulative dose will be used in this study is 3200 mg. Additionally, Brentuximab Vedotin has shown significant activity in relapsed refractory HL with minor toxicities.

PET scan after 2 cycles of ABVD has proven to be an excellent tool to identify patients that will have long term PFS of 95% when it is negative and only progression-free survival (PFS) of less than 15% when it is positive.

The primary endpoint of the study will be to assess the overall 3-Y PFS of the entire cohort of patients.

Eligibility Criteria:
Inclusion Criteria:

* All the following parameters should be met

  * Newly diagnosed untreated ,histologically proven CD30 positive classical Hodgkin Lymphoma (cHL)
  * Advanced stage (Stage IIB to IVB) as defined by Ann Arbor Staging System (Appendix 1)
  * Age ≥ 14, \< 60 years
  * ECOG performance status 0-2
  * Written informed consent for the trial
  * Adequate contraceptive precautions for all patients of childbearing potential
  * All prognostic group

Exclusion Criteria:

* Any of the following:

  * Pregnant or lactating women.
  * Presence of the following:

    1. Heart failure with LVEF \<50%
    2. Liver enzymes, \>2 ULN not attributed to Hodgkin Lymphoma.
    3. Another malignancy that is currently clinically significant or requires active intervention
  * Early-stage disease (Stage I- IIA).
  * Patients who are already participating to another clinical trial.
  * Known history of HIV seropositive status
  * ECOG performance status 3-4
  * Creatinin clearance \<50 ml/min
  * Prior treatment for Hodgkin Lymphoma excluding steroids
  * Medical or psychiatric conditions compromising the patient's ability to give informed consent
  * Patients with serious active infection
  * Pre-existing peripheral neuropathy (grade 2 or more).
Burden of Herpes Zoster and Post-herpetic Neuralgia Among People ≥ 50 Years Old in France

The purpose of this study is to assess the burden of Herpes zoster (HZ) and post-herpetic neuralgia (PHN) among people ≥ 50 years old in France, in terms of healthcare resources used, medical direct and indirect costs, as well as pain severity and impact on quality of life.

* An observational, prospective cohort study of patients ≥ 50 years old with a Herpes Zoster (HZ) diagnosis, carried out by a national random sample of community first line practitioners concerned by HZ diagnosis: general practitioners, dermatologists and ophthalmologists.
* All patients ≥ 50 years old with a HZ diagnosis (as the primary diagnoses and without history of previous HZ) during approximately 6 months inclusion period will be included in the HZ cohort, until total study target is achieved.
* All Patients of the HZ cohort presenting a Post-herpetic neuralgia (PHN) 3 months after onset of the HZ rash onset will be included secondarily in the PHN cohort
* Patients of the HZ cohort will be followed-up for 3 months (i.e. 1 and 3 months after HZ rash onset) and patients of the PHN cohort will be followed-up for additional 6 months (i.e., 6 and 9 months after HZ rash onset) using phone interviews with a nurse.
* 250 cases of HZ and 40 cases of PHN are expected, with the hypothesis of 16% of PHN 3 months after HZ rash onset.

Eligibility Criteria:
Inclusion Criteria:

* For HZ cohort

  * Patient with a first visit for a diagnosis of HZ and who attend the clinic within two week of the HZ start of symptoms,
  * Without history of previous HZ,
  * ≥ 50 years old,
  * Who agree to participate and signed informed consent,
  * Able to understand the study, to complete self-administered questionnaires and to answer phone interviews.
* For PHN cohort

  * All Patients of the HZ cohort presenting PHN 3 months after onset of the HZ rash onset will be included in the PHN cohort. PHN will be defined as the presence of HZ-associated severe pains: ≥ 3 of the ZBPI item "worst pain".

Exclusion Criteria:

* None
Pre-habilitation Program for Elective Coronary Artery Bypass Graft Surgery Patients

Low levels of physical fitness increase the risk of death in patients with cardiovascular disease. Although cardiac rehabilitation programs improve the health of patients after heart surgery, most patients are not referred until after surgery. Therefore, the purpose of this study was to determine if an exercise "pre-habilitation" (i.e., Prehab) program before heart surgery would improve the health of patients before surgery and whether these improvements would be maintained after surgery.

The investigators hypothesized that Prehab would promote the health of patients before heart surgery, and these improvements would be maintained three months post-operatively, as compared to patients who received standard care.

This was a single-centre, parallel randomized controlled trial conducted in Canada to determine the feasibility and efficacy of an exercise and education "pre-habilitation" (i.e., Prehab) program before elective coronary artery bypass graft surgery (CABG). We recruited 17 patients who were scheduled to undergo elective CABG surgery from February 2011-May 2012. Enrolled patients were assessed at baseline, one week pre-operatively, and three months post-operatively.

Eligibility Criteria:
Inclusion Criteria:

* On elective waitlist for coronary artery bypass graft surgery with a minimum anticipated wait time of 4-6 weeks or more
* No history of unstable angina
* Canadian Cardiovascular Society score of less than 4
* No history of myocardial infarction within the past 7 days
* Ejection fraction greater than 30%
* No history of dementia or psychiatric problems
* No self-reported dizziness or confusion
* Able to read, speak, and understand English
* Previously sedentary (reporting accumulating less than 45 minutes of moderate intensity physical activity per day on at least three days per week over the last three months)
* No previous participation in cardiac rehabilitation
* Lives in Winnipeg, Manitoba, Canada or has easy access to the Reh-Fit Centre (local medical fitness facility)

Exclusion Criteria:

* If patients cannot attend Prehab due to geographical limitations
* If patients cannot participate due to physical limitations
* Diagnosis of exercise-induced arrhythmia
Cardiopulmonary Training in the Victims With Multiple Morbidities by Application of Novel Heart Rate Sensing Clothes

Investigators assume that the wearable clothes can be applied to home-based health care and integrated into a case management model through telehealthcare. While prior to complete the case management, the feasibility should be tested and evaluate its reliability and validity of the physical information collected from the clothes. Therefore, investigators try to conduct a feasibility study to evaluate the reliability and validity of the exercise heart rate sensing e-clothes and after that, investigators will incorporate this wearable clothes to home-based exercise training as one of the major components in our case management model.

Easy-to-use and service touch points allow patients/ users to realize the value and status of their physiological functions/ parameters based on their evidence is important. According to the U.S. survey, 90% of people can change their lifestyle behaviors, improve their personal health awareness, achieve holistic health care and improve their quality of life due to "Quantify Self". Therefore, a broader health care system, health consumption services or ecological system has been building to integrate health care resources, extend health care services from hospital to communities and individual' homes. When people consume in their daily life, immediate public health guidance or professional intervention can be offered at the same time, not only can effectively maintain individuals' health, early detection of possible physiological signs/ parameters, can also delay the progression of the disease and reduce the burden of first-line health care workers. Therefore, it is the era of smart healthcare that provides a health service platform with APPs(Applications) to provide personalized integrated medical services. However, in order to monitor or evaluate the effect of treatment (i.e., exercise training) still needs to be provided through the actual feedback of individual physiological data.

Clothes with smart function which is able to connect with social media and APPs has been promoting and marketing as smart sports or lifestyle-monitor goods, such as exercise-related physical parameters and sleep quality quantifying. Sleep physiology information collected through the clothes including degree and quality of sleep can be recorded and transmitted to the remote health system via APP and cloud service platform. On this cloud platform, health information can exchange with clinician's physicians, offering advises for users to whether to go to the hospital for further examination.

Eligibility Criteria:
Inclusion Criteria:

* more than two chronic disease.(multiple morbidity)
* able to speak and understand Mandarin
* able to walk without assistance
* able to use smart phones and understand how to use the e-clothes and related app
* agreed to be randomized to one of the two groups

Exclusion Criteria:

* a history of cancer
* confirmed psychiatric disease
* inability to participate due to comorbid neurological and musculoskeletal conditions
* a history of arrhythmia