cyrilzakka/clinical-trials huggingface dataset:
Effects of Supplementation of Compound Nutrients on Plasma Homocysteine in Chinese Adults

The purpose of this study is to determine whether supplementation of compound nutrients, including folic acid, vitamin B6, vitamin B12, and betaine, will decrease the level of plasma homocysteine in Chinese adults with homocysteine levels above 10 μmol/L.


Eligibility Criteria:
Inclusion Criteria:

1. Aged 18 - 65 years;
2. Concentration of plasma homocysteine is between 10 and 100 μmol/L;
3. Free from any supplements or drugs that may decrease plasma homocysteine concentration for at least 1 month prior to the beginning of study;
4. Willing to participate in the study and sign informed consent.

Exclusion Criteria:

1. Pregnant or lactating women;
2. Allergic physique or allergic to our compound nutrients tablets;
3. Complicated with severe diseases;
4. Unable to conduct study procedures;
5. Participating in any other intervention studies.
Transversus Abdominis Plane Block in Microsurgical Breast Recon w/Abdominal Free Flap in Breast CA

The primary objective is to determine if pre-operative transversus abdominis plane (TAP) nerve blocks by continued infusion of local anesthetic post-operatively affects post-operative narcotic usage, as compared to a placebo TAP block, after breast reconstruction surgery.

Primary Objective: The primary objective is to determine if pre-operative transversus abdominis plane (TAP) blocks with continued infusion of local anesthetic post-operatively affect post-operative narcotic usage as compared to a placebo TAP block.

Secondary Objectives:

* Determine if pre-operative TAP blocks with continued infusion of local anesthetic post-operatively affect post-operative pain scores as compared to a placebo TAP block.
* Determine if pre-operative TAP blocks with continued infusion of local anesthetic post-operatively affect anti-emetic usage as compared to a placebo TAP block.
* Determine if pre-operative TAP blocks with continued infusion of local anesthetic post-operatively affect time to ambulation post-operatively as compared to a placebo TAP block.
* Determine if pre-operative TAP blocks with continued infusion of local anesthetic post-operatively affect time to first bowel movement as compared to a placebo TAP block.
* Determine if pre-operative TAP blocks with continued infusion of local anesthetic post-operatively affect patient-reported quality of life as compared to a placebo TAP block.

Eligibility Criteria:
Inclusion Criteria

* Prior diagnosis or presumed diagnosis of breast cancer or undergoing prophylactic treatment.
* Greater than 18 years old.
* Female.
* Undergoing microsurgical breast reconstruction with abdominal free flap.
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria

* True allergy to local anesthetics or opioids.
* History of addiction to narcotics within the last 24 months
* History of chronic pain on opioids within the last 24 months.
* Specific mental health issues such as schizophrenia or bipolar disorder.
* Patients who are pregnant.
The Effect of Physical Fatigue on Lower Limb Functional Performance Tests in a Healthy Population

The main objective of this project is:

1. To assess the influence of physical fatigue on a return-to-play test battery in a healthy population. In a later stage, these experiments could be carried out in a clinical context (e.g. in an ankle sprain population).

The researchers will use a randomized, placebo controlled, counter-balanced, cross-over design. Twenty healthy subjects will visit the lab 3 times. On the first visit (familiarisation trial), the investigators will collect the participants' characteristics. The participants will also be familiarized to the procedures and materials of the experiment during this first visit. The second and third visit contain the experimental setup and will proceed as follows: first, the participants will fill in a pre-test checklist, a mental fatigue scale (M-VAS) and motivation scale. In the mean time a little blood will be collected from the ear lobe to determine lactate and glucose levels; also, blood pressure will be checked. Next, the subjects will carry out a functional test battery (hop test, vertical jump test, Y-balance test, and a balance reaction-time test). Session rate of perceived exertion (SRPE) is measured to indicate how fatigued the participants feel due to the test battery; also, M-VAS is collected once more, as well blood lactate, glucose and blood pressure. These measures are followed by either a physical fatigue inducing task (Modified 30 seconds Wingate protocol) or time-matched control task (sitting on the bike without pedalling). Afterwards, researchers will collect blood lactate, glucose and blood pressure two times more; participants have to fill in M-VAS (2x), perform the same test battery, and fill in the SRPE scale one more time.

Heart frequency will be measured continuously during the trials.


Eligibility Criteria:
Inclusion Criteria:

* Healthy (No neurological/cardiorespiratory/psychological/musculoskeletal disorders)
* Male and female
* No medication
* Non-smoker
* Between 18 and 35 years old

Exclusion Criteria:

* Back and/or lower extremity injuries during the past 6 months
* Bone/joint abnormalities
* Dizziness, history of loss of consciousness, any inner ear disorders
* Nervous system disorders or dysfunctions
* Uncorrected eye disorders/dysfunctions
* Illness
* Use of medication or any kind of drugs
* Use of alcohol, caffeine and heavy efforts 24 hours before each trial
* Not eating the same meal the night before and the morning of each experimental trial
Fatigue in Multiple Sclerosis: Evaluated With 3 MRI and Transcranial Magnetic Stimulation

The purpose of this study is to investigate fatigue in patients with multiple sclerosis (MS) and to determine the correlation between the symptom and cerebral changes.

Only recruiting from:

Department of Neurology, Aarhus University Hospital, Denmark

Eligibility Criteria:
Inclusion Criteria:

* Relapsing remitting-multiple sclerosis (RR-MS) according to Poser criteria
* EDSS: max 3.5
* Right handed
* Normal function of the right hand

Exclusion Criteria:

* Disease interfering with MS
* Known dementia
* Drug or alcohol abuse
* Treatment with psychoactive drugs within one week before study entry
* Major changes of medical treatment within 3 weeks before study entry
* Attack within 4 weeks before study entry
* Pregnancy
* Conditions interfering with 3,4-diaminopyridine treatment
* Conditions interfering with MRI
* Conditions interfering with transcranial magnetic stimulation
Pilot Study of the QI Device for Monitoring of Patients With Congestive Heart Failure

The present study proposes to utilize a novel, wearable device, QI Device, which has multiple sensors embedded in a "wrist-watch" in order to explore its monitoring capabilities in individuals with congestive heart failure.

The QI Device is a self-contained, reusable, rechargeable, battery-powered, wrist-watch that simultaneously tracks and records a number of physiological health related parameters such as heart rate, blood pressure, respiratory rate, temperature, and motion/position. One advantage of this device over current home diagnostic systems is the capability for longitudinal monitoring.

Eligibility Criteria:
Inclusion Criteria:

* Adults over age 18
* Own, and comfortable using, a home computer with internet access (Phase 2 only)
* Acute hospitalization with a primary diagnosis of acute decompensated heart failure (ADHF) diagnosed on the basis of all of the following:

  1. Symptoms:

     * Onset or worsening of dyspnea within the past 2 weeks
  2. Physical exam (at least 1 present):

     * Rales/ Crackles on auscultation
     * Elevated JVP \> 10 cmH2O
     * Weight gain
     * LE edema
  3. Diagnostic imaging/ labs (at least 1 present):

     * Evidence of pulmonary congestion or edema on chest X-ray/ chest CT
     * Elevated BNP or NT-pro-BNP (age-adjusted)

Exclusion Criteria:

* Psychological or social situation that would make the study difficult for the patient
* Inability to consent
* Chronic atrial fibrillation or other dysrhythmia with a high (\>10%) burden of ectopic beats.
* Pregnant women
* Pneumonia - currently, or within the past 30 days
* Non-cardiogenic pulmonary edema (e.g. ARDS)
* Interstitial lung disease
* End-stage renal disease and on Hemodialysis
Incidence and Risk of Influenza in Myasthenic Patients

Upper respiratory infection , including influenza, may exacerbate the symptoms of myasthenia gravis (MG), which is an autoimmune disease that causes muscle weakness and, in some cases, can precipitate a myasthenic crisis

In the present study, we investigated the incidence and risk factors of influenza infection on in myasthenia gravis patients.

This is a descriptive study. The data will be analyzed retrospectively . Inclusion of 416 cases of influenza in myasthenic patients treated in the intensive care unit of Garches Hospital between January 1, 2009 and December 31, 2017.

Patients who meet the inclusion and non inclusion criteria and do not object to participate in the study will be collected in a database for analysis.

Eligibility Criteria:
Inclusion Criteria:

* Men or women over the age of 18.
* Myasthenic patients hospitalized in intensive care.
* Patients with confirmed influenza infection

Exclusion Criteria:

* Age \<18 years,
* Other neuromuscular diseases,
* Patient opposing the use of his data
Ultrasound-guided PRP Versus Steroid Injections in Management of Carpal Tunnel Syndrome

Patients will be randomly divided into 3 equal groups: Group I received ultrasound guided injection of 2 mL PRP into the affected carpal tunnel. Group II received ultrasound guided injection of 2 mL steroids (40 mg triamcinolone acetonide). Group III received ultrasound guided injection of 2 mL saline as placebo control.

Patients will be randomly divided into 3 equal groups: Group I received ultrasound guided injection of 2 mL PRP into the affected carpal tunnel. Group II received ultrasound guided injection of 2 mL steroids (40 mg triamcinolone acetonide). Group III received ultrasound guided injection of 2 mL saline as placebo control.

Each group will be injected twice with 2 weeks intervals. All procedures were done after informed consent. Evaluation of the patients at baseline, 3 and 6 months after last injection was done clinically by measuring visual analogue scale (VAS), electrophysiologically (by measuring motor and sensory nerve conduction studies of median nerve using a standardized technique) and ultrasonographic study by measuring cross sectional area (CSA) of median nerve at the level of pisiform.

Eligibility Criteria:
Inclusion Criteria:

* mild or moderate idiopathic CTS (diagnosed clinically, ultrasonography \& electrophysiologically and classified according to the American Association of neuromuscular diagnostic medicine monograph).

Exclusion Criteria:

* Patients with severe or secondary type of CTS
Muscle Atrophy in Sepsis

Severe sepsis will provoke signals leading to muscle atrophy and weakness. Electrical stimulation will reduce the impact of sepsis.

Hypothesis 1: Severe sepsis will be associated with downregulation of anabolic signaling molecules and genes, upregulation of catabolic signaling molecules and genes, and the development of histologic and electrophysiologic abnormalities within skeletal muscle.

Hypothesis 2: Electrical stimulation will improve muscle strength in patients with sepsis.

Hypothesis 3: Electrical stimulation will be associated with upregulation of anabolic signaling molecules and genes, downregulation of catabolic signaling molecules and genes, and improvement of histologic and electrophysiologic parameters within skeletal muscle of patients with sepsis.

Hypothesis 4: The ratio of catabolic:anabolic gene expression on Day 3 will be positively correlated with the severity of clinical weakness on Day 7

Eligibility Criteria:
Inclusion Criteria:

* Severe sepsis for \< 72hr
Effect of Delayed vs Immediate Umbilical Cord Clamping on Maternal Blood Loss in Term Spontaneous Vaginal Delivery

Policies for timing of cord clamping vary, with early cord clamping generally carried out in the first 60 seconds aLer birth, whereas latercord clamping usually involves clamping the umbilical cord greater than one minute after the birth or when cord pulsation has ceased


Eligibility Criteria:
Inclusion Criteria:

* singleton pregnancy
* at term
* cephalic presentation
* spontaneous labor
* spontaneous vaginal delivery

Exclusion Criteria:

* multiple gestation
* preterm gestation
* induced labor
* operative delivery
* hypertension or preeclampsia
* fetal anomaly
* abnormal placentation
* planned cord blood banking
* maternal bleeding disorder
Study of Estrogen Levels in Premenopausal Women Who Have Undergone Surgery for Breast Cancer and Are Receiving Triptorelin and Tamoxifen Citrate or Exemestane on Clinical Trial IBCSG 24-02

RATIONALE: Studying samples of blood from patients with breast cancer in the laboratory may help doctors learn how well triptorelin given together with tamoxifen citrate or exemestane works in lowering estrogen levels.

PURPOSE: This clinical trial is studying estrogen levels in premenopausal women who have undergone surgery for breast cancer and are receiving triptorelin and tamoxifen citrate or exemestane on clinical trial IBCSG-2402.

OBJECTIVES:

Primary

* Describe estrogen levels (estradiol \[E2\], estrone \[E1\], and estrone sulphate \[E1S\]) at different time points during the first 4 years of treatment with triptorelin in combination with either tamoxifen citrate or exemestane on clinical trial IBCSG-2402 in premenopausal women with resected breast cancer.
* Assess whether there is a suboptimally estrogen-suppressed subgroup of patients who receive exemestane.

Secondary

* Compare estrogen levels (E2, E1, E1S) at different time points during treatment with triptorelin in combination with either tamoxifen citrate or exemestane.
* Examine potential predictive factors of ineffective estrogen suppression (e.g., age, chemotherapy \[yes/no\], type of chemotherapy received, smoking history, BMI, and evidence of menses at study entry).
* Investigate the predictive value of optimal estrogen suppression during the first 6 and 12 months of treatment with regard to long-term estrogen suppression (4-year period).
* Compare disease-free survival of suboptimally estrogen-suppressed patients treated with exemestane with that of patients with optimal suppression (exploratory analysis).
* Examine related endocrine function (FSH and LH) to further elucidate causes of suboptimal estrogen suppression.

OUTLINE: This is a multicenter study.

Blood samples are collected at baseline and at 3, 6, 12, 18, 24, 36, and 48 months for measurement of estrogen levels (estradiol \[E2\], estrone \[E1\], and estrone sulphate \[E1S\]) by gas chromatography-mass spectrometry and measurement of endocrine function (FSH and LH).

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed resected breast cancer
* Concurrent enrollment on clinical trial IBCSG-2402 (SOFT trial) required

  * Randomized to receive triptorelin in combination with either tamoxifen citrate or exemestane
* Hormone receptor status:

  * Estrogen receptor- and/or progesterone receptor-positive tumor

PATIENT CHARACTERISTICS:

* Premenopausal

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Analysis of Circulating Tumor DNA Dynamics to Predict and Monitor Response to TKI in Patients With Advanced NSCLC.

This is an observational study, aiming to investigate whether the ctDNA dynamics analyzed by the K-TrackTM assay could predict early response to Tyrosine kinase inhibitors (TKIs) in patients with advanced non-small cell lung cancer (NSCLC).

1. Determine relationship between ctDNA dynamics and clinical response to TKI,

   * No response/progressive disease = ctDNA levels increase from baseline
   * Partial response/stable disease = ctDNA levels decrease from baseline
   * Complete response = ctDNA clearance.
2. Compare and combine ctDNA dynamics and RECIST1.1 to predict clinical response.
3. Determine relationship between ctDNA dynamics and progression free survival, overall survival.

This study is recruiting female and male patients, aged 18 and older:

* Who are diagnosed with advanced non-small cell lung cancer and indicated for TKI (first or second line). TKI combined with chemotherapy is allowed,
* Who have not started TKI / chemotherapy before enrollment,
* Who have no medical or psychiatric conditions or occupational responsibilities that may preclude compliance with the protocol,
* FFPE/FNA sample is available,
* Compliant with treatment protocol,
* Patients consented to participate in the study. As part of the protocol, demographic data, medical and family history, and any relevant prior concomitant medication data will be recorded during follow-up visits. All patients are to be followed for 2 years from enrollment, with CT scan imaging measured every clinical visit for 24 months.

Sample collection:

* 10 mL of peripheral blood (in Streck tubes) is collected for ctDNA analysis at 8 time points: pre-treatment (\<10 days before TKI), during TKI every 3 months until 21 months.
* 6-8 sections of formalin-fixed paraffin-embedded (FFPE) tumor samples before TKI/chemotherapy treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients are diagnosed with advanced non-small cell lung cancer and indicated for TKI (first or second line). TKI combined with chemotherapy is allowed.
* FFPE/FNA sample is available.
* Compliant with treatment protocol.
* Patients consented to participate in the study.

Exclusion Criteria:

* Patients already started TKI before enrollment.
* Patients already started chemotherapy before enrollment.
* Medical or psychiatric conditions or occupational responsibilities that may preclude compliance with the protocol.
* Patients did not agree to participate in the studies.
Effectiveness of mHealth Post-discharge Intervention for Patients With Severe Mental Illness

The overall aim of this program of research is to improve the continuity of care for patients with serious mental illness (SMI) by supporting a safer and more efficient bridge from hospital to outpatient care using a mobile device-delivered app called Transition-FOCUS (tFOCUS), which has previously been tested in community samples. The purpose of the proposed project is to establish the effectiveness of our empirically-supported, multi-component mHealth intervention.


Eligibility Criteria:
Inclusion Criteria:

* psychiatric inpatient/partial hospitalization
* diagnosis of schizophrenia-spectrum disorder or major mood disorder
* planned ongoing mental health treatment post-discharge in the community
* 18 years or older
* ability to speak and read English

Exclusion Criteria:

* lack of smartphone
* homelessness or housing instability that would prevent reliable follow-up
* discharge to a long-term restricted living setting
External Beam Radiotherapy for Muscle Invasive Bladder Cancer

In this phase 1 trial, the investigators will prospectively evaluate 3 different external beam radiotherapy (EBRT) schedules. In every schedule, the whole bladder will be treated to 40 Gray (Gy) in 20 fractions, 5 fractions/week, 4 weeks in total. Based on the summation of abnormalities seen on pre- (initial tumor region) and post transurethral resection zone of fibrosis Diffusion weighted-magnetic resonance imaging (MRI) images the tumor region is delineated and defined as a gross tumor volume (GTV). The GTV will be treated using a simultaneous integrated boost (SIB): without extending the 4-weeks treatment period, 3 different dose levels will be implemented in order to increase the biological equivalent dose (BED), as muscle invasive bladder cancer has been shown to be dose-sensitive.

3 different dose levels will be implemented in order to increase the biological equivalent dose (BED), as muscle invasive bladder cancer has been shown to be dose-sensitive.

* Level 1: 57.6 Gray (Gy) (20 x 2.88 Gy, 5 fractions/week, 4 weeks); BED: 61 Gy.
* Level 2: 60 Gy (20 x 3.00 Gy, 5 fractions/week, 4 weeks); BED: 64 Gy
* Level 3: 62.4 Gy (20 x 3.12Gy, 5 fractions/week, 4 weeks); BED: 67 Gy. Fiducials will be implanted at the edges of the postoperative bed during the second transurethral resection of the bladder to improve visualization of the gross tumor volume (GTV) during external beam radiotherapy (EBRT) and consequently improve treatment delivery accuracy. In order to further improve the treatment accuracy, 5 planning Computed Tomographies and plans, with different bladder fillings will be made upfront in our study. During treatment the plan corresponding best with bladder filling at time of EBRT will be selected and delivered.

Eligibility Criteria:
Inclusion Criteria:

* histological proven diagnosis of muscle invasive bladder cancer
* stage \<T3b tumours with pathological lymph nodes after extended pelvic lymph node dissection
* World Health Organisation performance state 0-2
* signed informed consent

Exclusion Criteria:

* contra-indication for Diffusion-Weighted-Magnetic resonance imaging
Evaluation of SSD8432 and Ritonavir in Adult Subjects With COVID-19 Clinical Study

This is a Randomized, double-blind, Placebo-Controlled, Phase II Clinical Study to evaluate SSD8432 in combination with Ritonavir in asymptomatic infections or mild/common safety study of efficacy and safety in adult subjects with COVID-19.

This is a Randomized, double-blind, Placebo-Controlled, Phase II Clinical Study to evaluate SSD8432 in combination with Ritonavir in asymptomatic infections or mild/common safety study of efficacy and safety in adult subjects with COVID-19.

This study planned to enroll 72 subjects, randomly divided into low-dose group, high-dose group and placebo group according to 1:1:1.

Eligibility Criteria:
Inclusion Criteria:

1. ≥18 and ≤80 years old, male or female.
2. Asymptomatic infection,mild or common type of COVID-19.
3. Initial positive test of SARS-CoV-2 within 5 days of randomization.
4. Initial onset of COVID-19 signs/symptoms within 3 days of randomization.

Exclusion Criteria:

1. Transnasal high-flow oxygen therapy or non-invasive ventilation, invasive mechanical ventilation, or ECMO is required or anticipated to be urgently required.
2. Prior to current disease episode, any confirmed SARS-CoV-2 infection.
3. Known medical history of active liver disease (other than nonalcoholic hepatic steatosis).
4. Receiving dialysis or have known moderate to severe renal impairment.
5. Known human immunodeficiency virus (HIV) infection.
6. Suspected or confirmed concurrent active systemic infection other than COVID-19 that may interfere with the evaluation of response to the study intervention.
7. Oxygen saturation of ≤ 93% on room air obtained at rest within 24 hours prior to randomization..
8. Treatment with antivirals against SARS-CoV-2 within 14 days.
9. Current or expected use of any medications or substances that are highly dependent on CYP3A4 for clearance.
10. Concomitant use of any medications or substances that are strong inducers of CYP3A4 are prohibited within 28 days.
11. Has received or is expected to receive COVID-19 monoclonal antibody, convalescent COVID-19 plasma or other prohibited concomitant medication.
12. Females who are pregnant or breastfeeding.