cyrilzakka/clinical-trials huggingface dataset:
Electrical Impedance Myography as an Outcome Measure in Amyotrophic Lateral Sclerosis Clinical Trials

Trials evaluating new therapies for stopping or slowing the progression of ALS depend critically upon the use of outcome measures to assess whether a potential treatment is effective. The more effective an outcome measure, the fewer patients need to be enrolled and the shorter the trial. Many outcome measures have been used over the years, including strength assessments, breathing tests, functional status surveys, and nerve testing, but all are far from ideal. A new method, called electrical impedance myography (EIM) appears to be especially promising in that it provides very consistent data from one testing session to the next, is sensitive to the muscle deterioration that occurs in ALS, and is entirely painless and non-invasive. In this study, investigators from multiple institutions plan to compare several different outcome measures, including EIM, in approximately 120 ALS patients, with each patient being followed for a period of one year. All of these measures will be compared to one another and an assessment of their ability to detect disease progression made. Our goal will be to determine whether EIM can serve as a valuable new outcome measure, ultimately leading to substantially faster, more effective ALS trials requiring fewer patients.


Eligibility Criteria:
Inclusion Criteria:

* Definite or probably ALS by El Escorial criteria
* Muscle strength of at 3.5 in one limb

Exclusion Criteria:

* Forced vital capacity of less than 70%
* Atypical forms of motor neuron disease (monomelic amyotrophy, primary lateral sclerosis)
* Pacemaker
Comparable Study of Different Thoracic Radiotherapy Regimens for Extensive Stage Small Cell Lung Cancer

Most patients with extensive stage small-cell lung cancer (ES-SCLC) who undergo chemotherapy, and prophylactic cranial irradiation, have persistent intrathoracic disease. A Dutch study recently proved that thoracic radiotherapy(TRT), using 30 Gy in 10 fractions of 3 Gy, could improve 2-year overall survival(OS) of this patient group compared with non-TRT group. But intrathoracic progression was still high, either with or without progression elsewhere, occurring in 43.7% in the TRT group. The ideal TRT regimen for ES-SCLC is undefined. Maybe higher dose can provide better local control(LC) and overall survival. In this study, the investigators propose to give an increased dose of TRT to determine whether higher dose will improve 2-year OS, LC and progression-free survival.

This is a multicenter, prospective, randomised phase III study. For patients with ES-SCLC who respond to chemotherapy after four to six cycles of standard chemotherapy (platinum etoposide), 45Gy/15F of thoracic radiotherapy will be used in experimental arm, while 30Gy/10F of thoracic radiotherapy will be used in the control arm. Both survival and toxicity of the two arms will be observed and compared.

Eligibility Criteria:
Inclusion Criteria:

* 18 - 70 years old, ECOG 0-2.
* Patients with histologically or cytologically proved small cell lung cancer.
* Extensive stage small-cell lung cancer (ES-SCLC), was characterized by tumors beyond the hemithorax, hilar, mediastinal, and supraclavicular nodes. According to 2007 AJCC cancer staging 7th edition, stage I-IIIB with lung metastases and stage IV should be defined as LD.
* Has 1-4 extracranial metastatic lesions.
* No brain or central nervous system (CNS) metastases.
* No prior history of anti-tumor treatment.
* Response after 4 to 6 cycles of EP-based chemotherapy within the past 4 weeks.
* No severe internal diseases and no organ dysfunction.
* Written informed consent provided.

Exclusion Criteria:

* Malignant tumors of other sites. Non melanoma skin cancer and Cervical carcinoma in situ were not included if curable.
* Active heart disease or acute myocardial infarction happen in six months.
* Psychiatric history.
* Pregnant woman or woman need to breast feed or woman with positive chorionic gonadotrophin (HCG).
* Uncontrolled diabetes or hypertension.
* Interstitial pneumonia or Active pulmonary fibrosis.
* Acute bacterial or fungal infection.
* Oral or intravenous use of steroids.
Integrative Couple Treatment for Pathological Gambling

The aim of the study is to compare marital treatment to individual treatment for pathological gambling.

The study as two goals: evaluate the efficacy of couple treatment for pathological gambling and develop a better understanding of the individual (substance use, mental health) and couple dimensions (communication, marital satisfaction, violence) as intermediate variables explaining this efficacy. Couples will be randomized between the couple treatment and the treatment as usual (individual or group). The experimental couple treatment is offered over 8 to 12 sessions of 90 minutes. The couple treatment called (Integrative Couple Therapy for Pathological Gambling - ICT-PG) is inspired by the "Alcohol Behavior Couple Therapy" from Epstein and McCrady, to which the team added diverse components to adjust to gamblers. During the sessions, the focus is on a) reducing/stopping gambling behaviors, b) helping the partner to stop behaviors facilitating gambling habits and rise the frequency of behaviors incompatible with gambling habits and c) improve marital components (communication, sharing positive moments, negotiation, mutual support).

The control group receives individual or group treatment as already offered by the specialized centers in addiction. Their partner can receive individual intervention if desired. All participants are recruited in Specialized Addiction Treatment Centers in Quebec province, Canada. Evaluation of participants is done at admission, three, nine and 18 months post-admission.

Repeated measures ANOVA will be used to compared evolutions of groups over time. Multiple regression will allow the estimation of components roles into as intermediate variables to predict rehabilitation.

Eligibility Criteria:
Inclusion Criteria:

* Living together for at least 1 year
* Diagnosis of pathological gambling (WMH-CIDI) during the last 12 months
* The gambler has not received treatment for their gambling for at least 6 months (excluding GA)
* Presence of gambling behavior in the past 3 months
* Degree of commitment to the couple indicating a desire to continue the relationship (score of 7 - MSI)

Exclusion Criteria:

* Alcohol/Drug Dependence gambler/partner (Severity of Alcohol Dependence Data questionnaire - SADD \>17 included in DEBA-A; Severity of Dependence Scale - SDS \> 5 Included in DEBA-D)
* Gambling problem for the partner (DEBA-Jeu \> 10)
* Presence of serious acts of violence endangering the safety of both spouses (CTS-2)
* Disorder and serious mental health unstabilized one of two members of the couple (ASI: psychological scale)
* Antisocial personality disorder or severe limit ( GAIN: 9 + Scale BCS / CDS)
* Scenario with strong suicidal ideation or attempt in the last 30 days or less in the partner (ASI: psychological scale)
* Low degree of commitment in the relationship of a risk of separation (8 + MSI)
Left Atrial Volume as Predictor for Arrhythmic Events and CRT Response

Left atrial volume role for CRT response and for arrhythmic events (VT/VF/AT/AF) onset


Eligibility Criteria:
Inclusion Criteria:

* Patient with left ventricular ejection fraction ≤ 35%, II, III or IV NYHA Class, even if optimal medical therapy.
* Patients with standard indication to CRT according current guideline, sinus rhythm at implantation, LBBB and QRS duration \>= 120 ms
* Patients who will undergo to a new CRT-defibrillator system implantation
* Patients who are able to understand and sign the informed consent
* Patients who are able to attend all required follow-up visits at the study centerfor 24 months

Exclusion Criteria:

* Age \< 18 years
* Women who are pregnant or who are planning to become pregnant
* Patients with permanent Atrial Fibrillation or persistent Atrial Fibrillation in the 90 days preceding the implantation
* Patients with organic mitral valve disease
* Patients with prosthetic heart valves
* Patients who will undergo to upgrading from other devices (PM or ICD) to CRT, heart transplantation, patients with CRT devices
Home To Stay: a Randomized Trial Evaluating a Post-discharge Mobile App for Elective Colorectal Surgery

A single center randomized controlled trial to evaluate the effect of a post-discharge mobile health application on 30-day re-admission and patient reported outcomes following elective colorectal surgery

Background: Following elective colorectal surgery, rates of re-admission are high and result in significant healthcare resource use. However, up to 20% of these re-admissions may be preventable. This represents an opportunity to improve patient outcomes, reduce health care utilization and costs through targeted interventions.

Home To Stay is an integrated discharge monitoring program using a mobile app platform that was developed to support the needs of patients following discharge after colorectal surgery. In the initial pilot testing, the 30-day re-admission rate for patients using Home to Stay was reduced from 18% to 6% and patient anxiety was reduced in over 75% of the participants.

Methods: This study is a two arm, single center, randomized control trial that will be conducted in the colorectal unit of an academic tertiary care center. Patients will be randomized1:1 using a single randomized consent design to either usual follow up in the control group or post discharge monitoring with Home to Stay in the intervention group.

Objective: The objective of this study is to evaluate the Home to Stay app and its effect on healthcare utilization and patient reported outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective, inpatient colorectal surgery
* Able to speak and read in English
* Able to provide informed consent
* Have access to a smartphone/tablet or desktop computer with internet access

Exclusion Criteria:

* Patients undergoing semi-elective/emergent procedure
* Patients undergoing elective day surgery
* Expected post operative admission of less than 3 days
* Discharge to another institution (rehabilitation facility/nursing home/long term care).
A Study on Postmarketing Xuezhikang Capsule for Treating Dyslipidemia

Dyslipidemia contributes greatly to the formation and progression of atherosclerosis (AS), which plays a dominant role in leading to CHD.

Xuezhikang is a partially purified extract of fermented red yeast rice (Monascus purpureus). It is composed of 13 kinds of natural statins, unsaturated fatty acids, ergosterol,amino acids, flavonoids, alkaloid, trace element, and so forth. Xuezhikang has been recommended in a guideline for China adult dyslipidemia prevention.

This study aims to evaluate the benefit and side effect of Xuezhikang, a potential alternative drug of statins, for patients with dyslipidemia, and thus provide further evidence for clinical application.


Eligibility Criteria:
Inclusion Criteria:

1. Age: 18 years to 75 years
2. Patients with Dyslipidemia should be diagnosed according to standard western medicine diagnosis criteria
3. TCM syndrome of patients with dyslipidemia should be diagnosed according to standard TCM syndrome diagnosis criteria
4. Patients who have taken lipid lowering drugs should stop taking for at least two weeks before taking part in this study
5. Patients agree to participate in this study and signed the informed consent form

Exclusion Criteria:

1. Pregnant (positive pregnancy test within 7 days of starting treatment), or lactating women.
2. Patients with Homozygous Familial Hypercholesterolemia
3. Patients with known allergy to Chinese medicine or any other drug
4. Patients with acute myocardial infarction, cerebrovascular accident , severe trauma , major surgery and cancer in half a year.
5. AST or ALT level increases at least twice the upper limits of normal in patients
6. Patients who are taking part in other clinical trials that will influence the results of this study
Within Subject Variability Study of ER Torsemide 20 mg Tablet in Healthy Subjects

The study will evaluate the within-subject variability of 20mg ER torsemide as compared to 20mg IR torsemide (Demadex) in fully replicate double-crossover trial in healthy volunteers, who are consuming a high-salt diet (300 mmol/day). The study will also evaluate the effects of ER torsemide and IR torsemide on 24h sodium excretion and total urinary excretion.

Immediate Release (IR) Torsemide is a highly effective natriuretic drug but its short duration of action is a major drawback, which allows significant post-dose sodium retention, and as consequence, limits salt loss in patients with heart failure, unless dietary salt intake is severely restricted. Extended Release (ER) torsemide is being developed to address the drawback by prolonging the duration of action to increase sodium excretion even in patients who consume high salt diet (300 mmol/day).

In addition, IR torsemide induces large and abrupt urination that, in some patients, causes incontinence, and as a result, compliance becomes challenging. ER torsemide is formulated to cause robust but gradual urination over an extended period to reduce accidental wetting and improve compliance.

In this study, ER torsemide is tested for within-subject variability in fully replicate design double-crossover trial in healthy volunteers who are on a 300 mmol/day sodium diet (high salt diet). The primary endpoint of the study is full pharmacokinetics measurements after a single dose of either ER torsemide or IR torsemide (Demadex). The secondary endpoints are 24h sodium excretion and total urinary excretion.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female, non-smoker, weight 50 kg for male and 45 kg for female, clinically acceptable laboratory profiles with ECG and chest X-ray performed within 6 months

Exclusion Criteria:

* participation in bioavailability/bioequivalence studies,
* history of drug abuse or alcohol dependence,
* history of allergies including drug allergies,
* known hypersensitivity to Torsemide or related drugs,
* presence of clinically significant disorder,
* systolic blood pressure \<90 mm Hg or \> 140 mm Hg diastolic blood pressure,
* history of incontinence,
* positive urine drug screening etc.
Erector Spina Plane Block vs Serratus Anterior Plane Block for Postoperative Mastectomy Pain

The aim of this study is to compare the efficiency of serratus anterior plane block and erector spina plane block on analgesic consumption, postoperative pain and patient's satisfaction and recovery quality in patients undergoing mastectomy.

Mastectomy may cause severe postoperative pain. There are several analgesic methods for postoperative pain management. Serratus anterior plane (SAP) block is an interfascial plane block which is performed into the fascial plane of serratus anterior muscle. It provides effective analgesia in anterior, posterior and lateral dermatomes of thorax. There are several studies about its analgesic efficacy for mastectomy pain. The erector spina plane (ESP) block is another novel plan block which provides analgesia at multi-dermatomal area of the anterior, posterior, and lateral thoracic and abdominal walls. There are some studies about its effectiveness for postoperative mastectomy pain management. However, according to our best knowledge, there is no literature comparing the efficacy of ESP block and SAP block patients undergoing mastectomy.

Eligibility Criteria:
Inclusion Criteria:

* American society of score anesthesiologist I-II-III
* Elective modified radical mastectomy
* 18-65 years old

Exclusion Criteria:

* neurological disease
* coagulopathy disease or using anticoagulants
* non-cooperative
* allergic to one of the drugs used in the study
* recurrent breast cancer
* body mass index is above 35
Evaluation of the Tolerance and Safety of a New Partly Fermented Anti-regurgitation Infant Formula

A randomised, controlled, double-blind trial to evaluate the tolerance and safety of a new partly fermented anti-regurgitation infant formula containing prebiotics and locust bean gum in infants with regurgitation.


Eligibility Criteria:
Inclusion Criteria:

1. Singleton healthy term infant aged 3 - 13 weeks;
2. Gestational age at birth 37- 42 weeks;
3. Normal birth weight for gestational age and gender i.e. 10th to 90th percentile compared to the WHO or local growth charts;
4. Infants with regurgitation that are otherwise healthy, based upon the following criteria: 1) Regurgitation of 2 or more times per day for 1 or more weeks according to reported history, 2) an indication for the use of AR formula according to the investigator at screening/randomisation.
5. Fully formula fed for at least 7 days before screening/randomisation;
6. Written informed consent from the parent(s) and/or legally acceptable representative(s), aged ≥ 18 years.

   -

Exclusion Criteria:

* 1. History of retching, hematemesis, aspiration, apnoea, failure to thrive, feeding or swallowing difficulties or abnormal posturing; 2. Gastrointestinal infection within 4 weeks prior to randomisation; 3. Congenital condition and/or previous or current illness and (or) medication use that could interfere with the main study outcomes according to the investigator; 4. Known cow's milk protein allergy, lactose intolerance, or galactosaemia including history of any other allergic manifestations or known allergy to any of the study product ingredients (especially scGOS); 5. Presence of any other gastrointestinal symptom(s)/disorder(s) that are not functional in nature, as assessed by the investigator's clinical judgement; 6. Received any of the following products/medication prior to randomisation: systemic antibiotics, prokinetics, proton pump inhibitors, complementary feeding/weaning within 4 weeks prior to randomisation; 7. Incapability of the parent(s) to comply with the study protocol or investigator's uncertainty about the willingness or ability of the parent(s) to comply with the protocol requirements; 8. Current participation in another clinical intervention study.
Study Evaluating TwoTablet Formulations of Neratinib (HKI-272)

This study will examine the bioavailability (the rate and extent to which the active ingredient or active moiety is absorbed from a drug product and becomes available at the site of action) of two tablet formulations of Neratinib (HKI-272) compared to the capsule formulation.


Eligibility Criteria:
Healthy male and female subjects, ages 18-50.
Efficacy of Artificial Intelligence-assisted Colonic Polyp Detection System

This is a randomized controlled multicenter clinical trial of computer-aided detection (CADe) system for the adjuvant diagnosis of intestinal polyps/adenomas ever conducted in a Chinese population. In addition, this study will evaluate the effect of CADe system on adenoma detection of endoscopists under fatigue.


Eligibility Criteria:
Inclusion Criteria:Patients who need to undergo colonoscopy. -

Exclusion Criteria:Patients with CRC, inflammatory bowel disease, previous colonic resection, and antithrombotic therapy precluding polyp resection were excluded.

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Motivational Interviewing to Address Freshman Weight Gain

The purpose of the study is to determine the effect of Motivational Interviewing and e-health education on body composition and psychological outcomes. After baseline testing, participants will be randomly assigned to a motivational interviewing or e-health education group for a 10-week intervention. Variables of interest include: body composition, physical activity, food consumption and self-determination theory constructs.


Eligibility Criteria:
Inclusion Criteria:

1. Classified as a college freshman and 18 years of age.
2. Low risk for medical complications from exercise (as determined by physical activity readiness questionnaire (PARQ+).
3. Neither currently engaging in exercise nor consistently exercising over the last three months (2 days per week or less).
4. Be considered overweight based on BMI (BMI at or above 25)
5. Not pregnant.

Exclusion Criteria:

* Those that do not meet inclusion criteria.
Different Injection Speed on Local Anaesthetic Spread of ESPB

The aim of this clinical trial is to investigate the effect of different injection speeds on the spread of local anesthetic during ultrasound-guided erector spinae plane block (ESPB) in patients undergoing CT-guided lung nodule localization. The primary question addressed is whether a high injection speed (30 ml delivered within 30 seconds) produces a different local anesthetic distribution compared with a lower injection speed (30 ml delivered within 180 seconds).

Senventy-four patients were selected to undergo CT guided puncture localization of lung nodules under local anesthesia, and the patients were divided into groups using a computer-generated random number in a ratio of 1:1. To ensure objectivity, a nurse who was not involved in the study prepared a sealed opaque envelope containing grouping information. Patients were randomly divided into two groups: control group (group C, 37 patients), and experimental group (group S, 37 patients). All patients underwent ultrasound guided ESPB before CT-guided nodule localization. Ultrasound guided ESPB method: Using a high-frequency linear probe (5-13 MHz, Sonosite, USA), the probe is placed parallel to the spine on the surface of the transverse process tip of the seventh thoracic vertebrae. Under ultrasound, the transverse process and spinal muscles are clearly exposed. Then, a long beveled needle is used, and inserted from the cephalad to caudal with in-plane technique. After the needle tip reaches between the transverse process and erector spinae muscles, 2ml saline is injected using water separation technique to confirm the position of the needle tip, then injecting 30ml local anesthetic solution (0.75% ropivacaine 15ml+iohexol 15ml). In the control group, the injection is administered at a rate of 30 ml within 180 seconds. In the experimental group, the injection is delivered at a faster rate of 30 ml withinr 30 seconds. After 30 minutes of block completion, CT scan and puncture localization were performed, following with 3D reconstruction. The primary outcome was mixture spread to the paravertebral space.The second outcomes were as follow: 1.spread to the intercostal space. 2. spread to the epidural space 3.spread to the neural foramina 4. cranio-caudal spread

Eligibility Criteria:
Inclusion Criteria:

Patients scheduled for CT-guided lung nodule localization under local anesthesia will be selected

1. aged 18-80 years
2. BMI 18-30 kg/m²
3. ASA classification I-III

Exclusion Criteria:

1. Allergy to the study drug or to local anesthetics
2. History of opioid abuse
3. Previous infection at the ESPB or PVB puncture site
4. Peripheral neuropathy
5. Dysfunction of blood coagulation
Active Surveillance for Low Risk Prostate Cancer

An active surveillance protocol for patients diagnosed low-risk prostate cancer will be held. We plan to use PSA (prostate-specific antigen) testing, DRE (digital rectal examination), TRUS (transrectal ultrasound), MRI (magnetic resonance imaging) and follow-up biopsies to monitor patients and detect cancer progression in time.


Eligibility Criteria:
Inclusion Criteria:

* prostate adenocarcinoma verified by at least 12 core biopsy
* patient must understand the sense of research, agree to participate and sign a form of agreement
* low oncological risk according to EAU (European Association of Urology) Guidelines: stage T1-T2a, PSA\<10 ng/ml, ISUP (International Society of Urological Pathologists score)=1 (Gleason score 3+3=6)
* not more than 33% cores with adenocarcinoma

Exclusion Criteria:

* previous treatment of prostate cancer
* other prostatic malignant neoplasms
* other oncological diseases
* treatment with 5-alfa-reductase inhibitors
* patient's refuse to continue study
* patient's desire to begin treatment