cyrilzakka/clinical-trials huggingface dataset:
ExtraCorporeal Membrane Oxygenation in the Therapy for REfractory Septic Shock With Cardiac Function Under Estimated

The ECMO-RESCUE study is a prospective, multicenter, non-randomized, cohort study. In this study, we aimed to assessed whether VA-ECMO treatment can improve the 30-day survival rate of patients with sepsis-induced refractory cardiogenic shock.

All patients who meet inclusion criteria and have no exclusion criteria are considered to be enrolled. During the period of study, the participants can decide whether to accept ECMO based on their personal conditions. If a patient is willing to accept ECMO treatment, we initiate VA-ECMO within 6 hours. Participants taking VA-ECMO during the period of study are referred to as cohort 1, and patients receiving only conventional therapy without ECMO belong to cohort 2. 30-day survival will be accessed to evaluate the survival benefit from ECMO therapy for sepsis-induced refractory cardiogenic shock.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 75 years.
* Patients admitted into ICU and diagnosed as septic shock (sepsis-3.0)13, after adequate fluid resuscitation, high-dose vasoactive drug application \[vasoactive inotropic score (VIS) \> 120\] and conventional therapy together with at least one of the following criteria: (1) sustained hypotension \[mean arterial pressure (MAP) \< 65 mmHg\]; (2) persistent lactacemia (two consecutive values \> 5 mmol/L with at least 30 min interval between samples), with non-decreasing trend on steady doses of inotropes and/or vasopressors; (3) persistent low mixed venous blood oxygen saturation (SvO2) (two consecutive values \< 55% with at least 30 min interval between samples), with non-increasing trend on steady doses of inotropes and/or vasopressors. The above condition lasts more than 5 hours.
* Rapidly deteriorating sepsis-induced myocardial impairment is defined by at least one of the following criteria: (1) rapidly deteriorating ventricular function (LVEF \< 35%); (2) cardiac index (CI) \< 2L/min/m2 (\> 3 hr); (3) emerging refractory arrhythmia.
* Informed consent provided by the patient or person with decisional responsibility.

Exclusion Criteria:

* Cardiac dysfunction caused by other causes is excluded, such as acute myocardial infarction, chronic heart failure, congenital cardiac disease, myocardial effusion, moderate to severe aortic regurgitation, severe aortic coarctation and so on.
* High suspicion of pulmonary embolism, tension pneumothorax or cardiac tamponade as a cause of shock.
* Prolonged cardiac arrest (\> 30 min) before ECMO, or CPR survivors remaining comatose.
* Irreversible condition or meet the inclusion criteria for more than 12 hr.
* Presence of active bleeding or anticoagulant contraindications.
* Peripheral artery disease disabling insertion of outflow cannula to femoral artery.
* Irreversible neurological pathology
* Severe underlying condition with lift expectancy less than 1 year.
* Special population, such as pregnancy, acquired immune deficiency syndrome (AIDS).
* Patient included in another interventional clinical trial.
Effect of Health Education on Water Handling Practices in Rural Pondicherry

The purpose of this study is to assess the drinking water handling practices at household level and to determine the effect of health education on the drinking water handling. Participants from study villages, mainly homemakers, school children and water tank operators who are willing to participate, will be targeted.

Baseline assessment of household practices related to water will be done. Followed by a health education regarding the healthy practices will be given to them. Practice of household water chlorination will be promoted. The healthy behavior will be reinforced through reminders and community activities of self help groups for one year.

The study participants will be benefited from survey in terms of

1. Improved knowledge and practices of drinking water handling
2. Risk reduction of water borne illness to family members


Eligibility Criteria:
Inclusion Criteria:

* Subjects of five study villages

Exclusion Criteria:

* Those who anticipate to move out of study area in next one year
Periosteal Electrical Dry Needling in Knee Osteoarthritis

To determine the effect of periosteal electrical dry needling as an adjuvant to MWM in knee osteoarthritis for pain management, for improvement in functional activities and for ROM (Range Of Motion)

Periosteal stimulation therapy (PST) or periosteal electroacupuncture applies direct electrical stimulation of the periosteum and its associated nerves using parsimoniously applied acupuncture needles over bony prominences. It is an aggressive local treatment for deep pain problems such as OA (osteoarthritis ) .

Mobilization with movement (MWM) is a manual therapy technique that is used most frequently for the management of musculoskeletal conditions. In this technique, the physiological movement is performed in a pain-free manner with accessory glides being applied in the direction towards the opposite of the previously painful movement to have the greatest improvement MWMs has shown promising various therapeutic benefits such as reduction of pain and improved range of motion. Previous evidence has shown the effectiveness of MWM on pain reduction and functional improvement in patients with knee OA.

The rationale for the use of PST in comparison with MWM techniques is to determine the effectiveness of periosteal electrical dry needling for the common use intervention for knee osteoarthritis.

Eligibility Criteria:
Inclusion Criteria:

1. Age group \>40,
2. Patient who met American college of Rheumatology criteria of Osteoarthritis,
3. Chronic knee pain \> 3 months,
4. Morning stiffness \<30 mins,
5. Crepitation
6. Bony tenderness

Exclusion Criteria:

1. Diagnosed Meniscal injury or Ligamentous injury,
2. History of Intraarticular injection in last 3 months,
3. generalized low back related leg pain,
4. Patients with fear of needles,
5. Patients administered with corticosteroids or receiving any other invasive treatment such as PRP, Stem cell therapy, Ozone therapy
6. History of any surgery of lower extremity in last 6 months
7. Malignancy
Eliminating Learning Curve Related Morbidity in Fast Track Laparoscopic Roux-en-Y Gastric Bypass

Background: Laparoscopic Roux en Y gastric bypass (LRYGB) is associated with a significant learning curve. We report the results of a systematic training programme from a high volume bariatric center measuring the outcome by comparing the results with data from a consecutive series of 1000 fast track LRYGB.

Method: Using a stepwise training programme the RY gastric bypass operation was divided into an upper and lower procedure and subdivided into 11 well defined steps. A laparoscopic surgeon without experience in upper GI surgery was mentored by an experienced bariatric surgeon. During 6 months full time fellowship 300 operations were performed.

Results: The trainee surgeon performed 61 upper procedures, and 121 lower procedures in which the mentor surgeon did the other part of the operation. In 110 patients the trainee performed both procedures. Two percent had peri-operative complications compared to 1% of 1000 patients. All were repaired and had an uneventful recovery. Two percent had postoperative complications \< 30 days compared to 2.8% in the clinic. In the trainees series there were no leaks compared to 1% in 1000 patients. Operative time was 56/55/70 min for operation 0-100/100-200/200-300 compared with an average of 47 minutes registered in the clinic. Concerning time to discharge there was no difference between patients operated by the trainee and the standard of the clinic.

Conclusion: Using a systematic training program in laparoscopic RY gastric bypass surgery eliminates morbidity of the learning curve without affecting the volume.


Eligibility Criteria:
Inclusion Criteria:

patients undergoing laparoscopic gastric bypass

Exclusion Criteria:

* super obesity
* male patients
A Study to Evaluate Sigma-1 and Dopamine-2 Receptor Occupancy by Pridopidine in the Human Brain of Healthy Volunteers and in Patients With Huntington's Disease

The purpose of this study is to demonstrate engagement of pridopidine with S1R and D2R (optional) in the living human brain. No formal statistical analysis will be conducted


Eligibility Criteria:
Inclusion Criteria:

* In general, good physical health as determined by medical history and psychiatric history, suicidality assessment \& physical examination
* Men who are potentially fertile (not surgically \[eg, vasectomy\] or congenitally sterile
* Patients with Huntington's disease (HD): diagnosis of HD and with an onset of HD after 18 years of age

  * Additional criteria apply, please contact the investigator for more information

Exclusion Criteria:

* The subject has been previously exposed to ionizing radiation or radioactive substances as a result of clinical research or medical treatment in the past 10 years.
* The subject has a counterindication to having an MRI
* History of alcohol, narcotic, or any other substance dependence in the past 2 years
* Additional Exclusion criteria to patients with Huntington's disease:
* The patient has a severe motor impairment that might cause artifacts.
* Patients with a known history of Long QT Syndrome or a first degree relative with this condition.
* Treatment with any investigational product within 6 weeks of screening or patients planning to participate in another clinical study assessing any investigational product during the study.

  * Additional criteria apply, please contact the investigator for more information
Dopamine Versus Norepinephrine Under General Anesthesia

Participants under general anesthesia will be randomly treated with an adjusted dose dopamine or norepinephrine to elevate 10% of mean arterial pressure. Systemic hemodynamic data is recorded by PRAM and the change of cardiac index is compared between groups.

After intubation under general anesthesia, radial arterial is cannulated and pressure transducer is connected to MostCare(core technique PRAM). CI, SVRI, SVI, SVV, dp/dt and HR are recorded before and after a infusion of dopamine or norepinephrine to elevate 10% of mean arterial pressure. Changes of these hemodynamic data are compared.

Eligibility Criteria:
Inclusion Criteria:

* undertake cardiac surgery for congenital heart disease

Exclusion Criteria:

* Aortic valve or aortic disease
* severe arrhythmia
* use of cardiovascular active drugs before anesthesia
* need to use a combination of different cardiovascular support drugs after anesthesia
A Pilot Study Evaluating Nicotine Lozenges and Self Help

The investigators are hypothesizing that by offering both self-help materials and mailed nicotine lozenges we will be able to help increase tobacco abstinence rates among ST users, as well as decrease tobacco withdrawal.

Smokeless tobacco (ST) is a known human carcinogen. Long-term ST use is known to increase the risk for oropharyngeal cancer. Most smokeless tobacco users wish to quit. Assisted-self help interventions (i.e., self-help manual, a targeted video, and two support telephone phone calls) have been shown to be superior to manual-only interventions for increasing tobacco abstinence rates. These interventions lend themselves to widespread dissemination, but abstinence rates at 6 months remains low (21%). Providing nicotine replacement therapy (NRT) to ST users receiving assisted self-help interventions could improve upon these ST abstinence rates. If found to be effective, this intervention may increase the ability to disseminate effective interventions to a population of tobacco users for whom few treatment resources currently exist.

Eligibility Criteria:
Inclusion Criteria:

1. male;
2. ≥18 years of age;
3. report ST as their primary tobacco of use;
4. have used ST daily for the past 6 months;
5. indicate that they want to quit;
6. have been provided with, understand, and have signed the informed consent.

Exclusion Criteria:

1. previously enrolled in a study involving the use of the nicotine lozenge;
2. currently using or have completed using (past 30 days) any other behavioral or pharmacologic tobacco treatment program;
3. currently enrolled in another research study;
4. describe having a medical history of: a) unstable angina; b) myocardial infarction within the past 6 months; c) cardiac dysrhythmia other than medication-controlled atrial fibrillation or PSVT; or d) medically-treated or untreated hypertension with BP ≥ 180 systolic OR ≥ 100 diastolic;
5. have phenylketonuria (PKU) \[nicotine lozenges contain aspartame which is metabolized to phenylalanine and not processed in individuals with PKU\];
6. have another member of their household already participating in this study;
7. have other medical or psychiatric conditions that would exclude the participant;
8. have a score of ≥ 15 on the Patient Health Questionnaire (PHQ-9) on the phone call pre-screen.
Arm-hand Boost Program During Inpatient Rehabilitation After Stroke

A pilot cross-over RCT including participants with sub-acute stroke is conducted in an inpatient rehabilitation setting. The experimental group (EG) receives an arm-hand boost program on top of their usual care program. The control group (CG) receives a dose-matched program of strengthening exercises for the lower limbs and general reconditioning. After 4 weeks, a cross-over is performed. Before, after 4 weeks and after 8 weeks of additional therapy, different clinical outcome measures for the upper limb are administered.


Eligibility Criteria:
Inclusion Criteria:

* first stroke, as defined by WHO,
* minimal stay of 4 weeks in inpatient setting at study start
* minimally 18 years old
* being able to sit independently (trunk control test, item 3 = 25),
* motor impairment in the upper limb (Fugl-Meyer assessment, stage 2 (synergies): 8-17p, or stage 2: \<8p combined witht stage 5 (hand): \>6p
* sufficient cooperation to perform intervention and evaluations

Exclusion Criteria:

* musculoskeletal and/or other neurological impairments with permanent damage that may hinder the study
* subdural hematoma, tumor, encephalitis, trauma, or other that lead to similar symptoms as stroke
* severe communication, cognitive or language impairments that hinder the investigations
* no written informed consent
HR-EEG Contribution in Prognostic Evaluation of Language Development in Children With ASD

The goal of this prospective observational multicentric cohort study is to evaluate the clinical prognostic value of the speech tracking score of language development in children with ASD aged from 3 years to 4 years and half at inclusion.

Participants will followed during 4 years with an annual visit. During these visits, each participant will be clinically evaluated (scales and tests) and performed an EEG-HR recording. Two groups will be formed, one with children diagnosed with ASD with language delay, and a control group composed of non-ASD children without language delay, matched on age and gender with the ASD group.

Two groups will be formed, one with children diagnosed with ASD with language delay, and a control group composed of non-ASD children without language delay, matched on age and gender with the ASD group.

- ASD group : For children in the ASD group, 4 visits were planned (inclusion visit, then at one year, two years and three years).

During study visit, each child will be clinically evaluated with standardized scales and tests and will performed an EEG-HR recording while listening to successive soundtracks (modulated pure tones, synthetic voice, recorded voice, real voice, with congruent and non-congruent pictorial supports).

- Control group : For children in the control group, 1 visit was planned : data will be collected at the inclusion visit only.

During this visit, each child will be clinically evaluated with standardized scales and tests and will performed an EEG-HR recording while listening to successive soundtracks (modulated pure tones, synthetic voice, recorded voice, real voice, with congruent and non-congruent pictorial supports).

Eligibility Criteria:
Inclusion Criteria:

For all participants

* Child aged from 3 years to 4 years and half at inclusion.
* Information delivered and no parental objection for study participation.

For ASD group

* Diagnosis of ASD according to DSM-V criteria.
* Expressive language level \< 27 months regarding on IDE scale.

For Control group - Matched on age (at +/- 3 months) and gender to ASD group participants.

Exclusion Criteria:

For all participants

* Any illness or treatment that could significantly alter EEG-HR recording (epilepsy, anti-epileptic treatment, psychotropic drugs...).
* Major hearing or vision disorders.

For ASD group

- Severe and characterised neurological pathology other than ASD

For Control group

* Characterised neurological or psychiatric pathology.
* Characteristic language delay.
A Study of the New Medical Device Polybactum®

The POLARIS trial is designed as a multicenter, open label, non-comparative, 3 months, clinical study.

Interventional, non-controlled, multicenter trial with a prospective design on one cohort of patients

To evaluate the efficacy of Polybactum® administered for 3 cycles (one cycle/month) in reducing the rate of recurrence of BV in women cured with vaginal metronidazole and to compare the results of the treatment with the rate of recurrence reported in appropriate selected international literature. Therefore, the Polybactum® early administration should be able to modify the basal individual risk of BV recurrence.

Eligibility Criteria:
Inclusion Criteria:

* Women above 18 years.
* BV diagnosed by Amsel criteria (see Annex 3) in the 6-9 days before study, and cured with metronidazole vaginal formulation (gel for 5 days or ovules for 7 days).
* Diagnosis of RBV (at least 2 episodes of BV in the last 12 months including the BV cured before baseline).
* Non lactating women or lactating non amenorrheic women.
* Read and signed informed consent.

Exclusion Criteria:

* Pregnancy.
* Candidiasis or mixed vaginitis.
* HIV or other immunodeficiency.
* Known allergy to metronidazole or to Polybactum® ingredients.
* Sex workers.
* Menstruation or pre-menopause/menopause.
* Patients concomitantly included in different interventional clinical trials.
* Unwillingness to provide the informed consent to the trial.
* Time between the last day of last menses and baseline visit \> 16 days or ≤5 days.
Effect of Dexmedetomidine on Sevoflurane Requirements and Emergence Agitation in Children Undergoing Ambulatory Surgery

Although the aetiology of emergence agitation (EA) derives from multiple factors, it is a frequent side effect of sevoflurane anaesthesia in children. Dexmedetomidine, a potent selective α2-adrenergic agonist, can reduce the doses of hypnotics, opioids, analgesics, and anaesthetics that must be concomitantly administered. This study was conducted to assess the effect of dexmedetomidine infusion on sevoflurane requirements and recovery profiles with EA in children undergoing ambulatory surgery.


Eligibility Criteria:
Inclusion Criteria:

* ASA class I
* obtaining written informed consent from the parents
* aged 1-5 years, and weighing \<20 kg who were undergoing ambulatory hernioplasty or orchiopexy

Exclusion Criteria:

* mental retardation
* developmental delays
* neurological or psychiatric illnesses
* coagulation disorder
* spinal anomalies
* bilateral procedures
Enhancing Diabetes and Hypertension Self-Management Rural Appalachian Patients In Patient-Centered Medical Homes

The goal of this R34 planning project is to test the feasibility and acceptability of a 12-week modified diabetes and hypertension self-management program using trained Health Coaches.

West Virginians have one of the highest prevalence of comorbid diabetes and hypertension in the nation that pose an enormous disease and economic burden in this medically underserved state. Self-management of these two commonly found chronic conditions are an essential component of comprehensive disease management. The goal of this R34 planning project is to test the feasibility and acceptability of a 12-week culturally-tailored, multimodal, diabetes and hypertension self-management program with a core (diet and physical activity) versus core plus (diet, physical activity and medication adherence) to an enhanced usual care (EUC) control group. Seventy-five eligible adults with comorbid diabetes and hypertension will be randomized with a 1:1:1 ratio, based on allocation sequence generated by the bio-statistician investigator in the team. The study will examine the extent to which key components (diet, physical activity, and medication adherence) contribute to the differences in clinical outcomes (HbA1c and blood pressure) between three groups using quantitative and qualitative focus groups and the RE-AIM evaluation framework. The longer term effects of the intervention will be evaluated in a subsequent R01 clinical trial.

Eligibility Criteria:
Inclusion Criteria:

* English speaking adults ≥ 18 years of age;
* co-occurring diagnosis of type 2 diabetes and hypertension
* body mass index ≥ 25.0
* willing to be randomized, and complete the intervention and all assessments.

Exclusion Criteria:

* currently pregnant or breastfeeding
* diagnosed with a severe mental illness
* have any condition that requires physical activity limitations or is contraindicated for the Dietary Assessment to Stop Hypertension (DASH) diet
* inability to complete the study protocol.