cyrilzakka/clinical-trials huggingface dataset:
Can we Get Conscious Sedation by Combining Dexmedetomidine With Alfentanil?

The main objective is to determine if dexmedetomidine combine with alfentanil allow a level of conscious sedation within maximum security conditions in an emergency department.

Patients included in the study will receive an injection of dexmedetomidine via a TIVA Injectomat Agilia, specially programmed for the injection of dexmedetomidine.

Patients will also receive a dose of alfentanil, 1 minute before the technical act.


Eligibility Criteria:
Inclusion Criteria:

Adult over 18 years, of both sexes, for which a procedural sedation is needed in emergency room. The rules for sedation, in accordance with the international guidelines, are:

* The insertion of a chest drain
* Abscess incision and drainage
* Closed reduction of a dislocated joint

Exclusion Criteria:

* Patients refusing to participate in the study (refusal to sign the consent form)
* Patients refusing sedation
* Patients unable to participate in the study (consent is impossible to obtain)
* Pregnant women
* The hypersensitivity to the active ingredient, dexmedetomidine hydrochloride.
* Patients with poor respiratory status determined by:

Respiratory rate \> 30 / min Oxygen saturation \<90%

* Patients with unfavorable hemodynamic status determined by :

A heart rate \> 120 / min A heart rate \< 50 / min Systolic blood pressure ≥ 180 mmHg or ≤100mmHg Diastolic blood pressure ≥ 110mmHg

* Patients with contraindication to the use of dexmedetomidine :

Advanced heart block (level 2 or 3) unless pacemaker Acute cerebrovascular disease
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HS-20004 in Healthy Chinese Volunteers

This trial is conducted in China. The aim of this trial is to assess the safety and tolerability of HS-20004 in healthy Chinese subjects.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) between 19 and 24 kg/m\^2， inclusive， and a total body weight of at least 50 kg;

Exclusion Criteria:

* Clinically relevant abnormalities of physical examination, laboratory values, vital signs or ECG findings at the screening, as judged by the Investigator
* Have any other medical abnormality (such as cardiovascular, hepatic, renal, gastrointestinal, immunologic, hematological, hormonal, metabolic, neoplasmatic or mental disease), which in the opinion of the investigator, might affect the absorption, distribution, metabolism, and excretion of the study drug, or prevent the patient from following and completing the protocol
* Family history of diabetes, thyroid cancer, submandibular gland cancer, or history of pancreatitis, cholelithiasis, drug allergy, or serious unconscious hypoglycemia Hepatitis B surface antigen, Hepatitis C antibodies or HIV (human immunodeficiency virus) antibodies positive
* History of drug or alcohol abuse within 6 months before randomization
* Use of GLP-1 analogues, DPP-IV enzyme inhibitors, as well as other hypoglycemic drugs within 3 months before randomization
* Use of any prescription drugs and Chinese herbal medicines within 4 weeks before randomization
* Use of non prescription drugs and food supplements (vitamins, etc.) within 2 weeks of randomization
* Participated any drug clinical trials within 3 months, or participated 3 or more than 3 drug clinical trials in the near year, or had blood donation/loss \>400mL within 3 months
* Female subject of childbearing potential who does not use an acceptable method of birth control, is pregnant or planning a pregnancy, or breastfeeding, or male subject who does not use an acceptable method of birth control, within six months before randomization Subject who cannot refrain from smoking, eating and/or drinking containing xanthine/caffeine, or strenuous exercise, or others that affect drug absorption, distribution, metabolism and excretion within 2 days before the study drug administration Subject who is unsuitable for inclusion in the study in the opinion of the investigator
Sequential Treatment With CD20/CD22/CD10-CART After CD19-CART Treatment Base on MRD in Relapsed/Refractory B-ALL

CD19-negative B-ALL relapses after CD19 CAR T-cell treatment have occurred in some patients. CD20/CD22/CD10 is still expressed in CD19 negative B-ALL cells which means these CD molecules may become new targets in treatment of CD19-negative relapse of B-ALL. Thus sequential treatment with CD20/CD22/CD10-CART after CD19-CART treatment in relapsed/refractory B-ALL will kill and eliminate CD19 negative B-ALL cells and prolong the remission time.

B-cell acute lymphoblastic leukemia is the most common type of leukemia and the prognosis of relapsed/refractory B-ALL is poor. Chimeric Antigen Receptor-transduced T cell (CAR-T) therapy is one of revolutionary targeted immunotherapy. CD19 CAR-T is the most commonly used engineered T cell in B-ALL. The treatment effect is significant and far more than traditional therapy in relapsed/refractory B-ALL. However, the remission time after CD19 CAR-T infusion is short.CD19-positive and CD19-negative B-ALL relapses after CD19 CAR T-cell treatment have occurred in some patients The cause of relapse after CAR-T infusion is minimal residual disease (MRD) which will induce CD19 negative relapse. CD20/CD22/CD10 is still expressed in CD19 negative B-ALL cells which means these CD molecules may become new targets in treatment of CD19 negative relapse of B-ALL. Thus sequential treatment with CD20/CD22/CD10-CART after CD19-CART treatment in relapsed/refractory B-ALL will kill and eliminate CD19 negative B-ALL cells and prolong the remission time.

Eligibility Criteria:
Inclusion Criteria:

1. Relapsed/Refractory B-ALL patients
2. Did not achieve complete remission after 2 times of standard plan chemotherapy
3. Relapsed after first induction chemotherapy
4. Did not response to chemotherapy before HSCT or relapsed after HSCT
5. Cannot receive allo-HSCT or refuse to receive allo-HSCT
6. Cell phenotype is CD19 and CD20/CD22/CD10/CD70 positive (single or combined)
7. Estimated survival time is more than 3 months in leukemia
8. Volunteered for this clinical trail and signed a consent form

Exclusion Criteria:

1. MRD was negative while the cell phenotype was CD19 expressed
2. Patients with severe insufficient cardiac, pulmonary and hepatorenal functions
3. Patients with severe mental illness, neurological disease or infectious disease
4. Patients with GVHD was taking immunosuppressants
5. Pregnant or lactating women
6. Patients have received other genetic therapy products
7. Transfection efficiency was less than 30%
8. Any situation may do harm to the subjects or interfere the results
Brachial Plexus Injury After Prone Positioning

The goal of this prospective observational study is to estimate the prevalence of brachial plexus injury after prone positioning in patients with ARDS and to evaluate the safety of swimmer position. The main questions it aims to answer are:

* Could arm positioning during pronation play a role in the development of any nerve injury at the brachial plexus level?
* Is swimmer position safe when adopted during prone positioning?

Participants will be studied at selective time points using EMG assessment.

Prone positioning will be performed according to the current guidelines. Particularly, face and limbs will be placed according to the "swimmer position", ensuring the face position in the direction of ventilator and limbs (one arm above head and opposite arm at side) positioned as to prevent abnormal extension or flexion against the shoulders and elbows. Patients will lie on low air loss pressure mattresses, thus avoiding the utilization of any thoraco-pelvic supports, which are not recommended. Electromyography (EMG) will be performed to evaluate the occurrence of brachial plexus injury (BPI).

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old
* Admission to ICU for severe ARDS
* Administration of sedation and neuromuscular blocking agents
* Presence of endotracheal intubation and mechanical ventilation
* Use of prone positioning to treat hypoxemia

Exclusion Criteria:

* Extracorporeal membrane oxygenation
* Prone positioning performed in other centers
* Prone positioning contraindications
* Neurodegenerative disorders
* Previous known brachial plexus injury
Electroacupuncture to Assist Ventilator Weaning in Severe Stroke

The purpose of this study is to evaluate the efficacy of electroacupuncture in assisting ventilator weaning in patients with severe stroke

Disuse atrophy of the major respiratory muscles and diaphragmatic dysfunction often develop during mechanical ventilation, and cause difficulties in ventilator weaning. Electroacupuncture was indicated to promote activities of diaphragm and improve diaphragmatic function. Our aim is to evaluate the efficacy of electroacupuncture in assisting ventilator weaning in patients with severe stroke. 100 eligible patients will be randomly assigned to receive electroacupuncture or sham electroacupuncture treatment one session per day until the success of ventilator weaning (up to 21 days). The primay outcome is the ventilation duration within 21 days after enrollment.

Eligibility Criteria:
Inclusion Criteria:

1. age ≥ 18 years and ≤ 75 years ;
2. within 7 days after the onset of stroke (ischemic or hemorrhagic), confirmed by a computed tomography (CT) or magnetic resonance imaging (MRI) scan of the brain;
3. GCS on admission ≤ 12 or NIHSS on admission ≥ 11 or APACHEⅡ ≥ 15;
4. received mechanical ventilation;
5. written informed consent is able to be obtained directly from the patient or an appropriate surrogate, based on local ethics committee recommendations.

Exclusion Criteria:

1. expected to be ventilated for \< 24 h;
2. already ventilated for \> 72 h;
3. GCS \<5;
4. with unstable vital signs and requiring the use of vasoactive agents;
5. concomitant medical illness that would interfere with the outcome assessments and/or follow-up;
6. had spinal cord injury above T8 level, or lower motor neuron impairment, or neuromuscular junction impairment，or chest wall deformities, or chest wall injuries within 6 months, or chest or abdominal surgery within 4 week, or were pregnant;
7. had acute skin injury on the selected acupoints;
8. currently participating in other investigational trials.
The Effect of Case Conferencing in Nursing Homes

This study evaluates the effect of using comprehensive geriatric assessment in combination with case conferences on the prevalence of neuropsychiatric symptoms (also known as behavioral and psychological symptoms of dementia) in Norwegian nursing homes

Long-term care patients in nursing homes (NH) are characterized by frailty and having multiple health problems and reduced quality of life. Some of these issues relates to the quality of care and do therefore possess a potential for improvement. There is a need for approaches enabling nurses to carry out effective interventions that can promote health related to sustain or improve the nursing home patients health status. Integrating a comprehensive geriatric assessment (CGA) and case conferencing (CC) might be an effective method to individualize care plans in order to improve quality of care.

The intervention nursing homes will implement CGA, using the International resident instrument suite for Long Term Care Facilities (InterRai LTCF) and CC. The patients will be included and assessed three times during a 12-month period (control and intervention NHs). In the intervention NHs the results from the CGA will be reviewed in monthly CCs. The CCs are structured and consist of four main steps; evaluating the effects of earlier interventions, defining patients risks or area for improvement, defining the aetiology of the risk or problem, defining interventions and measures for improvement along with an appropriate method for evaluation. The CC group's consensus is basis for the patient's care plan.

Eligibility Criteria:
Inclusion Criteria:

* registered as long term care patient
* been in the nursing home for more than a month
* Informed consent from the patient or legal guardians

Exclusion Criteria:

* life expectancy less than six months
TAK-438 - Safety, Blood Levels & Effects of Repeated Doses

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of TAK-438 in healthy, non-Japanese men male subjects following a randomized, double blind, placebo controlled, sequential panel, multiple-dose schedule.

The drug being tested in this study is called TAK-438. TAK-438 is being tested to find a safe and well-tolerated dose. This study looked at pharmacokinetic (effect of the body on the drug) and pharmacodynamic properties (effect of the drug on the body) as well as look at lab results and side effects in people who took TAK-438. This study was designed as a randomized, sequential-panel, multiple repeat dose study.

The study population consisted of 4 Cohorts with 12 participants in each Cohort; with 9 participants randomized to receive a single dose of TAK-438, and 3 participants to receive placebo. Participants in each Cohort received a single dose of study drug once daily after a 10-hour fast. The starting dose was 10 mg followed by administrations of 20, 40, and 30 mg.

This single-centre trial was conducted in the United Kingdom. The overall time to participate in this study was up to 37 days. Participants made 2 visits to the clinic for screening, one 11-day period of confinement to the clinic, and 2 further visits after the confinement period. All participants were contacted by telephone 7 days after last dose of study drug for a follow-up assessment.

Eligibility Criteria:
Inclusion Criteria:

* Male subjects aged 18 to 45, inclusive, who are in good health, as determined by medical history, physical examination, clinical laboratory evaluations and urine drug screen.
* The subject has the ability to tolerate the pH probe for 24 hours prior to Randomization (Day 1).

Exclusion Criteria:

* Clinically significant history of hypersensitivity to any drug or food or any excipients of TAK-438
* History of gastroesophageal reflux disease (GERD), symptomatic GERD, erosive esophagitis, duodenal ulcer,gastric ulcer, dyspepsia, Barrett's esophagus, or Zollinger-Ellison syndrome
* The subject has a positive test result for Helicobacter pylori at the Initial Screening Visit
* Any clinically significant results from physical examinations or clinical laboratory results as deemed by the investigator.
An Expanded Access Program of Cretostimogene Grenadenorepvec for Treatment of NMIBC for Patients Unresponsive to BCG

This is an open-label, expanded access trial designed to provide access to cretostimogene in patients with NMIBC (specifically CIS with or without HG Ta/T1) unresponsive to BCG.

All participants will be assigned the same treatment schedule. Participants will receive an induction course and, if there is no disease recurrence at Week 13, participants will receive a cycle of 3 weekly treatments up to Week 15.

If there is persistent HG Ta and/or CIS at Week 13, participants may receive a second induction course.

If there is no disease present thereafter, participants will receive a cycle of 3 weekly treatments every 12 weeks through Month 12.

After Month 12, participants will receive a cycle of 3 weekly treatments every 6 months through the last treatment cycle at Month 24, or until discontinuation from the study treatment.

Disease status will be assessed using urine cytology, cystoscopy, and directed TURBT/biopsy (if indicated) every 12 weeks and CTU/MRU every 24 weeks, for up to 2 years.

Eligibility Criteria:
Inclusion Criteria:

1. Have pathologically confirmed BCG unresponsive CIS. There is no maximum limit to the amount of prior BCG treatment, but maintenance BCG should be administered on a schedule consistent with standard induction-maintenance protocols. Specifically, the definition of BCG unresponsive CIS will also require the following:

   * Pathologically confirmed relapsed or persistent CIS (with or without HG Ta or HG T1 disease)
   * Completion of qualifying BCG treatment (e.g., "5+2" minimum exposure) within 15 months of the initial qualifying dose of BCG.
   * Pathological confirmation of BCG unresponsive CIS with or without HG Ta or HG T1
2. Have all Ta and/or T1 disease and all CIS resected or fulgurated, as feasible, prior to study treatment
3. Ineligible to receive radical cystectomy (medically unfit) or refusal of radical cystectomy according to Investigator assessment.
4. Acceptable baseline organ function

Exclusion Criteria:

1. Muscle invasive bladder cancer, locally advanced or metastatic bladder cancer.
2. Has had active autoimmune or inflammatory disease requiring systemic treatment within 4 weeks of Day 1. Replacement therapy is not considered an excluded form of systemic treatment and is allowed.
3. Has received systemic anti-cancer therapy, including investigational agents, within 4 weeks of Day 1
4. Is pregnant, currently breastfeeding or intending to breastfeed, beginning at Screening through 6 weeks after the last study treatment.
Transcutaneous Tibial Nerve Stimulation for Idiopathic Overactive Bladder

This study was designed to assess the efficacy of trans cutaneous tibial nerve stimulation on symptoms of overactive bladder in women with idiopathic overactive bladder

Idiopathic overactive bladder is defined the presence of a sense of urgency with or without accompanying urinary incontinence without an organic pathology or urinary infection. Its prevalence was reported to be between 7.7 to 31 % in women. In this prospective randomized controlled study, we aim to assess the efficacy of trans cutaneous tibial nerve stimulation on symptoms of overactive bladder in women with idiopathic overactive bladder.

Eligibility Criteria:
Inclusion Criteria:

* Overactive Bladder Questionnaire Validation Study questionnaire 8 scores higher than 11.
* Post voiding residue levels less than 100 ml.
* Women aged between 18-70

Exclusion Criteria:

* Prior history of pelvic surgery
* Pelvic organ prolapsus of grade 2 or more.
* Current urinary tract infection
To Investigate the Efficacy of Treatment With Oral NA-921 (Bionetide) Versus Placebo in Females With Rett Syndrome

Primary Objective • To investigate the efficacy of treatment with oral Bionetide versus placebo in girls and women with Rett syndrome

Key Secondary Objective

• To investigate the efficacy of treatment with oral Bionetide versus placebo on ability to communicate in girls and women with Rett syndrome

Co-Primary Endpoints

* Rett Syndrome Behavior Questionnaire (RSBQ) total score - Change from Baseline to Week 12
* Clinical Global Impression-Improvement (CGI-I) Score at Week 12

Key Secondary Endpoint

Change from Baseline to Week 12 in:

• Communication and Symbolic Behavior Scales Developmental Profile™ Infant-Toddler Checklist- Social Composite Score (CSBS-DP-IT Social)

Eligibility Criteria:
INCLUSION CRITERIA

1. Female subjects 5 to 20 years of age, inclusive, at Screening
2. Body weight ≥12 kg at Screening
3. Can swallow the study medication provided as a liquid solution or can take it by gastrostomy tube
4. Has classic/typical Rett syndrome (RTT)
5. Has a documented disease-causing mutation in the MECP2 gene
6. Has a stable pattern of seizures, or has had no seizures, within 8 weeks of Screening
7. Subjects of childbearing potential must abstain from sexual activity for the duration of the study and for at least 30 days thereafter or must agree to use acceptable methods of contraception. Subject must not be pregnant or breastfeeding.
8. The subject's caregiver is English-speaking and has sufficient language skills to complete the caregiver assessments
9. Subject and caregiver(s) must reside at a location to which study drug can be delivered and have been at their present residence for at least 3 months prior to Screening

EXCLUSION CRITERIA

1. Has been treated with insulin within 12 weeks of Baseline
2. Has current clinically significant cardiovascular, endocrine (such as hypo- or hyperthyroidism, Type 1 diabetes mellitus, or uncontrolled Type 2 diabetes mellitus), renal, hepatic, respiratory or gastrointestinal disease (such as celiac disease or inflammatory bowel disease) or has major surgery planned during the study
3. Has a history of, or current, cerebrovascular disease or brain trauma
4. Has significant, uncorrected visual or uncorrected hearing impairment
5. Has a history of, or current, malignancy
6. Has a known history or symptoms of long QT syndrome
Active Play in After School Programs

Background: Physical activity (PA) is a key component in health promotion and prevention of overweight. Interventions delivered in after-school programs (ASP) have the potential to become a means of ensuring PA among young schoolchildren. This requires a motivational climate, allowing for self-determination and the intrinsic values of the activity, on the activity's character of play. ASP staff could be trained in stimulating all children in physical activities in their everyday life. Physiotherapists in primary care possess knowledge of motor development and learning, and are important contributors to an ASP-based physical activity intervention.

Aim: To develop a complex intervention that emphasizes physical activity play, and to examine through a cluster-randomized trial the extent to which the intervention promotes PA and health-related quality of life and prevents overweight in a population of young children. We aim to increase the knowledge and autonomy supportive skills among ASP staff members, enabling them to promote physical activity through play among all first graders in ASP.

In addition to investigate if the children benefit from receiving autonomy support, we aim to study whether the ASP staff themselves benefit from giving autonomy support in terms of increased need satisfaction and autonomous motivation for work.

The intervention: Includes training of ASP-staff members in the fundamental principles of self-determination theory and practical applications for motivating young children in PA through play. Information will be given on the benefits of a physically active lifestyle and the staff will be encouraged to map opportunities for PA in their local ASP and to incorporate strategies to increase PA through play among the children throughout the day.

Methods/design: A complex intervention using a mixed methods approach will be developed and evaluated. A pilot trial will assess the potential of this approach and provide information necessary to perform a cluster-randomized controlled trial (RCT). The cluster-randomized controlled trial (RCT) will together with qualitative interviews and observations, evaluate the effectiveness of the intervention. Outcomes will be measured at baseline (September /October 2016) at the end of the intervention which lasts for 7 months (May 2017), and 1 year after the end of the intervention (May 2018)


Eligibility Criteria:
Inclusion Criteria:

* Attends first grade in one of the ASPs included

Exclusion Criteria:

* Does not attend first grade in one of the ASPs included