cyrilzakka/clinical-trials huggingface dataset:
Integrated Community Case Management (ICCM) Delivered by Village Health Teams in Bushenyi District in Uganda

In Sub-Saharan Africa (SSA), many children die from diarrhoea, acute respiratory illness (ARI) and malaria, despite well- recognized, inexpensive and highly effective treatments, since health access and human resources are limited. Healthy Child Uganda (HCU) is a Ugandan-Canadian partnership that since 2003, has developed, implemented and evaluated a Village Health Volunteer (VHV) program in 175 rural villages. Volunteers, selected by peers, provide health education and refer sick children. Volunteer retention (94%) and significant decreases in child deaths are remarkable. Now, HCU wonders whether VHV scope can extend to provide treatment for sick children using Oral Rehydration Salts (ORS)/Zinc, antibiotics, and antimalarials. Use of lay providers in this capacity, called integrated community case management (iCCM), has been proposed as a potential inexpensive solution to SSA's human health resource crisis.

PRIMARY QUESTION: In rural southwest Uganda, can iCCM provided by lay volunteers, improve the proportion of children with diarrhoea receiving ORS/Zn, ARI receiving antibiotics, and fever/malaria receiving antimalarials? Secondary study questions consider VHV capacity to prescribe appropriate drug, dose, duration; iCCM acceptance by family, and VHV; VHV retention/motivation; program cost. Selected VHV will be iCCM trained then receive treatments for distribution. Qualitative and quantitative methods including household surveys, and focus groups will consider pre/post intervention differences and differences in control and intervention populations. A research short course and micro research grants (\~ $3000 to multidisciplinary groups pursuing relevant questions) will promote health system evaluation capacity. Lessons learned are critical as SSA countries move forward in planning for increased iCCM programming.


Eligibility Criteria:
Inclusion Criteria:

* Children under five (\< or =59 months)

Exclusion Criteria:

* Children over five years (\> 59 Months)
Cognitive Behavioral Therapy (CBT) for PTSD in Veterans With Co-Occurring SUDs

With this research, the investigators hope to learn if cognitive behavioral therapy (CBT) for posttraumatic stress disorder (PTSD) works in people who have both PTSD and problems with drugs or alcohol. In the past, people who had problems with drugs and alcohol were not given treatment for their PTSD. It was believed that PTSD treatment would get in the way of their drug and alcohol treatment. Now the investigators believe that the PTSD symptoms may make it harder to avoid using drugs and alcohol, so the investigators want to see if people can get treatment for both problems at the same time.

One hundred-sixty Veterans from 3 sites who have both PTSD and substance use disorders will be in the study. In order to know if the PTSD treatment is helpful, half of the Veterans in this study will receive PTSD treatment and half will continue to get their usual mental health and/or substance abuse treatment. Who gets which treatment will be decided by a random process. The investigators will then compare the 2 groups to see if there are differences in their PTSD symptoms.

A randomized clinical trial to evaluate the effectiveness of a relatively simple, manual-guided cognitive behavioral therapy (CBT) for PTSD in patients with substance use disorders (SUDs). One hundred sixty outpatients with comorbid PTSD and SUDs from three VA facilities will be randomly assigned to receive either CBT for PTSD in conjunction with standard treatment as usual (TAU) (n = 80) or TAU only (n = 80).

Eligibility Criteria:
Inclusion Criteria:

* At least age 18.
* Current SUD diagnosis.
* Score of at least 45 on CAPS.
* Must speak English.
* Must agree to be taped.

Exclusion Criteria:

* Acute psychotic symptoms, if not well connected with appropriate mental health services.
* Severe suicidality.
* Individuals with unstable medical or legal situations that would make completion of the study highly unlikely.
INVSENSOR00013 Respiratory Rate Clinical Performance Study

The objective of this prospective study is to compare the noninvasive respiration from pleth (RRp) performance of the Masimo INVSENSOR00013 device against the respiratory rate measured by capnography (RRref), Masimo's RAM technology and the manual annotation.


Eligibility Criteria:
Inclusion Criteria:

* 18 to 70 years old
* Physical status of ASA I or II
* Must be able to read and communicate in English
* Has signed all necessary related documents, e.g. written informed consent, confidentiality agreement
* Passed health assessment screening
* Negative pregnancy test for female subjects of child bearing potential

Exclusion Criteria:

* Physical status of ASA III, IV, or V
* Subject has any medical condition which in the judgement of the investigator, renders them inappropriate for participation in the study
* Inability to tolerate sitting still or minimal movement for at least 30 minutes
* Positive pregnancy test for female subjects
* Refusal to take pregnancy test for women of child bearing potential
* Nursing female subjects
* Refusal of male subjects to agree to shave hair off areas where the sensor will be applied (neck) when deemed necessary
* Subjects wearing acrylic nails or subjects refusing to remove nail polish
* Subjects who have a nail deformity on the measurement finger
* Subjects who do not have adequate skin integrity on the measurement finger
* Excluded at the Principal Investigator's discretion
Acupuncture Combined With Mindfulness: ACUMIND

This study aims to gather preliminary data regarding acupuncture and mindfulness in the treatment of chronic pain.

Neither acupuncture nor mindfulness have been studied with respect to chronic pain in an outpatient integrative health (IH) oncology clinic in the USA. Likewise, the combination of acupuncture and mindfulness combined as not been studied. Given that both acupuncture and mindfulness have demonstrated some analgesic relief in an acute pain setting, each merit study for pain relief in an outpatient setting.

The investigators are evaluating the impact of two different acupuncture approaches for patients reporting chronic pain. Acupuncture will be provided by a Licensed Acupuncturist for patients reporting chronic pain. Participants will be randomized to one of two treatments - acupuncture as usual or acupuncture plus mindfulness.

The investigators will collect data regarding chronic pain, interoceptive awareness, emotion regulation, and acceptability. The study is open to participants with any etiology and any location of chronic pain.

Eligibility Criteria:
Inclusion Criteria:

* Patient is age 18 or older.
* Patient is experiencing pain (rated ≥3 on a 0-10 scale) lasting for three or more months.
* Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.
* ONLY FOR THOSE WITH A DIAGNOSIS OF CANCER: ECOG status of 0 (asymptomatic), 1 (symptomatic but completely ambulatory) or 2 (symptomatic, \<50% in bed during the day).

Exclusion Criteria:

* Patient has received 5 or more acupuncture treatments in the last 2 months.
The Safety and Efficacy of the Suture-Mediated Closure System

This was a prospective, multicenter, randomized, controlled, non-inferiority clinical study with the primary objective of validating the safety and efficacy of the Suture-Mediated Closure System for percutaneous closure of the common femoral artery puncture site.

This study was a prospective, multicenter, randomized, controlled, non-inferiority clinical trial. It is planned to be conducted in multiple clinical trial institutions and enroll 228 subjects. Eligible subjects were randomly divided into the experimental group or the control group at a ratio of 1:1.

Eligibility Criteria:
Inclusion Criteria:

* Between 18 years old and 85 years old, randomized
* Patients who can be examined or treated with a common femoral artery puncture interventional catheter using a 5F to 22F sheath tube
* Patient(or their guardians) who submitted a written informed consent for the this trial

Exclusion Criteria:

* Known to be pregnant or lactating
* The diameter of femoral artery on the puncture side was less than 5mm
* Patients requiring anterograde puncture approach
* Have participated in or plan to participate in another clinical trial in the same period
* Known allergy to any components of the device, and/or contraindications to contrast agents and anticoagulants
* International normalized ratio (INR) \>2.0
* Traumatic vascular injury at the approach site
* Systemic or local groin infection
* Cerebrovascular accident or myocardial infarction within 3 months
* An arterial catheter needs to be placed at the access site
* Morbidly obese (BMI ≥40 kg/m2)
* The entire common femoral artery wall assessed by ultrasound, calcification located in the anterior wall cut, the extent of more than 50% circumferential or common femoral artery stenosis ≥50
* Femoral artery aneurysm, arteriovenous fistula or pseudoaneurysm in common femoral artery
* Using a clip vessel occluder at the past ipsilateral femoral artery access site
* Use of a puncture point occlusion device at the ipsilateral femoral access site within the past 30 days
* Underwent an intervention via ipsilateral femoral artery puncture within the past 30 days or within the next 30 days
* Ipsilateral femoral vein sheath needed to be used
* Evidence of previous common femoral artery surgery on the same side (e.g., inguinal incision)
* Hematoma at ipsilateral arterial access
* Other circumstances that the investigator deemed inappropriate for participation in the trial.femoral artery aneurysm, arteriovenous fistula or pseudoaneurysm in common femoral artery
Preoperative Dexamethasone to Improve Quality of Recovery After Laparoscopic Bariatric Surgery

In the obese patient, adequate pain relief in the postoperative period is an important parameter that affects patient comfort and hospital stay. Increasing patient comfort and recovery quality can be achieved by avoiding undesirable effects such as nausea and vomiting, as well as analgesia. In our study, our aim is to evaluate the effect of dexamethasone added to multimodal analgesia on postoperative patient comfort in the obese patient group with a 40-item scale.

Postoperative pain prolongs hospital stay, delays wound healing, increases infection rates, and increases the incidence of drug side effects due to the use of systemic pain relievers (especially opioids).

Good pain control facilitates respiratory effort, allows the patient to perform respiratory exercises and cough to correct the increased thoracic fat mass and impaired respiratory mechanics due to anesthesia. The patient without pain is mobilized early and discharged early.

Our aim is to evaluate the effect of dexamethasone added to multimodal analgesia on postoperative patient comfort in the obese patient group with a 40-item scale.

Patients will be divided in to two groups (group D and group C):

Group D (Dexamethasone Group):

Patients who used/applied dexamethasone before bariatric surgery were included in this group.

Group C(Control Group):

Patients who did not use dexamethasone or steroid-derived drugs were included in this group.

The patients included in the study were evaluated with the 40-item recovery quality scale (QoR-40) 24 hours after the operation.

İn addition all patients will be administered iv morphine pca (patient controlled analgesia) for the first 24 hours postoperatively

Eligibility Criteria:
Inclusion Criteria:

* Body mass index\>30 kg/m2
* The American Society of Anaesthesiologists (ASA) physical status class I, II
* The American Society of Anaesthesiologists (ASA) physical status class III only because of morbid obesity
* Patients who will undergo an elective laparoscopic sleeve gastrectomy (LSG)
* Those who are literate enough to answer the compilation quality score (QoR-40) questionnaire

Exclusion Criteria:

* refusal to participate
* allergy to the study drugs
* chronic kidney disease (creatinine\>150 μmol/L)
* mental illness
* liver, respiratory or oncological disease,
* cardiac dysfunction (ejection fraction \<40%),
* uncontrolled hypertension,
* preoperative analgesic use,
* chronic pain,
* history of alcohol or drug addiction
Effectiveness of Intensive Training in Upper Limb Rehabilitation After Stroke.

The aim of the study is to analyse the effect of intensive training on upper limb function in stroke patients.

16 stroke patients were randomly divided into two groups: the intensive group and the control group.

The control group will be trained with robotic exoskeleton for upper limbs and task specific training, 3 sessions per week for 4 weeks, for 1 hour per day.

The intensive group will do robotic exoskeleton for upper limbs and task specific training, 5 sessions a week for 4 weeks, for 2 hours a day.

Abtract

Aim: The aim of the study is to analyze the effect of intensive training on upper limb function in stroke patients.

Methods: The control group will be trained with robotic exoskeleton for upper limbs and task specific training, 3 sessions per week for 4 weeks, for 1 hour per day.

The intensive group will do robotic exoskeleton for upper limbs and task specific training, 5 sessions a week for 4 weeks, for 2 hours a day. The primary outcome measure include is the Fugl Meyer Assessment (FMA).Secondary measures include the Box and Blocks Test (BBT), dynamometer, Motor Activity Log (MAL), Stroke Impact Scale (SIS), Functional Independence Measure (FIM) and Canadian Occupational Performance Measure (COPM).

Assessments occur at baseline, after 4 weeks of intervention, and at 1 month after intervention commencement. Analysis will be intention to treat using a generalised linear mixed model to report estimated mean differences in scores between the two groups at each timepoint with 95% confidence Interval and value p.

Hypothesis: If an intensive training programme is effective in improving upper limb motor function, its implementation for clinical practice could be beneficial for improving upper limb motor function and quality of life in people who have suffered a stroke.

Eligibility Criteria:
Inclusion Criteria:

* People diagnosed with stroke (ischaemic or haemorrhagic).
* Patients in a subacute or chronic state.
* Patients must be over 18 years of age and under 80 years of age.
* Patients with impaired functionality of the upper limb.

Exclusion Criteria:

* Persons diagnosed with other pathologies, other than those indicated in the inclusion criteria.
* Mini-Mental State Examination (MMSE), the minimum score to be achieved will be 22 points.
* Severe difficulties in understanding language (aphasia).
* Behavioural or behavioural disturbance.
* Treatment with botulinum toxin 3 months prior to the intervention.
An Open-Label Study of Two Formulations of LX1033 in Healthy Human Subjects

The purpose of this study is to assess the pharmacodynamic effects, pharmacokinetics, and safety of two oral formulations (tablet and capsule) of LX1033 in normal healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Adult subjects age 18 to 55 years
* Vital signs acceptable at Screening
* Body mass index (BMI) between 18 and 35 kg/m\^2 at Screening
* Considered to be in good health, as determined by the Investigator
* Normal ECG findings
* Negative urine screen for drugs of abuse and negative breath test for alcohol
* Negative hepatitis B surface antigen, hepatitis C antibody, and HIV1 and HIV2 antibody tests within the last 28 days
* Ability to provide written informed consent

Exclusion Criteria:

* Use of any medication (including acetaminophen) within 5 days of dosing
* Use of any investigational agent or selective serotonin reuptake inhibitors (SSRIs) within 30 days of study start
* Administration of any protein or antibodies within 90 days of study start
* Donation or loss of greater than 450 mL of blood within 45 days of study start
* Known history of hepatic disease or significantly abnormal liver function tests
* History of alcoholism or substance abuse within 3 years prior to study start
* Participation in any other clinical study within 30 days preceding the first dose of study drug
* Positive serum pregnancy test
Dexmedetomidine Infusion Versus Oral Melatonin for Prevention of Intensive Care Delirium

This study aims to compare the effect of dexmedetomidine infusion and oral melatonin on preventing delirium in intensive care unit (ICU) patients.

Delirium is experienced in 20% to 40% of the critically ill and up to 80% of mechanically ventilated (MV) medical or surgical patients . It is a confessional state that has been described as a transient global disorder of cognition, awareness, and attention and as such is not only challenging for the treating medical team, but also has a considerable impact on affected patients. It is associated with prolonged hospital length of stay and time on MV, deterioration in cognition, and increased morbidity and mortality causing additional health-care expenses.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 21 years or older.
* Either gender.
* Healthy gastrointestinal function (patients tolerated oral medications by gavage or mouth).
* Richmond Agitation Sedation Scale (RASS) \>-1.
* No basic delirium or mood changes before admission to intensive care unit(ICU).

Exclusion Criteria:

* Patient refusal.
* History of irreversible brain disease consistent with severe dementia.
* Patient admitted with a primary neurologic condition or injury (e.g., intracranial hemorrhage).
* Heart rate (HR) less than 50 beats/ min or second- third degree heart block in the absence of a pacemaker.
* Acute alcohol withdrawal requiring benzodiazepine administration.
* History of hepatic encephalopathy or end-stage liver disease (Child-Pugh class B or C).
* The expected duration of intensive care unit (ICU) stay less than 5 days.
* Inability to obtain informed consent.
* Pregnancy.
* Allergy to dexmedetomidine or melatonin.
Opioid and Cannabinoid Interactions

This study will examine the effects of doses of marijuana/placebo and doses of opioid/placebo, alone and in combination. The primary outcomes are related to pharmacodynamic measures (subjective ratings of drug liking and other abuse-related effects; physiological outcomes) to determine the interaction effects of these compounds.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults ages 18-50
* Current non-medical use of opioids and marijuana

Exclusion Criteria:

* Physical dependence on opioids, alcohol benzodiazepines/sedative/hypnotics
* Seeking treatment for drug use
* Significant medical problems
Exercise and Nutrition in the Mental Health of the Older Adult Population

Resistance exercise and the Mediterranean diet are complementary, evidence-based approaches to improving physical and mental health throughout all stages of life.

For older adults, maintain flexibility, muscle strength, balance and posture, reducing the risk of falls and injuries; They relieve chronic pain, improve sleep quality, and reduce stress and anxiety. For young people, they improve concentration, attention and memory, reduce stress and anxiety, promote a positive body image and increase self-esteem. Overall benefits include promoting the mind-body connection, facilitating healthy aging, and being accessible and adaptable to various individual and socioeconomic needs.

The main components of the Mediterranean diet are: high in fruits, vegetables, legumes, nuts, whole grains, fish and olive oil; moderate in dairy and red wine; and low in red meat and processed products. Benefits for older adults include reducing the risk of cardiovascular disease, decreasing chronic diseases and pro-inflammatory factors, and preventing obesity and cognitive decline. The overall impact improves bone and cardiovascular health, and strengthens the immune system.

The combination of resistance exercise and a Mediterranean diet offers a comprehensive approach to improving health and well-being throughout life, promoting physical and mental health, facilitating active and healthy aging, and being accessible and beneficial for people of all socioeconomic backgrounds


Eligibility Criteria:
Inclusion Criteria:

* Were 65 years or older were eligible for the study
* Had not been part of any resistance program in the last 12 months
* They could understand and follow the instructions, activities and protocols of the exercise program.

Exclusion Criteria:

* They suffered from any systemic condition (e.g., neurodegenerative, musculoskeletal, or visual diseases) that prevented them from performing the exercises.
* Had any vestibular disease or disorder
* Consumed medications that influenced the central nervous system, balance or coordination (for example, antidepressants, vestibular sedatives or anxiolytics).
Rhythmic Handwriting Deficits and General Rhythmic Abilities in Children

Patients with Developmental Coordination Disorder (DCD), a neurodevelopmental disorder that affects motor skills and motor learning (APA, 2013), have been reported to manifest rhythmic deficits in handwriting domain, as well as general rhythmic deficits (i.e., regardless handwriting context per se) (Rosenblum \& Regev, 2013). Accordingly, children with DCD struggle in tasks like synchronising to an external musical rhythm (in rhythm production tasks) or even in discrimination tasks such as detecting beat deviations, i.e., in rhythm perception tasks (INSERM collective expertise, 2019).

These rhythmic deficits which manifest in a variety of tasks and conditions support the hypothesis of a "generalised dysrhythmia" in DCD, according to which the rhythmic deficits - in perceptual tasks and motor production - could have a common source, namely a mechanism devoted to rhythm processing (a cerebral mechanism involved in the perception of rhythm) and independent of the effectors involved and the type of task considered.

However, the nature of the relationships between general rhythmic skills (perceptual and motor) and rhythmic abilities when engaged in handwriting movement is largely unknown in DCD. Whether a common source drives these diverse rhythmic deficits remains to explore. If this hypothesis were to be confirmed, this would pave the way for innovative therapeutic tools (e.g., serious games) for training a central rhythmic processing mechanism (rhythm perception), which could positively impact in turn rhythmicity of thandwriting movement in this population.


Eligibility Criteria:
Inclusion Criteria:

* Children aged 7 to 10 inclusive
* Children who can read and write
* Diagnosis of DCD according to DSM-5 criteria (APA, 2015)
* Native French speaker
* Living with at least one parent

Exclusion Criteria:

* Intellectual development disorder confirmed or suspected during the initial evaluation phase in the MPEA department.
* Presence or suspected presence of a visual impairment at the root of the motor skills deficit.
* Presence or suspected presence of a neurological motor disorder (e.g. sensory impairment, cerebral palsy, muscular dystrophy, degenerative disease).
* Not affiliated to a social security scheme or not benefiting from such a scheme.
* Absence of written, informed consent from parents.