cyrilzakka/clinical-trials huggingface dataset:
WarmSmart Warming Protocol

Hypothermia during surgery and in the postoperative period is associated with adverse outcomes including impaired drug metabolism, cardiac morbidity, shivering, impaired immune function, coagulopathy, and increased use of hospital resources. Several clinical studies have demonstrated that maintenance of normothermia during the perioperative period significantly reduces morbidity.

Mercury Biomed has developed a patient-warming system, WarmSmart, that potentially transfers adequate heat through hands and feet based on the physiological principle of peripheral arterio-venous shunt vaso-dilation. The technology works as a two-step process by selective thermal stimulation along the spinal cord to up-regulate blood flow to arterio-venous shunts and triggering arterio-venous shunt vasodilation and by applying circulating water heat exchangers to the palmar and plantar glabrous skin to warm highly perfused shunts in that area.

General anesthesia reduces the vasoconstriction threshold (triggering core temperature) by 1-2°C, thus promoting arteriovenous shunt dilation. It remains unknown, though, whether cervical spine warming further augments arterio-venous shunt dilation during general anesthesia. If spine heating proves unnecessary under anesthesia, Mercury Biomed's WarmSmart warming could be simpler and less expensive. Investigators therefore propose to test the hypothesis that cutaneous heating near the cervical spine does not further augment arterio-venous flow in fingers during general anesthesia.

Investigators propose to enroll ten patients. The patients will be pre-warmed and warmed intraoperatively with forced-air to maintain a core temperature near 36°C.

A ThermaZone® Device capable of heating the cervical spine area will be positioned behind the patient's neck upon arrival in the operating rooms. Additionally a forced-air warmer will be positioned appropriately and activated as soon as practical, usually after prepping and draping. Ambient temperature will be maintained near 20°C.

After about one hour of anesthesia when temperature and other factors are stable, investigators will start a 30-minute observation period. Thereafter investigators will activate the cervical spine warming system for 30 minutes (warming measurement period) and thereafter have a 30 minutes control period again.

Measurements will be recorded such as mean-skin temperature, distal esophageal temperature, MAC fraction, mean-arterial pressure and finger blood flow.


Eligibility Criteria:
Inclusion Criteria:

1. Body-mass index 20-33 kg/m2;
2. Age 18-70 yrs;
3. ASA Physical Status 1-3.

Exclusion Criteria:

1. Serious skin lesions on the hands or arms;
2. History of serious vascular disease in the arms, including Raynaud's Syndrome;
3. Pre-operative fever or infection;
4. Surgery expected to be supine and in neutral position.
First-In-Human Dose-Escalation Study of STP1002 in Patients With Advanced-Stage Solid Tumors

This is an open-label, multicenter, dose-escalation study to evaluate the safety, tolerability, and pharmacokinetics (PK) and to determine the maximum tolerated dose (MTD) of STP1002 in patients with advanced-stage solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Advanced-stage solid tumor (metastatic or locally advanced and unresectable) with histologically confirmed diagnosis of CRC, NSCLC, GC, RCC, or HCC
* Measurable lesion(s) according to RECIST 1.1 criteria
* Performance status of ≤ 2 on the Eastern Cooperative Oncology Group (ECOG) scale.
* Ability to swallow capsules
* Received last chemotherapy, biologic, or investigational therapy at least 4 weeks prior to first dosing of study treatment
* Has received or is intolerant to all standard of care treatment options with known clinical benefit
* Life expectancy of more than 3 months
* Adequate hematological, hepatic and renal function
* For women of childbearing potential, a negative serum pregnancy test performed within 7 days prior to start of treatment

Exclusion Criteria:

* Received treatment within the last 28 days with a drug that has not received regulatory approval for any indication at the time of study entry
* Major surgery within the last 28 days prior to the first dose of investigational drug
* Prior radiation therapy within 14 days prior to study Cycle 1 Day 1 and/or persistence of radiation-related adverse effects.
* Concurrent treatment with any anticancer agent
* Currently taking either strong CYP inhibitors or inducers
* Known brain metastases, uncontrolled seizure disorder, or active neurologic disease
* Significant cardiovascular impairment
* Pregnant or nursing
* Known HIV infection, active hepatitis C and/or hepatitis B infection
* Known bleeding disorder or coagulopathy
* Active drug or alcohol abuse or history of alcohol or drug abuse during the last two years.
* Diagnosis of osteoporosis at the time of the screening
* Any history of retinal pathology including diabetic retinopathy, macular degeneration, or other retinal degenerative disease
A Comparison of the Alignment Achieved Using Computer-guided Indirect Bonding of Orthodontic Brackets to Conventional Appliance Placement

Technological advances have made computer aided orthodontic treatment planning possible. 3D dental scanners and software make it possible to design and approve the outcome before treatment begins. Manufacturers have provided different customized appliance systems that would help practitioners achieve those computer-designed outcomes. The purpose of this study is to determine the accuracy of computer-guided indirect bonding of orthodontic brackets at achieving the predicted alignment and comparing that to the accuracy of conventional orthodontic bracket placement at achieving a predetermined goal. The results of this study will help orthodontists and patients know if there is an advantage to using custom appliances. The study will be a prospective clinical study and will include a total of 60 arches from 30 patients enrolled at the Harvard School of Dental Medicine. 15 patients will be assigned to each of the two study groups (Motion View or control). Both groups will have a 3D intra-oral scan to measure the initial discrepancy and determine the computer-simulated design that the orthodontist believes is the optimized outcome. At the end of each patient's participation, a 3D intraoral scan will be taken and used to assess intra-arch leveling and alignment using ABO's objective grading system's criteria for alignment, marginal ridges and buccolingual inclination. Each arch will then be superimposed on the predicted outcome to determine how accurate each system was at achieving the planned movements in all 3 dimensions. We hypothesize that the accuracy of computer-guided indirect bonding (Motion View) at achieving the predicted outcomes will differ in comparison to the accuracy of conventional orthodontic bracket placement at achieving a predetermined goal.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects seeking orthodontic care
* All permanent teeth must be erupted, excluding second and third molars
* Class I, II, and III cases
* No more than 7 mm crowding
* No more than 45 degrees of rotations

Exclusion Criteria:

* Presence of systemic disease
* Craniofacial anomalies, including cleft lip and palate
* Syndromes affecting bone or teeth
* Congenitally missing teeth, excluding third molars
* Presence of bridges or implants
* Periodontal disease
* Use of drugs affecting tooth movement or bone metabolism (NSAIDS, bisphosphonates, PTH, corticosteroids)
* Pregnancy
Cartoon Distraction and Parental Presence on Anxiety in Pediatric Anesthesia

Nearly 50% of young children undergoing surgery exhibit high level of anxiety during induction of anesthesia because of exposure to unfamiliar environment and people and separation from parents. Increased preoperative anxiety may impact postoperative behavior changes such as emergence agitation, separation anxiety and sleep disturbance. Although some pediatric anesthesiologists routinely permit parental presence to reduce the anxiety during induction of anesthesia, previous studies have reported conflicting results. Recently the distraction using video game or animated cartoon has been reported to reduce anxiety of young children during induction of anesthesia. However, it was still undetermined whether distraction has its own ability to reduce children's anxiety separated from parental presence because they evaluated the effect of video method in the parental presence. The investigators design to investigated the efficacy of distraction with watching cartoon, parental presence and combined with watching cartoon and parental presence on reduction of anxiety during inhalational induction of anesthesia using sevoflurane. In addition this study includes long-term effect of each intervention such as postoperative emergence agitation and postoperative behavior change in children.

This study is different from previous reports as follow. First, investigators separate the effect of cartoon distraction and parental presence on minimizing preoperative anxiety and determine whether an interaction between two different interventions is existent. Second, investigators evaluate the effect of preoperative anxiety on the long-term behavioral change of children. It was not clarified yet in clinical practice. Third, investigators evaluate the effect of each intervention on parental anxiety before and after induction of anesthesia.

Eligibility Criteria:
Inclusion Criteria:

1. American Society of Anesthesiologists (ASA) physical status 1 and 2
2. 1-7 years old.
3. elective, single minor surgery under general anesthesia

Exclusion Criteria:

1.Chronic illness, psychological or emotional disorder, abnormal cognitive development 2.Previous anesthetic experience 3.Closure both eyes after surgery 4.Sedative medication or psychoactive drugs medication, 5.History of allergy to the drugs used in our study 6.Expected difficult intubation or respiration such as abnormal airway, reactive airway disease, upper respiratory infection in recent 3 weeks

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Mindfulness Based Intervention (MBI) on the Quality of Life and Non-Motor Symptoms (NMS) of Persons With PD

Scientific Abstract:

The investigators propose a study to examine the impact of a Mindfulness Based Intervention (MBI) on the quality of life and Non-Motor Symptoms (NMS) of persons with Parkinson's disease (PD).

NMS add significantly to the disease burden and negatively impact the quality of life in PD (1,2). In a previous study the investigators confirmed the high prevalence of NMS in PD patients with either early- or late-onset of disease (3). Despite currently available treatments, PD leads to worsening disability and there remains a need for new approaches. A Mindfulness Based Intervention may provide an important adjuvant therapy in the treatment of PD in relation to NMS and quality of life.

A minimum of 100 patients will be randomly assigned to the MBI or 'Treatment As Usual' (TAU) groups. Clinical assessments (motor and non-motor scores) will be performed in both groups. The TAU group will be offered MBI after completion of the study.

To the best of our knowledge, this is the first large scale study using MBI in this indication.

The investigators propose a study to examine the impact of a Mindfulness Based Intervention (MBI) on the quality of life and Non-Motor Symptoms (NMS) of persons with Parkinson's disease (PD).

NMS add significantly to the disease burden and negatively impact the quality of life in PD (1,2). In a previous study the investigators confirmed the high prevalence of NMS in PD patients with either early- or late-onset of disease (3). Despite currently available treatments, PD leads to worsening disability and there remains a need for new approaches. A Mindfulness Based Intervention may provide an important adjuvant therapy in the treatment of PD in relation to NMS and quality of life.

A minimum of 100 patients will be randomly assigned to the MBI or 'Treatment As Usual' (TAU) groups. Clinical assessments (motor and non-motor scores) will be performed in both groups. The TAU group will be offered MBI after completion of the study.

To the best of our knowledge, this is the first large scale study using MBI in this indication.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of PD according to the UK Brain Bank Criteria;
* Patients in Hoehn \& Yahr stage 1-3;
* Lack of features suggestive of atypical Parkinsonism;
* No history of neuroleptics or other drugs that induce parkinsonism in the last 60 days;
* Currently optimally treated with medication and unlikely to be requiring anti-PD medication adjustments in the next 4 months;
* On a stable dose of all medications for 30 days;
* Lack of cognitive dysfunction as based on the MoCA (score ≥ 26).

Exclusion Criteria:

* Cognitive dysfunction based on the MoCA (score \< 26);
* Patients with Hoehn \& Yahr stage 4 and above when in 'on' stage;
* Unstable, major psychiatric or life threatening concomitant disease.
Preventive Oral Care

The purpose of the investigators project is to examine if the investigators may affect a reduction in respiratory infections in a pediatric long term care facility by institution of a comprehensive oral care program. The investigators wish to base their project on work such as of Yoneyama et al 2002, which hypothesized and showed that "silent" aspiration of oropharyngeal contents is a causative factor in development of respiratory infection in elderly institutionalized clients. It was found that an advanced oral hygiene program greatly reduced the incidence of respiratory infection. Although no similar research projects were found to have involved children, the investigators hope that a similar program of oral care will allow the investigators to likewise reduce the incidence of respiratory infection among the pediatric clients in our facility.

The investigators propose to examine two groups of children which are fed by gastrostomy feedings only. One group will continue to receive oral care as performed today. The study group will have their teeth brushed three times a day by the nursing staff by using a suction connected toothbrush, daily examination of the oropharynx by the nursing staff, and use of chlorhexidine varnish or another suitable antibacterial agent in the oropharynx.

The investigators will retrospectively examine our records (a 12 month period) for febrile days, antibiotic use and hospitalization days due to respiratory causes. The investigators will then compare these to the febrile days, antibiotic use and hospitalizations to the 12 month period \[post implementation of the oral care program.

The importance of this program is to examine whether by implementation of a relatively inexpensive and low-tech intervention may meaningfully reduce the morbidity and mortality due to respiratory infection among our clients (which from our experience is the main cause of morbidity and mortality in the investigators institution). The investigators expect that by reducing the incidence of respiratory disease among our clients that the investigators will greatly reduce suffering among the children and their families, improve their quality of life and ease the financial and organizational burdens as a result of caring for respiratory infections.

As was noted before, no prior research was found which studied the pediatric population in a long term care facilities. It is our belief that this project represents a unique research opportunity which may bring great benefit to the children and caregivers.


Eligibility Criteria:
Inclusion Criteria:

* Clients who receive gastrostomy feedings only
* ALEH Infirmary

Exclusion Criteria:

* Oral Feeding
Radiofrequency Technic's Impact on Perineal Postpartum Pain

A study in the postpartum period reveals that among women who delivered vaginally and having perineal lesions, between 95 and 100% of them suffer from perineal pain (episiotomy, tears from 1st to 4th degree) to 24 hours of vaginal delivery; and between 60 and 91% 7 days after delivery.

Severe pain that is not taken into account can become chronic pain. It has physical and psychological consequences. It is therefore essential to prevent these risks in young mothers.

The main objective of this study is to assess the efficacy of radiofrequency treatment on perineal pain postpartum, after a vaginal delivery, instrumented or not, in patients with perineal lesions.

A double-blind randomized prospective single-center study will be conducted on patients delivering at Marseille's north hospital.

Women who gave birth to the North hospital site, with perineal lesions (tears, episiotomy) will be invited to enroll in the study.

Patients will be then randomized into two groups, one with radiofrequency treatment, the other without treatment with radiofrequency.

The duration of inclusion is provided over 6 months. Each topic will be followed over a period of 1 month. The total study duration is 7 months.

The expected results are a significant reduction in pain scores during the first days postpartum in women with perineal alteration caused by a vaginal delivery instrumented or not. Also an improvement in the quality of life of patients during the first days.


Eligibility Criteria:
Inclusion Criteria:

* Patients who naturaly delivered with ou without instruments such as Suction cup, spatulas, forceps
* Patients presenting perineal lesions

Exclusion Criteria:

* Patients who delivered through cesarean section
Association Between Fibrinogen-to-albumin Ratio and Delirium After Deep Brain Stimulation Surgery in Parkinson's Disease

Postoperative delirium (POD) remains one of the most common neuropsychiatric complications after deep brain stimulation (DBS) surgery. The fibrinogen-to-albumin ratio (FAR) has been shown to significantly correlate with prognosis of many diseases associated with inflammation, but the relationship between FAR and POD is unclear. The investigators aimed to investigate the association between POD and FAR in Parkinson's disease (PD) patients receiving DBS surgery. For this aim, the present study was conducted to provide a new method for the early recognition and perioperative management of delirium after DBS surgery in PD patients.


Eligibility Criteria:
Inclusion Criteria:

* Over 55 years old
* American Society of Anesthesiologists (ASA) physical status I-III
* Bilateral subthalamic nucleus deep brain stimulation surgery

Exclusion Criteria:

* Preoperative delirium
* Missing preoperative laboratory parameters on fibrinogen or albumin
* Persistent infectious diseases
* Coagulopathy and autoimmune-illness or malignancies
Catestatin and Hypertension in Pregnancy

Catestatin is a kind of protein involved with cardiovascular disease. Accumulated evidence shows that Catestatin may be a predictor of primary hypertension, but whether it plays the same role in pregnant hypertensive disorders needs to be determined. By measuring the plasma level of Catestatin, main biochemical marks and UCG in healthy pregnancy and pregnancy with hypertension, the research may contribute to this problem.


Eligibility Criteria:
Inclusion Criteria:

* Healthy pregnancy women
* Pregnancy women with hypertension

  1. Despite the pregnant gestational age , systolic blood pressure ≥140 mm Hg OR a diastolic blood pressure of ≥90 mm Hg measured three times more than 24 hours apart
  2. Pregnant gestational age \> 20 weeks, systolic blood pressure ≥140 mm Hg OR a diastolic blood pressure of ≥90 mm Hg measured twice more than 4 hours apart

Exclusion Criteria:

* Lack of blood sample at the specified enrollment period
* Women who refuse the study
* Other illness which needs medications interfering with blood pressure (eg: Asthma requiring systemic steroids)
* Known coronary artery disease or heart failure
* Serious medical illness (eg: renal insufficiency, congestive heart disease, chronic respiratory insufficiency, uncontrolled infection).
* multiple endocrine neoplasia or Cushing's syndrome or mixed tumours or pheochromocytoma or medullary thyroid carcinoma.
* previous history of malignant tumour, with the exception of carcinoma in situ of the uterine cervix or non-melanoma skin cancer
* renal insufficiency
Stemchymal® for Polyglutamine Spinocerebellar Ataxia

The purpose of the clinical trial is to study the therapeutic efficacy and safety of Stemchymal® infusions for polyglutamine spinocerebellar ataxia treatment by a randomized, double-blind, placebo-controlled study design. Eligible subjects will receive Stemchymal® through intravenous infusion.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects are with genotypically confirmed SCA3.
2. Subjects' SARA scores are in the range of 5 to15.
3. Subjects are between 20 and 70 years of age.
4. Subjects who have signed informed consent.
5. Female subjects of child-bearing potential who are capable of conception must be post-menopausal (one year or greater without menses), surgically incapable of childbearing, or practicing effective methods of birth control.
6. Male subjects must be practicing a medically accepted form of contraception during the study period. Abstinence is an acceptable method of contraception.

Exclusion Criteria:

1. Subjects who have been enrolled in any kind of cell therapy within six months prior to screening visit (Visit 1).
2. Female subjects who have a positive pregnancy test result.
3. Subjects who have had severe vital organ diseases, including but not limited to cardiac (e.g., heart failure), liver (e.g., acute hepatic failure or chronic liver cirrhosis), lung (e.g., respiratory failure) and renal (e.g., hemodialysis or peritoneal dialysis) diseases, within six months prior to screening visit (Visit 1).
4. Subjects with immunological disorders (e.g., systemic lupus erythematosus), within six months prior to screening visit (Visit 1).
5. Subjects with other neurological disorders (e.g., Alzheimer's disease), within six months prior to screening visit (Visit 1).
6. Subjects who had received chemotherapy/radiotherapy within five years prior to screening visit (Visit 1).
7. Subjects with any history of malignant tumors.
8. Subjects with dementia or other psychiatric illnesses, including but not limited to disabling depression, bipolar disorder, schizophrenia.
9. Subjects with a Beck Depression Inventory Second Edition (BDI-II) score of over 20 points.
10. Subjects not suitable for this clinical trial according to investigator's judgment.