cyrilzakka/clinical-trials huggingface dataset:
A Protocol to Streamline Dental Care in Autistic Children

The investigators aim at creating a dedicated pathway to allow accessibility to dental care for ASD children within a hospital Dentistry Department, in order to diminish the need for general anesthesia. Visual pedagogy, parent training, a strict schedule for appointments (every two months) spanning over three years and longer duration of dedicated examination are set up for a group of ASD children, whose behavior is compared to that of children seen one or twice a year.

Treated group:

Enrollment: caregivers receive instructions and a visual pedagogy aid with instructions for toothbrushing. They complete also enrollment and informed consent forms.

At the first visit: caregivers receive a dental mirror to be used at home. Children are free to explore the office and dental room.

Subsequent visits, every two months for three years: trials are made to establish contact with children, make them seat at the dentist's chair, execute dental visits and treatments as needed.

Control group: subjects (similar inclusion and exclusion criteria) that access the Department for clinical reasons or control visits, but cannot comply with the strict two-months schedule.

Eligibility Criteria:
Inclusion Criteria:

* Age: 4 to 13 years old at the beginning of the treatment,
* Diagnosis: formally diagnosed by a Neuro-psychiatrist and recognized by authorities (for school support) as having Autistic Spectrum Disorder (ASD), possibly also in the frame of genetic syndromes, or Pervasive Developmental Disorder-Not Otherwise Specified (PDD-NOS), a diagnosis present in DSM 4 and merged to ASD in DSM 5.

Exclusion Criteria:

* Age outside the selected range
* additional diseases, preventing autonomous oral hygiene (e.g., motor diseases),
* for the Treated Group: familiarity with dental treatments (possible one or few visits in the past, but not on a regular base)
Is There a Relationship Between Stress Tolerance and Analgesic Consumption in Obese Patients?

Preoperative anxiety level of patients affects postoperative analgesic consumption. However, there were no studies that showed a relationship between the level of stress tolerance and analgesic consumption in the literature. In this study, investigators wanted to investigate the effect of stress tolerance on analgesic consumption of patient.

After approval, patients enrolled in the study is invited to complete the Pain Catastrophizing Scale questionnaire, Distress Tolerance Scale and Beck anxiety scale.After surgery, VAS scores of the patients will be evaluated (in the recovery room, 2,6,12 and 24 hours). and patients with VAS\> 3 will receive 2 mg of morphine.The relationship between total analgesic consumption and the stress tolerance will be evaluated.The study will be performed with 69 sleeve gastrectomy patients(BMI\>30).

Eligibility Criteria:
Inclusion Criteria:

* Between 18 and 60 years
* Planned to sleeve gastrectomy
* An American Society of Anesthesiologists score of 1 or 2 BMI\>30

Exclusion Criteria:

* Psychiatric diseases
* Rejected to participation
Validation of a Midwifery Model in Palestine 2

A midwife-led continuity model of care was implemented in governmental maternal facilities in Palestine. Midwives from the hospitals provided outreaching caseload ante- and postnatal care to women in rural villages clinics and homes. This study investigated if the model had impact on important maternal and neonatal health outcomes. A retrospective cohort design was used.

Background: A midwife-led continuity model of care was implemented in governmental maternal facilities in Palestine. Midwives from the hospitals provided outreaching caseload ante- and postnatal care to women in rural villages clinics and homes. This study investigated if the model had impact on important maternal and neonatal health outcomes.

Method: A retrospective cohort design was used. Nablus governmental hospital, Rafidia's medical records were reviewed and data extracted involving 2199 women with singleton pregnancies, residing in rural villages, and their new-born babies born between January 2016 and February 2017. Outcomes were limited to the available information in the hospital's birth registry. Important maternal outcomes were postpartum anaemia (Hb \<11), mode of delivery and induction of labour. Important outcomes for new-borns were premature delivery \< 37 weeks, birth weight \< 2500g and 1500g and referral to neonatal intensive care unit. Outcomes were compared between women receiving the midwife-led continuity model of antenatal care and women receiving regular care.

Eligibility Criteria:
Inclusion Criteria:

* Women with singleton pregnancies residing in rural areas giving birth at Nablus governmental hospital, Palestine

Exclusion Criteria:

* Multiple pregnancies
* Women residing in urban areas
The Effect of Gum Chewing on Postoperative Ileus

The purpose of this study is to see if chewing gum after surgery for perforated appendicitis will shorten the time of intestinal dysfunction.

After operations for a ruptured appendix, children are usually not allowed to eat or drink anything. This is because the infection inside the abdomen and the manipulation of the intestines during the operation cause the bowels to stop their normal movement. The resulting lack of bowel function is called an "ileus". When this occurs, intestinal secretions and anything taken in by mouth can become backed up, causing bloating, abdominal pain, nausea and vomiting. Children are not allowed to eat or drink anything during this time and require fluid hydration through an IV or even nutrition through an IV. This ileus usually lasts an average of 4-5 days, and can sometimes delay the discharge of children who are otherwise ready to go. The purpose of this research study is to determine if simple things, like gum chewing or anti-motion sickness bracelets can help speed the time it takes for the bowels to begin working after an operation for a ruptured appendix. Because the gum is not swallowed, it does not have the same effects as eating and drinking would on someone with an ileus. The same is true for the anti-motion sickness bracelets. Yet, it is thought that the chewing action from gum may stimulate the intestines into thinking that food is on the way and cause them to start working sooner than they otherwise might. The same may be true for the bracelets, and some studies show them to be helpful with nausea after surgery. Nevertheless, the effects of a bracelet on postoperative ileus are unproven.

Eligibility Criteria:
Inclusion Criteria:

* any child who has undergone appendectomy for perforated appendicitis

Exclusion Criteria:

* age less than or equal to 5 years
* unable to chew gum safely
* interval appendectomy
Mesothelin/GPC3/GUCY2C-CAR-T Cells Against Cancers

The second generation of mesothelin targeted CAR-T cells that secret a fusion protein of IL21 and scfv against PD1 have been constructed and their anti-cancer function has been verified by multiple in vitro and in vivo studies. Clinical studies will be performed to test anti-cancer function of the CAR-T cells for immunotherapy of human cancer patients with Mesothelin expressions. In this phase I study, the safety, tolerance, and preliminary efficacy of the Mesothelin-CAR-T cell immunotherapy on human cancers will firstly be evaluated.

1. Choose appropriate patients with advanced pancreatic cancer or other cancers, with written consent for this study;
2. Perform biopsy to determine the expression of Mesothelin of the tumors by western blotting or IHC;
3. Collect blood from the patients and isolate mononuclear cells, activate the T cells and transfect the T cells with Mesothelin targeting CAR, amplify the transfected T cells as needed, test the quality and killing activity of the CAR-T cells and then transfer them back the patients via systemic or local injections, and follow up closely to collect related results as required;
4. To enhance the killing capability, cotreatment the patients with PD1/PDL1/CTLA4 antibodies may be applied;
5. Evaluate the clinical results as needed.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with advanced cancer that expresses Mesothelin protein; 2. Life expectancy \>12 weeks; 3. Adequate heart, lung, liver, kidney, and blood function; 4. Available autologous transduced T cells with greater than or equal to 20% expression of Mesothelin-CAR determined by flow-cytometry and killing of Mesothelin-positive targets greater than or equal to 20% in cytotoxicity assay; 5. Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent.

-

Exclusion Criteria:

1. Had accepted gene therapy before;
2. Severe virus infection such as HBV, HCV, HIV, et al;
3. Known HIV positivity;
4. Active infectious disease related to bacteria, virus,fungi,et al;
5. Other severe diseases that the investigators consider not appropriate;
6. Pregnant or lactating women;
7. Systemic steroid treatment (greater than or equal to 0.5 mg prednisone equivalent/kg/day);
8. Other conditions that the investigators consider not appropriate. -
Three Doses of TAS-108 to Treat Recurrent or Recurrent Inoperable Breast Cancer

This study is being done to find out how safe TAS-108 is and how well TAS-108 works on recurrent or recurrent inoperable breast cancer.

The objective of this study is to investigate the efficacy and safety of TAS-108 administered in postmenopausal patients with locally advanced or locally recurrent inoperable or progressive metastatic breast carcinoma who have previously responded to one or two standard endocrine therapies, with or without one prior chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal females
* Histologically or cytologically confirmed diagnosis of breast carcinoma
* Locally advanced or locally recurrent inoperable or metastatic breast carcinoma with documented disease progression
* Has laboratory documentation of positive estrogen receptor (ER) and/or progesterone receptor (PgR) status, and has responded to the standard first or second line hormonal anti-tumor therapy given
* Has received and whose disease progressed after one or two prior systemic hormonal anti-tumor therapies
* Performance status of greater than or equal to 2 on the Zubrod scale
* Predicted life expectancy of greater than or equal to 12 weeks
* Must give written informed consent
* Measurable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria
* Absolute granulocyte count of greater than 1,500/meqL, platelet count greater than 75,000/meqL, and a hemoglobin of greater than 10 g/dL
* Adequate liver and renal function as defined by a bilirubin of less than 1.5 times the upper limit of normal and a creatinine of less than 1.5 times the upper limit of normal
* Transaminases must be less than 2.5 times the upper limit of normal except for patients with liver metastases who may have transaminases less than 5 times the upper limit of normal.
* The patient has recovered from all previous anti-cancer treatment related to toxicities to at least Grade 1.
* All previous investigational drugs must be stopped at least four weeks before commencement of treatment with TAS-108.
Post-Marketing Surveillance Study: 12 To 24 Weeks Study On The Treatment Emergent Adverse Events In Patients With Type 2 Diabetes Taking Exenatide In Korea

The objective of this regulatory Post-Marketing Surveillance in Korea is to reconfirm the clinical usefulness of Exenatide through collecting, reviewing, identifying and verifying the safety and effectiveness information about Exenatide in general practice.


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Male or female at least 18 years of age
* Patients who are to initiate Exenatide treatment for type 2 diabetes at baseline, following their treating physicians' advice
* Patients, who in the opinion of the treating physicians, comply with all the recommendations stated in the relevant product information

Exclusion Criteria:

* Are simultaneously participating in a different study that includes a treatment intervention and/or an investigational drug
* Are pregnant or have intentions of becoming pregnant within the duration of the study
* Contraindications
The Effects of Altering Physical Activity on Cardiometabolic Health

The effects of physical inactivity on variations in blood glucose and vascular health are not fully understood. The purpose of this study is to determine if an acute transition from physical activity to inactivity alters vascular health. Specifically, the investigators wish to examine in healthy, lean physically active individuals (obtaining greater than 10,000 steps/day) if decreasing physical activity (obtaining less than 5,000 steps/day) will alter blood flow following a meal a marker of vascular health. Furthermore, the investigators wish to examine if a one day return to physical activity (obtaining \>10,000 steps/day) can restore the detrimental effects on blood flow following a meal.

Herein, we tested the hypothesis that an acute reduction in daily activity (from \>10,000 to \<5,000 steps/day) for 5 days in healthy individuals reduced meal-stimulated blood flow and if a 1 day return to activity improved this outcomes.

Eligibility Criteria:
Inclusion Criteria:

* BMI: less than 30 kg/m2
* Physically active: exercise greater than 60mins per week

Exclusion Criteria:

* smoking
* type 2 diabetes
* Underlying conditions that limit ability to exercise safely
* Recent weight gain or loss(\> 5% of body weight in 3 months)
* Recent (\< 3 mo) changes in medication use or dose
* Pregnancy
An Open-Label Study of an Ophthalmic Solution to Reduce Intraocular Pressure in Patients With Ocular Hypertension

The purpose of this study is to determine the safety and tolerability of topical C-KAD Ophthalmic Solution in reducing intraocular pressure in patients with ocular hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Both eyes having intraocular pressure in the range of 22-30 mmHg at baseline
* Both eyes having best corrected visual acuity better than 20/50

Exclusion Criteria:

* Advanced glaucoma
* Closed or barely open anterior chamber or history of angle closure
A Study of Fibrocaps in Liver Surgery in the Netherlands

A multi-center, prospective, randomized, single-blind, controlled, comparative efficacy and safety trial in subjects undergoing open liver resection surgery. The study will enroll 42 eligible subjects and be conducted at 4 sites in the Netherlands.

This will be a multi-center, prospective, randomized, single-blind, controlled, comparative efficacy and safety trial in 60 subjects undergoing hepatic resection. Subjects will be randomized in a 2:1 ratio to Fibrocaps + Gelfoam or Gelfoam on the day of surgery.

The Fibrospray device will be used to apply Fibrocaps to the Target Bleeding Site. All investigators using the Fibrospray device will be trained on the correct and safe set-up and use of Fibrocaps and the Fibrospray device prior to participating in this clinical trial.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female ≥ 18 years of age
2. Subjects who are able and willing to provide written and signed informed consent
3. Willing to use a medically accepted form of contraception from the time of consent to completion of all follow-up study visits
4. Has a life expectancy of at least one year
5. Presence of mild or moderate bleeding/oozing and control by conventional surgical techniques including but not limited to suture, ligature, and cautery is ineffective or impractical

Exclusion Criteria:

1. Pregnant or lactating women
2. Has a known intolerance to blood products or to Fibrocaps components
3. Unwilling to receive human blood products
4. Subject has a known allergy to porcine gelatin
5. Has a mental or physical condition that would, in the opinion of the Investigator, place the subject at an unacceptable risk or render the subject unable to meet the requirements of the protocol
6. Currently participating or has participated in another clinical study involving another investigational agent within 4 weeks of the planned date of surgery, or is planning participation in another clinical trial during the 4 weeks after surgery
7. Has any clinically-significant coagulation disorder that may interfere with the assessment of efficacy or pose a safety risk to the subject according to the Investigator
8. Platelets(PLT) \< 100 x109 PLT/L during screening
9. Activated Partial Thromboplastin Time (aPTT) \> 100 seconds during screening
10. International Normalized Ratio (INR) \> 2.5 during screening
Individualized PEEP in Thoracic Surgery

Intraoperative protective ventilation with low tidal volumes (TV), positive end-expiratory pressure (PEEP) and possibly lung recruitment maneuvers (RMs) reduces postoperative pulmonary complications. In thoracic surgery, in one-lung ventilation (OLV), the evidence is lacking. However, in this context protective ventilation with PEEP titration is related to better intraoperative oxygenation and respiratory mechanics. It is not clear whether this strategy is associated also with better postoperative oxygenation and less postoperative pulmonary complications.

In this randomized controlled trial the investigators will enroll 42 patients scheduled for elective thoracic surgery (minithoracotomic or video-assisted thoracoscopic segmentectomies and lobectomies). Patients will be randomized in two groups: BEST PEEP and STANDARD PEEP. In OLV the investigator will set a TV = 5ml/kg IBW in volume control ventilation (VCV) and an adequate respiratory rate (RR) to keep PaCO2 \< 60 mmHg. With the patient in lateral decubitus and open chest, a cycling step RM (in pressure control ventilation, RR =10/min, I:E=1:1, up to Paw = 40 cmH20 with a PEEP = 20 cmH2O, lasting 2.5 minutes) and a PEEP decremental titration trial (in VCV, from 16 to 4 cmH2O) will be performed to all patients. Then, after another RM, in STANDARD PEEP group a PEEP of 5 cmH2O will be set, and in BEST PEEP group an individualized PEEP (the one corresponding to the lower driving pressure, +2 cmH2O) will be applied till the end of surgery. A blood gas analysis will be performed before surgery, with the patient in supine position breathing room air (T1). The respiratory mechanics (Ppeak, Pplateau, PEEP, driving pressure) and blood gas (PaO2, PaCO2, pH, HCO3, lactates) parameters will be then collected at the following time points: T2 - 5 minutes after induction, patient supine, two lung ventilation; T3 - lateral decubitus, chest open, OLV, before RM; T4 - 10 minutes after second RM; T5, 6, 7 - every hour after T4; T8 - at the end of OLV, before lung re-expansion; T9 - patient supine, two lung ventilation, before neuromuscular block reversal. Postoperatively all patients will spend at least one hour in a Recovery Room, in oxygen-therapy through a Venturi mask with FiO2 = 60%. A blood gas analysis and data about pain (NRS scale 0-10) and sedation (Ramsey score) will be collected at 1 hour postoperatively (T10). The primary outcome of the study is intra- and postoperative oxygenation and secondary outcomes are intraoperative respiratory mechanics parameters.

Eligibility Criteria:
Inclusion criteria:

* Patient's consent to the trial
* Candidate to elective lung lobectomy or segmentectomy (minimally invasive thoracotomy or video-assisted thoracoscopy)
* ASA class 1-3
* BMI \< 30 kg/m2

Exclusion criteria:

* Pregnancy
* Previous pneumothorax,
* Emphysematous bullae
* Severe COPD
* METs \< 4 due to cardiac disease
IVIG Versus Plasmapheresis in the Treatment of Guillian Barrie Syndrome Patients

In this study, the investigators address the question: whether treatment with IVIG is superior to treatment using plasmapheresis for functional recovery of patients with GBS? Recovery was quantified using: The changes in the A-Clinical grading scale MRC ( medial research council sum score ) and B-overall neuropathy limitations scale as the primary outcome and the changes in Neurophysiological study 3 months after treatment as a secondary outcome.

This information will be used to evaluate which treatment is more beneficial to GBS patients.

Guillain-Barré syndrome (GBS) is an inflammatory disease of the PNS and is the most common cause of acute flaccid paralysis, with an annual global incidence of approximately 1-2 per 100,000 person-years. Patients with GBS typically present with weakness and sensory signs in the legs that progress to the arms and cranial muscles, although the clinical presentation of the disease is heterogeneous and several distinct clinical variants exist. Diagnosis of GBS is based on the patient's history and neurological, electrophysiological, and cerebrospinal fluid (CSF) examinations. Electrophysiological studies: provide evidence of peripheral nervous system (PNS) dysfunction and can distinguish between the subtypes of GBS: acute inflammatory demyelinating polyradiculoneuropathy (AIDP), acute motor axonal neuropathy (AMAN), and acute motor-sensory axonal neuropathy (AMSAN). Disease progression can be rapid, and most patients with GBS reach their maximum disability within 2 weeks. About 20% of patients with GBS develop respiratory failure and require mechanical ventilation. Cardiac arrhythmias and blood pressure instability can occur owing to the involvement of the autonomic nervous system. Immunomodulatory therapy should be started if patients are unable to walk independently for 10 m. Evidence on treatment efficacy in patients who can still walk independently is limited, but treatment should be considered, especially if these patients display rapidly progressive weakness or other severe symptoms such as autonomic dysfunction, bulbar failure, or respiratory insufficiency. Clinical trials have demonstrated a treatment effect for intravenous immunoglobulin (IVIg) when started within 2 weeks of the onset of weakness and for plasma exchange when started within 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Age: 18-70 years old,
* Onset: Recent onset of GBS through the first 2 weeks.
* Gender: Male or Female Inclusion Criteria.

Exclusion Criteria:

* patients with metabolic disorders, or malignancy,
* other causes of peripheral neuropathy
Feasibility of Constant Work Rate Testing to Detect Exercise-induced Laryngeal Obstruction

TITLE Feasibility of constant work rate testing to detect exercise-induced laryngeal obstruction

DESIGN Prospective observational pilot study

AIMS To investigate if constant work rate testing at different work rates will sufficiently induce detectable exercise-induced laryngeal obstruction (EILO) using CLE.

POPULATION Adult patients with EILO

DURATION 01.09.2022 - 30.06.2023


Eligibility Criteria:
Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the study.
* Male or Female, aged 18 or above with a clinical suspicion of having EILO.
* Individuals with concurrent asthma can participate in the study provided that their asthma is well-controlled, determined by a negative bronchoprovocation test.

Exclusion Criteria:

* No EILO found in Clinical standard-of-care CLE test
* Not able to complete the exercise test for other reasons than breathlessness or leg fatigue (e.g. injury, disease or disability preventing cycling to maximal exertion).
* Comorbidities other than asthma, which, judged by the investigator, might confound the test results or pose a medical risk to the patient (e.g. cardiac disease, exercise-induced anaphylaxis).
* Current smokers (\< 6 months of stopping) or individuals with a significant smoking history (\>10 pack years).
* Pregnancy.