cyrilzakka/clinical-trials huggingface dataset:
Expanded Access Protocol for Subjects Previously Treated With Gedatolisib in B2151009

Continued access to treatment for subjects who continue benefit from therapy with gedatolisib in combination with palbociclib, and fulvestrant or letrozole.

The primary purpose of this study is to provide continuing access to treatment for subjects who continue benefit from therapy with gedatolisib in combination with palbociclib, and fulvestrant or letrozole.

Eligibility Criteria:
Inclusion Criteria:

1. Currently enrolled in the B2151009 clinical study and benefiting from treatment with gedatolisib in combination with other therapies as determined by the Investigator
2. Previously demonstrated compliance and are willing and able to comply with scheduled visits, treatment plans, and other study procedures
3. No evidence of progressive disease, as determined by the Investigator
4. Provide written informed consent prior to enrolling and receiving treatment

Exclusion Criteria:

1. Permanently discontinued from treatment in Study B2151009, or discontinued from Study B2151009 for any reason
2. Women who are pregnant, intend to become pregnant, or nursing
Prospective Randomized Trial of Moderate vs Deep Neuromuscular Blockade During Laparoscopic Ventral Hernia Repair

The proposed study aims to assess the effect of different levels of muscle relaxation on the success of low-pressure insufflation, surgical conditions and patient recovery following laparoscopic repair of a ventral hernia (VHR) between 2 and 10cm in diameter. Patients will be randomized to moderate (TOF 1-2) or deep (post tetanic count 1-2) relaxation.

Specific Aim 1. Compare two different modes of neuromuscular blockade (moderate and deep) on the ability to maintain low insufflation pressure during laparoscopic VHR. All procedures will start with low-pressure insufflation (8 mm Hg). Surgeon assessment of the conditions will be serially performed during surgery on an established visual scale. If conditions are deemed less than adequate (score 1-2), insufflation pressure will incrementally increase up to 15 mm Hg. Outcome for this specific aim will be the mean insufflation pressure during each procedure, and the ability to perform low-pressure laparoscopic VHR.

Specific Aim 2. Evaluate the success of moderate neuromuscular blockade on the ability to maintain good conditions (visual scale grade 4 or 5) for each. Surgical conditions will be considered successful when scores are maintained at 4 or 5 throughout the duration of the procedure. Outcome for this aim will be the mean score for surgical condition assessment for each procedure, using a previously published surgeon-driven scoring system (score 4-5 will be used as a surrogate of good visualization).

Specific Aim 3. Assess patient recovery with low and high insufflation pressures during laparoscopic VHR. Patient overall satisfaction with recovery, pain level, pain medication requirement, PONV incidence and severity will be assessed in multiple time points following surgery. Outcomes for this aim will be mean pain (visual scale), PONV severity (analogue score) and incidence (binary outcome), and patient satisfaction using the QoR-15 survey. Assessments will be performed at 30 minutes, 1, 12 and 24 hours following surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients age 18-75 years old
* Umbilical, ventral, epigastric, spigelian or incisional hernia
* Plan for laparoscopic ventral hernia repair with mesh
* Estimated fascial defect between 2-10 cm in maximum diameter

Exclusion Criteria:

* Allergy to medications delineated in the protocol (muscle blockade, anesthetics, reversal agents)
* Inability to provide informed consent
* Body mass index of 35 or over
* Multiple recurrent hernias (\>1)
* Creatinine clearance \< 30 ml/min (using the Cockcroft-Gault calculation)
Neonatal Non-Invasive Hemoglobin Determination

The purpose of this study is to evaluate hemoglobin (Hgb) measurement by Masimo-developed pulse co-oximetry in pediatric patients weighing less than 3 kilograms (Kg).

This collaborative study with Masimo Corporation will involve 2 phases. In the first phase of this study, 25 subjects weighing 0.5 to 3.0 kg will be recruited and hemoglobin values will be obtained from the non-invasive probe at the same time as blood samples are routinely drawn for Hgb analysis using the cyanomethemoglobin method (ADVIA 2121). Masimo Corporation will use this data to calibrate or modify the hemoglobin reading (SpHb®) sensors and monitors. All results and conclusions from this phase will be discussed with the investigation team in order to determine if additional subjects are needed (at increments of 25 subjects at a time). Once the sensor designs have been optimized, another group of patients will be studied to document the accuracy and precision of the hemoglobin reading (SpHb®) measurements.

Eligibility Criteria:
Inclusion Criteria:

1. Males or females weighing 0.5 kg to 3 kg.
2. Neonates and infants and children admitted to the Children's Hospital of Philadelphia (CHOP)operating room (OR), PICU and NICU where hemoglobin measurements are anticipated.
3. Parental/guardian permission (informed consent)

Exclusion Criteria:

1. Subjects where blood samples are obtained through access types other than venous or arterial (e.g: intraosseous).
2. Subject weighing more than 3 kg.
3. Subjects who are too small or with any anatomical limitations that would preclude proper attachment of the adhesive sensor.
4. Any skin rash on the intended site of measurement. Severe allergy to adhesive tapes.
Acute Effects of an Herbal Tea on Immune Surveillance and Activation.

A small cross-over trial on 24 people involving an herbal tea blend to test whether consuming 1 cup of tea triggers changes in the numbers of natural killer cells in the blood circulation as evidence of immune cell trafficking within 2 hours.

A randomized, cross-over, controlled study design will be used to evaluate the effects of consumption of 1 cup of an herbal tea blend to consumption of the same volume of warm water. The study is of 3 weeks' duration, with evaluation of the herbal tea blend versus warm water at week 1 and week 2 with a one week washout between visits. On each visit, a baseline blood draw is performed, followed by consuming of the herbal tea blend or warm water. Blood draws are performed at 1 and 2 hours after consumption.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults;
* Age 18-75 years (inclusive);
* Veins easy to see in both arms (to allow for the multiple blood draws);
* Willing to comply with a 24-hour wash-out period for vitamins and nutritional supplements;

Exclusion Criteria:

* Previous major gastrointestinal surgery (absorption of test product may be altered) (minor surgery not a problem, including previous removal of appendix and gall bladder);
* Taking anti-inflammatory medications on a daily basis;
* Currently experiencing intense stressful events/ life changes;
* Currently in intensive athletic training (such as marathon runners);
* Currently taking antipsychotic medications such as clozapine, Risperdal, Abilify, Zyprexa or Seroquel;
* Actively depressed;
* An unusual sleep routine (examples: working graveyard shift, irregular routine with frequent late nights, studying, partying);
* Unwilling to maintain a constant intake of supplements over the duration of the study;
* Anxiety about having blood drawn;
* Women of childbearing potential: Pregnant, nursing, or trying to become pregnant;
* Known food allergies related to ingredients in active test product.
Improved Treatment Course for Patients With Migraine and Tension-type Headache

The purpose of the study is to improve treatment for newly referred patients with migraine and tension-type headache to the Danish Headache Center.

All patients will recieve an electronic questionnaire just before the first visit concerning their current and previous history of headache and headache treatment.

Half of them will enter a special telephone-intervention (TeII) program with two planned phone-calls after 8 and 16 weeks from first visit. The other half of patients will follow the normal follow-up program.

All patients will be seen by a headache specialist after 6 months and will be asked to fill in a follow-up electronic questionnaire.


Eligibility Criteria:
Inclusion Criteria:

* Migraine and/or tension-type headache

Exclusion Criteria:

* Other headache diagnoses, including cluster headache, medication overuse-headache, other secondary headaches, trigeminal neuralgia.
* Included in clinical trials at the DHC.
Exploration of the Mechanism of Movement Improvement During RBD in Parkinson's Disease Using NIRS

The purpose of this study is to confirm the improvement of movement during RBD in Parkinson's disease and to explore the neuronal network involved in this improvement using NIRS.

The aim of this study is to compare the quality of movement during REM sleep during RBD episodes and movement awake without and with dopaminergic treatment while measuring cortical activity using NIRS.

Eligibility Criteria:
Inclusion Criteria:

* Idiopathic Parkinson's Disease (Hughes AJ et al., 2001)
* Patients with REM sleep behaviour sleep disorder according to the ICSD2 (International Classification of Sleep Disorders 2) criteria and frequent reported several times per week by the spouse
* Informed written consent signed
* Patient aged 40 to 90 years
* Affiliate or benefiting from a social security scheme.

Exclusion Criteria:

* Atypical Parkinson's Syndromes
* Patient not accepting polysomnography

  * Contraindications to cerebral Magnetic Resonnance Imaging (MRI): pacemaker, cochlear implants, certain heart valves, claustrophobia, pregnancy.
  * Limit of validity of the MRI: if the patient presents dyskinesias preventing immobile maintenance of a few minutes in the MRI for the acquisition of images
Assessing the Clinical Performance of Two Frequent Replacement Silicone Hydrogel Multifocal Contact Lenses

The purpose of this clinical trial is to assess the clinical performance of LID223194 Multifocal (MF) contact lenses and commercially available Air Optix plus HydraGlyde (AOHG) MF contact lenses. Eligible subjects will wear each study lens type in a cross-over fashion as randomized for approximately 2 days.

Subjects will be expected to attend 3 scheduled visits for an individual duration of participation of up to 10 days.

Eligibility Criteria:
Key Inclusion Criteria:

* Able to understand and sign an consent form (ICF) that has been approved by an Institutional Review Board (IRB);
* Willing to stop wearing habitual contact lenses for the duration of study participation;
* Currently wearing multifocal soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months;
* Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

* Any eye infection, inflammation, or abnormality or disease (including systemic) that contraindicates contact lens wear, as determined by the investigator;
* Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the investigator;
* History of refractive surgery, or plan to have refractive surgery during the study;
* Current or history of dry eye in either eye that would preclude contact lens wear, in the opinion of the investigator;
* Monovision contact lens wear;
* Other protocol-defined exclusion criteria may apply.
A Double-blinded, Randomised, Three-period Crossover Euglycaemic Clamp Trial Investigating the Pharmacokinetics, Glucodynamics and Safety of BioChaperone Human Insulin, Human Insulin (Huminsulin® Normal) and Insulin Lispro (Humalog®) in Subjects With Type 1 Diabetes

The addition of BioChaperone to already marketed prandial human insulin preparations may accelerate the onset and shorten the duration of action due to facilitation of the insulin absorption after subcutaneous injection.

The aim of the trial is to assess the efficacy and safety of BioChaperone human insulin in subjects with type 1 diabetes under a dose of 0.2 U/kg.

This trial is a single center, randomised, double-blinded, three treatment, three-period cross-over, 10-hour euglycaemic clamp trial in subject with type 1 diabetes mellitus. Each subject will be randomly allocated to a single dose of BioChaperone human insulin 0.2 U/kg, a single dose of Huminsulin® Normal 0.2 U/kg and a single dose of Humalog® 0.2 U/kg on 3 separate dosing visits.


Eligibility Criteria:
Inclusion Criteria:

* Male subject with type 1 diabetes for at least 12 months
* Treated with multiple daily insulin injections or insulin pump (CSII) for at least 12 months
* Body mass index: 18.5-28.0 kg BW·m-2
* HbA1c: ≤ 9.0%

Exclusion Criteria:

* Diabetes mellitus type 2
* Receipt of any investigational product within 3 months prior to first dosing of investigational product in this trial
* Clinically significant abnormalities as judged by the Investigator
* Any systemic treatment with drugs known to interfere with glucose metabolism
* History of alcoholism or drug/chemical abuse as per Investigator's judgement
* Use of any tobacco or nicotine-contained product within one year prior to screening
Exogenous Ketone Esters for Refractory Status Epileptics

This study aims to investigate the efficacy of add-on exogenous ketone esters for the treatment of children with refractory generalized convulsive status epilepticus

Generalized convulsive status epilepticus (GCSE) is a common neurological emergency in children with significant morbidity and mortality. Benzodiazepines (Bzs) are the initial anti-seizure medications (ASMs) for children with GCSE, but nearly a third of cases are not controlled by (Bzs). Moreover, about 40% of cases not responding to BZs are not controlled by second-line ASMs.

Ketogenic diet (KD) has been classically used for treating children with drug resistant epilepsy. Recently, KD has been used for refractory and super refractory status epilepticus. However, KD takes time to achieve ketosis and may be practically challenging in emergency situations and critically ill patients. Exogenous ketone esters (EKE) could be a more convenient and rapid way to achieve ketosis in acute settings.

Eligibility Criteria:
Inclusion Criteria:

* Refractory Generalized convulsive status epilepticus.

Exclusion Criteria:

* Failure to obtain informed consent.
* Recent intake of exogenous ketones, ketogenic diet, or any dietary restrictions/modifications.
* Hemodynamic or cardio-respiratory instability.
* Traumatic brain injury.
* Hypo-/hyperglycemia.
* Metabolic acidosis.
* Ketosis (βHB \> 2 mmol/L).
* Associated severe disease condition, including hepatic, renal, respiratory, cardiac, gastrointestinal, endocrinal, and immune systems.
* Malnutrition/obesity.
* Limitations to nasogastric tube feeding.
* Inborn errors of metabolism.
* Allergies or any other contraindication to exogenous ketone esters.
* Current or recent (within the last 24 hours) propofol therapy.
* Intake of carbonic-anhydrase inhibitors.
A Wake Prone Positioning in Non-intubated Patients With Acute Hypoxemic Respiratory Failure

Patients admitted to the ICU with severe hypoxemia are at high risk for mortality. Few therapies have been proven to improve patient outcomes or duration of mechanical ventilation e.g. low tidal volume ventilation, prone positioning, and a fluid-restrictive strategy. Prone positioning is a technique used to help patients with acute respiratory distress syndrome breathe better. There is high degree of uncertainty on its effects on clinical outcomes in non-intubated patients with acute hypoxemia and larger studies are needed.

we plan to study the effect of prone positioning versus standard treatment in non-intubated patients with acute hypoxemia admitted at Respiratory Intensive Care Unit (RICU), Chest Department, Assiut University Hospital, Egypt.

Eligibility Criteria:
Inclusion Criteria:

* patients aged 18 years or older who are not intubated and required at least 40% oxygen (via low- or high-flow oxygen devices) or noninvasive positive pressure ventilation.

Exclusion Criteria: Patients will be excluded from the study if they :

had received invasive mechanical ventilation, had contraindications to prone positioning, are at risk of complications from prone positioning, had been self-prone positioning prior to enrollment and Pregnancy.
The Efficacy of EMDR in Youngsters With Autism

Rationale: Currently, for youngsters there is no treatment available that directly targets the core symptoms of autism. EMDR is hypothesized to improve the core symptoms of ASD by reducing the generally high stress levels experienced during social interactions, and increasing the functional connectivity in neuronal networks associated with executive functioning and limbic circuitry.

Objective: The primary objective of the study is to determine if EMDR reduces the core symptoms of ASD and daily experienced stress in youngsters diagnosed with ASD.

Study design: Longitudinal multiple single case studies. Study population: Youngsters aged 12-21 years who are diagnosed with ASD and have a full-scale IQ of 80 or more (N=20).

Intervention: 10 weekly EMDR sessions.

Main study parameters/endpoints: The main endpoint of the study are autism symptoms, which will be assessed using the Social Responsiveness Scale (SRS-A) and the Autism Diagnostic Observation Schedule (ADOS 2). The SRS-A will be administered prior, during and after treatment. The ADOS 2 will be administered prior to treatment and after treatment completion. In addition, we will also administer the Trauma Symptom Investigation Form in Autism Spectrum Disorders (TIF-ASD) questionnaire prior to, during, and after treatment. Furthermore, to answer more fundamental questions concerning the working mechanism of EMDR in ASD, other secondary outcome measures (i.e. PSS-10, AWMA-2) will be included.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Participants are expected to benefit from treatment. The risks associated with study participation are considered negligible and the burden associated with participation is estimated as low.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with ASD (with or without comorbid psychiatric disorders, except PTSD and anxiety disorders)
* Full-scale IQ of 80 or more
* Able to understand and speak Dutch

Exclusion Criteria:

* Receiving other treatments than medication on a stable dosage.
* PTSD or other comorbid psychiatric disorders that require immediate and continuous treatment.
A Clinical Evaluation of the Durata or Optisure High Voltage Leads and Ellipse VR ICD Undergoing MRI, an IDE Study

To demonstrate safety and efficacy of the Durata or Optisure high voltage lead and Ellipse VR ICD in an MRI environment.

The intent of this IDE study is to evaluate the safety and efficacy of the Durata or Optisure lead and Ellipse VR ICD that have undergone an MRI scan. The patient population under study includes patients indicated for or who have been implanted with a Durata or Optisure lead and an Ellipse VR ICD.

Eligibility Criteria:
Inclusion Criteria:

* Are implanted with the Durata or Optisure lead for at least 60 days (can include patients with Durata or Optisure lead for \> 60 days OR patients with a new Ellipse VR ICD and/or Durata/Optisure lead implanted for at least 60 days
* Are implanted with an Ellipse VR ICD pectorally
* Be willing to undergo an elective MRI scan without sedation NOTE: Antianxiety agents (e.g. minor tranquilizers, etc.) may be used as long as the patient can communicate with site personnel during the MRI scan
* Capture threshold is stable \< 2.5V @ 0.5ms
* Ventricular sensing is measurable (patient has underlying rhythm \> 30bpm) and the sensing amplitude is \> 4mV
* Be able to provide informed consent for study participation (legal guardian or legally authorized representative is NOT acceptable)
* Be willing and able to comply with the prescribed follow-up tests and procedures
* Are not contraindicated for an MRI scan (per the MRI Screening Form)

Exclusion Criteria:

* Have a competitor's MRI compatible endocardial lead implanted or capped
* Have another existing active implanted medical device, e.g., neurostimulator, infusion pump, etc., that has MR labeling that will not allow the MRI scans per this protocol to be completed.
* Have a lead revision of the Durata/Optisure lead occur \< 60 days of the baseline visit
* Have other non-MRI compatible device or material implanted NOTE: MRI compatible knee replacements, hip replacements, stents, etc. may be included as long as the labeling of these devices allow MRI scans conducted per this protocol NOTE: MRI compatible mechanical, prosthetic, and bioprosthetic heart valves may be included as long as the labeling of these devices allow for MRI scans conducted per this protocol NOTE: Non-removable dental implants may be included
* Have a lead extender, adaptor, or capped/abandoned lead
* Enrolled or intend to participate in a clinical drug and/or device study (investigational device, investigational drug, new indication for a device or drug or additional testing beyond standard of care procedures), which could confound the results of this trial as determined by SJM.
* Pregnant or planning to become pregnant during the duration of the subject's participation in the study
* Have a life expectancy of less than 12 months due to any condition
* Patients with exclusion criteria required by local law (e.g., age)
Parents' Adherence to Treatment Recommendations

The primary purpose of this study was to test whether conducting a brief motivational interview that focused on perceived barriers to treatment seeking would increase the likelihood that a parent with psychiatric problems would seek treatment for themselves.

The primary aim of this study was to test a method for increasing adherence to treatment recommendations for parents of children with emotional/behavior problems. Mental health problems in parents can be a serious risk factor for psychiatric and medical problems in children, yet most parents of children receiving services for mental health or medical problems do not get treatment for their own problems. The specific aim of this study was to increase parents' adherence to recommendations for treatment. Parents were randomly assigned to either the Enhanced Motivational Intervention (EMI) or an information only control group. The EMI involves motivational interviewing comprised of a brief intervention that elicits the parents' "story," provides education about their problem(s), describes the potential link between parents' and children's symptoms, assesses their prior treatment history, expectations, and concerns about treatment, identifies potential barriers to treatment seeking, and determines the next step. Evaluations at baseline and 8-weeks and 4-months post intervention will assess parents' symptoms, functioning, and service utilization. The investigators hypothesized that adherence to treatment recommendations would be significantly greater for parents in the EMI group compared to parents in the control group.

Eligibility Criteria:
Inclusion Criteria:

* Parent or guardian of a child who is receiving services for emotional or behavioral problems.
* Must have legal custody of the child

Exclusion Criteria:

* Current psychosis