cyrilzakka/clinical-trials huggingface dataset:
Data Collection on the ATI Neurostimulation System: SPG Stimulation for Cluster Headache

The primary objectives of the Registry are to:

1. Monitor the transfer of the ATI Neurostimulation System and its safety/clinical performance to a larger number of centers in the post market phase and
2. Collect additional evidence to support reimbursement and clinical acceptance and long term follow up


Eligibility Criteria:
Inclusion Criteria:

* Subject meets CE marked labeling for cluster headache.
* Subject's typical cluster headache bouts last a minimum of 16 weeks, in the opinion of the Investigator.
* Subject agrees to maintain current preventive headache medication regimens (no change in type, frequency or dose except to manage tolerability) from Study Enrollment through the completion of the Therapy Evaluation Period.
* Subject has the ability to read, comprehend and to reliably record information as required by the Protocol.
* Subject is able to provide written informed consent prior to participation in the study.

Exclusion Criteria:

* Subject has had a change in type, dosage or frequency of taking preventive headache medications \< one (1) month prior to Study Enrollment.
* Per the CE marked labeling: In the opinion of the Investigator, subject has bony facial deformities, inappropriate surgical anatomy or has had facial surgery in the surgical area on the same side as the planned surgery that would prevent the proper placement of the ATI Neurostimulator.
* Subject has other significant pain problem that might confound the study assessments in the opinion of the Investigator.
Role of Anti-IgE in Severe Childhood Eczema

To evaluate the efficacy of anti-IgE (Omalizumab/Xolair) in children with severe eczema.

To address the value of anti-IgE in children with severe eczema.

Eligibility Criteria:
Inclusion Criteria:

1. Children between the ages of 4-19 years
2. Severe eczema
3. Raised SpIgE or SPT to at least 1 food allergen or 1 aeroallergen AND/OR
4. Clinical impression that allergic exposures cause worsening eczema.
5. Total IgE level \>300 kU/l
6. Clinically proven IgE-mediated allergic disease.
7. Written informed consent to participate.

Exclusion criteria:

1. Inability to comply with 2-4 weekly injections and clinic visits
2. Evidence of underlying immune compromise, autoimmune disease, immune complex mediated conditions.
3. Uncontrolled infection or unstable eczema.
4. Malignancy or a history of malignancy.
5. Pre-existing hepatic or renal impairment
6. Known cardiovascular or ischaemic cerebrovascular abnormality.
7. Other serious or uncontrolled systemic disease.
8. Pregnancy or lactation.
9. Known history of hypersensitivity or anaphylaxis to anti-IgE injections or its constituents.
10. Insufficient understanding of the trial assessments.
11. Participation in a CTIMP in the previous 60 days or (if known) 4 half-lives of the relevant medication, whichever is the greater.
12. Investigator feels that there is a good clinical reason why the child would be unsuitable.
Pemetrexed Plus Gemcitabine in Metastatic Breast Cancer Patients After Receiving Taxane Therapy

The purpose of the study is to determine if the two drugs can help patients feel better while causing the tumor to become smaller or disappear; evaluate the safety of giving both pemetrexed and gemcitabine in patients with advanced breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Must have received prior chemotherapy with Taxol (paclitaxel) or Taxotere (docetaxel).
* Less than 3 different chemotherapy treatments for metastatic disease.
* Prior treatment with hormonal and/or radiation therapy.
* Must have disease that can be measured.
* Must be able to take care of self needs for example personal hygiene

Exclusion Criteria:

* Must not be pregnant or breast-feeding.
* Cancer that has spread to the brain.
* Treatment with Gemcitabine or Pemetrexed
* Unable to take folic acid or Vitamin B12
* Treatment for another cancer within the last 5 years
Postoperative Analgesia of Quadratus Lumborum Block Versus Epidural Block After Major Abdominal Surgeries

Acute postoperative pain is an important issue after major abdominal surgeries for which different analgesic modalities have been tried.

Epidural analgesia is the recommended technique to relieve pain after major abdominal surgeries owing to the proved superior analgesia, reduction of opioid-related side effects as nausea, vomiting, pruritis and sedation, earlier recovery of bowel function and earlier ability for postoperative mobility. However, it is not without complications.

Quadratus lumborum block is an ultrasound-guided block that provides patients with both visceral and somatic blockade. It lessens the potential risks associated with neuraxial techniques, so it may represent a novel alternative approach for analgesia after major abdominal surgeries.

The aim of this study is to detect the feasibility of ultra-sound guided bilateral quadratus lumborum block as a postoperative analgesic modality after major abdominal surgery in comparison to epidural block and its effects on total rescue analgesic requirements in the 1st postoperative 24hours, time to first analgesic request, pain VAS scores, intraoperative and postoperative hemodynamics and postoperative opioid-related side effects.

Under complete aseptic conditions, the patients will receive either thoracic epidural block or bilateral ultrasound-guided quadratus lumborum block after induction of general anaesthesia

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status I-III

Exclusion Criteria:

* Patient's refusal
* Significant cardiac, disease.
* Significant hepatic disease.
* Significant renal disease (serum creatinine ˃ 1.5 mg/dl).
* Patients with drug abuse
* Allergy to study medications
* Mental disease
* Communication barrier.
* Coagulopathy.
* Local skin infection
Descemet Membrane Endothelial Keratoplasty vs. Descemet's Stripping With Endothelial Keratoplasty vs. Descemet Stripping Only

This study aims to evaluate and compare incidence of post-operative cystoid macular edema (CME) after Descemet Membrane Endothelial Keratoplasty (DMEK), Descemet's Stripping Automated endothelial Keratoplasty (DSEK) and Descemet Stripping Only (DSO).

Patients that are undergoing any of these procedures will be asked if they are willing to have a baseline pre-operative Optical Coherence Tomography (OCT) scan completed within 4 weeks of surgery. Additional OCT scans will be collected during routine follow up care. It is hypothesized that the rates of CME will be lower with DSO compared to DMEK and DSEK.

Eligibility Criteria:
Inclusion Criteria:

* Any patient that is undergoing DSO or endothelial corneal transplantation vis DMEK or DSEK

Exclusion Criteria:

* Patients that do not have an optical coherence tomography measurement pre- operatively
* Patients that don't have an optical coherence tomography measurement post- operatively
* Patients with a previous history of uncontrolled macular edema
Efficacy of Percutaneous Injection of Triamcinolone in the Treatment of Mammillary Fistula

The investigators recently proposed a new hypothesis on the pathogenesis of mammillary fistulae (MF) suggesting that occlusion of hair follicles by keratinous plugging may relevantly contribute to the development of MF. The investigators believe that the pathogenesis of MF mimics the behaviour of hidradenitis suppurative, as both clinical entities manifest themselves as a chronic, suppurative and recurrent inflammatory process. This new proposal has led to the present suggestion of a therapeutic alternative for MF.

To compare the results from a prospective observational database with two groups of patients:

1. patients with MF treated by percutaneous drainage and saline solution.
2. patients with MF treated by percutaneous drainage and saline solution plus percutaneous triamcinolone.

These patients are treated following usual clinical practice in our Department. All the procedures are made through an ultrasound-guided way. During the follow-up of these cases (clinical and with ultrasound) resolution rate will be registered by the same investigator.

The follow-up will be at least 6 months.

Eligibility Criteria:
Inclusion Criteria:

* mammillary fistula
* older than 18 years
* patient acceptation to the recruitment

Exclusion Criteria:

* diabetes mellitus
* arterial hypertension
* immunodepression
* peptic ulcer
* chronic bowel inflammatory diseases
Evaluation of the Ability to Detect Bowel Gas During Laparoscopic Surgery

This study will determine the ability of the device to draw a small amount of gas from an insufflated abdomen during laparoscopic surgery and accurately detect if gaseous content from the bowel is present.

Undetected bowel perforation is a rare but dangerous complication of laparoscopic surgery. If the injury is not detected and treated at the time of the surgical procedure, the patient can suffer sever complications including septic shock and eventually death. Our goal is to test a novel device that can detect bowel gas leakage from a perforation and alert the surgeon during the operation by evaluating the gases present in the insufflated abdomen during surgery. During laparoscopic surgery, carbon dioxide in inserted in the abdominal cavity in order to perform the operation. This is dynamic process as insufflation is a constant during the entire procedure to maintain a constant pressure and compensate small leaks due to the insertion and retrieval of instruments.

This study will determine the ability of device to be attached to a standard Veress needle or trocar during the operation and periodically draw a small amount of gas from the abdomen to evaluate the gas and accurately detect gaseous content from the bowel. Before the device can be used to detect bowel perforations, first we must ensure that it can accurately detect bowel gas in an insufflated abdomen.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 - 60 years old with the diagnosis of morbid obesity, who qualifies for laparoscopic gastric bypass surgical therapy, and has elected to undergo laparoscopic gastric bypass surgery.
2. Receiving care in the Stanford Hospital General Surgery Bariatric Surgery Clinic under the care of Dr. Dan Azagury
3. The patient is scheduled for laparoscopic roux en y gastric bypass surgery, with Dr. Azagury.
4. Willing and cognitively able to sign informed consent.

Exclusion Criteria:

1. Lack of or inability to provide informed consent.
2. Less than 18 years of age or greater than 60 years of age
3. Planned deviation from the standard laparoscopic gastric bypass operation
4. Conversion intra-operatively from a laparoscopic gastric bypass to an alternative laparoscopic surgical operation or to an open gastric bypass operation.
5. Enrollment in another device or drug study that may confound results.
Renal Denervation in Patients With Chronic Heart Failure With Preserved Ejection Fraction

This study aims to explore the potential of RDN as a therapy for HFpEF in a Prospective, Multicenter, Randomized, Blinded, Sham-controlled Study.

Heart failure is one of the most important diseases worldwide, with a 5-year mortality of up to 75% in symptomatic patients. While substantial progress has been made in the treatment of patients with reduced left ventricular ejection fraction (HFrEF), mortality for patients with heart failure and preserved ejection fraction (HFpEF) remains unchanged, despite a comparable prevalence and mortality of the disease as for heart failure with reduced ejection fraction. Heart failure with preserved ejection fraction has a high mortality, which is contrasted by a total absence of therapy options besides symptomatic diuretic treatment. This study aims to explore the potential of RDN as a therapy for HFpEF in a Prospective, Multicenter, Randomized, Blinded, Sham-controlled Study.

Eligibility Criteria:
Inclusion Criteria:

1. signs or symptoms of heart failure;
2. normal or mildly abnormal systolic LV function (LVEF ≥ 50%);
3. evidence of diastolic LV dysfunction.
4. Individual should fulfill the diagnostic WHO criteria for hypertension: SBP \> 140 mmHg and/or DBP \> 90 mmHg, and is treated with at least 2 antihypertensive drugs. This treatment is expected to be maintained for at least 6 months. Using this regimen the blood pressure should be adequately controlled (\< 140/90mmHg by 24 hour ambulatory BP measurement).
5. Individual is adhering to a stable drug regimen HFNEF, with no changes for a minimum of 2 weeks prior to enrollment, and which is expected to be maintained for at least 6 months.

Exclusion Criteria:

1. Known secondary cause of hypertension
2. Anatomy not eligible for renal denervation
3. Systolic heart failure (LVEF \< 50%)
4. Individual has an estimated glomerular filtration rate (eGFR) of \< 30mL/min/1.73m2, using the MDRD calculation.
5. Individual has any serious medical condition, which in the opinion of the investigator, may adversely affect the safety and/or effectiveness of the participant or the study (i.e., patients with clinically significant peripheral vascular disease, abdominal aortic aneurysm, bleeding disorders such as thrombocytopenia, haemophilia, significant anaemia, or arrhythmias such as atrial fibrillation).
6. Individual is pregnant, nursing or planning to be pregnant.
Study To Assess Efficacy, Safety, Tolerability And Pharmacokinetics Of PF-07038124 Ointment In Participants With Atopic Dermatitis Or Plaque Psoriasis

This study is being conducted to provide data on efficacy, safety, tolerability and PK of PF-07038124 ointment versus vehicle control in the treatment of mild to moderate AD and mild to moderate plaque psoriasis.


Eligibility Criteria:
Inclusion Criteria:

* Atopic Dermatitis (AD): Have been diagnosed with AD for at least 3 months; Have an Investigator's Global Assessment (IGA) score of 2 (mild), or 3 (moderate); Have AD covering 5% to 20% (inclusive) of BSA.
* Plaque psoriasis: Have been diagnosed with plaque psoriasis (psoriasis vulgaris) for at least 6 months; Have a Physician Global Assessment (PGA) score of 2 (mild), or 3 (moderate); Having plaque psoriasis covering 5% to 15% (inclusive) of BSA.

Exclusion Criteria:

* Presence of skin comorbidities that would interfere with study assessment or response to treatment.
* Current or recent history of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiovascular, or neurological disease.
* Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
An Investigational Drug Study in the Treatment of Primary Dysmenorrhea (0663-064)

The purpose of this study is to evaluate the pain relieving effect and safety of an investigational drug in women with moderate to severe primary dysmenorrhea (painful menstruation).


Eligibility Criteria:
Inclusion Criteria:

* Women 18 years of age or older suffering from painful menstruation

Exclusion Criteria:

* Women taking medications that are not allowed in the study (such as pain medications, antidepressants, tranquilizers, hypnotics, sedatives, or oral contraceptives).
* Women who are pregnant, breast-feeding or within 6 weeks of giving birth
Transradial-Band Pilot Study

In the study group, the TR-Band will be in left in place for 15 minutes before it is gradually deflated by 25% at 15 minute intervals. In the standard of care group, the TR-Band is left in place for 60 minutes before it is gradually deflated by 25% at 15 minute intervals. The aim of the study is to reduce the time the device is in place while minimizing potential complications.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years and older
* Have an acceptable Barbeau test (i.e. type A through C)
* Have acceptable coagulation parameters (based on PT, INR, platelet count, and appropriate pre-procedural management of anticoagulants, See Table 1)
* The caliber of the left radial artery based on a pre-procedure sonographic evaluation will need to be greater than or equal to 1.6 mm.
* The appropriate pre-procedural management of anticoagulants is based on the consensus guidelines established by Patel et al16.
* INR less than 1.5
* Platelet count greater than 50,000 platelet/uL
* Prothrombin time less than 15 seconds

Exclusion Criteria:

* If there is an unacceptable risk of bleeding diathesis, or
* If he or she is not a suitable candidate for transradial access based on a Barbeau test type D or a diameter of the left radial artery less than 1.6 mm.
Concurrent Treatment of Substance Abuse and Child Maltreatment

The co-occurrence of child maltreatment and parental substance-use problems is a major public health problem with serious consequences for children, parents, families, and the community at large. The need for effective dual treatment of caregiver substance abuse and child maltreatment is unquestionable, but there is a dearth of controlled treatment outcome studies with substance-using parents who have engaged in child maltreatment. This project examines two evidence-based treatments-Contingency Management for substance-use problems and Pathways Triple P parenting intervention to improve parenting for prevention of child-maltreatment recurrence. These two systematic interventions are being tested in the context of traditional outpatient treatment for substance-use problems.


Eligibility Criteria:
Inclusion Criteria:

* open child protective services case for child maltreatment
* beginning intensive outpatient treatment for drug or alcohol use problem
* at least one child 2-8 years of age

Exclusion Criteria:

* not primary custodial parent for child 2-8 years of age
* serious mental illness
* residing outside the two participating counties
Effect of Exercise Training in Patients With Pulmonary Hypertension

Pulmonary Hypertension (PH) is a serious disease with a dismal prognosis when left untreated. Advances in medical therapy have improved survival according to recent registries and systematic reviews, but are associated with high healthcare costs.

Earlier studies in Heidelberg, Germany showed good evidence for the effect of exercise training on improving exercise performance, quality of life and pulmonary hemodynamics in patients with pulmonary hypertension.

The main objectives of the present project are:

1. to investigate the quality of the implementation of a standardized 3 week in-hospital exercise training program on markers of outcome and disease severity in PH-patients in Switzerland immediately after training and after 3 and 12 month.
2. to look whether training with hyperoxia vs. standard care might be more effective.

This is a multicentre, randomized parallel-group trial where the intervention rehabilitation is delayed in one group so that they can serve as standard care controls for the others.

In a nested single-centre randomized-controlled trial patent will additionally be randomized to receive either usual rehabilitation (UR) or rehabilitation with standardized supplemental oxygen therapy (SSOT) during nights and ergometer training.

Patients will receive a PH specific rehabilitation program during 3 weeks followed by an instructed home-based training program for 12 weeks. Patients who are not already under long-term oxygen therapy (LTOT) due to daytime hypoxemia will additionally be randomized to receive standardized supplemental oxygen therapy (SSOT) during training and nights upon written informed consent.


Eligibility Criteria:
Inclusion Criteria:

* WHO functional class II-IV
* PH diagnosed by right heart catheter showing:
* Baseline mean pulmonary arterial pressure (mPAP) ≥ 25 mmHg
* Baseline pulmonary vascular resistance (PVR) \> 240 dyn x s x cm-5
* Baseline pulmonary capillary wedge pressure (PCWP) ≤ 15 mm Hg
* Patients receiving maximal PH therapy including intensified treatment with diuretics and who have been stable for 2 months before entering the study
* PH target therapy should not be expected to change during the entire 15-week study period
* Negative pregnancy test (β-HCG) at the start of the trial
* Able to understand and willing to sign the Informed Consent Form

Exclusion Criteria:

* PH due to significant left heart disease (Wedge ≥ 15mmHg) or lung disease (FEV1 ≤ 60% predicted)
* Pregnancy at study onset
* Walking disability
* Any change in disease-targeted therapy within the last 2 months
* Any subject who is scheduled to receive another investigational drug during the course of this study
* Any other relevant concomitant disease
* Systolic blood pressure \< 85 mmHg
* History or suspicion of inability to cooperate adequately
Study Evaluating the Treatment of OTX-TKI for Subjects With Neovascular Age-related Macular Degeneration

Evaluate the safety, tolerability, and efficacy of OTX-TKI for intravitreal use in subjects with Neovascular Age-Related Macular Degeneration

Multicenter, double masked, randomized, parallel-group study to evaluate the safety, tolerability, and efficacy of OTX-TKI for intravitreal use in subjects with Neovascular Age-Related Macular Degeneration

Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis, within 3 years of screening, of previously treated subfoveal neovascularization (SFNV) secondary to nAMD with leakage involving the fovea, previously treated with documented evidence of an initially favorable clinical response to anti-VEGF therapy (i.e. aflibercept, ranibizumab, brolucizumab, or bevacizumab).
* The macular appearance on OCT is considered to be free of excess intraretinal and/or subretinal fluid as judged by the investigator.
* Must have received at least 3 anti-VEGF injections in the past year.
* Have received the most recent anti-VEGF injection within the past 1-4 weeks prior to screening visit.
* BCVA ETDRS score between 24 and 83 letters (\~20/25 to \~20/320 Snellen equivalent)

Exclusion Criteria:

* Have evidence of a scar, fibrosis or atrophy of \>50% of the total lesion in the study eye
* Have presence of a disease other than choroidal neovascular membrane (CNVM) due to AMD in the study eye that could affect vision or safety assessments
* Have monocular vision (fellow eye Snellen BCVA is 20/200 or worse
Tulobuterol Patch in Pediatric Patients Undergoing Tonsillectomy

* Tonsillectomy is a common pediatric procedure for the treatment of sleep-disordered breathing and chronic tonsillitis. Up to half of children having this procedure experience a perioperative respiratory adverse event.
* We tried to determine whether tulobuterol patch (transdermal bronchodilator) premedication decreases the risk of perioperative respiratory adverse events in children undergoing anesthesia for tonsillectomy.


Eligibility Criteria:
Inclusion Criteria:

* pediatric patients undergoing tonsillectomy

Exclusion Criteria:

* recent upper respiratory infection (2weeks)
* Allergy to tulobuterol patch
* Patients receiving catecholamine (epinephrine, isoproterenol)
* hyperthyroidism
* hypertension
* cardiac disease
* Diabetes melitus
* atopic dermatitis
* Asthma