cyrilzakka/clinical-trials huggingface dataset:
Semi-automatic Measurement of Renal Volume at CT Angiography to Plan Repair of Aortic Aneurysms in Patients With Horseshoe Kidney.

The horseshoe kidney (HK) is a congenital anomaly in which the kidneys are fused in front of the anterior aortic wall in its most common form. The association of abdominal aortic aneurysm (AAA) and horseshoe kidney (HK) is a rare and challenging condition, occurring in less than 0.2% of all AAA cases. In these cases, open surgery is still widely practiced in many centers, with either a transperitoneal or retroperitoneal approach. Typically, several polar arteries arise from the distal abdominal aorta or the iliac arteries to perfuse the HK.

A key consideration for the surgery is whether or not to preserve the vascularization of the variant kidney. Preserving them can be challenging, but removing them can lead to a significant reduction in renal volume and subsequent loss of function. In open surgery repair, it is recommended to reanastomose as many arteries as possible to the prosthesis, even though this introduces additional technical challenges, especially in emergency situations. Computed Tomography Angiography (CTA) is the best diagnostic test for performing a preoperative vascular assessment.

The purpose of the present study is to develop a semi-automated model on preoperative CCTA to measure the volume of parenchyma perfused by each artery to determine whether or not these should be preserved. The model will be validated on post-surgical CCTA in patients with HK treated for AAA.

Customized use of this tool could be a valuable method in surgical decision making, determining which arteries can be made safe during surgery and addressing a rare but complex clinical need.


Eligibility Criteria:
Inclusion Criteria:

* Adult subjects (≥18 years old) surgically treated for AAA with HK at San Raffaele Hospital between January 2019 and December 2023, with appropriate pre- and postoperative CTA, pre- and post CT.

Exclusion Criteria:

* Pediatric patients (age \<18 years)
* Absence of pre- and postoperative CT images
* Performance of surgery other than open surgery.
EFFECTIVENESS: Hopewell Hospitalist: A Video Game Intervention to Increase Advance Care Planning by Hospitalists

Hopewell Hospitalist is a theory-based adventure video game designed to increase the likelihood that a physician will engage in an advance care planning (ACP) conversation with a patient over the age of 65. Drawing on the theory of narrative engagement, players assume the persona of a hospitalist physician and navigate a series of clinical encounters with seriously-ill patients over the age of 65. Players experience the consequences of having (or not having) ACP conversations in a timely fashion. The planned study is a crossover phase III trial testing the effectiveness of providing physicians with a link to a free version of Hopewell Hospitalist as a means for increasing ACP rates measured by ACP billing frequency.


Eligibility Criteria:
Hospitalist Inclusion Criteria:

* Employed by Sound
* Not previously included in the Efficacy Trial Arm of the study.

Hospitalist Exclusion Criteria:

* Not employed by Sound
* Does not provide informed consent
* Previously included in the Efficacy Trial Arm of the study.
Dynamic Splinting for Excessive Pronation Following CVA

The purpose of this study is to examine range of motion and lasting effects of Botox injections along with the use of the Supination Dynasplint.


Eligibility Criteria:
Inclusion Criteria

Patients enrolled will have been diagnosed with excessive pronation following a stroke and will display the following symptoms:

* Pronation Contracture
* Ability to provide consent and follow directions as related to the protocol

Exclusion Criteria

* Treatment with Benzodiazepines
* Treatment with Baclofen (pump or oral)
* Treatment with Dantrolene sodium
* Treatment with Tizanidine
A Study to Evaluate the Safe and Effective Use of the Prefilled Safety Syringe or the Auto-injector for the Subcutaneous Self-injection of Bimekizumab Solution by Subjects With Active Psoriatic Arthritis

The purpose of the study is to evaluate for each self-injecting device presentation the ability of subjects with psoriatic arthritis (PsA) to safely and effectively self-inject bimekizumab at study start and 4 weeks after training in self-injection technique using the bimekizumab safety syringe (SS) or the bimekizumab auto-injector (AI).


Eligibility Criteria:
Inclusion Criteria:

* Subject fulfills all inclusion criteria for the PA0012 \[NCT04009499\] study
* Subject is considered reliable and capable of adhering to the DV0004 protocol (eg, able to understand and complete questionnaires, able to use investigational self-injecting device presentations according to the instructions for use (IFU), and able to adhere to the visit schedule) according to the judgment of the Investigator
* Subject is willing to self-inject

Exclusion Criteria:

-Subjects are not permitted to enroll in DV0004 if any of the PA0012 \[NCT04009499\] study exclusion criteria are met
Comparative Study Between Steroid Plus Anesthetic Block and CRF in Participants With Hip Osteoarthritis

This will be a prospective, multi-center, double-blinded, randomized study designed to compare the efficacy of Conventional Radiofrequency (CRF) and the anesthetic block of the anterior sensory branches to the hip to control pain and improve function related to hip osteoarthritis.

This prospective, double-blinded (participant and outcome assessor) clinical trial was designed to investigate the results of the intervention Continuous Radiofrequency (CRF) in the treatment of participants with chronic hip pain secondary to hip osteoarthritis. Participants will be randomized in a 2-arm, parallel groups. The intervention group will be submitted to an anesthetic block of the sensory branches of femoral and obturator nerves to the hip, with 1 ml of 1% lidocaine with 1ml of steroid (Betamethasone Dipropionate 5 mg/ml + Betamethasone Sodium Phosphate 2 mg/ml) for each branch, followed by denervation with CRF (22¬gauge 5¬mm active tip cannula, 10cm in length) with the tip temperature set at 90° C in a single cycle of 90 min. The sham group will be submitted to the same anesthetic block, followed by a simulation of CRF use. The surgeon performing the procedures will only be informed of the randomization after completing the anesthetic block on the participants to avoid bias at its accuracy. Participants will be evaluated at four follow-up: before intervention and after 1, 12, and 24 weeks, to access the Western Ontario and McMaster Universities score (WOMAC) as the primary outcome.

Eligibility Criteria:
Inclusion Criteria:

* Participants 18 years or older
* Symptomatic unilateral hip osteoarthritis (OA)
* Pain for more than 6 months in the groin, anterior, anterolateral ou lateral region
* OA radiologically classified as Kellgren and Lawrence Tipo II-IV,
* VAS ≥ 4
* Considered non-responder to conservative treatment for the participant for 6 months.
* In case of difficulty in selecting participants with symptomatic unilateral OA, symptomatic bilateral hip OA will be admitted and submitted to the same treatment on both sides, after notification and approval from the Ethic Board of each institution involved.

Exclusion Criteria:

* Participants with radiculopathy ipsolateral
* Knee OA ipsolateral,
* Previous hip arthroplasty
* Pain exclusively in the posterior region of the hip
* Infiltration of the hip for less than 3 months
* Neurological disease compromising gait
* Peripheral neuropathy
* Psychiatric disease that compromise collaboration with the protocol
* Implanted pacemaker
* Prothrombin Activity Time (PT/INR) \> 3 and
* Litigation process related to the disease.
Study of Ruxolitinib in Pancreatic Cancer Patients

The purpose of this study was to determine whether ruxolitinib added to capecitabine is effective in improving the overall survival of patients with metastatic pancreatic cancer.

The study consisted of an open-label, safety run-in period that was composed of 1 patient cohort with 9 patients/cohort. This phase of the study determined the safety of the capecitabine/ruxolitinib combination in this patient population.

A randomized, double-blind study with two treatment arms was conducted once the safety run-in results from the first part of the study showed that the capecitabine/ruxolitinib combination was safe and additional patients could be treated. All patients have received capecitabine therapy in addition to the ruxolitinib or placebo (Study Drug).

Treatment for all patients consisted of repeating 21-day cycles. Capecitabine was self-administered for the first 14 days of each cycle, and the Study Drug was self-administered during the entire 21-day cycle. Treatment cycles continued as long as the regimen was tolerated and the patient did not meet any of the discontinuation criteria. In the event of disease progression, capecitabine therapy was discontinued but the Study Drug could continue to be administered. Subjects who discontinued treatment with the Study Drug continued to be followed to obtain information regarding subsequent treatment regimens and survival.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Diagnosis of metastatic pancreatic cancer; subjects must have had measurable, or evaluable disease that was histologically confirmed
* Karnofsky performance status of ≥ 60
* Subjects must have failed 1st-line gemcitabine treatment for metastatic pancreatic cancer:

  o An alternate chemotherapeutic agent was an acceptable substitute as 1st-line therapy in the event that the subject was intolerant to or ineligible to receive gemcitabine
* ≥ 2 weeks elapsed from the completion of previous chemotherapy, and subjects must have recovered or been at new stable baseline from any related toxicities

Exclusion Criteria:

* More than 1 prior chemotherapy regimen (not including adjuvant therapy) for metastatic disease
* Evidence of central nervous system (CNS) metastases (unless stable for \> 3 months) or history of uncontrolled seizures
* Ongoing radiation therapy or prior radiation therapy administered as a second-line treatment
* Other active malignancy except basal or squamous carcinoma of the skin
* Inability to swallow food or any condition of the upper GI tract that precluded administration of oral medications
* Inadequate renal, hepatic and bone marrow function demonstrated by clinical observations and/or laboratory assessments
Assessment of a Upper Limb Robotic Device in Stroke Patients

The objectives of this phase II clinical study are: evaluate the efficacy, safety, patient adeherence and clinical applicability of a new robotic device for patients with stroke at a physical rehabilitation institution (Instituto de Medicina Física e Reabilitação do Hospital das Clínicas da Universidade de São Paulo - IMREA HCFMUSP - Rede de Reabilitação Lucy Montoro, unidade Vila Mariana). Methods: 10 patients with stroke diagnosis and Fugl-Meyer score ranging from 34 to 55 will be selected to be included in the study. After signing the informed consent form and being assessed by the baseline evaluations, they will undertake 18 sessions of robotic therapy, which in its turn will be prescribed three times a week. After this period, the patients will be evaluated for future comparison of both the pre-treatment and final assessments.


Eligibility Criteria:
Inlcusion Criteria:

1. Between 40 and 65 years.
2. Both genders.
3. Clinical and radiological diagnosis of ischemic stroke in the vascular territory of the middle cerebral artery or anterior cerebral artery.
4. Clinical assessment of disability with diagnosis of right or left hemiparesis.
5. Onset between 24 and 36 months.
6. Clinical stability verified in medical evaluation.
7. Spasticity less than or equal to 2 in Modified Ashworth Scale.
8. Moderate motor impairment in upper limb, according to Fugl-Meyer Assessment Upper Limb score (34 to 55 points).
9. To remain seated in a backrest chair during the intervention period (about 55 minutes).
10. Acceptance of informed consent form to participate in the study.

Exclusion Criteria:

1. Joint, muscle or tendinous lesions and/or pain that can occur during the intervention and make it difficult or impossible to perform robotic tasks.
2. Progressive worsening of spasticity.
3. Withdrawal of the informed consent form.
4. New episode of stroke.
5. Comorbidities that may occur during interventions such as hypertension, seizures, diabetes, among other uncontrolled clinical issues.
Multicenter Study to Evaluate the Clinical and Cost-effectiveness of a Culturally Adapted Therapy (C-MAP)

To evaluate the clinical and cost-effectiveness of a culturally adapted therapy (C-MAP) in patients with a history of self-harm

Suicide is a serious global public health issue, ranked amongst the leading causes of death in many countries. Most of these (75%) are in the low and middle income countries (LAMIC) and globally suicide is the second leading cause of death in young people 15-29 years of age. There is no official data on suicide from Pakistan, a conservative South Asian Islamic country with historically low suicide rates. Both suicide and attempted suicide are illegal acts, as well as socially and religiously condemned, however, there is accumulating evidence that suicide rates have been gradually increasing in Pakistan over the last few years.

The culturally adapted psychological intervention C-MAP utilizes problem solving components within a brief intervention that can be widely utilized in clinical practice. Our previous pilot trial in Karachi shows the efficacy of CBT based intervention(C-MAP) in people who had recently self harmed.The findings from this work have highlighted the applicability of such an intervention to health services in Pakistan for patients who present after a self-harm episode

Eligibility Criteria:
Inclusion Criteria:

1. Patients over the age of 18 years will be considered eligible for the study.
2. Participants will have to be living within the catchment area of the participating practices and hospitals.
3. Not needing inpatient psychiatric treatment.

Exclusion Criteria:

1. Temporary resident unlikely to be available for follow up.
2. Participants with ICD-I0 mental disorder; due to a general medical condition or substance misuse, dementia, delirium, alcohol or drug dependence, schizophrenia, bipolar disorder, learning disability.
3. Unable to engage, participate or respond to the research questionnaires.
Effects of Lowering Dialysate Calcium Level on Progression of Coronary Artery Calcification and Bone Histomorphometry

The high rate of cardiovascular complications in the dialysis population cannot be explained by traditional cardiovascular risk factors. One of such factors proposed to contribute to the cardiovascular mortality in dialysis patient population is vascular calcification possibly resulting from disturbances of calcium-phosphate metabolism.

The aim of this study is to assess the effects of treatment with dialysate containing 1.75 or 1.5 mmol/L to 1.25 mmol/L calcium regarding coronary artery calcification and bone histomorphometry in hemodialysis patients.

Sample size calculations were based on previously reported changes in coronary artery calcification scores in hemodialysis patients during time (90% power with a two-sided, alpha error rate of 5%). Four hundred fifty-seven hemodialysis patients, taking drop-out rate into consideration, will be enrolled in this prospective-controlled study.The cases already being treated with calcium-based phosphate binder and dialysate containing 1.75 or 1.5 mmol/L calcium will be enrolled from eight hemodialysis centers.The cases will be randomized to two arms:

1. Dialysate containing 1.25 mmol/L calcium + calcium-based phosphate binder group: Dialysate calcium will be reduced from 1.75 or 1.5 mmol/L to 1.25 mmol/L in this group. Patients will use calcium-based phosphate binder according to phosphate level.
2. Dialysate containing 1.75 mmol/L calcium + calcium-based phosphate binder group (Control group): Dialysate calcium will remain or switched to 1.75 mmol/L and patients will be on calcium-based phosphate binder.

The study will last for 18 months.Coronary artery calcification (Multi-slice CT), bone histomorphometry, and bone mineral density will be assessed in the beginning and at the end of the study. Coronary artery calcification and bone mineral density will be measured in all patients; bone histomorphometry will be assessed in 150 patients, 75 from each group.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 18 and 80 years
* On maintenance bicarbonate hemodialysis scheduled thrice weekly, at least 12 hours/week
* To be treated with a dialysate containing 1.75 or 1.5 mmol/L calcium
* Willingness to participate in the study with a written informed consent

Exclusion Criteria:

* To be scheduled for living donor renal transplantation
* To have serious life-limiting co-morbid situations, namely active malignancy, active infection, end-stage cardiac, pulmonary, or hepatic disease
* Pregnancy or lactating
* To be unable to give informed consent because of mental incompetence or a psychiatric disorder
* To be on vitamin D treatment within six months of randomization or having iPTH values over target levels (\>300 pg/mL)
* Hypercalcemia (Ca \>10.5 mg/dl) with use of dialysate containing 1.75 or 1.5 mmol/L calcium
Zolpidem (Myslee) Post Marketing Study in Adolescent Patients With Insomnia - Evaluation With Polysomnography

To evaluate the efficacy of zolpidem for adolescent insomniacs with polysomnography

The study consists of two parts. All patients will receive placebo in one part and Zolpidem in the other part in a single blind manner. Efficacy will be measured with polysomnography .

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed as having nonorganic insomnia of nonorganic sleep disorder in ICD10

Exclusion Criteria:

* Patients with schizophrenia or manic-depressive illness
* Patients with insomnia caused by physical diseases
* Patients having a history of hypersensitivity to zolpidem
* Patients with attention-deficit hyperactivity disorder
Sodium Restriction in the Management of Cirrhotic Ascites

To determine the relationship between degree of sodium restriction and dietary compliance with clinical outcome of diuresis of portal hypertensive ascites in cirrhotic patients from a county hospital population.

Primary objective: Demonstrate that, when accompanied by the appropriate diuretic regimen, a No Added Salt diet (4 grams sodium per day) is as effective as a Low Sodium diet (2 grams sodium per day) in the management of cirrhotic ascites.

Secondary objectives:

1. Demonstrate that patient acceptance is greater and diuresis faster with a No Added Salt diet compared with a Low Sodium diet
2. Demonstrate that side-effects of diuretic therapy are the same or less when patients are on a No Added Salt diet
3. Determine if glomerular filtration rate estimated from the modified diet in renal disease equation differs from that obtained by a 24 hour urinary creatinine in patients with cirrhotic ascites

Eligibility Criteria:
Inclusion Criteria:

* Cirrhotic patients of any etiology with ascites from portal hypertension diagnosed by paracentesis,
* Age 18-75
* Clinical or radiographic (abdominal CT or ultrasound) estimate of moderate - severe ascites
* Spanish-speaking subjects will be eligible for participation

Exclusion Criteria:

* Active drug or alcohol abuse,
* Active complications of SBP, hepatic encephalopathy, or GI bleed within 2 weeks,
* Hemorrhagic ascites, malignant ascites,
* Creatinine \>2 mg/dL or CCl \< 30 mL/min,
* K \> 5.5 mmol/L,
* Diuretic refractory ascites
* Allergy to or intolerance of either spironolactone or furosemide
* Homelessness, incarceration, inability to follow up in clinic, or comply with diet.
Anesthesia and Motor Evoked Potential (MEP) Recruitment

Test the hypothesis to recruit larger motor responses to transcranial stimulation.

The study is designed to test the hypothesis that it is possible to recruit larger motor responses to transcranial stimulation by increasing the number of stimulating pulses under both baseline conditions and conditions of increased anesthetic suppression of the motor responses.

Eligibility Criteria:
Inclusion Criteria:

* Age 12 through 17 years
* Diagnosis of idiopathic scoliosis
* Scheduled for posterior spinal fusion with neurophysiological monitoring
* No known allergies to propofol or remifentanil
* No contraindication to total intravenous anesthesia
* No contraindications to the administration of volatile agents

Exclusion Criteria:

* Failure to consent or assent to study
* Diagnosis other than idiopathic scoliosis
* Poorly controlled seizures or the presence of a cochlear implant
* Patient history or family history of malignant hypothermia or mitochondrial myopathies
Efficacy and Safety of Summers Non-Pesticide Lice Asphyxiator (L.A.)for the Treatment of Head Lice

A Multi-center, Randomized, Vehicle Controlled, Double Blind Clinical Trial to Evaluate the Efficacy and Safety of Summers Non-Pesticide Lice Asphyxiator (L.A.) for the treatment of Head Lice.


Eligibility Criteria:
Inclusion Criteria:

1. Males and females 6 months of age or older.
2. Have an active infestation with Pediculus capitis, the human head louse, with at least three live lice at baseline.
3. Agree not to use any other pediculicides or medicated hair-grooming products during the duration of the study.
4. Be healthy, non-febrile, and not suffering from an infection likely to require antibiotic therapy during the study period.
5. Subject or guardian is able to understand the new HIPAA regulations and sign the HIPAA form.
6. Subject or guardian has read, understood, and signed appropriate informed consent in English. If English is not the primary language, the information about the study must be explained in their language and a copy of the informed consent must be in that language.
7. Subject is willing to participate in the study, and abide by the protocol requirements.

Exclusion Criteria:

1. Participation in any clinical study within the past 30 days.
2. Known hypersensitivity to any ingredient in the product formulation.
A Phase II Study of Irinotecan in 3 Line or More Therapy in Local Recurrence or Metastatic Breast Cancer

A phase II study of irinotecan in 3 line or more therapy in local recurrence or metastatic breast cancer. Evaluate the effect and safety of irinotecan in local recurrence or Metastatic breast cancer patients who recieved anthracycline or taxane drugs. The primary endpoint is Disease Control Rate and Progression free survival. The second endpoint is 3 or 4 grade Adverse Events 、overall survival.All the patients will recieve this therapy till disease progress or other occurrence of withdrawal standards.

A phase II study of irinotecan in 3 line or more therapy in local recurrence or metastatic breast cancer. Evaluate the effect and safety of irinotecan in local recurrence or Metastatic breast cancer patients who recieved anthracycline or taxane drugs. The primary endpoint is Disease Control Rate and Progression free survival. The second endpoint is 3 or 4 grade Adverse Events 、overall survival. irinotecan 100mg/m2,iv,day1,day8,every 3cycles.If no AE happens, increase irinotecan dose to125mg/m2 at the second cycle.All the patients will recieve this therapy till disease progress or other occurrence of withdrawal standards.

Eligibility Criteria:
Inclusion Criteria:

* Mestatic breast cancer patients whose disease recurrent after using anthracycline or taxane drugs

Exclusion Criteria:

* Heart Disease.etc