cyrilzakka/clinical-trials huggingface dataset:
Ultrasound Versus Fluoroscopic Guided Sacroiliac Joint Injection In Patients With Chronic Sacroiliac Joint Pain

Sacroiliac joint injection in sacroiliitis

Comparison of ultrasound guided and fluoroscopic guided sacroiliac joint injection

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of sacroiliitis.
* At least 3 positive physical examination maneuvers \[FABER (flexion, abduction, and external rotation), POSH (posterior shear), REAB (resisted abduction), Fortin's finger test\],
* Moderate to severe pain (NRS pain score ≥ 3/10) refractory to oral anti-inflammatory.
* Age from 18ys to 60ys.

Exclusion Criteria:

* Ages less than 18 or more than 85 years.
* Body Mass Index (BMI) above 35 kg/m2.
* A diagnosis of severe anxiety or depression and other psychological disorders.
* Allergy to local anesthetics or steroids and pregnancy.
* Multiple comorbidities (renal , hepatic, cardiac).
* Coagulation disorder as bleeding tendency and platelet dysfunction.
* Contraindication for prone position or radiological exposure.
* Patient refuse .
* Pain suggestive of bilateral sacroiliac joint involvement (it would have been difficult to assess pain and disability secondary to each SIJ).
Impact of Gamma-OH on Sleep in ICU Patients

The Main objective of the trial is to assess sleep quality with Gamma-OH® in patients difficult to wean from mechanical ventilation in the ICU.


Eligibility Criteria:
Inclusion Criteria:

* intubated at least 24 hours
* difficult weaning from mechanical ventilation according to international guidelines, i.e. who failed at least one spontaneous breathing trial.
* Patients will be included after to obtain inform consent.

Exclusion Criteria:

* neuromuscular disease
* central nervous disease
* psychiatric disease
* severe obesity
Safety and Efficacy of Systemic Chemotherapy Plus PD-1 Inhibitor in Combination With Bevacizumab in Gastric Cancer With Peritoneal Metastasis

It is an open label, phase II study involved receiving albumin-bound paclitaxel plus S-1 combined with sintilimab and bevacizumab in patients with gastric cancer peritoneal metastasis.


Eligibility Criteria:
Inclusion Criteria:

* 18 to 75 years patients histologically or cytologically confirmed the presence of GC or gastroesophageal junction tumor with PM (HER2 negative). The ECOG performance status is 0-1 and the expected survival time is more than 3 months. Did not receive any therapy for GC within the last six months (chemotherapy, radiation therapy, or both).

Exclusion Criteria:

* Principal exclusion criteria: The obstruction of the cardia and pylorus affects the patient\&#39;s eating and gastric emptying, or has difficulty swallowing tablets. HER2-positive GC and gastroesophageal junction tumors. Subject with other malignancies, except for non-melanoma skin cancer or in-situ cervical carcinoma under adequate treatment, or other treated malignancies without evidence of recurrence for 5 years. Previously received the following therapies: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or drugs that stimulate or co-inhibit T cell receptors (eg, CTLA-4, OX-40, CD137). Received systemic treatment with Chinese medicines or immunomodulatory drugs (including thymosin, interferon, interleukin, except for local use to control pleural effusion) with anti-tumor indications within 2 weeks before the first administration; Active autoimmune disease requiring systemic therapy (eg, disease-modifying drugs, glucocorticoids, or immunosuppressants) occurred within 2 years prior to first dose; Replacement therapy (such as thyroxine, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency, etc.) is not considered systemic therapy.
Surgical Management of Post-Traumatic Kyphosis

The goal of this observational study is to examine the safety and efficacy of posterior sugary only in addressing post traumatic kyphosis. The main question\[s\]it aims to answer are:

Is it a safe procedure? Is it a sufficient approach to address deformity? Participants will be managed by posterior only surgery to address their deformity and will be assessed for the radiological and functional outcomes.


Eligibility Criteria:
Inclusion Criteria:

- All patients with age range from 18-65 years old with PTK underwent corrective surgery and have been followed for at least 2 years with complete documentation.

Exclusion Criteria:

* Traumatic cervical spine deformities
* Pathologic fracture spine
* Congenital or developmental cases
* Degenerative cases
Randomized Study Evaluating the Role of Surgeon-Performed Ultrasound in the Management of the Acute Abdomen

The purpose of this study is to evaluate whether surgeon-performed ultrasound as a supplement to clinical investigation when a patient presents with abdominal pain in the emergency department can improve the management of the patient.

Surgeon-performed ultrasound bedside in the emergency department when a patient presents with abdominal pain is quite common in Continental Europe and USA. It is considered to be implemented at emergency departments all over Sweden. This is the first randomized study performed to evaluate the method. In our study we compare diagnostic accuracy and further management of patients admitted to the emergency department for abdominal pain, with or without examination with surgeon-performed ultrasound bedside.

Eligibility Criteria:
Inclusion Criteria:

* Admitted to emergency ward for abdominal pain
* 18 years or older

Exclusion Criteria:

* Pregnancy
* Condition that has to be taken care of immediately
* Inability to communicate with the investigator
* Previously diagnosed abdominal condition
* Severe drug or alcohol addiction
* Dementia
A Phase III Study of an Otic Formulation in Acute Otitis Externa

The purpose of this study is to determine if an otic formulation is safe and effective for the treatment of acute otitis externa (AOE).


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of AOE based on clinical observation and of presumed bacterial origin
* A minimum combined score of ≥4 in at least 1 affected ear at the Day 1 exam for tenderness, erythema, and edema
* Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

* Duration of pretherapy signs or symptoms of AOE greater than four (4) weeks
* Presence of a tympanostomy tube or perforated tympanic membrane in the treated ear(s). Patients with a history of tympanic membrane perforation should not be enrolled unless the absence of a current perforation can be confirmed at Visit 1 prior to enrollment
* Clinically diagnosed chronic suppurative otitis media, acute otitis media, acute otorrhea in patients with tympanostomy tubes, or malignant otitis externa
* Known or suspected ear infection of fungal or mycobacterial origin
* Prior otologic surgery within 6 months of study entry
* Seborrheic dermatitis or other skin conditions of the external auditory canal
* Current or prior history of an immunosuppressive disorder (e.g., HIV positive) or current immunosuppressive therapy (e.g., cancer chemotherapy) or known acute or chronic renal disorders or active hepatitis
* Diabetic patients (controlled or uncontrolled) based upon assessment by Investigator
* Any systemic disease or disorder, complicating factor or structural abnormality that would negatively affect the conduct or outcome of the study \[e.g., cleft palate (including repairs), Downs Syndrome, and cranial facial reconstruction\]
* Any current known or suspected infection (other than AOE) requiring systemic antimicrobial therapy
* Use of prohibited medications or inadequate washout of any medication listed in protocol
* Concomitant use of topical or oral analgesics (i.e., NSAIDs and aspirin products) which may have anti inflammatory effects. Patients on low dose aspirin therapy (81 mg per day) at the time of enrollment may be enrolled and continue the low dose aspirin during the study. Use of acetaminophen ("Tylenol") is permitted during the trial
* Other protocol-defined exclusion criteria may apply
Study of RAD001 and Bevacizumab in Recurrent Ovarian, Peritoneal, and Fallopian Tube Cancer

This study will investigate the efficacy as well as the safety of RAD001 in combination with bevacizumab for recurrent ovarian, peritoneal, and fallopian tube cancer. RAD001 will be taken orally once daily and bevacizumab will be administered once every 14 days. The study will be conducted over a period of about 3 to 4 years.

In this trial, approximately 50 patients will receive the study drug, RAD001 in combination with bevacizumab (Avastin)chemotherapy. RAD001 will be taken orally once daily and bevacizumab will be administered intravenously once every 14 days. In addition to study treatment, a few blood samples and a sample of the patients tumor from a previous surgery if available will be collected for research.

Eligibility Criteria:
Inclusion Criteria:

* Patients may or may not have measurable disease. Measurable disease is defined according to RECIST criteria. If the patient has had previous radiation to the marker lesion(s), there must be evidence of progression since the radiation was completed.
* Minimum of four weeks since any major surgery, completion of radiation, or completion of all prior systemic anticancer therapy (adequately recovered from the acute toxicities of any prior therapy)
* Fasting serum cholesterol ≤300 mg/dL OR ≤7.75 mmol/L AND fasting triglycerides ≤ 2.5 x ULN.
* Performance status £ 2
* Signed informed consent.

Exclusion Criteria:

* Prior treatment with any investigational drug within the preceding 4 weeks
* Chronic treatment with systemic steroids or another immunosuppressive agent
* Patients should not receive immunization with attenuated live vaccines within one week of study entry or during study period
* Uncontrolled brain or leptomeningeal metastases
* Other malignancies within the past 5 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin.
* Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation
* Uncontrolled diabetes mellitus
* A known history of HIV seropositivity
* Impairment of gastrointestinal function or gastrointestinal disease
* Patients with an active bleeding diathesis or on oral anti-vitamin K medication (except low dose coumadin)
* Women who are pregnant or breast feeding, or women able to conceive and unwilling to practice an effective method of birth control.
* Patients who have received prior treatment with an mTOR inhibitor (sirolimus, temsirolimus, everolimus).
* Patients with a known hypersensitivity to RAD001 (everolimus), other rapamycins (sirolimus, temsirolimus) or excipients, or bevacizumab
* Patients with serious non-healing wound, ulcer, or bone fracture.
* Patients with known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies
Effectiveness of Generic Versus Reference Cetrorelix Acetate for Ovarian Stimulation Using a Gonadotropin-releasing Hormone（GnRH）Antagonist Protocol in Women Undergoing IVF

The goal of this clinical trial is to compare the clinical outcomes using different cetrorelix acetate in the context of a GnRH antagonist protocol for ovarian stimulation in women undergoing IVF or intracytoplasmic sperm injection(ICSI) treatment.The main question it aims to answer is whether the generic cetrorelix acetate is non-inferior to the reference product in the GnRH antagonist based protocol for women undergoing IVF. Ovarian stimulation was achieved by several types of follicle-stimulating hormone(FSH) or by FSH combined with luteinizing hormone activity. Daily dose of generic cetrorelix acetate (0.25 mg SC) or original cetrorelix acetate (0.25 mg SC) will be administered when the lead follicle was 14 mm. When more than two follicles reached 17 mm, oocyte maturation was triggered with 250 mcg of recombinant human chorionic gonadotropin.


Eligibility Criteria:
Inclusion Criteria:

* Infertile couples plan to undergo IVF / ICSI pregnancy treatment into screening procedures and clinical study

  1. All subjects should sign the informed consent form
  2. Infertile women \<43 years old
  3. With flexible GnRH antagonist

Exclusion Criteria:

* Subjects could not enter the study if they meet any one of the following criteria

  1. Preimplantation Genetic Testing (PGT)
  2. Untreated hydrosalpinges, moderate or severe endometriosis, recurrent spontaneous miscarriage, endometrial pathology, uterine malformations, etc
  3. Endocrine diseases (such as hyperthyroidism, hyperprolactinemia, etc.) or other systemic disease and other systemic diseases (such as hypertension, diabetes, etc.)．
  4. Other factors were considered inappropriate by the investigator to participate, or assisted reproductive technology/pregnancy contraindications
A Clinical Study of MK0991 (Caspofungin) in Japanese Patients With Deep-seated Candida or Aspergillus Infections (0991-062)(COMPLETED)

The purpose of this study is to investigate the safety and efficacy of MK0991 in patients with deep-seated mycoses.


Eligibility Criteria:
Inclusion Criteria:

* Japanese Patients In Whom A Causative Fungus Is Detected Before Treatment With The Study Drug Or Patients With Strongly Suspected Deep-Seated Fungal Infection Due To Candida species (Spp.) Or Aspergillus Spp.

Exclusion Criteria:

* Patients With Mycoses Other Than Ones Due To Candida Spp. Or Aspergillus Spp.
* Patients Who Will Receive Other Systemic Antifungal Agents For The First Time In Screening Period.
Pulmonary Function After Arterial Sleeve Lobectomy

Lung cancer is the leading cause of cancer death worldwide. Despite the evolution of medical and multimodal treatments, surgical treatment remains the curative management in the localized cancer.

Historically, in central lung tumors, pneumonectomy was the gold standard. Currently, bronchial sleeve lobectomy is recommended as first-line treatment over pneumonectomy when complete resection is possible (Grade 2C).

In the case of pulmonary artery invasion, lobectomy with arterial resection and reconstruction is now an accepted option for central localized cancer.

Despite surgical challenge, arterial sleeve lobectomy is oncologically comparable with pneumonectomy while avoiding the high morbi-mortality.

Indeed, this surgery has shown better results than pneumonectomy in terms of overall survival, post-operative mortality, and quality of life.

Initially performed in patients with impaired cardio-pulmonary reserves, this parenchymal sparing procedure can be realised in all patients, when anatomical conditions allow a complete resection.

In the literature, no study has yet specifically investigated postoperative respiratory function after arterial sleeve lobectomy.

The investigators designed a retrospective monocentric study at the University Hospital of Montpellier on 81 lobectomies with pulmonary artery sleeve resection for lung cancer, from January 2001 to December 2020.


Eligibility Criteria:
Inclusion Criteria:

* all major lung resection with pulmonary artery reconstruction for lung cancer
* from January 2001 to December 2020 at University Hospital of Montpellier
* patient \> 18 years

Exclusion Criteria:

0
Intestinal Stem Cells Characterization

A monocentric pilot studying intestinal organoids from endoscopic biopsies of IBD (Crohn and ulcerative colitis), FAP patients and healthy controls. Investigate the morphological characteristics of organoids, the expression of genes and proteins of the Wnt/APC/beta-catenin pathway within both ISC.

Intestinal organoids are 3D mini-guts produced in vitro based on intestinal stem cell (ISC) capabilities. These organoids contain all of the intestinal epithelial cells. The renewal of the two kinds of ISCs, which are present at the bottom of intestinal crypts, is controlled by Wnt/APC/beta-catenin pathway. Mutations of genes involved in this pathway are found in intestinal polyposes like familial adenomatous polyposis (FAP, APC gene).

This model is of interest to study early pathophysiological events occurring within intestinal epithelium, in the context of FAP and inflammatory bowel diseases (IBD). An excessive proliferation or an abnormal healing is found in FAP and IBD respectively. Investigators hypothesized that it could specifically involved one of the 2 ISCs. Columnar basal cells (CBC) and ISC located at the +4 position from the bottom of the crypt (ISC+4) can both differentiate into absorptive or secretory intestinal epithelial cells. However, CBC and ISC+4 could have different metabolic, migratory functions, or stress survival.

Investigators designed a monocentric pilot study to develop intestinal organoids from endoscopic biopsies of IBD (Crohn and ulcerative colitis), FAP patients and healthy controls. Investigators plan to investigate the morphological characteristics of organoids, the expression of genes and proteins of the Wnt/APC/beta-catenin pathway within both ISC. Will also be studied the expression of key genes of tumor initiation (PTEN, BMPR1A, p53 and KRAS) and inflammatory parameters (cytokines and lipid mediators).

The results of this study could improve the understanding of intestine renewal. Later on, the development of new drugs could beneficiate to IBD and FAP patients.

Eligibility Criteria:
Inclusion Criteria: patient must have a coloscopy for intestinal pain -

Exclusion Criteria: cancer

-
Do Discounted Vouchers for Medical Cannabis Reduce Opioid Use in Adults With Pain

This study will examine how discounted vouchers for medical cannabis use affects opioid analgesic use in adults with chronic pain. Our study findings will have critically important implications to shape clinical care and medical cannabis policies.

This study will examine how discounted vouchers for medical cannabis use affects opioid analgesic use in adults with chronic pain. ReLeaf-V is a 4-arm blinded randomized controlled trial (RCT) of 352 adults with (a) severe or chronic neuropathic or joint pain, (b) opioid analgesic use, and (c) active certification for medical cannabis. We will randomize participants to a discounted voucher for: 1) a placebo soft-gel capsule product, 2) high THC:low CBD soft-gel capsule product (4.3mg THC/0.7mg CBD), 3) equal THC:CBD soft-gel capsule product (2.5mg THC/2.5mg CBD), or 4) low THC:high CBD soft-gel capsule product (0.2mg THC/4.8mg CBD). Over 14 weeks, participants will have 5 research visits in which data will be collected from questionnaires, and medical and Prescription Monitoring Program (PMP) records. The primary independent variable will be randomization arm, and the primary outcome will be cumulative opioid analgesic dose.

Eligibility Criteria:
Inclusion Criteria:

1. \>18 years old
2. English or Spanish fluency
3. active certification for medical cannabis
4. intends to have a soft-gel capsule product dispensed at Vireo Health
5. medical cannabis qualifying conditions or complications of (a) chronic pain, or (b) pain that degrades health and functional capability as an alternative to opioid use or substance use disorder or (c) severe or chronic pain
6. joint or neuropathic pain
7. current severe pain
8. dispensed opioids analgesics within the last 60 days

To maintain the integrity of the study, we do not disclose all inclusion criteria to potential participants.

Exclusion Criteria:

1. inability to provide informed consent
2. inability to complete study visits over 14 weeks
3. terminal illness
4. current or prior psychotic disorder
5. current or prior buprenorphine or methadone treatment for opioid use disorder
6. NYS medical marijuana prescriber does not approve changes to product and dosing recommendations listed on the participant's certification form
7. Allergy to tapioca or coconut
8. currently pregnant, planning to become pregnant within the next 3 months, or breastfeeding
9. a condition that is considered by a pharmacist or medical provider to be a clinical contraindication to medical cannabis use (e.g. unstable cardiac arrhythmia or specific drug-drug interaction)
Clopidogrel Hyper-Responsiveness: Incidence and Associated Outcomes in Patients With Cerebral Aneurysms

This registry study will investigate the incidence of and outcomes associated with clopidogrel hyper-responsive patients treated at Methodist Dallas Medical Center, beginning in January 2018, who suffered cerebral aneurysms.

This registry study will investigate the incidence of and outcomes associated with clopidogrel hyper-responsive patients treated at Methodist Dallas Medical Center, beginning in January 2018, who suffered cerebral aneurysms.

Perioperative and short-term clinical data will be obtained from electronic medical records. All the data variables will be documented in an Excel sheet (Appendix B). This section will provide an overview of the data collected which will include, but are not limited to, the following:

• Pre-Operative Information: Demographics (e.g., age, gender), patient characteristics (e.g., BMI, American Society of Anesthesiologists class), and pre-operative medical history (e.g., tobacco use; comorbidities: hypertension, cardiopulmonary disease, diabetes; etc.).

Eligibility Criteria:
Inclusion Criteria:

Age 18 years or older Diagnosed with cerebral aneurysms (i.e. ICD-10 i67.1) Pre-intervention treatment with clopidogrel

Exclusion Criteria:

* Does not meet inclusion criteria specified in 3.1
Single Ventricle Reconstruction Extension Study (SVR II) - Pediatric Heart Network

The Single Ventricle Reconstruction (SVR) Trial looked at how infants with single ventricle heart defects did after the first stage of surgery (Norwood operation). Infants enrolled in the trial got one of two kinds of shunts during the Norwood; a modified Blalock-Taussig shunt (MBTS) or right ventricle to pulmonary artery shunt (RV-to-PA shunt).

The purpose of this study is to learn if children (2-6 years of age) who were enrolled in the SVR Trial do better with one of the two shunts (MBTS or RV-to-PA) in the years after surgery.

Among critical congenital heart lesions, hypoplastic left heart syndrome (HLHS) and related single right ventricle (RV) anomalies are associated with the highest morbidity and mortality. The first stage in palliation for patients with these defects is the Norwood procedure. The essential components of the Norwood procedure include (1) an atrial septectomy, (2) anastomosis of the proximal pulmonary artery to the aorta with homograft augmentation of the aortic arch, and (3) establishment of a source of pulmonary blood flow, with either a modified Blalock-Taussig shunt (MBTS) or the right ventricle to pulmonary artery (RV-to-PA) shunt. In May 2005, the Pediatric Heart Network began a multi-center, randomized trial, the Single Ventricle Reconstruction (SVR) Trial, comparing outcomes in subjects with HLHS or other single RV anomalies palliated using the Norwood procedure with either a MBTS or the RV-to-PA shunt. The primary outcome of this trial was freedom from death or cardiac transplantation by 12 months post-randomization.

The Single Ventricle Reconstruction Extension (SVR II) Study is an extension of the SVR Trial that compares clinical outcomes and RV performance following the RV-to-PA shunt versus MBTS modifications of the Norwood procedure in subjects at 6 years post-randomization. Data is collected annually between ages 2 and 6 years, as well as before and after the Fontan surgery. Vital status and medical history is ascertained annually until the last enrolled subject is 6 years old. Data is obtained through medical record review, phone interview with the parent or guardian, electrocardiography (ECG), core laboratory analysis of echocardiographic images and Holter monitors, and completion of questionnaires regarding neurodevelopmental outcomes, behavior, health-related quality of life, and family functioning. The primary outcome variable in SVR II will be freedom from death or cardiac transplantation at 6 years post-randomization. All subjects who were randomized in the SVR trial will be included in analysis of this endpoint.

Eligibility Criteria:
Inclusion Criteria:

* Randomized subject in the Single Ventricle Reconstruction Trial

Exclusion Criteria:

* No subjects enrolled in the the original SVR Trial will be excluded from analysis of the primary endpoint