cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Minimally Invasive Ilium Osteotomy and Its Bone Repairing Effect

In this research, a new bone harvesting technique is introduced in order to find an iliac crest bone harvesting method for patients with less trauma, less postoperative pain in donor sites, and lower incidence of postoperative complications, so as to get ideal bone grafting materials at a small cost, enhance the effect of osteogenesis repair on bone defect or fusion site, and improve the operation quality.

Based on the domestic and foreign research on minimally invasive bone harvesting, we have developed a disposable battery-powered bone harvesting device that can be used for milling bone tissues. Using this disposable battery-powered bone harvesting device, cancellous bone milling can be performed in a small bone hole with a diameter of 7.5 mm. The morselized bone or bone chips it milled can be used for bone fusion at the desired site. The technique adopts patented milling tool bit and electric drive, with high operation efficiency, so the surgery can be completed very quickly. The bone trauma in the operation can be significantly reduced and the pain in the donor site can be greatly alleviating. Moreover, the technique can obviously reduce the duration of bone harvesting and the cost of operating room. In addition, significant reductions in postoperative pain will also be helpful to a range of clinical advantages and benefits, such as the average hospitalization days, and will be expected to benefit significantly in patients undergoing autologous bone harvesting.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with clinical bone defects or need for bone fusion;
2. Age 18 to 65, and gender is not limited;
3. Informed consent has been signed.

Exclusion Criteria:

1. Age less than 18 or greater than 65;
2. Patients with severe deformities of the iliac bone or extensive defects of the iliac bone, which are not suitable for bone extraction;
3. Patients with coagulation dysfunction;
4. Patients who are unwilling to perform iliac bone extraction;
5. BMI \& lt; = 18.5 kg/m2;
6. Patients with type I and type II diabetes;
7. Osteoporosis(T \& lt; = -2.5);
8. Moderate and severe anemia(hemoglobin \& lt; 9g/L) or hypoproteinemia(albumin \& lt; 30g/L);
9. Patients with malignant neoplasms; Patients with mental illness and those who are unconscious and unable to express themselves accurately.
Increasing COVID-19, Influenza, and Pneumonia Vaccine Uptake

This proposed study seeks to community knowledge and understand the experience of underserved communities in the exploration of reducing health disparities and increasing vaccine uptake and acceptability COVID-19, influenza, and pneumonia for AA and Latinx populations. Unique in its design, it has the following characteristics: 1) multifaceted, 2) culturally tailored, 3) community-based, and 4) mixed methods in which the outcomes of interest will be measured before and after the intervention with 18-month interval. Furthermore, we seek to enhance our partnerships and collaborations with churches in South Los Angeles by supporting efforts to encourage COVID-19, influenza, and pneumonia vaccination uptake among underserved minorities in one of the most challenged and hard-to-reach population areas in the nation.

This study seeks to augment community knowledge and increase vaccine uptake among under-resourced African American and Latinx communities in South LA via leveraging trusted church leaders, educators and influencers to delivering COVID-19, influenza, and pneumonia education on vaccination. Unique in its design, this study has the following characteristics, beneficial to the acceptability and success of the proposal, it is: 1) multifaceted, 2) culturally tailored, and 3) community-based, in which the outcomes of interest will be compared longitudinally between arms 1-3, including measurement before and after the intervention with 9- and 18-month interval.

Eligibility Criteria:
Inclusion Criteria:

* Parishioner at a church receiving the VEPMP intervention
* Identify as African American or Latinx,
* at least 65 years and older
* Have Not received a vaccine for COVID-19, influenza, or pneumonia within the previous 24 months
* Agrees to study terms, which include follow-up interviews 9 and 18 months after study enrollment

Exclusion Criteria:

* Does not attend or identify as a Parishioner at a church receiving the VEPMP intervention
* Does not identify as African American or Latinx
* Under the age of 65 years
* Received all vaccine doses for COVID-19, influenza, or pneumonia within the previous 24 months
A Phase 3 Study Of OCU400 Gene Therapy for the Treatment Of Retinitis Pigmentosa

This is a Phase 3 study to Assess the Efficacy, Safety and Tolerability of OCU400 in patients with retinitis pigmentosa (RP) associated with RHO mutations and patients with any other RP associated mutation with a clinical phenotype of RP.

This is a multicenter, assessor blinded and randomized study which will enroll 150 subjects.

A total of one hundred and fifty (150) RP participants will be enrolled in this study- 75 in each of either two arms, RHO arm (n=75) or Gene agnostic arm (n=75). RHO arm will only enroll participants with confirmed genetic diagnosis of mutation in RHO gene; whereas Gene Agnostic arm will enroll RP Participants based on clinical diagnosis of RP and a confirmed genetic diagnosis with a gene associated with RP.

Subjects in each arm will be randomized into treatment (N=50) and control groups (N=25). Subjects in the treatment group will receive a sequential, bilateral sub-retinal injection of OCU400 if both eyes meet inclusion criteria. Control or untreated group subjects will receive OCU400 subretinal injection after completion of 12-month follow-up.

Eligibility Criteria:
Inclusion Criteria:

1. Males or females ≥ 8 years of age
2. Clinical diagnosis of RP with confirmed genetic diagnosis of autosomal dominant RHO mutation or any other mutation associated with RP.
3. BCVA ≤ 75 letters and ≥25 letters as measured by an ETDRS chart.
4. Visual field of \>5° in any meridian as measured by a III4e isopter or equivalent.
5. Able to perform a Luminance LDNA at certain light intensity at the Screening visit.
6. Presence of photoreceptors as determined by SD-OCT

Exclusion Criteria:

1. Subject lacks evidence of outer nuclear layer
2. Previous treatment with a gene-therapy or cell therapy product or treatment with any investigational drug or ocular device within one year.
3. History of corticosteroid related IOP spikes or uncontrolled glaucoma.
4. Absence of large regions of sensitivity in the pericentral and peripheral retinal regions
5. Cataract surgery within 3 months. YAG capsulotomy within 1 month. Any other intraocular surgery within 6 months.
6. Active ocular/intraocular infection, any history of rhegmatogenous retinal detachment or Current retinal detachment or retinal implant.
7. Breast-feeding, pregnancy, sperm donation or inability to practice strict contraception
Capsular Repair in FAI Impingement Surgery

The Investigator's hypothesis is that capsular repair (after CAM or mixed Femoroacetabular Impingement (FAI) surgery) requiring moderate capsulotomy, would result in similar patient outcomes in the short, mid and long term, both clinically and radiographically, compared to those without capsular repair. The objective of this clinical trial is to evaluate the clinical efficacy with regards to pain, range of motion and return to work and activities of daily living. Secondary objective is to evaluate radiographic characteristics between both groups.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients aged between 16-51 years of age.
2. Healthy patients undergoing hip arthroscopy due to Cam or mixed FAI
3. No major osteoarthritic (OA) changes according to X-Ray and surgery observation (Tonnis 0-1)
4. No previous hip surgery
5. No other influential disabilities in lower limbs
6. No chronic use of NSAID, analgesics, steroids or chemotherapy drugs
7. Base line activity level (Tegner 3 and above)

Exclusion Criteria:

1. Patients with concomitant disease that may affect joints
2. Patients with major ligamentous laxity
3. Patients who have undergone only minor vertical capsulotomy (as in small pincer only lesions)
4. Patients with extreme range of motion needs (such as ballet dancers)
5. Patients suffering from connective tissue disease
6. Patients suffering from bilateral symptomatic FAI that are being operated on for their first hip
7. Patients with relative or proven dysplastic hip determined by center edge angle and/or extreme version abnormalities as measured on apical CT/MR cuts and pelvic XR
8. Patients who needed Ilio-Psoas release
9. Patients whose cartilage hip status was defined as advanced OA during surgery
10. Patients who following surgery would be instructed to avoid full weight bearing on the operated hip for more than 4 weeks
11. Concomitant use of PRP (platelet rich plasma) or hyaluronic acid during the surgical procedure
12. Patients with preoperative hip stiffness
One-stop-shop Endoscopy in Reflux-patients: Evaluation of ENT and GI Features

Patients suffering from gastroesophageal reflux may suffer from both esophageal and laryngeal irritations. The investigators developed an endoscopic technique called functional endoscopy to evaluate alterations in the larynx and pharynx as well as in the esophagus simultaneously as one-stop-shop.

Patients suffering from gastroesophageal reflux may present to a variety of medical specialists according to their individual complaints (e.g., heartburn, hoarseness, dysphasia). In general, these addressed specialist may focus their attention to their individual fields of interest.

The investigators developed an endoscopic technique called functional endoscopy to evaluate patients with various GI- or ENT (ear-nose-throat)-symptoms being suggestive for gastroesophageal reflux disease.

In functional endoscopy, unsedated patients are examined with an ultrathin endoscope via the transnasal route. Reflux-associated features in the field of interest of the ENT-doctor and the GI-specialist are recorded and documented in the same session.

Eligibility Criteria:
Inclusion Criteria:

- Patients suffering from dysphasia, heartburn, laryngitis or pharyngitis suggestive for gastroesophageal reflux disease

Exclusion Criteria:

* Age under 18 years
* Inability to understand information for participation
* Refusal of participation
Influence of Intensive Lipid Lowering Treatment Compared to Moderate Lipid Lowering Treatment

The aim of this study was to measure the effect of low- and high-dose lipid-lowering treatment with rosuvastatin on the coronary physiology parameters.


Eligibility Criteria:
Inclusion Criteria:

1. ST-segment elevation myocardial infarction
2. no prior treatment with statins and
3. a non significant lesion in one of the two non-culprit coronary arteries

Exclusion Criteria:

1. age below 18 or above 81 years,
2. unconscious patients,
3. serum creatinine \> 176μmol/L,
4. hypothyroidism ((TSH \> 1.5 x ULN (upper limit of normal)),
5. current liver disease (ALAT \> 2 x ULN),
6. unexplained creatine kinase \> 3 x ULN,
7. alcohol or drug abuse within the last five years,
8. prior myopathy or serious hypersensitivity reaction caused by statins,
9. women with childbearing potential who were not using chemical or mechanical contraception,
10. pregnant or breastfeeding women,
11. history of malignancy unless a disease-free period of more than five years was present,
12. patients with abnormal lung function test (LFT),
13. participation in another investigational drug study less than four weeks before enrolment in the present study,
14. treatment with cyclosporine or fibrates
Pancreatic Duct Stent for Acute Necrotizing Pancreatitis

The research design is a randomized prospective clinical study comparing the incidence of Walled Off Necrosis (WON) in patients with acute necrotizing pancreatitis.

This is a randomized trial comparing the incidence of WON in patients with acute necrotizing pancreatitis, according to the placement or non-placement of an Advanix or a Cook Pancreatic Duct (PD) stent during Endoscopic Retrograde Cholangiopancreatography (ERCP) within 1-2 week of symptom onset. Patients will be randomly allocated to either treatment arm i.e. to either PD stent placement or no PD placement in a 1:1 ratio. The type of stent to be placed is at the discretion of the physician based on the clinical needs and presentation of the patient at the time of procedure. This is based on factors such as the size of the WON, the patient's anatomy, and other variables. Patients will be assessed at 4-6 weeks post-ERCP for the primary outcome measure, which is the incidence of WON on contrast-enhanced CT.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 19 years
2. The subject (or when applicable the subject's LAR) is capable of understanding and complying with protocol requirements.
3. The subject (or when applicable the subject's LAR) is able to understand and willing to sign an informed consent form prior to the initiation of any study procedures.
4. All patients with acute necrotizing pancreatitis and bedside index for severity in acute pancreatitis (BISAP) score of ≥ 3, who have been referred to Florida Hospital for Percutaneous endoscopy gastrojeunostomy (PEG-J) tube placement and/or ERCP for assessment of the PD
5. Absence of pancreatic fluid collection (defined as those \> 3cm in size located along the course of the main PD on cross-sectional imaging) at the time of study enrollment
6. No disconnected pancreatic duct syndrome (DPDS) on cross-sectional imaging or ERCP

Exclusion Criteria:

1. Age \<19 years
2. Unable to obtain consent for the procedure from either the patient or LAR
3. Patients with acute interstitial pancreatitis, without pancreatic necrosis
4. Patients with BISAP score ≤ 2
5. Patients with pancreatic fluid collection \> 3cm in size located along the course of the main PD on cross-sectional imaging prior to the initial ERCP
6. Patients with DPDS on cross-sectional imaging or ERCP
7. Unable to safely undergo ERCP for any reason
8. Failed cannulation during ERCP
The Effect of Preoperative Ketamine on the Emergence Characteristics in Children Undergoing Entropion Surgery

The investigators evaluate extubation time and recovery profiles in children undergoing entropion surgery.

This study will compare the extubation time and recovery profiles (degree of postoperative agitation and cough) between sevoflurane group and desflurane group. General anesthesia will maintained with sevoflurane 2-3vol% or desflurane 6-7vol%. After surgery, the investigators will measure the duration of extubation and recovery profiles between two groups.

Eligibility Criteria:
Inclusion Criteria:

* American society of anesthesiologist class 1 patients
* 3-6 years children undergoing entropion surgery

Exclusion Criteria:

* Do not agree with participate this study
The Press Fit Condylar (P.F.C.) Sigma Rotating Platform (RP) TC3 Revision Knee in Revision Knee Arthroplasty

The purpose of this study is to evaluate the long-term clinical and functional performance of the P.F.C. Sigma Rotating Platform TC3 knee system in revision knee surgery and to determine whether the implant design results in a longer-lasting knee replacement.

Primary outcome: Implant survival at 5 years Secondary Outcomes:Evidence of clinical and functional outcome determined by the Knee Society Score, anterior knee pain (Patellar Score). Evidence of health related quality of life determined by WOMAC OA index. Patient satisfaction at 1 and 5 years. Radiographic analysis according to Knee society guidelines. Implant survival annually to 15 years.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects over the age of 21 years (and skeletally mature).
* Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.
* Subjects who, in the opinion of the Investigator, are able to understand this investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.
* Subjects whose primary diagnosis includes non-inflammatory or inflammatory degenerative joint disease.
* Subjects who require revision of any previous knee arthroplasty.
* Subjects who, in the opinion of the Clinical Investigator, are considered to be suitable for treatment with the investigation device, according to the indications specified in the package insert leaflet.
* Subjects who require revision of the femoral and/or tibial components. (Both components must be replaced as part of the study.)

Exclusion Criteria:

* Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study (including malignancy, severe osteoporosis or disabling musculoskeletal problems).
* Women who are pregnant.
* Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.
* Subjects who have participated in a clinical study with an investigational product in the last 60 days (excluding any primary knee replacement study).
* Subjects who are currently involved in any injury litigation claims.
* Subjects with global instability, deficient extensor mechanism or severe bone loss (eg. due to fracture or tumour resection).
* Subjects who have had their contralateral knee replaced within the previous 6-month period.
Laser Therapy for Perioral Dermatitis

Perioral dermatitis is an inflammation of the skin around the mouth. The cause of perioral dermatitis is unknown. Current treatment methods include oral antibiotics and topical calcenurin inhibitors, both of which produce side effects and have been relatively ineffective in the treatment of perioral dermatitis. The investigators hope to assess the efficacy of laser therapy in treatment of perioral dermatitis by using laser therapy on one half of the patients face and having patients apply topical medication (clindamycin) to their face for 8 weeks. The side of their face that receives laser therapy will be randomized. The investigators will assess the efficacy of laser therapy by counting the number of lesions that patients have before and after laser therapy, comparing photos of patient's perioral dermatitis before and after treatment, and having patient's rate their satisfaction of the treatment.


Eligibility Criteria:
Inclusion Criteria:

* age 18 years or older
* perioral dermatitis for greater than 1 month
* willing to return for follow-up visits 2 weeks, 4 weeks and 8 weeks following treatment.

Exclusion Criteria:

* skin type V or VI (due to risk of hyperpigmentation)
* pregnant
* breastfeeding
* unable to understand English
* mentally impaired
* incarcerated
Effect And Safety Of Ziprasidone Compared To Other Atypical Antipsychotic Drug In Schizophrenic Patients

Evaluation of the antipsychotic efficacy and safety of ziprasidone versus olanzapine, risperidone or quetiapine in patients with schizophrenia, schizoaffective and schizophreniform disorders under naturalistic conditions of clinical practice


Eligibility Criteria:
Inclusion Criteria:

* Inpatients or outpatients with schizophrenia, schizoaffective and schizophreniform disorders (DSM-IV).
* Patients without adequate current treatment (i.e. intolerance to their current treatment or lack of efficacy of current treatment) based on clinical judgement of the investigator

Exclusion Criteria:

* A history of intolerance to ziprasidone, olanzapine, risperidone or quetiapine or any of its ingredients
Randomized Study of Intravenous Immunoglobulin (IVIg) in Patients With Subacute Proximal Diabetic Neuropathy

OBJECTIVES: I. Determine the effect of intravenous immunoglobulin on recovery time of patients with proximal diabetic neuropathy.

II. Determine whether rate of response is dose dependent in these patients.

PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled study. Patients are randomized to treatment with low dose intravenous immunoglobulin (IVIg), high dose IVIg, or placebo.

Patients must first complete baseline evaluation. Patients receive IVIg or placebo on days 1, 2, 3, and 5, biweekly at weeks 2-4, weekly at weeks 5-8, and every other week at weeks 9-12.

Patients are assessed at 6, 12, 36, 52, and 104 weeks.

Completion date provided represents the completion date of the grant per OOPD records

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Diagnostically proven non-insulin dependent diabetes mellitus as defined by the following criteria: Presence of classic symptoms, such as polyuria, polydipsia, ketonuria, and rapid weight loss, together with plasma glucose elevations Elevated fasting glucose concentration on more than one occasion
* Diagnostically proven proximal diabetic neuropathy with any of the following symptoms: Severe thigh, hip, or leg pain Greater than 20% weight loss Progressive proximal weakness in the painful leg Weakness in the contralateral lower limb Thoracic or cervical root distribution Symmetric distal polyneuropathy or autonomic neuropathy may be mild or absent

--Prior/Concurrent Therapy--

* At least 6 months since prior immunosuppression or plasma exchange
* No history of prior renal transplant

--Patient Characteristics--

* Age: 18 and over
* Performance status: Gait impairment at least grade 2
* Hematopoietic: Not specified
* Hepatic: Not specified
* Renal: Creatinine no greater than 1.4 mg/dL (women) Creatinine no greater than 1.5 mg/dL (men) No history of renal failure
* Cardiovascular: No history of cardiac failure
* Neurologic: Normal nerve conduction studies or changes compatible with distal symmetric diabetic neuropathy or diabetic lumbosacral radioplexus neuropathy Spinal fluid cell count less than 5 cells/mm3 Normal cerebral spinal fluid cytology No structural spine disease No inherited neuropathy
* Other: Electromyographic evidence of proximal lower limb plexus OR Radicular denervation compatible with proximal diabetic neuropathy No other systemic disease or malignancy Normal IgA levels No chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) No systemic amyloidosis No monoclonal gammopathy associated neuropathy No history of allergy to serum products No selective cervical or root involvement without lower limb weakness No evidence of secondary diabetes
Androcur Effects on Quality of Life

Androcur is an antiandrogenic drug, which blocks the action of male sex hormones. Androcur is used for treatment of advanced prostate cancer. This study investigates the effect of Androcur on quality of life of prostate cancer patients who are taking the drug for 12 months


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed adenocarcinoma of the prostate
* Inoperable prostate tumor or progradiated after surgery/ irradiation therapy
* Locally advanced tumor or distant metastases is present

Exclusion Criteria:

* Patient not fulfil the recruitment criteria
* Liver disease; Dubin-Johnson syndrome; Rotor syndrome; previous or existing liver tumours (in carcinoma of the prostate only if these are not due to metastases); wasting diseases (with the exception of carcinoma of the prostate); depression; previous or existing thromboembolic processes; diabetes with vascular changes; sickle-cell anaemia.
* As regards patients with prostatic carcinoma who have a history of thromboembolic processes and/or an existing sickle-cell anaemia, or diabetes with vascular changes, the risk:benefit ratio must be considered carefully in each individual case before the use of Androcur