cyrilzakka/clinical-trials huggingface dataset:
A Real-World Evidence Study of Goniotomy With the C-REX™ Instrument in Patients With Primary Open Angle Glaucoma

This study enrolls adults with primary open angle glaucoma (POAG) who underwent goniotomy intraocular pressure (IOP)-lowering surgery with the C-Rex Instrument. Patients are consented prior to surgery and followed for 12 months postoperatively. Data regarding IOP, use of glaucoma medications, and any device-related complications are collected during the study time period.

This a multicenter, observational real-world evidence study of eligible adults with primary open angle glaucoma (POAG) in whom ab-interno goniotomy surgery with the C-Rex Instrument was performed.

Data is collected from the preoperative visit(s) that directly preceded the surgery, the surgical procedure, and post-surgical visits through 12 months postoperatively.

Specific data collected includes C-Rex Instrument goniotomy surgical details, preoperative and postoperative IOP and use of ocular hypotensive medications, and device-related safety events.

Eligibility Criteria:
Inclusion Criteria:

* Primary open angle glaucoma
* Goniotomy surgery performed using the C-Rex Instrument

Exclusion Criteria:

* History of intraocular surgery within 8 weeks prior to C-Rex surgery
* Preoperative IOP higher than 33 mmHg
* Presence of a glaucoma type other than POAG
* Presence of clinically significant intraocular pathology other than cataract or glaucoma
Prospective Registry of Patients With Pancreas Adenocarcinoma Resectable and Borderline

Unlike other types of gastrointestinal tumors, there is controversial evidence of the efficacy of neoadjuvant therapy in patients with borderline and resectable adenocarcinoma (ADK) of the pancreas, the objective of this study is to perform a "snapshot" of the usual practice in our setting in terms of neoadjuvant therapy in ADK, both in terms of the different regimens used as well as the results in terms of morbidity, mortality and survival.

Likewise, in a second phase, a prospective registry of patients included in the neoadjuvant regimen for both resectable and borderline ADK diagnosed in Catalonia will be launched, which will provide us with valuable information to try to answer open questions in the context of borderline and resectable ADK treatment.


Eligibility Criteria:
Inclusion Criteria:

* resectable or borderline pancreas ADK
* with or without radiotherapy
* any type of approach
* any type of surgery

Exclusion Criteria:

* locally advanced ADK
* No consent
CART-19 Cells For R/R B-ALL

There are limited treatment options for relapse/refractory B-cell acute lymphoblastic leukemia(ALL). However,CART-19 cells has emerged as a powerful targeted immunotherapy for highly refractory CD19+ acute lymphoblastic leukemia (ALL). This study aims to assess the safety and toxicity of CART-19 cells to patients with relapse/refractory B-cell ALL.


Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent
* Aged between 1-60 years
* Patients with relapsed/refractory B-cell ALL
* Cardiac: Left ventricular ejection fraction ≥ 50%
* Adequate renal and hepatic function
* Performance status: Karnofsky ≥ 70%

Exclusion Criteria:

* Pregnant or lactating females.
* Any co-morbidity precluding the administration of CART-19 cells.
OCT Biomarkers for Diabetic Retinopathy

Diabetic retinopathy (DR) is caused by changes in the blood vessels of the retina associated with long-term Type 1 or Type 2 diabetes mellitus. DR is a leading cause of blindness in the United States. Standard optical coherence tomography (OCT) cannot directly detect vascular changes, which may occur early affecting the passage of blood through the tiny capillaries (reduced capillary flow) or cause the greatest damage through formation of abnormal blood vessel growth (neovascularization). Currently, fluorescein angiography (FA) is the gold standard for detecting these changes, but FA requires an injection of a dye into the vein of the arm of the patient. This dye can cause undesirable side effects. Recently, OCT has been used to make functional measurements (such as total retinal blood flow among others) and to perform angiography. Thus, functional OCT may provide a useful, alternate way to evaluate diabetic retinopathy.


Eligibility Criteria:
Inclusion Criteria for participants with diabetes:

* Male or female participants 18-79 years old
* With Type 1 diabetes for over 5 years or Type 2 diabetes of any duration

Exclusion Criteria for participants with diabetes:

* Vision worse than 20/200
* Inability to maintain fixation for OCT imaging
* Significant kidney disease, kidney failure or kidney transplant
* Unstable medical status, including blood pressure greater than 180/110 or unstable heart disease
* Pregnant or nursing an infant
* Presence of an eye disease (other than diabetic retinopathy) that can affect retinal blood flow, retinal permeability or retinal anatomy
* Significant cataract, corneal scar, vitreous bleed or other media opacity
* History of major eye surgery within 4 months prior to enrollment in this study

Inclusion Criteria for participants without diabetes (controls):

* Male or female participants 18-79 years old

Exclusion Criteria for participants without diabetes (controls):

* Vision worse than 20/200
* Inability to maintain fixation for OCT imaging
* Significant kidney disease, kidney failure or kidney transplant
* Unstable medical status, including blood pressure greater than 180/110 or unstable heart disease
* Pregnant or nursing an infant
* Presence of any eye disease that can affect retinal blood flow, retinal permeability or retinal anatomy
* Significant cataract, corneal scar, vitreous bleed or other media opacity
* History of major eye surgery within 4 months prior to enrollment in this study
Post-operative Mobilisation After Rotator Cuff Repair

The aim of this study is to compare rehabilitation with the wearing of a sling, to rehabilitation without any immobilization after an arthroscopic repair of the supraspinatus tendon. The goal is to offer to patients a simplified rehabilitation management, with a faster recovery, less pain and a quicker return to normal life.

Rotator cuff tear is a frequent problem, increasing with age1. Thus arthroscopic repair is a frequent surgery. Despite this important number of cuff repair, the re-tear rate varies from 20 to 90% depending on tear severity and type of repair1,2. Many factors are implicated in tendon healing and post-operative clinical results. Some are unchangeable (age, tear size, chronicity...) but some are under the surgeon control like the surgical technique and the post-operative rehabilitation protocol. It exists many surgical repair techniques6, 7, with a massive development of technology during the last twenty years. However in terms of rehabilitation, there is only few studies and evidence of best practices4. The main aspect on which the surgeon can act, is the immobilization time. Actually, standard protocols include an immobilisation of 4 to 6 weeks before physiotherapy beginning5.

A recent review of the literature3 has highlighted five studies comparing different rehabilitation protocols, which include different immobilization periods ranging from 0 to 8 weeks, and different types of mobilization (under physiotherapist supervision or not, with machine or not). They found a similar rate of re-tear between the different protocols. But early passive motion enables to improve the range of motion during first 3-6 months, with similar results at one year.

However in all these studies, all patients had to wear a sling for at least 4 weeks, even in the early mobilization group. But the investigators don't know if this sling is really useful, probably not if the investigators follow the logic of faster recovery and same long term results with early mobilization. At our best knowledge, no study has sought to compare the usefulness of sling wearing after a rotator cuff repair. Removing sling could simplify rehabilitation and should provide a return to normal function faster, with greater satisfaction and a similar rate of re-tear.

The aim of this study is to compare rehabilitation with the wearing of a sling, to rehabilitation without any immobilization after an arthroscopic repair of the supraspinatus tendon.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years old
* Small tear (\< 3cm) of the supraspinatus tendon
* Arthroscopic cuff repair

Exclusion Criteria:

* Lesion of the anterior or posterior rotator cuff
* Significant other trauma of the involved upper member (e.g. associated scapular or clavicular fractures, acromioclavicular dislocation)
* Preoperative shoulder stiffness
* Inability to follow properly post-surgery recommendations.
Prosthetic Motility and Complications in Pegged Versus Unpegged Hydroxyapatite Orbital Implants

Pegging the hydroxyapatite for increasing prosthetic motility sometimes leads to some complications for the patient. These complications ranging from discharge, granuloma formation, exposure, implant infection to socket discomfort and etc. We are going to compare prosthetic motility, objectively and subjectively (patients satisfaction) before and after pegging the hydroxy- apatite, and evaluate the complications after pegging.


Eligibility Criteria:
Inclusion Criteria:

* orbital hydroxyapatite implants

Exclusion Criteria:

* history of systemic disease
* history of radio therapy
* secondary hydroxapatite implant
* complications lead to re-surgery
A Double-Blind Study To Evaluate the Long-Term Safety and Effectiveness of 60 mg Versus 120 mg of Aerosol Pentamidine in the Prophylaxis of Pneumocystis Carinii Pneumonia in AIDS Patients

To evaluate the safety, tolerability, and description of time to Pneumocystis carinii pneumonia (PCP) for long-term biweekly administration of 1 of 2 doses of aerosol pentamidine when used as a prophylactic agent in patients who have had one episode of AIDS-associated PCP.


Eligibility Criteria:
Inclusion Criteria

Patients who have completed 16 treatments under Fisons study no. 87-71 entitled, "A Double-Blind Group Comparative Study To Evaluate the Safety and Effectiveness of Three Different Doses of Aerosol Pentamidine in the Prophylaxis of Pneumocystis Carinii Pneumonia in Patients With AIDS Post First Episode PCP." Detailed safety parameters must have been documented for 6 months.

* Patients must receive the first dose on this study within 2 weeks of their last dose under study no. 87-71.

Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

* Requiring ongoing active therapy for an opportunistic infection (O.I.) at time of entry or those patients with either of the following AIDS-defining O.I.'s at entry:
* Toxoplasmosis.
* Cryptococcosis.
* Pulmonary Kaposi's sarcoma.
* Asthma poorly controlled by medication.
* Receiving active therapy for tuberculosis.

Patients with the following are excluded:

* Requiring ongoing active therapy for an opportunistic infection (O.I.) at time of entry or those patients with either of the following AIDS-defining O.I.'s at entry:
* Toxoplasmosis.
* Cryptococcosis.
* Pulmonary Kaposi's sarcoma.
* Unwilling to sign informed consent.
* Cannot cooperate with study procedures.
* Asthma poorly controlled by medication.
* Receiving active therapy for tuberculosis.

Active substance abuse.
Self-pressurized Air-Q With Blocker and Air-Q Blocker in Low Risk Female Patients Undergoing Ambulatory Surgery

In this study investigators shall compare between the two types of air-Q 's; the Air-Q ILA blocker and the Air-Q SP with blocker , regarding good sealing and oropharyngeal leak pressure

The Air-Q family has introduced many improved designs, among which the Air- Q blocker intubating laryngeal airway (Air-Q ILA blocker) in 2011. It has all the previously mentioned advantages, and in addition, a new, built-in, soft guide channel that accepts regular Nasal Gastric (NG) tubes to suction or optional Blocker Tubes for accessing the posterior pharynx and managing the esophagus. investigators can suction the pharynx or suction, vent and block the upper esophagus. Ever since the idea of SAD has launched and applying an optimum intra-cuff pressure that maintains enough sealing and at the same time not injurious to the oropharyngeal mucosa concerns anesthesiologists A good seal will provide good ventilation, will guarantee the desired depth of anesthesia at lower gas flows and with lesser leaks to the esophagus, it will not cause rise in intragastric pressure thus preventing regurgitation However When the cuff pressure is more than the mucosal perfusion pressure, it is likely to either cause postoperative pharyngo-laryngeal symptoms (sore throat, dysphagia, dysphonia) or cause local mucosal trauma and nerve injuries Therefore, in 2013 another improvised design of the Air-Q family has evolved, a Self-pressurized Air Q (air-Q SP) with blocker) . It has a drain tube through which a suction tube is passed like the Air-QILA blocker , And Instead of the pilot balloon and inflating cuff, the air-Q SP with blocker incorporates a self-regulating periglottic cuff at the end of this tube, a communication orifice at the junction of the peri-glottic cuff and the airway tube. This communication between two spaces enables the cuff to dynamically regulate intra-cuff pressure depending on airway pressure. This distinguishing feature of the air-Q SP may result in reduced risk for airway morbidities related to cuff hyperinflation. In this study investigators shall compare between the two types of air-Q 's; the Air-Q ILA blocker and the Air-Q SP with blocker , regarding good sealing and oropharyngeal leak pressure

Eligibility Criteria:
Inclusion Criteria:

1. Female patients between the age group of 18 and 50 years.
2. Patients of American Society of Anaesthesiologists (ASA) class I and II.
3. Patients with Ganzouri airway score less than 4.

Exclusion Criteria:

1. ASA III - V patients.
2. Airway score ≥ 4 according to El-Ganzouri Airway Scoring System.
3. Patients with any oropharyngeal pathology.
4. Patients known to have risk of gastric aspiration, gastro-esophageal reflux disease, hiatus hernia or previous upper gastrointestinal tract surgery
The Management of Sportsman's Groin Hernia in Professional and Amateur Soccer Players

The purpose of this study is to compare the surgical treatment for sportsman's hernia in our department to the current literature. Our hypothesis is that combined solution for the two major problems that cause pain in this syndrome - repair the weakness in the posterior wall of the inguinal canal with "tension free" technique (mesh repair) and reducing the muscle strain on the abdominal wall by cutting, partially, the tendon of the external oblique muscle, will shorten the time to return to full physical activity in soccer players.


Eligibility Criteria:
Inclusion Criteria:

* Soccer players who reffered to our clinic
* soccer players diagnosed with sportsman's hernia
* Failure of conservative treatment
* Underwent conventional surgery for sportsman's hernia in our department
* Completed the follow-up in our clinic
* age : 14-40
* male and female

Exclusion Criteria:

* soccer players who were diagnosed of had there surgery in other places
* soccer players who recover after conservative treatment
Droxidopa in Treating Patients With Neurogenic Hypotension

Please note that the continuation study can be found at http://clinicaltrials.gov/show/NCT00633880.

RATIONALE: Neurogenic hypotension is a fall in blood pressure that occurs when one moves from a lying down to a standing position or after eating a meal. It causes one to feel dizzy, light headed, and weak. Neurogenic hypotension is caused by a problem in the part of the nervous system that controls such functions as heart rate and blood pressure. Droxidopa, a drug that may increase blood pressure, may be an effective treatment for neurogenic hypotension.

PURPOSE: Clinical trial to study the effectiveness of droxidopa in treating patients who have neurogenic hypotension.

PROTOCOL OUTLINE:

Patients receive escalating doses of droxidopa or placebo for 7-14 days. Patients undergo blood pressure measurements hourly in both supine and standing positions.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Orthostatic hypotension due to autonomic nervous system failure Fall in systolic blood pressure (supine to standing) of at least 20 mm Hg and diastolic blood pressure of at least 15 mm Hg AND Symptoms of hypotension such as dizziness, light-headedness, unsteadiness, dimming or blurred vision
* History of syncope or near-syncope

--Prior/Concurrent Therapy--

* Endocrine therapy: No concurrent adrenergics Concurrent fludrocortisone allowed
* Other: Concurrent indomethacin, support garments, and high salt diets allowed
A Phase I Study of TQB728 Tablets on Tolerance and Pharmacokinetics

This is a open-label, phase I study to evaluate tolerance and pharmacokinetics of TQB3728 tablets in subjects with advanced solid tumor or hematologic tumor.


Eligibility Criteria:
Inclusion Criteria:

* 1.Understood and signed an informed consent form. 2.Histologically or cytologically confirmed advanced/metastatic or refractory solid tumor or lymphoma. No approved standard treatment regimen or ineffective or intolerant to standard treatment regimen.

  3.Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2; Life expectancy ≥12 weeks.

  4. Has at least one measurable lesion (solid tumors based on RECIST V1.1, lymphoma based on Lugano 2014).

  5.Adequate organ system function. 6.Male or female subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study (such as intrauterine devices , contraceptives or condoms) ；No pregnant or breastfeeding women, and a negative pregnancy test are received within 7 days before the first administration.

Exclusion Criteria:

* 1.Hypersensitivity to TQB3728 or its excipient. 2.Has received chemotherapy, radiotherapy, hormone therapy, immunotherapy, targeted therapy, biotherapy or any other antitumor therapy within 4 weeks before first administration.

  3.Has received allogeneic hematopoietic stem cell transplantation or organ transplantation, or received autologous hematopoietic stem cell transplantation within 12 weeks before administration.

  4.Has multiple factors affecting oral medication. 5.Has primary CNS lymphoma or CNS metastasis with untreated or uncontrolled symptoms.

  6.Pregnant or lactating women. 7.Has severe or uncontrolled systemic disease. 8.Has serious cardiovascular diseases. 9.Has neurological or mental disorders. 10.Has autoimmune disease or diseases requiring systemic hormones or immunosuppressive drugs.

  11.Has active viral infection. 12.The related toxicity of previous anti-tumor therapy has not recovered to CTCAE ≤ grade 1, except for hair loss.

  13. Has received major surgery within 4 weeks before the first administration. 14.Has participated in other clinical trials within 4 weeks before participating in this trial.

  15.According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.
Group Based Parent Training for Children With Autism and Disruptive Behaviors

The goal of the study is to providing parents of children diagnosed with autism spectrum disorders (ASD) and disruptive behaviors essential skills to manage their children's behaviors using an evidence based parent training protocol. Beyond the feasibility of delivering an evidence based intervention in groups and with community partners, primary and secondary outcomes in both the children and the parents who participated in the study are assessed during and after the intervention process

the investigators will deliver parent-mediated, community-implemented, group intervention for parents of young children with autism and disruptive behavior. The intervention is 11-12 weeks and will take place in community settings such as special education schools and community centers.

Within these meetings parents will be given the skills to understand their child's behavior and work to modify those that are clinically disruptive to the child and their environment.

Groups will be facilitated by student therapists under direct weekly supervision of a Board Certified Behavior Analyst (BCBA). Data will be collected before, after, and throughout the intervention, primarily by parent-report with one teacher-report measure and two (pre/post) filmed parent-child interactions.

The primary desired outcome is a measurable decrease in the child's disruptive behaviors and an increase in their adaptive behaviors. Although the intervention specifically targets disruptive behavior, we expect to see consequent improvement in a number of linked domains. These represent desired secondary outcomes.

First, as a result of receiving concrete skills and seeing improvement in their child's behavior, as well as due to participation in the group with other families, a reduction in parental stress and an increase in their perceived self-efficacy should occur, as well as a reduction in the stress of the non-participating parent.

Second, after the reduction in disruptive behaviors there should be an improvement in autism symptomatology. Improvements in behavior will allow the child to benefit more from their environments, leading to social and developmental gains.

In the context of the current study, the impact of the intervention on family accommodation is also assessed, hypothesizing that by learning how to analyse and modify behaviors, parents are gaining a broader insight into the impact their own behaviors have on that of their children.

Eligibility Criteria:
Inclusion Criteria:

* Formal ASD diagnosis

Exclusion Criteria:

-
Vaginal Dinoprostone Administration Prior to Insertion Levonorgestrel-releasing Intrauterine System in Women With no Previous Vaginal Delivery

To investigate whether vaginal dinoprostone administered before the levonorgestrel-releasing intrauterine system(IUs) insertion reduces failed insertions, insertion-related complications, and pain in Women With no Previous Vaginal Delivery.

Long-acting reversible contraception methods are highly effective methods for reduction of the unplanned pregnancy rate worldwide. The intrauterine device is a single procedure that provides reliable, effective and long term contraception for many women. However, the insertion procedure can be associated with a troublesome degree of pain that prevent some women from choosing its use. Different interventions have been described to decrease pain perception during intrauterine device insertion with no agreement on an effective one.

Eligibility Criteria:
Inclusion Criteria:

* Non-pregnant women
* Women that did not receive any analgesics or Dinoprostone in the 24 hours prior to insertion
* Women who delivered only by cesarean section

Exclusion Criteria:

* Women with any uterine abnormalities as congenital anomalies, endometrial lesions, adenomyosis, fibroids.
* Those with a Category 3 or 4 conditions for intrauterine device insertion according to the WHO Medical Eligibility Criteria for contraceptive use
* Allergy to dinoprostone.
* Women refuse to participate in the study