cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Fluorescein Use During Cystoscopy

This study is a prospective randomized controlled study. Female patients over 18 years of age, who present for treatment of pelvic organ prolapse and/or stress urinary incontinence at the Pelvic Floor Center at the Johns Hopkins Bayview Medical Center, and who consent to undergo a urogynecologic surgical procedure, will be considered for inclusion in the study. Their histories will be reviewed by their attending surgeon and if they meet inclusion and exclusion criteria, they will be recruited for participation. The primary investigator and co-investigators (attending physician, fellows) will determine patient eligibility. Regarding privacy issues, the patients will be consented for both the procedure and for the study with careful attention made to emphasize patient confidentiality. When the patient presents for surgery, they will be randomized to receive either preoperative pyridium or intraoperative fluorescein or no dye. Given the color differences between the dyes, blinding will not occur. The process for recruitment will be consistent and any deviations from the protocol will be reported to the Johns Hopkins Internal Review Board.


Eligibility Criteria:
Inclusion Criteria:

• English speaking, female patients, ages 18 and older, undergoing urogynecologic surgery for pelvic organ prolapse or urinary incontinence with a planned concomitant cystoscopy at Johns Hopkins Bayview

Exclusion Criteria:

* Non-English speaking,
* Known allergic reactions or sensitivities to sodium fluorescein or phenazopyridine
* Known glucose-6-phosphate dehydrogenase or nicotinamide adenine dinucleotide- methemoglobin reductase deficiency
* Pregnant or breastfeeding
* Known renal disease or renal failure
* Undergoing concomitant non-urogynecologic procedures
* Dementia or cognitive impairment
The Hypotensive Effect of Propofol: an Observational Study

Hypotension is a recognized frequent complication of induction of anesthesia. The intent of this research is to determine the incidence of hypotension in patients receiving anesthetic induction with propofol. This investigation seeks to examine how normal clinical practice or a "real world" understanding of the usual response to propofol affects hemodynamics without isolating or standardizing other variables. The current research concerns hypotension in normal clinical practice where variability exists. This project aims to gather information and data in an attempt to form a foundation upon which each of the other variables affecting blood pressure may be subsequently assessed.


Eligibility Criteria:
Inclusion Criteria:

* All ASA 1-3 patients who are to receive propofol induction for general anesthesia

Exclusion Criteria:

* Allergy to propofol
* ASA 4 and above
Quantifying Patient-Specific Changes in Neuromuscular Control in Cerebral Palsy

Impaired neuromuscular control hinders movement for individuals with cerebral palsy and other neurological disorders. In this research, the investigators are developing new tools to quantify impaired neuromuscular control in cerebral palsy and evaluate changes after one of the most common treatments, orthopaedic surgery. The results from this research will empower clinicians to identify patient-specific factors that contribute to impaired movement and improve treatment and quality of life.

The long-term goals of this research are to quantify patient-specific changes in neuromuscular control in order to optimize treatment planning and improve mobility for individuals with cerebral palsy (CP). As a first step, the aims of this proposal are to evaluate neuromuscular control before and after one of the most common treatments for individuals with CP, orthopaedic surgery. The investigators will evaluate if patient-specific measures of neuromuscular control, based upon the framework of muscle synergies, can predict improvements in walking ability after surgery. Further, investigators will determine whether neuromuscular control changes after surgery and if these changes contribute to improvements in movement. To achieve these goal the investigators will implement and test new tools to quantify neuromuscular control which integrate clinical gait analysis and two computational techniques: synergy analysis and dynamic musculoskeletal simulation. This research will provide the foundation to use measures of altered neuromuscular control to inform treatment planning, develop alternative treatments, and improve mobility in CP and other neurologic disorders.

Eligibility Criteria:
Inclusion Criteria:

* Diplegic cerebral palsy
* Mild or Moderate Impairment, Gross Motor Function Classification System (GMFCS) Levels I-III
* Will receive follow-up care and physical therapy within the Gillette Children's Specialty Healthcare system

Exclusion Criteria:

* Botulinum toxin injections, baclofen, or other similar treatments in the 3 months prior to pre-operative gait analysis
Prednisone-Placebo vs Prednisone-Valacyclovir in Bell´s Palsy

Since steroids carry a moderate beneficial effect in Bell's palsy, and to address this question, valacyclovir was added to prednisone for the treatment of this condition.

Between December 2002 and December 2003, a total of 52 subjects with BP were evaluated, 42 fulfilled the inclusion criteria and entered the study, 1 patient was lost to follow-up after the first visit, leaving a total of 41 patients with complete clinical follow-up.

To be included in the study, patients had to be evaluated within the first 72 hours and could have no contraindications to steroid or valacyclovir therapy.

Patients were randomly assigned to either the prednisone-valacyclovir (group 1) or the prednisone-placebo group (group 2) Among the 41 patients completing the study, 19 pertenecian al group 1 and 21 group 2 Both groups received prednisone, a dose of 1 mg/kg body weight was given daily for 7 days (one single dose after breakfast). The treatment was tapered over the next 14 days. Those taking valacyclovir received 1000 mg in two daily doses for 7 days. All subjects were instructed about eye protection and lubrication were followed at regular intervals until recovery or for a minimum period of 3 months. Follow-up included examination at 1, 2, 4, 8 and 12 weeks after the first visit. Patients with incomplete recovery at 3 months were controlled until complete recovery or stabilization of the paralysis. All subjects were evaluated for laboratories parameters. Routine blood count, blood sugar, and liver function tests were performed at first visit.

There were no severe side effects attributable to the valacyclovir-prednisone treatment in this study.

Informed consent was obtained from all patients. Facial nerve function was assessed using the facial grading system (FGS) The scale used provides a quantitative score with three components; resting symmetry, symmetry of voluntary movement and synkinesis and a composite score was obtained.

Student's t-test was employed for quantitative....variables. Comparison of treatment results between both groups was performed by....means of an analysis of variance (ANOVA) test of two ways (therapy and time).

All statistical tests were considered received the same level of significance (P = 0.05).

Eligibility Criteria:
Inclusion Criteria:

* Patients with Bell´s palsy evaluated within the first 72 hours.

Exclusion Criteria:

* Peptic ulcer
* Tuberculosis
* Moderate or severe diabetes
* Moderate or severe hypertension
* Glaucoma
* Manifest cardiac disease
* Psychosis
* Renal or hepatic dysfunction, and
* Pregnancy.
Efficacy of Different Electrical Stimulation Placement in Patients With Overactive Bladder Syndrome

This experiment is expected to understand the benefits of different settings of electrical stimulation in the treatment of overactive bladder.

This experiment is expected to understand the benefits of different settings of electrical stimulation in the treatment of overactive bladder.The study will adopt a longitudinal research design with randomized quasi-experimental trial.The patients will recruited and be randomly assigned to Group A (Parasacral transcutaneous electrical stimulation) or Group B (Intravaginal electrical stimulation). There will be 30 participants in each group. Data will be collected 2 times.

Eligibility Criteria:
Inclusion Criteria:

* Urinary incontinence due to detrusor overactivity
* No patients had been taking anticholinergics or tricyclic depressants and none had been treated by pelvic floor exercise, bladder training, or pelvic surgery before entry into the study.

Exclusion Criteria:

* stress incontinence
* urinary tract infection
* neurological disease
* genital prolapse higher than stage II on POP-Q system
* pregnancy
* diabetes mellitus
* a history of anti-incontinence surgery and/or prolapse repair
* pelvic tumors and previously treated with radiation therapy or antimuscarinic agents
* patients who were not cooperative
* electrical stimulation contraindications
A Comparative Study Between Two Formulations of the Ciprofloxacin Hydrochloride + Hydrocortisone Otic Suspension

The objective of this study is to compare the efficacy and safety profiles of the test product containing 2 mg/mL ciprofloxacin hydrochloride associated with 10 mg/mL of hydrocortisone with the reference product Cipro HC®, in patients with acute otitis externa.

Phase III, non inferiority, multicentric, controlled, single blind, parallel-group, randomized study.

Population: 224 patients with external otitis , men and women aged between 1 - 70 years.

Primary endpoint: The primary endpoint of this study is the elimination of pain, swelling and otorrhea (cure).

Secondary endpoint: The endpoint will be the identification of the side effects of medication use.

Eligibility Criteria:
Inclusion Criteria:

* Informed of the nature of the study and given written informed consent;
* Patients with acute otitis externa;
* Intact tympanic membrane.

Exclusion Criteria:

* Known allergy or sensitivity to Ciprofloxacin Hydrochloride and Hydrocortisone;
* Patient has the tympanic membrane not intact;
* Diabetes
* Bilateral Acute Otitis Externa;
* Pregnant or lactating patients;
* Overt fungal Acute Otitis Externa;
* Other diseases of the ear
* Current Infection requiring systemic antimicrobial therapy.
* Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study.
HPV Self-sampling in the General Population

A randomized controlled trial comparing three strategies for cervical cancer screening: direct mailing of HPV self-sampling kit ("Outreach" arm), choice between self-sampling or healthcare provider sampling ("Choice" arm), and standard care (control arm) in two French departments.

In France, over 3,000 women are diagnosed annually with cervical cancer and 1,100 die from it, despite organized screening programs. The national screening coverage rate of 59% (2018- 2020) remains well below the European Union's recommended target of 70% and even further from the French Cancer Plan 2014-2019 objective of 80%. This study evaluates two innovative strategies to improve participation rates in two French departments (Marne and Aube). Eligible women aged 30-65 years will be randomized into three arms. The "Outreach" arm receives HPV self-sampling kit directly at home with SMS reminder at 3 months if no participation. The "Choice" arm can choose between ordering a self-sampling kit or visiting a healthcare provider with SMS reminder at 3 months if no participation. The control arm follows standard procedure with self-sampling offered at 12-month reminder. Women with positive HPV self-sampling tests will be followed for triage cytology, with assistance provided for appointments in the "Outreach" arm and reminders at 6 months post-positive result in the "Choice" arm. The study assesses participation rates, triage completion rates, feasibility, acceptability, and cost-effectiveness of these strategies. If successful, findings could inform modifications to the national organized screening program.

Eligibility Criteria:
Inclusion Criteria:

* Women aged 30 to 65 years old
* Living in the study area (Departments of Marne and Aube, France)
* At moderate risk of cervical cancer, i.e. eligible to the organised programme and receiving the first invitation of the screening round (not a reminder letter)

Exclusion Criteria:

* Outside the target age (less than 30 years old, or 66 years old and more)
* Already participating in the current screening round
* Total hysterectomy
* History of cervical cancer
* Current follow-up for abnormal cervical screening result or cervical lesions
Laser Ablation After Stereotactic Radiosurgery

The need for new technologies and devices in the field of neurosurgery is well established. In April 2013, FDA cleared NeuroBlate™ System, minimally invasive robotic laser thermotherapy tool. It employs a pulsed surgical laser to deliver targeted energy to abnormal brain tissue caused by tumors and lesions. This post-marketing, multi-center study will include patients with metastatic tumors who failed stereotactic radiosurgery and are already scheduled for NeuroBlate procedure. The study will collect clinical outcome, Quality of Life (QoL) and, where feasible, healthcare utilization data for publication.


Eligibility Criteria:
Key Inclusion Criteria:

1. Patient has signed and received a copy of the Informed Consent Form
2. Patient may have up to 3 target supratentorial metastatic lesions previously treated with stereotactic radiosurgery, with radiological evidence of progression, pseudoprogression or radionecrosis. Subject may have additional non target lesions present as long as they are not expected (in Investigator's judgment) to contribute to symptomatology during the course of the study or confound interpretation of radiological and clinical measures.
3. Karnofsky Performance Status (KPS) ≥ 60.

Key Exclusion Criteria:

1. Females who are pregnant, breast feeding, or plan to become pregnant in the 6 months following index procedure.
2. Leptomeningeal metastases.
3. Uncontrolled infectious process.
4. Uncontrolled hypertension (systolic \>180 mm Hg), angina pectoris, or cardiac dysrhythmia, or recent (within 6 weeks) history of intracranial hemorrhage.
5. Serious infection, immunosuppression or concurrent medical condition (chronic or acute in nature) that may prevent safe participation or ability to meet follow-up requirements.
6. Abnormal absolute neutrophil count (ANC\<1000/mm), platelets (\<100,000/mm) or the administration of antiplatelet agents (aspirin, plavix etc) or anticoagulation within 7 days prior to treatment.
7. Inadequate bone marrow, liver and renal function (e.g., total bilirubin \> 1.5 x ULN; AST, ALT \> 2.5 x ULN; alkaline phosphatase \> 2.5 x ULN; serum creatinine \> 1.5 x ULN).
Gait Analysis in Females Suffering From Patellofemoral Pain Syndrome (PFPS)

The purpose of the study was to evaluate the spatial and temporal variables during walking cycle in adolescent females suffering from patellofemoral pain syndrome (PFPS) versus healthy adolescent females .


Eligibility Criteria:
Inclusion Criteria:

* peripatellar or retropatellar knee pain worsen with upstairs and walking

Exclusion Criteria:

* previous knee or patella surgeries
Laparoscopic Versus Open Appendectomy

Appendectomy is the most common surgical procedure performed in emergency surgery. Because of lack of consensus about the most appropriate technique, appendectomy is still being performed by both open (OA) and laparoscopic (LA) methods. In this retrospective analysis, the investigators aimed to compare the laparoscopic approach and the conventional technique in the treatment of acute appendicitis.


Eligibility Criteria:
Inclusion Criteria:

* acute appendicitis

Exclusion Criteria:

* Pregnant women and patients with severe medical disease (hemodynamic instability, chronic medical or psychiatric illness, cirrhosis, coagulation disorders) requiring intensive care
Promoting Positive Emotional Functioning in Police and Military Populations

This study will examine whether actively serving and veteran members of the Canadian Armed Forces (CAF) and Royal Canadian Mounted Police (RCMP) who complete a treatment targeting anhedonia symptoms and amplifying positive emotional processing: 1) experience significant symptom reductions in anxiety, trauma, and depressive symptoms; 2) report increased experience of positive emotions; 3) report improvements to broad functioning and quality of life; and 4) find the treatment to be highly tolerable.


Eligibility Criteria:
Inclusion Criteria:

* Be an actively serving or veteran member of the CAF and RCMP;
* Have been referred to receive the treatment protocol at the OSIC at Deer Lodge Centre by a doctor or psychologist;
* Have previously participated in at least one evidence-based psychological treatment for depressive, anxiety, or trauma-and-stressor-related condition at OSIC but remain clinically symptomatic;
* Be able to speak, read, and write in English;
* Have no current psychosis, untreated bipolar disorder, or current suicidal ideation with plan and intent;
* Be on a stable medication regime and agree to not make changes for the duration of the treatment.
Assessment of Individual Follow-up by Coaching Program for Type 1 Diabetes Children

The purpose of this project is to assess the introduction of an individual follow-up distance coaching (phone and messages on a secure line platform) in order to optimize the health care of type 1 diabetes children with therapy adjustment difficulties. It is a personalized, multi-disciplinary, medical et paramedical. It will consist of an individual coaching for the children and families with therapy adjustment difficulties.

The hypothesis is that the proposed coaching would allow to improve the patient glycemic control not only during this coaching, but also, to bring long lasting improvement following the coaching.


Eligibility Criteria:
Inclusion Criteria:

* Less than 18 years old when coaching starts.
* Any diabetic patient (girl or boy) who doesn't master the adjustments of the treatment according to the investigator's judgment (non-adaptations of the treatment between 2 consultations or mistakes in adapting the insulin doses, not taking properly into account previous days tendencies, food, or activities) and/or average HbA1c of more than 8% during the last year.
* The patient, his 2 parents or legal representatives all agree to participate in the research
* Absence of justice protection measures
* Good predictable observance of the protocol
* Family can be reached by phone during the coaching timetables working hours or must be listed on the platform line " MyDiabby ".

Exclusion Criteria:

* Non auto-immun diabetes
* Major understanding difficulties from the relatives (difficulties in understanding French or what anticipatory adaptation means)
* The child or parents or legal representatives refuse to participate and to sign a consent
* Contact on the phone or on the platform impossible according to the protocol procedures
* Patient non-registered under Social Security
* Patient under justice protection measures
Study to Assess the Pharmacokinetic and Pharmacodynamic Bioequivalence of CHS-1701 With Neulasta

This is a randomized, single-blind, 3-period crossover study in healthy subjects to assess PK, PD, and safety (including immunogenicity) of a single 6mg subcutaneous injection of CHS-1701 (Coherus pegfligrastim) or 6mg SC dose of Neulasta (pegfilgrastim) given during each period.

This is a randomized, single-blind, 3-period crossover study in healthy subjects to assess PK, PD, and safety (including immunogenicity) of a single 6mg subcutaneous injection of CHS-1701 or 6mg SC dose of Neulasta given during each period.

The screening period may occur up to 28 days prior to the confinement period. After screening, eligible subjects will be randomly assigned to one of three possible treatment sequences. Treatments will be spaced by not less than 28 days.

Eligibility Criteria:
Inclusion Criteria:

1. Adult male or female of ages 18 to 45 inclusive
2. Body weight \> 50 kg (110 lb.) and body mass index between 18 and 28 kg/m2 inclusive
3. Medically healthy with clinically insignificant findings based on medical history, 12-lead ECG, and physical examination
4. Negative urine pregnancy test in women of childbearing potential

Exclusion Criteria:

1. Previous exposure to pegfilgrastim or filgrastim
2. Current or previous cancer, diabetes, or any clinically significant cardiovascular, metabolic, endocrine, renal, hepatic, gastrointestinal, hematologic, respiratory, dermatological, neurological, gynecologic, psychiatric, or other disorder
3. History of chronic or acute respiratory illness within the past 3 months
4. Positive urine drug or alcohol screen or unwillingness to abstain from alcohol or recreational drugs for the duration of study participation
5. No prescription or nonprescription drugs during the study
6. Participation in an investigational clinical study within 30 days prior to screening
7. History of known clinically significant drug and/or food allergies, including allergic reaction to latex
A Study of CS1003 in Subjects With Advanced Solid Tumors or Lymphomas

This is a phase Ia/Ib, open-label, multiple-dose, dose-escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of CS1003 in subjects with advanced solid tumors or lymphoma.


Eligibility Criteria:
Inclusion Criteria:

1. Willing to sign the informed consent.
2. Subjects must have histologically or cytologically confirmed advanced or metastatic solid tumor or unresectable lymphoma and have progressed, are intolerant to, refuse to accept or do not have access to standard therapy.
3. ECOG performance status of 0 or 1.
4. Subjects with evaluable but non-measurable lesion are eligible for Phase Ia. Subjects must have at least one measurable lesion per RECIST Version 1.1 to be eligible for Phase Ib.
5. Archived tumor tissue samples need to be collected, or subjects consent to undergo pre-treatment biopsy if archived sample is not available.
6. Life expectancy ≥ 3 months.
7. Subject must have adequate organ function.
8. Use of effective contraception (males and females).

Exclusion Criteria:

1. Subjects with known symptomatic or untreated brain metastasis or other CNS metastasis.
2. Subjects with active autoimmune diseases or history of autoimmune diseases.
3. Subjects who have to receive glucocorticoids (prednisone at \> 10 mg/day or equivalent) or other immunosuppression within 14 days prior to the first dose of CS1003.
4. Subjects with other malignant tumor(s) in the past 2 years are not eligible for Phase Ib
5. Subjects who have received any immune checkpoint treatment, including PD-1, PD-L1, etc.
6. History of HIV infection.
7. Subjects with active Hepatitis B and C infection requiring therapy.
8. Subjects with active infection of tuberculosis.
9. History of organ transplantation.
10. Unresolved toxicities from prior anti-cancer therapy.
11. History of uncontrolled allergic asthma and serious hypersensitive reaction to monoclonal antibodies.
12. Subjects with major cardiovascular diseases.
13. History of alcoholism or drugs abuse.
14. Any condition that, in the opinion of the investigator or sponsor, would jeopardize compliance.