cyrilzakka/clinical-trials huggingface dataset:
Effect of Acupuncture Augmented With Pelvic Floor Exercises on Overactive Bladder

The aim of this study is to investigate the effect of pelvic floor exercises augmented with acupuncture on overactive bladder

Overactive bladder syndrome (OAB) is a common complaint affecting 11.8% of the population. OAB is defined by the International Continence Society as "urinary urgency, usually accompanied by frequency and nocturia, with or without urgency urinary incontinence, in the absence of urinary tract infection or other obvious pathology."Urinary frequency accompanies OAB in 20%-25% of cases, and nocturia is present in 70%-75% of cases. Around one in three people with OAB also experience urinary incontinence. . OAB can be further categorized into "OAB-dry" (urinary incontinence is absent) and "OAB-wet" (urinary incontinence is present). 2 OAB is a long-term condition that reduces quality of life, leading to anxiety and depression and a negative effect on self-esteem.

Pelvic floor exercises and acupuncture play an important role in overactive bladder.This trial has 2 groupes ,one will recieve pelvic floor exercises augmented with acupuncture ,the second will recive pelvic floor exercises only for 12weeks.

Eligibility Criteria:
Inclusion Criteria:

Patients with a clinical diagnosis of idiopathic OAB syndrome. Willingness to take part in the study protocol. Ability to complete outcome measures. Ability to give informed consent. Acupuncture not contra-indicated. Age:50-60 years. Vaginal delivery.

-Parity:2-3times. Body mass index \<35kg/m2.

Exclusion Criteria:

* - Evidence of other pathology that may be contributing to OAB symptoms i.e., urinary tract infection or a neurological condition.
* Smoking.
* Taking sedative and hypnotic drugs.
Test-Retest Reproducibility of 18F-DCFPyL PET/CT in the Evaluation of Patients With Metastatic Prostate Cancer

In this study, the investigators intend to validate 18F-DCFPyL test-retest reproducibility in metastatic lesions, in order to investigate whether it serves as a reliable response assessment tool, both to interpret existing studies and to design future longitudinal trials.

The investigators will image patients with widely metastatic castration-sensitive (CSPC) or castration-resistant prostate cancer (CRPC) using 18F-DCFPyL-PET/CT for detection of tumor burden and perform a lesion-based head-to-head comparison with a subsequent near-term (one to seven days) 18F-DCFPyL-PET/CT follow-up scan, to assess test-retest reproducibility of this second-generation PSMA-targeted compound. Second, as it has not been specifically investigated with this compound before, intra-observer agreement as well as inter-scan variability will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Willing and able to provide written informed consent
* History of histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology
* Patients with metastatic castration-sensitive (CSPC) or castration-resistant prostate cancer (CRPC) with evidence of metastatic disease on conventional imaging with CT or bone scan.
* Prior docetaxel-based chemotherapy is permitted
* Documented metastatic prostate cancer progression as assessed by the treating oncologist with either one or both of the following and has not initiated a new therapy after determination of progression: Rising PSA over a minimum 1-week interval and/or radiographic progression in soft tissue and bone metastases (combination of bony and soft tissue metastases)
* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2

Exclusion Criteria:

* Serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection
* Administered a radioisotope ≤5 physical half-lives prior to the date of study PET/CT
* Administered IV X-ray contrast medium ≤24 hours prior to the date of study PET/CT
* Administered oral contrast medium ≤120 hours prior to the date of study PET/CT
* Condition or situation which, in the investigator's opinion, may put the patient at significant risk, may confound the study results, or may interfere significantly with patient's participation in the study
Evaluation of the Effectiveness of a Flu Vaccination Campaign for Healthcare Workers of a Teaching Hospital: a Pre-post Study

The goal of this observational study is to evaluate the effectiveness of the vaccination strategy implemented during the 2019/2020 flu vaccination campaign compared with the previous one. The main question it aims to answer is whether there are differences in the total coverage of influenza vaccination, in different categories of professionals and in different operating units.


Eligibility Criteria:
Inclusion Criteria:

* Health personnel employed by the Fondazione Policlinico Universitario "A. Gemelli" IRRCS

Exclusion Criteria:

-
Narrow-diameter Implants Replacing Maxillary Lateral Incisors

To present the 5-year clinical, radiographic, and aesthetic outcomes in patients with congenitally missing lateral incisors (MLIs) rehabilitated with two narrow-diameter implants (NDIs).


Eligibility Criteria:
Inclusion Criteria:

* Patients affected by congenital missing with uni- or bilateral maxillary lateral incisors (i.e. 12 and/or 22)
* Patients with systemic health or controlled medical conditions
* Patients arrested skeletal growth as documented by two body height measurements at least one year apart not indicating continuous growth (Jensen, 2019)
* Written Informed Consent

Exclusion Criteria:

* Patients contraindications to implant therapy (Hwang \& Wang, 2006, 2007) including
* Heavy smoking: \>20 cigarettes/day
* Poor oral hygiene
* Compromised compliance
* Periodontally compromised conditions
* Patients with MLI's with the canine situated in the MLI region
Effects of Phenylephrine on Cardiac Preload

In patients under general anesthesia, episodes of hypotension are often treated with phenylephrine. The effect of phenylephrine is conventionally attributed to afterload increase.

The aim of the study is to describe the time course of the effects of phenylephrine on the cardiac preload and cardiac output, and to evaluate whether phenylephrine, as an exclusive alpha-mimetic, could be beneficial for preload optimisation.

In consecutive patients scheduled for laparoscopic sigmoidectomy, all hemodynamic and respiratory variables are recorded electronically for subsequent offline analysis.

All patients are ventilated in volume control mode with a tidal volume of 8 ml/kg ideal body weight.

During steady-state Target Controlled Infusion (TCI) propofol/remifentanil anesthesia, when the Mean Arterial Blood Pressure (MAP) dropped below 80% of the awake state for at least 5 minutes, a phenylephrine bolus of 2 μg/kg is administered. If necessary this is repeated, or a continuous administration of phenylephrine is started at a rate of 10-30 μg/kg/u.

All patient manipulations during the procedure are electronically recorded and time stamped for subsequent off-line data analysis.

The first episode in each patient where phenylephrine is administered and in a period of at least 10 minutes when minimal or absent patient manipulation occurred, the hemodynamic variables are analysed to describe the effects of phenylephrine administration on the dynamic preload parameters and macro-hemodynamics.

Eligibility Criteria:
Inclusion Criteria:

* Adult
* necessity for arterial blood pressure monitoring
* necessity for central venous blood pressure monitoring

Exclusion Criteria:

* unwilling or unable to grant written informed consent
* cardiac arrythmia
* contra-indication for phenylephrine
* contra-indications for atropine
* contra-indication for Total Intravenous Anesthesia
Immunogenicity Assessment of Subjects Receiving Rabies Post-exposure Prophylaxis in Cambodia

A rabies virus neutralizing antibody (RVNA) concentration ≥ 0.5 IU/ml at 14 days after immunization is considered a proxy for protection in vaccine efficacy studies. Abridged and dose-sparing vaccination regimens increase accessibility and reduce both direct and indirect costs, especially in resource-constrained countries where RABV prevalence is highest. Several efficacy studies evaluated safety and immunogenicity of abridged regimens in healthy adult volunteers using either four-site intradermal (ID) or intramuscular (IM) regimens, showing them to be safe and immunogenic.

Researchers at the Institut Pasteur du Cambodge (IPC) have previously conducted a retrospective study on clinical outcome at ≥6 months in 3318 Cambodians who received intradermal Vero cell vaccine post-exposure prophylaxis after a bite by a rabid or sick-looking but untested dog in 2003-2014. Here, the investigators could show that there was no significant difference in survival among patients who received 3 versus 4 sessions of the Thai Red Cross (TRC) ID regimen. In a separate study, investigators measured antibody responses in order to evaluate the immunogenicity of the TRC regiment after 3 sessions versus 4 sessions. The investigators did not observe an increase in rabies virus seroneutralization titers 14 days after the fourth immunization compared to 14 days after the third immunization. These results contributed to changes endorsed by the WHO in its April 2018 guidelines. The "Institut Pasteur du Cambodge (IPC) regimen" of three PEP sessions of two-site ID 0.1 mL vaccine doses each at days 0, 3 and 7 is the first one-week PEP regimen to be recommended.

In the current research project, the aim is to compare further different PEP vaccination strategies in a real life setting of individuals attending the rabies vaccination center at Institut Pasteur du Cambodge (IPC) in Phom Penh, Cambodia. The antibody kinetics and cellular immune responses in patients following either the one-week, 2-site ID regimen (IPC regimen) or the two-week IM regimen (4-dose regimen) as well as the participants' survival for both protocols after 6 months are evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Subjects entering a rabies post-exposure vaccination course whatever the vaccine used with or without administration of rabies immunoglobulin (RIGs).
* Subjects with ability to attend all scheduled visits and to comply with all study procedures

Exclusion Criteria:

* Subjects with history of previous rabies vaccination
Breast Versus Bottle Study

The objective of the proposed research is to conduct a within-subject experimental study that will assess the effect of feeding mode (breast- versus bottle-feeding) on the quality and outcome of infant feeding interactions.


Eligibility Criteria:
Inclusion Criteria:

* Mothers 18-40 years of age
* Infants 0-24 weeks of age
* Infants who have not yet been introduced to complementary foods and beverages
* Dyads are breast- and bottle-feeding
* Mother is predominantly or solely responsible for infant feeding

Exclusion Criteria:

* preterm birth (i.e., gestational age \<37 weeks)
* low birth weight (\<2500 g)
* maternal smoking during pregnancy
* current or past medical conditions that interfere with oral feeding
* history of slow growth or failure to thrive
* weight for length percentile \<5th
* diagnosed developmental delay (e.g., Down's syndrome)
Entrainment Between Clinician and Patient During Palpation

This study will assess the physiological interaction between the palpating clinician and a research participant using a laser Doppler flow meter to detect changes in blood flow parameters.

Research participants will lie on their backs on a soft table while a licensed physician, with special training in osteopathic palpation and manipulation approaches, touches, and administers a slight inhibition of occipital bone motion for five minutes per stage. Both will have a non invasive skin sensor (probe), called a laser Doppler flow meter, attached to their forehead to detect changes in subcutaneous blood flow velocity. The signal from the device will be augmented and transmitted for display onto a digital polygraph recorder. Then, using Fourier transformation software, the signal will be displayed as a graph for spectral analysis to determine the effect on specific wave forms related to autonomic activity. The interaction between the two individuals will be assessed for evidence of entrainment phenomenon, i.e., the influence of one biorhythm upon another.

Eligibility Criteria:
Inclusion Criteria:

* healthy adult that can lie on his or her back on a padded table without moving for 35 minutes.

Exclusion Criteria:

* head trauma within the last six months, seizure disorder, pregnant, brain disease or injury, using beta or alpha blocker medication, unable to lie still for 35 minutes, allergy to the hypoallergenic sticky tape used to attach sensor to forehead
Way to Be Active IV (Framing vs Incentives)

Employers are increasingly looking for opportunities to motivate sedentary employees to become more physically active. Workplace walking programs have had mixed success and typically show most improvement among participants that are already fairly active at a baseline. The goal of this study is to determine whether a financial incentive program can motivate sedentary employees to increase the number of steps they walk per day to meet a minimum threshold.

The primary outcome measure is the proportion of days a minimum activity of 7000 steps or more is achieved. Outcomes will be assessed each week for 3 months using incentives followed by 3 months of follow-up without incentives. Secondary outcomes will include the average steps walked per day.


Eligibility Criteria:
Inclusion Criteria:

* Age greater than 18.
* Participant will need an iPhone or Android smartphone to be able to use the Moves App for tracking steps

Exclusion Criteria:

* Pregnant or lactating
* Currently participating in another physical activity study
Effect of Neoadjuvant Chemoradiation on Pathologic Complete Response Rates in Locally Advanced Breast Cancer Patients

This is a phase II randomized trial comparing pathologic complete response rates in locally advanced patients recieving either neoadjuvant chemotherapy or neoadjuvant chemoradiation.

A prospective randomized phase II trial, that enrolled locally advanced breast cancer patients who were randomized to recieve either neoadjuvant systemic treatment or neoadjuvant systemic treatment concurrently with radiotherapy. Surgery is done for all patients later on as indicated.

The pathological response rates between both groups will be compared, as well as surgical complications and acute radiation toxicity.

Eligibility Criteria:
Inclusion Criteria:

1. Female patients.
2. Age: 21 years or older.
3. ECOG performance status (PS) score 0 to 2.
4. Locally advanced tumors (stage IIIA or above) of any subtype.
5. Early breast cancer of the HER2+ or TNBC subtype when:

   1. Node-negative, T2 or T3.
   2. Node-positive, any T stage.

Exclusion Criteria:

1. Patients initially presenting with metastatic breast cancer.
2. Patients unfit to receive planned regimen of treatment that had a poor PS (i.e.: PS 3 and 4).
3. Inflammatory breast cancer (T4d) patients.
4. Patients having contraindications to radiotherapy (e.g.: Pregnancy, history of previous chest wall, breast, or axillary irradiation)
5. History of previous ipsilateral breast surgery.
6. Comorbidities that would affect skin healing or integrity, like uncontrolled diabetes mellitus or active autoimmune collagen or vascular diseases
Positron Emission Tomography in Monitoring Treatment Response in Women With Newly Diagnosed Breast Cancer

This study will investigate the sensitivity and specificity of FLT-PET/CT in primary breast cancer detection and in the use of FLT-PET in monitoring how well a breast tumor respond to treatment. We will compare this technique with other imaging modalities as well as with tissue collection (during a biopsy). We will recruit women with a newly diagnosed invasive breast cancer, who are able to tolerate undergoing a PET/CT (possibly two scans) scan,

Our overall goal is to use this clinical trial as a platform to validate fibroblast activation protein (FAP) as a biomarker for the tumor microenvironment and to explore the dynamic interaction between proliferating tumor cells and the tumor microenvironment. Our long term goal is to develop new drugs that will target the tumor microenvironment as novel therapeutic and chemoprevention strategies.

Eligibility Criteria:
Inclusion Criteria:

* Breast biopsy positive for an invasive malignancy (core needle, mammatone, or incisional biopsy)
* Participants must be planning to have surgery at the Hospital of the University of Pennsylvania
* Participants must be able to tolerating lying on the table for about an hour
* Newly diagnosed primary breast cancer, which is classified as being operable (T1-T4)

Exclusion Criteria:

* Pregnant women
* History of severe renal disease
* Prior history of breast cancer of the study breast within the last five years.
Impact of DuoTherm on Acute Opioid Use and Low Back Pain

Evaluate the change in opioid use in patients with moderate to severe low back pain when dispensed a multimodal DuoTherm mechanical stimulation (M-Stim) unit compared to TENS Transcutaneous Electrical Nerve Stimulation.

160 patients with acute or exacerbations of chronic low back pain (LBP) presenting for chiropractic and rehabilitation care will be stratified by opioid use status (naive or prior use for LBP) and randomized to one of two conditions: an M-Stim pain relief belt device incorporating 8 patterns of vibration motors (and optional heat, cold, and pressure) delivered through a sculpted metal plate; or a 4-lead TENS unit with 8 channels of stimulation and adjustable intensity. Patients will be prompted by a Qualtrics text link to a secure data recording site collecting opioid brand, dose, pill number, and source, and pain data.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged 18-90 presenting for treatment of acute low back pain or acute exacerbation of chronic LBP; pain duration \<3 months not on chronic opioids, chronic opioids permitted for chronic pain \>=3 months; self-report NRS measures \>=4, capacity to understand all relevant risks and potential benefits of the study (informed consent); willingness to communicate information on opioid use including prescription formulation, pill #, dose, and source.

Exclusion Criteria:

* Opioid prescription in the past month; Radicular pain likely reflecting a surgical or mechanical problem; BMI greater than 50 (device won't fit); sensitivity to cold or vibration (e.g Raynaud's or Sickle Cell Disease); diabetic neuropathy rendering a patient unable to determine if the device is too hot; new neurologic deficits, skin lesions over the low back area; a contraindication to any medication for pain management that would impact analgesic use record; inability to apply DuoTherm or TENS device; pacemaker that would render patients unable to use the TENS device.
Toxin Treatment for Amyotrophic Lateral Sclerosis (ALS) Related Sialorrhea

Evaluation of the decrease of the secretion of saliva in patients with amyotrophic lateral sclerosis by a local ultrasound-guided bilateral injection of botulinum toxin type A in parotids and submandibular glands. The investigators want to demonstrate 1 month after the injection, by a multicenter French randomized double blind study, an improvement of at least 25 % of the functional embarrassment due to saliva, estimated with a visual analogue scale, a decrease of the quantity of saliva and a decrease of the embarrassment for the main caregiver.

The patient will benefit from an ultrasound guided injection of botulinum toxin A (Botox®) or placebo (NaCl 0.9 %) and will be followed up in consultation at 4, 12, 16 (if reinjection) and 24 weeks. He will be contacted by telephone in 2 and in 8 weeks (percentage of decrease of functional embarrassment, percentage of decrease of salivary secretion rate). He can be able to benefit in the open label phase of a botulinum toxin type A injection at the 12-week follow up if he estimates that first injection was not effective or if the efficiency of the first injection began to become blurred. After the 6 months of the study, the patient will benefit again from the usual follow-up as advised by the French consensus conference in November, 2005.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Obtaining of a written consent after information
* Diagnosis of probable or certain ALS according to the El Escorial criteria of the World Federation and Neurology Committee on Neuromuscular Diseases
* Patient having a follow-up in an ALS center
* Sialorrhea with VAS functional embarrassment \> or equal at 50/100.
* Patient beneficiary of Social Security regime

Exclusion Criteria:

* Evolving disease associated with predictable survival \< 1 month
* Patient having previously received an injection of botulinum toxin in the salivary glands
* Patient taking the other medical treatments for sialorrhea in the 7 days before the inclusion in the study (scopoderm, trihexyph'nidyle, atropine, ipatropium, amitriptyline, clomipramine, oxybutinine, diphenhydramine, beta-blockers)
* Patient having benefited from radiotherapy or from surgery on the salivary glands
* Behavioral problems, dementia or other psychiatric problems
* Myasthenia
* Known Pregnancy or absence of contraception recognized as effective, breast feeding
Retrospective Study of Suture Tape for Soft Tissue Reconstruction in Patients Suffering From Lateral Ankle Instability

This study is intended to be a retrospective chart review of patients with chronic ankle instability who have undergone a lateral ligament reconstructive procedure for ATFL repair (isolated or non-isolated) with suture tape augmentation. Patients that have been treated at any of the participating institutions that have undergone an ATFL reconstruction with Arthrex InternalBrace augmentation who have postoperative hospital or ASC records of safety and effectiveness as measured by adverse events, potential complications, and potential functional outcomes past the 10-week time point will be included.


Eligibility Criteria:
Inclusion Criteria:

* Patients between and including the age of 14-75 at the time of surgery
* Patients who were diagnosed with lateral ankle instability by physician clinical assessment
* Patients who underwent an ATFL repair with Arthrex InternalBrace augmentation device (does not require an isolated repair)

Exclusion Criteria:

* Significant secondary procedures done at the time of repair, including significant osteochondral lesions and/or significant microfracture of the talus or tibia that warrant modifying the typical lateral ligament repair post-op rehab protocol. (Minor microfractures and OCD lesions that do not warrant bone debridements, synovectomies, and bone spur removals are allowed)
* Any concomitant orthopedic procedure that will extend the post-op rehabilitation (e.g., casting/immobilization) beyond the routinely prescribed rehab protocol following an ATFL reconstructive procedure.
* Patients undergoing a Calcaneal osteotomy
* Patients with less than 6 weeks follow-up
* Patients with incomplete medical records
* Patients with Worker's Compensation Cases
* Any patient with a history of infection of the ankle predating the ankle repair
* Any orthopedic issue outside of the ankle that the Investigator feels may impede functional endpoint outcome measures.
* Patients who have a medical history that would likely make the patient an unreliable research participant