cyrilzakka/clinical-trials huggingface dataset:
A Study of the Safety and Efficacy of Injectable Risperidone in the Prevention of Bipolar Mood Episodes

The purpose of this study is to determine if risperidone is effective and safe in the prevention of mood episodes in patients with bipolar 1 disorder.

RISPERDAL CONSTA (risperidone long-acting injection) may provide substantial improvement, by reducing patient non-compliance, in the long-term treatment of bipolar I disorder. This is a randomized (patients are assigned different treatments based on chance), double-blind, (neither the patient nor the physician knows whether drug or placebo is being taken, or at what dosage) placebo-controlled study to explore the safety and effectiveness of RISPERDAL CONSTA in the prevention of mood episodes in patients with bipolar 1 disorder. This study includes 5 periods: a screening period lasting up to 1 week; an open-label RISPERDAL (oral risperidone) treatment period lasting 3 weeks; an open-label RISPERDAL CONSTA stabilization period lasting 26 weeks; a double-blind period lasting up to 24 months; and an open-label extension with RISPERDAL CONSTA lasting 8 weeks. Efficacy will be assessed using the Young Mania Rating Scale (YMRS), Montgomery-Åsberg Depression Rating Scale (MADRS), Clinical Global Impressions - Severity (CGI-S) scale, Medical Outcomes Study Short Form 36 (SF-36), and the Personal and Social Performance (PSP) scale. Safety will be evaluated throughout the study and includes assessment of adverse events, clinical laboratory tests (including hematology, serum chemistry, blood glucose/lipid profile, prolactin, and urinalysis); electrocardiograms (ECGs), vital signs (pulse and blood pressure), physical examination, body mass index (BMI), and the Extrapyramidal Symptom Rating Scale (ESRS). Oral risperidone (flexible dosage) 1 to 6 mg/day for the first 3 weeks. Risperidone LAI i.m. injections (12.5mg, 25 mg, 37.5 mg, or 50 mg) given every 2 weeks for up to approximately 2.6 years (only 6 months for patients receiving placebo during DB-period)

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of bipolar 1 disorder, currently experiencing a mixed or manic episode or stable
* Two or more bipolar mood episodes in the last 2 years excluding current episode
* Negative pregnancy test

Exclusion Criteria:

* History of \> than 4 mood episodes a year during the last two years
* patients experiencing a depressive episode
* History of antisocial or borderline personality illness
* Has unstable or serious general medical illness
* Has received medications disallowed by study criteria.
Extracorporeal Shock Wave Therapy on Diabetes Related Frozen Shoulder

The aim of this study is to observe the changes in the combined ESWT application and physiotherapy program in the frozen shoulder pathology associated with diabetes. Different treatment approaches will try to identify the most effective treatment method. Changes in muscle tone, pain, range of motion and functionallity will be observed with ESWT treatment. For the first time placebo-controlled research is being conducted with different doses of ESWT in our country and in the World literature. In this way the lower floor of the further work to be done will be established.

The study will be performed with participants who has diabetic frozen shoulder diagnosis after clinical examination and imaging procedures performed, held at Okan University Hospital, Physical Therapy and Rehabilitation Clinic. Data will be recorded with the shoulder evaluation form in the study and cases will be divided into three groups with simple randomization method. The initial range of motion of the participants will be evaluated bilaterally using an electro-goniometer. The muscle tone evaluation will be made with MyotonPro. Muscle strength assessment will be performed with the MicroFET2 dynamometer at the appropriate measurement positions. Participants' pain assessment will be done in the rest, activity and night pain using the Visual Analog Scale. The Shoulder Pain Disability Scale will be used to assess participants' shoulder function. The short-form-36 questionnaire will be used evaluating the quality of life. Physiotherapy application will be applied to all three groups in the form of standard treatment protocol, duration and number. For the first group ESWT application will be done at energy density of 0.12 mJ/mm2, in the second group, at an energy density of 0.3 mJ/mm2, for the third group application will be done as sham ESWT. The ESWT will be administered once a week and in two separate sessions of 2000 strokes. After initial measurements, re-evaluations will be done in the fourth and sixth weeks. The statistics will be analyzed by appropriate methods.

Eligibility Criteria:
Sex: No limit on eligibility based on the sex of participants.

Gender: Eligibility is not based on gender.

Age Limits:

Minimum Age: 30 years Maximum Age: 65

Inclusion Criteria:

Pain in the shoulder joint longer than for six weeks The shoulder joint movements of cases at least two of the abduction, flexion, external rotation, and internal rotation movements with a limitation of motion \> 50% Differentiated from other pathologies according to shoulder MRI results

Exclusion Criteria:

Limitation of pain due to cervical radiculopathy Rotator cuff massive tears Recurrent subluxation Trauma or patients with active infection Using cardiac pills, patients Blood coagulation disorders Neurologic causes-restriction of movement in shoulder joint due to cerebrovascular pathologies, Limitation of movement due to rheumatic causes

Sampling Method: Simple random sampling
Estrogen Treatment in Acromegalic Women

Oral estrogens may be an effective adjuvant treatment for control of acromegaly in patients with resistance to somatostatin analogs.

This will be a canadian multicenter study with a randomized, double-blind, placebo-controlled design, to assess the efficacy and safety of adjuvant alesse in female acromegalic patients with suboptimal response to sandostatin LAR treatment.

Eligibility Criteria:
Inclusion Criteria:

* Women 18 years and older treated with somatostatin analogs
* Active acromegaly

Exclusion Criteria:

* Cardiovascular or cerebrovascular disease
* Thrombophlebitis or thromboembolism
* Breast cancer
* Non-controlled arterial hypertension
* Smoking
* Pregnancy or lactation
Assessment of Intracellular Cytokines and Markers in Cells (Phase 3)

This is a single arm, prospective, bilateral, non-randomized study that will be split into four elements. Element 1 will be an in vitro non-clinical study and described in the laboratory protocol. Elements 2, 3 and 4 will each be a single non-dispensing visit.


Eligibility Criteria:
Inclusion Criteria:

* Potential subjects must satisfy all of the following criteria to be enrolled in the study:

  1. They are of legal age (18 years) and capacity to volunteer.
  2. They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.
  3. They are willing and able to follow the protocol.
  4. They agree not to participate in other clinical research for the duration of this study.

     Exclusion Criteria:
* Potential subjects who meet any of the following criteria will be excluded from participating in the study:

  1. They have had cataract surgery.
  2. They have had corneal refractive surgery.
  3. They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
  4. They are pregnant or breast-feeding.
  5. They have any infectious disease (e.g. hepatitis) or any immunosuppressive disease (e.g. HIV) or a history or anaphylaxis or severe allergic reactions.
  6. They have taken part in any other contact lens or care solution clinical trial research, within two weeks prior to starting this study.
  7. They are currently regularly (once per day or more) using oral or inhaled steroids or anti-inflammatory medications.
  8. They are using any topical medications such as eye drops or ointments.
  9. They are a current (i.e. within the last three months) contact lens wearer (wearing a lens in one or both eyes).
  10. History of allergic reaction to sodium fluorescein or topical anesthetic.
  11. They have Grade 3 or greater of any of the following ocular surface signs: corneal edema, corneal vascularization, corneal staining (white light evaluation), tarsal conjunctival changes or any other abnormality which would normally contraindicate contact lens wear.
  12. Any active ocular infection or inflammation.
A Behavioral Health Intervention Using Digital Technology in Radiation Therapy for Prostate Cancer Patients

The purpose of this study is to determine how to incorporate a smart water bottle to improve bladder filling for prostate cancer patients undergoing radiation therapy.


Eligibility Criteria:
Inclusion Criteria:

* Age older than 17 but less than 81.
* Non-metastatic prostate cancer patients undergoing definitive radiation treatment.
* Patients that self-identify as "smartphone owners".
* Patients with either iPhone (iOS 13.0 or higher) or Android (version 5.0.1 or higher) based smartphone access.
* English or Spanish speaking patients.

Exclusion Criteria:

* Patients with any history of pre-existing urinary retention.
* Patients with any history of kidney, urothelial tract or bladder cancer.
* Post-operative prostate patients.
* Patients that plan to be treated with pelvic lymph node radiation coverage.
* Patients without a functional bladder.
* Patients with a history of prior pelvic surgery or penile augmentation (circumcision is okay).
* Patients who have previously received any form of pelvic radiation.
* Patients unable to give informed consent.
* Patients who refuse to drink room-temperature water used for bladder filling.
* Patients without functional vision.
* Patients who are colorblind.
* Patient who refuse to use the smartphone app or who refuse consent.
Pain Outcomes Following Intralesional Corticosteroid Injections

Corticosteroid therapy, including intralesional and topical applications, has many indications within the fields of Dermatology, Plastic Surgery, and Orthopedics. However, these injections can be quite painful, which leads many patients to discontinue treatment.

Often, the injection involves a mixture of local anesthetic and corticosteroids despite a lack of evidence that the use of lidocaine improves pain. Due to the acidic pH, the lidocaine component of the injection can actually cause a significant burning sensation during the procedure. Lidocaine does not have anti-inflammatory properties and does not treat the underlying pathology. By including another medication, lidocaine also adds cost and risk to the procedure.

The purpose of this study is to see if removing lidocaine from intralesional injections decreases the pain of injection.


Eligibility Criteria:
Inclusion Criteria:

* \>12 years old presenting with an indication for intralesional steroid injection

Exclusion Criteria:

* Unconsentable
* Not a candidate for corticosteroid injection
* Contraindication to lidocaine
A Study of the Safety and Efficacy of a New Treatment for Non-Infectious Intermediate or Posterior Uveitis

This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone for the treatment of non-infectious intermediate or posterior uveitis.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older with a diagnosis of chronic intermediate uveitis in at least one eye

Exclusion Criteria:

* Uncontrolled systemic disease
* Any active ocular infections
Immunogenicity and Safety of the Concomitant Administration of a Tdap Vaccine and Meningococcal ACWY Conjugate Vaccine in Healthy Subjects Aged 11-25 Years

Immunogenicity and Safety of the Concomitant Administration of a Tdap Vaccine and Meningococcal ACWY Conjugate Vaccine in Healthy Subjects Aged 11-25 Years


Eligibility Criteria:
Inclusion Criteria:

* Male and female 11-25 years old healthy subjects;
* who had received the primary immunization with a vaccine containing DT or Tdap antigens and a T, Td, or Tdap booster injection at least 5 years prior to study entry

Exclusion Criteria:

* previous ascertained or suspected disease caused by N. meningitidis
* previously been immunized with a meningococcal vaccine or vaccine containing meningococcal antigen(s)
* serious acute, chronic or progressive disease
* history of any anaphylaxis, serious vaccine reactions, or allergy to any vaccine component
* known or suspected impairment/alteration of immune function, either congenital or acquired
Predictive Value of Inflammatory Indexes and CHA2DS2-VASc Score for LVT in ANT-MI With Left Ventricular Dysfunction

To investigate the predictive value of inflammatory indexes and CHA2DS2-VASc score for anterior myocardial infarction (ANT-MI) with left ventricular thrombus(LVT) (LVT).

The clinical data were collected from 371consecutive patients with ANT-MI in our hospital from January 2014 to January 2021.As a result,totally 62 patients with LVT were selected as the experimental group and 186 patients with non-LVT as the control group .The observation indexes included baseline data, coronary angiography, disease course, laboratory examination and auxiliary examination.Patients with severe organic disease and having previous history of left ventricular aneurysm( LVA) and LVT were excluded.Data was analyzed by software SPSS 22.0 for statistical analysis,and the logistic regression model was established.A P\<0.05 was considered statistically significant, and the risk factors of LVT formation were retrospectively analyzed.

Eligibility Criteria:
Inclusion Criteria:

acute anterior myocardial infarction with left ventricular dysfunction

Exclusion Criteria:

end-stage organic disease, thrombotic hematological disorders, previous anticoagulant use, and poor echogenicity
Evaluation of the Treatment of Recurrent Corneal Erosions by Anterior Stromal Puncture With Nd: YAG Laser

To evaluate the clinical outcomes in patients with recurrent corneal erosions who received anterior stromal puncture by use of neodymium:yttrium-aluminum-garnet (Nd:YAG) laser.

Participants: From 2000 to 2005, thirty-three eyes in 33 patients with unilaterally recurrent corneal erosions who showed poor response to conservative managements and were treated with Nd:YAG laser were studied.

Intervention: Anterior corneal stromal puncture with Nd:YAG laser was performed in the loosened epithelium or epithelial defect area. The causes and frequency of corneal erosions and the spot numbers and total energy of the Nd:YAG laser were recorded. Slit-lamp biomicroscopic examination, refraction, corneal topography, and times of laser were reviewed. A questionnaire regarding the preoperative and postoperative difference in the intensity of pain and frequency of corneal erosion was provided.

Main Outcome Measures: Rate of recurrence and pain assessment by numerical rating scale.

Eligibility Criteria:
Inclusion Criteria:

* patients with recurrent corneal erosions who showed poor response to conservative managements and were treated with Nd:YAG laser.

Exclusion Criteria:

* Slit-lamp biomicroscopic examination in both eyes of patient showed any evidence of anterior basement membrane dystrophy.
Reduction of Gastrointestinal Toxicity in Prostate Cancer by Proton Spot Placement

This purpose of this study is to examine the placement of proton spots during pencil beam scanning proton therapy for low and intermediate risk prostate cancer. The researchers will test a unique technique called "Spot Delete" to control the placement of spots during treatment planning. They will also use a special computer model to study how the energy of the proton beam (linear energy transfer) is related to rectal and bladder side effects. The study involves creating a treatment plan based on a CT scan, which helps guide the proton beam in the body. The clinical team uses this CT scan to find the best placement for the protons. The "Spot Delete" method prevents protons from stopping in the rectum, sigmoid, and small bowel, which is thought to be related to acute or late toxicities, such as tenesmus, diarrhea, fecal incontinence, proctitis, and rectal hemorrhage.

Patients will be randomized into two groups of spot placement. In the experimental arm, "Spot Delete" will be used to prohibit proton spots from being placed in the rectum, sigmoid, and small bowel. In the control arm, proton spots are placed by the treatment planning system are not modified. Medical staff will document gastrointestinal toxicities (diarrhea, fecal incontinence, proctitis, and rectal hemorrhage) and genitourinary toxicities (hematuria, urinary incontinence, urinary retention, urinary obstruction, urinary pain, urinary frequency, and urinary urgency) in the electronic medical record.

This study carries the same risks as regular proton therapy. Proton therapy, like other cancer treatments, may cause the aforementioned side effects. It is important to note that the "Spot Delete" technique aims to specifically address the bladder and bowel reactions, so there might be a potential reduction in this particular risk. Dose constraints will be the same for each treatment arm. Though not expected, it is theoretically possible that this method may counterintuitively increase side effects involving the bladder or bowel. Likewise, increased side effects in other organs are not expected, but are theoretically possible. For this reason we believe there is clinical equipoise between the two trial arms.

Eligibility Criteria:
Inclusion Criteria:

* Pathological proven diagnosis of prostatic adenocarcinoma
* History and physical exam to establish clinical staging
* Clinical stage T1-T2c (AJCC 7th edition)
* Prostate specific antigen (PSA) \< 20 ng/mL
* Gleason Score ≤ 7
* Eastern Cooperative Oncology Group (ECOG) Performance status 0-1
* Patients must be 18 years of age or older
* Willingness and ability to complete the International Prostate Symptom Score (IPSS) survey and Expanded Prostate Cancer Index Composite (EPIC) questionnaire

Exclusion Criteria:

* Prior radiotherapy to the pelvic area
* Prior prostate cancer therapy: cryotherapy or hyperthermia
* Prior systemic therapy (chemotherapy) for prostate cancer
* Regional lymph nodes (common iliac, external iliac, internal iliac, presacral) are a target of treatment
* Active diverticulitis, ulcerative colitis, or Crohn's disease
Effects of Kinesio Taping in Patellofemoral Pain

The study aims to analyze the immediate effects and 72 hours after application of the Kinesio Taping (KT) in the electromyographic activity of the vastus medialis oblique (VMO) and vastus lateralis (VL), the isokinetic performance of the quadriceps and referred pain of subjects with PFPS. The volunteers will be randomly assigned to one of the three groups and perform one of the protocols: control - remain at rest; KT - application of Kinesio Taping with tension in the VMO region; placebo - application of Kinesio Taping without tension, in the same region. All volunteers will be submitted to the evaluation of pain intensity, the electromyographic activity of the VMO and VL and dynamometric parameters in 3 times: before the application of KT, immediately after the application of KT and after 72h of application. Average effect estimates (differences between groups) for all variables will be calculated using the mixed model ANOVA with a significance level of 5% (p ≤ 0.05).


Eligibility Criteria:
Inclusion Criteria:

* Female between 18 and 35 years;
* BMI below 30;
* Clinical diagnosis- previous pain or retropatellar in at least two of the following functional activities: stay for a long time sitting, up or down stairs, run, kneel, crouch, jump;
* Onset of symptoms insidiously and nontraumatic;
* Pain intensity 3 or more on EVA;
* Presence of pain for at least 1 month;

Exclusion Criteria:

* Be performing currently physiotherapy;
* It present surgery, trauma or musculoskeletal system of the lower limb injury within 6 months;
* There have other pathologies associated with the knee joint;
* Does not run the tests properly;
* Does not attend all assessments.
Changes of Pulse Pressure Variation Duing Tidal Volume Challenge in Patients With Spontaneous Breathing

Background: Predicting preload responsiveness by using dynamic indicators before administering fluids to critically ill patients is nowadays routinely performed at the bedside. Unlike other dynamic indicators of preload responsiveness that require cardiac output monitoring, pulse pressure variation (PPV) can be simply obtained via an arterial catheter . However, PPV is not reliable in mechanically ventilated patients with spontaneous breathing activity. We hypothesized that an increase in PPV after a tidal volume (TV) challenge (TVC) or a decrease in PPV during passive leg raising (PLR) will predict preload responsiveness in such cases.

Objective: to examine if the change in PPV during PLR and after a TVC can predict preload responsiveness in patients with mechanical ventilation and persistent spontaneous breathing

Prospective non interventional study conducted in two intensive care units. Patients under mechanical ventilation with spontaneous cycles, for whom the physician in charge decided to test preload responsiveness were included. We collected demographic and clinical information, the use of mechanical ventilation and its parameters, the use of vasopressors and their dosage and blood lactate.

Firstly, transthoracic echocardiography (TTE) was performed to measure the velocity time integral (VTI) of the left ventricular outflow tract .

A PLR maneuvre is performed with TTE probe in place and a new assessement of VTI is measured, in addition to the PPV and other hemodynamic parmeters (Diastolic, mean and systolic arterial pressure, heart rate, CVP). Delta VTI is the difference between VTI during PLR and VTI at baseline divided by VTI at baseline.

Patients were considered as preload responsive when delta VTI was ≥10%. Secondly, a TVC was performed by increasing the TV by 2mL/kg predicted body weight from its baseline value . PPV was recorded before and after the TVC in addition to the other hemodynamic parmeters listed above. Further more, respiratory parameters are collected: ventilator setting, plateau pressure, upper airway pressure, before and during the TVC.

Eligibility Criteria:
Inclusion Criteria:

* adult critically ill patients if the clinicians in charge decided to test preload responsiveness because of mean arterial pressure (MAP) \< 65 mmHg (measured by an arterial catheter) or other symptoms of acute circulatory failure (e.g. oliguria, skin mottling, tachycardia, hyperlactatemia)

Exclusion Criteria:

* Arrythmia
* no spontaneous breathing
* difficult condition for tansthoracic echocardiography
Deep Brain Stimulation Effects on Gait and Balance in Patients With Parkinson's Disease

The purpose of this study is to evaluate the effect of Deep Brain stimulation (DBS) on walking in patients with Parkinson's disease that have had DBS. While DBS improves Parkinson's disease (PD) symptoms and walking in many patients in some of the patients walking problems persist. This study aims to find out what are the best stimulation parameters of the DBS in order to improve walking.


Eligibility Criteria:
Inclusion Criteria:

* Patients with idiopathic Parkinson's disease stage 1-3 that underwent subthalamic nucleus (STN) Deep Brain Stimulation (DBS) and have walking difficulties 6-12 months after DBS.
* On stable dose of dopaminergic drugs
* Age 45-70 years of age

Exclusion Criteria:

* Past medical history of seizures
* Renal insufficiency
* Cardiac arrhythmia
* Severe arthritis
* Women of childbearing potential
* Dementia
* Less than 45 years of age or older than 70 years of age