cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Rituximab Given at Fixed Dose (1000 mg on Days 1 and 15) Compared to the Standard Regimen in Adult's Immune Thrombocytopenia

The aim of this large French multicentric retrospective study was to compare the efficacy and safety of two (the standard and the Rheumatoid arthritis) rituximab regimens in adult's immune thrombocytopenia .

Every adult (age ≥ 18 years) seen in one of the 3 participating centre (dijon, Marseille, Mondor) over a 7-year period (2005-2012) with a definite diagnosis of primary ITP according to the American Society Hematology guidelines who received RTX regardless the regimen could be included.

Eligibility Criteria:
Inclusion Criteria:

* Primary ITP
* Age \> 18 years

Exclusion Criteria:

* Secondary ITP
* Age \< 18 years
Pexy Versus Non-pexy for Full Thickness Rectal Prolapse

No randomized controlled trial (RCT) has compared no rectopexy to rectopexy for external full-thickness rectal prolapse (FTRP). This study was performed to test the hypothesis that recurrence rates for FTRP following no rectopexy are not inferior to those for rectopexy.

Method: This is a multicenter randomized non-inferiority trial. Eligible patients were randomized to no rectopexy or rectopexy. The no rectopexy arm was defined as abdominal surgery with rectal mobilization only. The rectopexy arm was defined as abdominal surgery with mobilization and pexy. Sigmoid resection was not randomized and was added in the presence of constipation. The endpoint was recurrence rates defined as presence of external FTRP after surgery. A pre-RCT meta-analysis suggested a sample size of 251 patients based on a 15% expected difference in the 5-year cumulative recurrence rate. Recurrence-free curves will be generated and compared using the Kaplan-Meier method and log-rank test, respectively. A Bonferroni adjustment was used. An adjusted p value of \<0.01 was considered significant.


Eligibility Criteria:
Inclusion Criteria:

* informed consent
* mental ability to understand the procedure
* age range 18 to 70
* both sex

Exclusion Criteria:

* patients with recurrent rectal prolapse
* previous pelvic or colorectal surgery
* previous operation for fecal incontinence
* Cancer
* chronic intestinal Inflammatory diseases
Subarachnoid or Infiltration for Hemorrhoidectomy

There will be compared the postoperative analgesic effect of infiltration or spinal block for hemorrhoidectomy

This is a prospective, randomized study, including 40 patients between 18 and 60 years, of both genders, ASA 1 or 2.

Patients in group 1 (n = 20) will be submitted to spinal block and group 2 (n = 20) to infiltration. The spinal block will be performed with 10 mg of 0.5% bupivacaine. The infiltration will be performed with 10 ml of 0.5% bupivacaine with epinephrine on each side.

Will be evaluated: intensity of pain on a numerical scale from 0 to 10 every 15 minutes, relaxation of the sphincter muscles, intensity of pain after the operation every 30 minutes until reached the criteria for discharge, muscle strength of the lower limbs every 30 minutes, BP, HR, SO2, FR, other items that determine the conditions of discharge (urine output, nausea and vomiting), time to hospital discharge, and duration of analgesia. Adverse effects and complications will be noted.

Eligibility Criteria:
Inclusion Criteria:

* Will be included 50 patients, ASA physical status 1 or 2 undergoing hemorrhoidectomy after approval by the Ethics Committee and signed Consent Form

Exclusion Criteria:

* There will be excluded patients with associated diseases (fistula, fissure), infection at the puncture site, using anticoagulants or analgesics (up to 2 weeks before the procedure) and pregnant.
Effect of a Gait Retraining Intervention and a Minimalist Footwear Transition on Foot-ankle Strength, Running Economy and Injury in Endurance Runners.

The main aim is to determine whether a gait retraining intervention will improve the strength of the foot-ankle muscle, the running economy and reduce the injury incidence in a one-year follow-up study. The secondary aim is to seek whether a minimal foot-ankle strength is necessary to reduce the risk to sustain to a running-related-injury to transit toward a forefoot strike pattern or toward a minimalist footwear for an endurance runner.

Participants will be assessed at baseline, at 2 month follow-up, at 6 month follow-up and at 12 month follow-up. Assessment will be composed by questionnaires, a foot screening, maximal voluntary isometric strength of foot-ankle muscle with hand held dynamometer. Then, participants will run on a treadmill at self-paced and at 10 km/h with to measure their running economy and their footstrike pattern. In function of their distribution, participants will receive either nothing (control group) or minimalist footwear or a training to modify their footstrike pattern toward a more forefoot strike.


Eligibility Criteria:
Inclusion Criteria:

* Run 15 km per week since minimum 6 month

Exclusion Criteria:

* No running related injuries in the last 3 month before the participation.
* Have never worn minimalist footwear (minimalist index superior to 70%)
* Have never modified their footstrike pattern
Red Cell Distribution Width and Lactate Albumin Ratio as Prognostic Markers for Mortality in Sepsis and Septic Shock

The aim of this study is to find the utility of red cell distribution width and lactate/albumin ratio as prognostic markers in sepsis and septic shock patients.

Several indicators are being used to predict the prognosis of sepsis. Commonly used prognostic indicators include Acute Physiological and chronic health evaluation II (APACHE II), Sequential Organ Failure Assessment (SOFA), Mortality in Emergency Department Score (MEDS), New York Sepsis severity score.

Red cell distribution Width and lactate albumin ratio are being investigated for there prognostic value in septic patients.

Eligibility Criteria:
Inclusion Criteria:

1. Age from 18 to 60 years old.
2. Clinical criteria of sepsis
3. Or clinical criteria of septic shock including sepsis with persisting hypotension requiring vasopressors to maintain mean arterial pressure \> 65 mmHg and having a serum lactate level \> 2 mmol/L despite adequate volume resuscitation.

Exclusion Criteria:

1. No informed consent.
2. Patient with incomplete information and data.
3. The patient who received blood transfusion within 90 days before emergency admission.
4. The patients who are known to have long-term conditions causing anemia like sickle cell anemia, thalassemia, iron deficiency anemia.
5. Malignancy and chemotherapy during the previous 90 days.
6. Patients with either hepatic dysfunction, renal failure, having any disease in which albumin should be supplemented as liver cirrhosis with ascites, nephrotic syndrome and burns.
Smartphone Addiction and Temporomandibular Dysfunction

The aim of this study was to investigate the effect of smartphone addiction on temporomandibular dysfunction with the determinants of pain threshold, head posture and neck disability level.

Firstly, the purpose of the research and the evaluation methods were explained to the students. Students who volunteered to participate in the study and met the inclusion criteria were included in the evaluation. Approval was obtained from the evaluated students with the 'Informed Voluntary Consent Form'. Then, the students will fill in the Descriptive Data Form. The risk of smartphone addiction of the students who filled out the Descriptive Data Form was assessed with the Smartphone Addiction Scale-Short Form, TMD dysfunction status was assessed with the Fonseca Anamnestic Index, neck disability status was assessed with the Neck Disability Index, TMJ pain was assessed with the Numeric Pain Scale, head posture was assessed with a goniometer, and pressure pain threshold of the tenar and masseter muscles was assessed with an algometer. The evaluations took an average of 45 minutes for each student. The evaluations of the students were performed only once.

Eligibility Criteria:
Inclusion Criteria:

* To study at Bandirma Onyedi Eylül University
* Students between the ages of 18-30 years, whose voluntary consent was obtained and who use smartphones

Exclusion Criteria:

* Individuals undergoing masseter botox application
* Individuals diagnosed with TMJ disorder and/or bruxism
* Individuals with musculoskeletal system problems such as fractures of the hand, fingers, upper extremities and/or TMJ, rheumatoid disease with evidence of systemic, specific pathological conditions
* Individuals who have undergone any surgical operation related to hand, finger, upper extremity and/or TMJ problem
* Individuals who have received hand, finger, upper extremity and/or TMJ-related physiotherapy and rehabilitation services in less than 6 months
* Individuals with facial paralysis
* Individuals with diagnosed psychiatric illness.
A Technology-based Intervention With Retired People

The main objective of the study is to understand retired people's perception of retirement, to know their personal experience and to jointly seek solutions to the needs and problems encountered.

Secondarily, the aim is to understand the impact that an active aging program intervention implemented in retired people, based on the use of technology and considering the basis for the adaptation of the Prochaska and Diclemente Trans-Theoretical Model, can have in their quality of life.

The present study has been approached from a mixed-methods research. Mainly, the study is focused on a Research-Action-Participation method in order for empowering and to people having more control over their lives. This approach was used taking into account the many changes caused by leaving working life to begin the stage of retirement. In reference to participatory methods, techniques such as brainstorming, and consensus-building and visual techniques have been included.

The quantitative approach is a complementary method to the qualitative approach based on a quasi-experimental study, as no control group has been introduced. From this approach, a descriptive and comparative study has been carried out on quality of life and the behavior adopted in the adaptation to retirement, both measured before and after the intervention.

The intervention program developed consists of a brief-intervention about 5 sessions lasting between 45-60 minutes. It was intended to address the concerns and needs that emerge from the participants' interviews. The intervention is based on the principles of the process of adaptation to retirement defined by Atchley and the Prochaska and Diclemente Model on the phases of preparation for retirement. The material to be used will be based on existing resources for retired people, awareness through multimedia material and knowledge of possible contributions of different technological devices to healthy-lifestyle.

Eligibility Criteria:
Inclusion criteria:

* People retired recently (since 10 years maximum)
* People who attend regularly the institution selected for recruitment, which is attended by retired people over the age of 60 years old.

Exclusion criteria:

* People who present cognitive and psychological alterations that may interfere in the interview
* People who have not had paid employment
* People who have completed previously a preparation for retirement's program.
Effects of Music Intervention on the Brain Development of Preschool Children

The purpose of this research study is to learn more about the effects a musical intervention has on typical brain development in preschool-aged children.

This study will advance the science on brain research in young children by determining the effects of a musical intervention or training on children's brain development. The study will investigate how regular instruction in the Suzuki-like method of violin affects brain structure and function over the course of approximately five (5) months in preschool-aged children participating in an Early Childhood/Headstart preschool program when compared to a control group of their peers.

Eligibility Criteria:
Inclusion Criteria:

* Children who are between the ages of 3 and 4.5 years old and are involved in the intervention arm of the Avera Family Wellness Program
* Children who are between the ages of 3 and 4.5 years old and are involved in the control arm of the Avera Family Wellness Program

Exclusion Criteria:

* Unable to provide written consent to participate in the research project
* Unable to complete the MRI scan
Safety, Tolerability, Pharmacokinetics,Pharmacodynamics Study of LAPS-Exendin in Subjects of Type 2 Diabetes Mellitus

The purpose of this study is to investigate the safety and tolerability of repeated doses of HM11260C when given different regimens in subjects with type 2 diabetes mellitus (T2DM) on stable metformin monotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Is male or female and 18 to 65 years of age, inclusive, at screening
* Has a history of T2DM and a stable dose of metformin
* Has HbA1c levels at screening between 7% and 10%

Exclusion Criteria:

* Is pregnant or lactating
* Has type 1 diabetes
* Has a significant change in body weight in the 3 months before screening
* Has a fasting plasma glucose level greater than 240 mg/dL (13.3 mmol/L) at screening
* Has an estimated glomerular filtration rate rate \<75 mL/min/1.73 m2 or has ≥75 mL/min/1.73 m2 \<estimated glomerular filtration rate \<90 mL/min/1.73 m2 with a urine albumin to urine creatinine ratio \>30 mg/g.
* Has alanine aminotransferase or aspartate aminotransferase values \>2.0 × upper limit of normal or total bilirubin \>1.5 × upper limit of normal unless the subject has a known history of Gilbert's syndrome
* Has fasting serum triglycerides \>400 mg/dL (\>4.52 mmol/L) or \>250 mg/dL (\>2.85 mmol/L) if not on stable lipid-lowering therapy for at least 4 weeks prior to screening, or has calcitonin ≥50 ng/L. Subjects with a history of Fredrickson's Type I, IV or V hyperlipidemia will be excluded.
* Has any history of GI intolerance, chronic diarrhea, inflammatory bowel disease, partial bypass or gastric banding
* Has any acute illness within 5 days before first study drug administration
* Has elevated amylase, ongoing cholelithiasis, cholecystitis at screening, or history of pancreatitis
* Is a heavy tobacco user(more than 10 cigarettes a day)
* Is a heavy alcohol user
* Has a positive screen for drugs of abuse
JAVEMACS: Japan AVElumab Maintenance And Continuous Treatment Study

This study is a multicenter, non-interventional, retrospective, medical chart review of locally advanced or metastatic (la/m) Urothelial Cancer UC participants who were prescribed avelumab as first line maintenance therapy after a platinum-based chemotherapy. This study aims to understand the index date (i.e., at the initiation of avelumab maintenance therapy) demographics and clinical characteristics of participants with locally advanced/metastatic Urothelial Carcinoma in Japan, and to describe their treatment patterns and outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Participants diagnosed with locally advanced/metastatic urothelial carcinoma (la/m UC) before receiving avelumab first line maintenance therapy
* Participants with la/m UC (irrespective of tumor histology) whose disease has not progressed (ongoing stable disease, partial response, or complete response) following completion of first line PBCT and who has been treated with avelumab
* Participants who has been started avelumab first line maintenance therapy for la/m UC from 24 Feb 2021 (date of approval for UC) to 6 months before the date of approval of implementation of this study at each site
* Participants aged \>= 18 years old at index date
* Other protocol defined inclusion criteria could apply

Exclusion Criteria:

* Participant participated in a clinical trial in la/m UC during the study periods.
Special Drug Use-results Survey for Long-term Use（Avacopan）

The purpose of this survey is evaluating the safety and efficacy of long-term administration of avacopan for Japanese patients with microscopic polyangiitis or granulomatosis with polyangiitis under actual conditions of use.

The purpose of this survey is evaluating the safety and efficacy of long-term administration of avacopan for Japanese patients with microscopic polyangiitis or granulomatosis with polyangiitis under actual conditions of use.

Eligibility Criteria:
Inclusion Criteria:

* Patients with granulomatosis with polyangiitis or microscopic polyangiitis who are treatment with avacopan
Gingivitis Reduction After Use of 0.45% Stannous Fluoride Toothpaste

The 6-month clinical study was designed to investigate clinical efficacy on plaque and gingivitis for the stannous fluoride containing toothpaste (SNAP) compared to Colgate Cavity Protection Toothpaste after 3 and 6 months of product use.


Eligibility Criteria:
Inclusion Criteria:

* Potential subjects must meet all of the following criteria
* Subjects, ages 18-70, inclusive
* Availability for the six-month duration of the clinical research study
* Good general health
* Initial gingivitis index of at least 1.0 as determined by the use of the Loe-Silness Gingival Index
* Initial plaque index of at least 1.5 as determined by the use of the Quigley-Hein Plaque Index
* Signed Informed Consent Form

Exclusion Criteria:

* Presence of orthodontic appliances
* Presence of partial removable dentures
* Tumor(s) of the soft or hard tissues of the oral cavity
* Moderate and/or advanced periodontal disease, rampant caries, or any condition that the dental examiner considers exclusionary from the study
* Five or more carious lesions requiring immediate restorative treatment
* Antibiotic use any time during the one-month period prior to entry into the study -Participation in any other clinical study or test panel within the one month prior to entry into the study
* Dental prophylaxis during the past two weeks prior to baseline examinations
* History of allergies to oral care/personal care consumer products or their ingredients -On any prescription medicines that might interfere with the study outcome
* An existing medical condition that prohibits eating and/or drinking for periods up to 4 hours
* History of alcohol and/or drug abuse
* Self-reported pregnancy and/or lactating subjects.
The Clinical and Laboratory Phenotypes of Severe Asthma Patients in Clalit Health Services Haifa

Asthma is a chronic illness characterized by inflammation of the airways. Severe asthma is defined in the literature as asthma not controlled by medication. In recent years it has become known that severe asthma is a variable disease and has subtypes relating to the age of onset, type of inflammation and allergy, obesity, etc.

Our aim is to characterize the phenotypes of severe asthma population in our clinic and compare the prevalent phenotypes to the phenotypes described before.

Study measures will include the following:

* asthma demographic and symptoms questionnaire
* Validation of proper inhaler technique
* Height, weight measurements
* Forced spirometry and reversibility testing
* DLCO
* Fractional excretion of NO in exhaled breath
* Chest and sinus CT
* Induced sputum analysis
* Complete blood count, electrolytes, immunoglobulin E, Aspergillus Specific IgE
* Skin allergy testing

Eligibility Criteria:
Inclusion Criteria:

1. Presence of Asthma- typical symptoms and signs accompanied by either: a. obstruction in Spirometry, OR- b. positive methacholine test
2. Regular use of high dose of inhaled corticosteroids (1000 micrograms of fluticasone per day or equivalent) in addition to a long acting beta agonist (LABA).
3. Lack of asthma control- 2 or more exacerbations in the past year- exacerbations defined by hospitalization or care in an emergency department or treatment with systemic glucocorticosteroids for exacerbation of asthma symptoms.

Exclusion Criteria:

1. Presence of another relevant respiratory illness, such as chronic obstructive pulmonary disease (COPD)
2. lack of adherence to medical therapy
Long-Term Safety and Efficacy of rFIXFc in the Prevention and Treatment of Bleeding Episodes in Previously Treated Participants With Hemophilia B

The primary objective of the study is to evaluate the long-term safety of rFIXFc in participants with hemophilia B.

The secondary objective of this study is to evaluate the efficacy of rFIXFc in the prevention and treatment of bleeding episodes.

Participants will follow either a prophylaxis or on-demand regimen. The starting dose in this study will be determined by the clinical profile of the patient in the preceding studies, B-LONG 998HB102 (NCT01027364) and Kids B-LONG study 9HB02PED (NCT01440946)

Eligibility Criteria:
Key Inclusion Criteria:

* Subjects who have completed studies 998HB102 (NCT01027364) or 9HB02PED (NCT01440946) or other studies with rFIXFc
* Ability to understand the purposes \& risks of the study and provide signed and dated informed consent.

Key Exclusion Criteria:

* High-titer inhibitor (\>/=5.00 BU/mL)

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Effectiveness and Safety of Convalescent Plasma in Patients With High-risk COVID-19

The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has affected the global population with significant morbidity and mortality. One of the main concerns is the management of the patients since there is no specific treatment for this condition. Therefore, in SARS-CoV-2 patients the compassionate use of off-label therapies has been initiated; such as the use of plasma from convalescent patients. This treatment has been used in other pandemics like SARS-CoV-1, H5N1, H1N1, Ebola, among others. This study is a phase II/III randomized clinical trial to assess the effectiveness and safety of convalescent plasma administration in patients with high-risk SARS-CoV-2.

This is a Phase II/III randomized clinical trial to assess the effectiveness and safety of anti-SARS-CoV-2 convalescent plasma in i) hospitalized adult patients with high-risk of progression SARS-CoV-2 infection and ii) patients in Intensive Care Unit (ICU).

Compatible ABO plasma from convalescent patients will be administered at a dose of 400 ml divided into two doses intravenously. Outcomes will be measured as follows:

\* Group of patients with critical illness:

Primary outcomes (Effectiveness and safety):

* Mortality
* Safety: Presence of adverse events

Secondary outcomes:

* Intensive care unit length of stay
* Evolution of clinical and paraclinical aspects.

  * Group of patients at high risk of progression:

Primary outcomes (Effectiveness and safety):

* Mortality
* Safety: Presence of adverse events
* Admission to ICU in 30 days
* Mechanical ventilation requirement

Secondary outcomes:

* Hospital/Intensive care unit length of stay
* Evolution of clinical and paraclinical aspects.

Eligibility Criteria:
Inclusion Criteria:

All patients

* Patients diagnosed with COVID-19 infection by RT-PCR technique
* Patients ≥ 18 years of age
* Patients in standard care according to the national guide
* Onset of symptoms ≤ 14 days
* Signature of informed consent report

Patients at high risk of progression, defined by all of the following:

* Score greater than 9 on the CALL scale
* Pao2 / Fio2 ≤ 200 (parameters adjusted to the height of Bogotá, Colombia)
* X-ray or CT compatible with pneumonia
* Hospitalized patients

Critically ill patients, defined by any of the following:

* Mechanical ventilation requeriment
* Patients in Intensive Care Unit or Intermediate Care Unit
* Ventilatory failure, septic shock, dysfunction or multi-organ failure

Exclusion Criteria:

* Negative RT-PCR result from secretion 48 hours prior to study recruitment
* History of allergic reaction to blood or plasma in patients with a known history of IgA deficiency
* Patients participating in other clinical trial
* History of allergy to blood products
* History of confirmed infection and that required antibiotic or antifungal treatment 30 days prior to recruitment
* Pregnant women