cyrilzakka/clinical-trials huggingface dataset:
Feasibility Usability & Acceptability Study: Symptom Reporting by Children Adolescents & Young Adults w/Cancer

The purpose of this project is to pilot test an electronically delivered symptom assessment tool Pediatric Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (Ped-PRO-CTCAE), completed by children/adolescents and young adults (AYAs) and caregivers and shared with their clinicians during an outpatient clinic visit, in preparation for a future test of intervention efficacy.


Eligibility Criteria:
Inclusion Criteria:

1. First diagnosis of cancer
2. Receiving cancer therapy: surgery, myelosuppressive chemotherapy and/or radiation
3. 7-21 years of age
4. Completed at least 1 month of cancer chemotherapy treatment and are within 7-28 days of starting a treatment cycle or during ongoing therapy, followed at least every month in clinic
5. If surgery was part of treatment, the patient must be 3-6 weeks post surgery before participating in study
6. Caregiver must be present and 18 years and older.
7. Ability to understand and the willingness to personally sign the written IRB approved informed consent or assent document as appropriate.

Exclusion Criteria:

1. Child must be able to read or listen to and understand English and not have cognitive/memory impairments determined by the child's clinician
2. Caregiver must be able to read and understand English.
Efficacy of Self - Adjustable Clavicular Brace Versus Standard Clavicular Brace for Treatment of Mid Shaft Clavicle Fracture: A Randomized Controlled Study

A randomized control trial was conducted to compare the outcomes of conservative management for closed midshaft clavicular fractures using self-adjustable clavicular brace and standard clavicular brace.

Ten patients aged 18-75 years with midshaft clavicle fractures were enrolled in the study during February 2022 to February 2023. 6 patients were managed with standard clavicular brace and 4 patients with self-adjustable clavicular brace. All patients were scheduled for follow-up appointments at 1 week, 2 weeks, 4 weeks, 6 weeks and 12 weeks. Results were assessed based on clinical, functional and radiographic outcomes using the DASH questionnaire, pain, measured by VAS, analgesic usage, displacement, shortening, time to union, and patient satisfaction,

Eligibility Criteria:
Inclusion Criteria:

* Patient with aged between 18 - 75 years old
* Closed isolated fracture midshaft of clavicle within 9 days after the injury date

Exclusion Criteria:

* After bracing, fracture displacement and/or shortening \> 2 cm or fracture comminution \> 3 fragments
* Segmental fracture
* Open fracture
* Impending open fracture (soft tissue compromise/skin lesion)
* Ipsilateral upper extremities fracture which disturbs clavicular bracing
* Floating shoulder which surgical treatment is indicated.
* Patients with other injuries (e.g. head injury, chest and abdomen injury) which interrupted clavicular bracing
* Pathologic fracture
* Patient has limitation for clavicular brace application
* Pregnant women
Impact of Weight Loss Following Bariatric Surgery on Pulmonary Function in Patients With Morbid Obesity

Increase in body mass index (BMI)is associated with a decrease in expiratory flows.Obesity is also associated with an increased prevalence of asthma.Consequences of obesity on respiratory function and on bronchial responsiveness are still to be documented.

This study aims to evaluate, before and after surgery, the impact of a bariatric surgery (biliopancreatic diversion with duodenal switch)on respiratory function in patients with morbid obesity .

Our hypothesis is that weight loss following bariatric surgery will induce significant improvements in pulmonary function and airway responsiveness, and, as a consequence, a reduction in respiratory symptoms,these changes being correlated with a reduction in systemic markers of inflammation. Maintenance of weight loss after one year will permit the persistence of these improvements

Patients will be evaluated before the surgery (time zero), 6 months and one year after their surgery. A control group of patients on a waiting list for bariatric surgery will be evaluated at time zero and after 6 months and one year.

At each visit,patients will:

* fill a standardized respiratory questionnaire and a questionnaire on sleep apnea; questionnaires on asthma control will be completed by patients with asthma.
* have a spirometry, pulmonary volumes measures by body plethysmography and methacholine inhalation test with evaluation of symptoms perception.
* an induced sputum will be performed.
* A blood sample will be drawn to evaluate inflammation and measure C-reactive protein concentration in plasma.
* An allergy skin prick test will be done at time zero.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index \>or= 35 kg/m2
* Non-smokers or ex-smokers (\<10 packs-year)

Exclusion Criteria:

* Previous bariatric surgery
* previous vagotomy
* no compliance to visits
* subjects unable to provide an informed consent or to understand the questions included in questionnaires
* Patients with cardiac pacemaker
* hemodynamically significant valvulopathy
A Study to Assess the Efficacy and Safety of PPC-06 (Tepilamide Fumarate)

This is a randomized, double-blind, placebo-controlled, multicenter study designed to assess the safety and efficacy of PPC-06 (tepilamide fumarate) extended release in subjects with moderate-to-severe plaque psoriasis.

This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study designed to assess the safety and efficacy of PPC-06 in subjects with moderate-to-severe plaque psoriasis. Study subjects will be enrolled at approximately 75 sites in the United States (US).

Approximately 400 subjects who meet the study entry criteria will be randomly assigned in a 1:1:1:1 ratio to 1 of the 4 treatment arms:

1. PPC-06 400 mg once daily (QD)
2. PPC-06 400 mg BID
3. PPC-06 600 mg BID
4. Placebo BID The maximum study duration for each subject will be approximately 29 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Generally healthy males or non-pregnant females age ≥18 years at the time of screening (or who have reached the state minimum legal age of consent).
* Stable, moderate-to-severe plaque psoriasis diagnosed for at least 6 months prior to randomization (no morphology changes or significant flares of disease activity in the last 6 months in the opinion of the investigator or as reported by the subject).
* Severity of disease meeting all 3 of the following criteria prior to randomization (at the Baseline \[Day 0\] visit):

  1. PASI score of ≥12
  2. Total body surface area (BSA) affected by plaque psoriasis of ≥10%
  3. IGA score of \>3
* Must be a candidate for phototherapy and/or systemic therapy for psoriasis.

Exclusion Criteria:

* Subjects with non-plaque psoriasis (ie, predominantly inverse, erythrodermic, predominantly guttate, or pustular psoriasis).
* Subjects with drug-induced psoriasis or subjects with drug-exacerbated psoriasis that has not resolved within 4 weeks prior to screening.
* Subjects who have received systemic non-biologic psoriasis therapy or phototherapy (including either oral and topical psoralen and ultraviolet A (PUVA) light therapy, ultraviolet B, or self-treatment with tanning beds or therapeutic sunbathing) within 4 weeks prior to the Baseline Visit.
* Subjects who had topical psoriasis treatment within the previous 2 weeks prior to the Baseline Visit.
* Subjects with history of concurrent or recent use of any biologic agent within the following washout periods prior to baseline visit:

  * Etanercept - 35 days
  * Infliximab, adalimumab - 12 weeks
  * Ustekinumab - 24 weeks
  * Any other biologic agent \<5 half-lives prior to the Baseline Visit
* Subjects with history of use of any investigational drug within 28 days prior to randomization, or 5 pharmacokinetic/ pharmacodynamic half-lives (whichever is longer).
Effect of Climatic Factors on the Seasonal Fluctuation of Pulmonary Embolism

To estimate the risks of daily hospital admissions for pulmonary embolism associated with short term exposure to climatic factors (temperature, precipitation, air pressure, sunshine duration, relative humidity, wind speed, and ambient fine particulate matter \[aerodynamic diameter ≤2.5 μm; PM2.5\]) in China.

Hospital admissions for pulmonary embolism were identified based on the primary diagnosis. The central adjudication committee at Peking Union Medical College Hospital (Beijing, China) reviewed all medical and death records and determined the final diagnosis. Two adjudication committee members verified events independently, and discrepancies were resolved by discussion involving additional committee members.For each admission, we extracted data on the date of admission, sex, age, and location of the patient from hospital information system.

All the data of daily meteorological variables for the same period, including temperature variables (°C) (the min, max and mean temperature), relative humidity (%), air pressure (hPa), precipitation (mm), wind speed (m/s) and sunshine duration (h), were collected from the China Meteorological Data Sharing Service System (http://www.escience.gov.cn/metdata/page/index.html). The data on PM2.5 levels in each city was collected from the National Air Pollution Monitoring System.

An overdispersed generalised additive model was used to estimate associations between climatic factors and pulmonary embolism admissions. A distributed lag non-linear model (DLNM) was employed to examine their lagged effects.

Eligibility Criteria:
Inclusion Criteria:

* Males and females.
* With a primary diagnosis of pulmonary embolism based on clinical symptoms, with or without radiologic features.

Exclusion Criteria:

* Lack of important data.
"Evaluation of the Effectiveness of the MDT Method (Mechanical Diagnosis and Therapy) in the Management of Low Back Pain in the Subacute Phase"

The investigators propose to carry out a study evaluating the effectiveness of the MDT method (mechanical diagnosis and therapy) in the subacute phase of common low back pain.

Few studies have specifically evaluated the effectiveness of the MDT method in the subacute phase, a phase that appears to be crucial before the chronicization of low back pain.

The main objective of this study will be to evaluate the pain of patients managed by the MDT method.

The analysis of the main criterion (Visual Analog Scale) will be done using a type individual clinical trial specific: the Single Case Experimental Design or SCED in lines of multiple bases.

This type of study makes it possible to carry out a comparative test on a single subject acting as its own witness in order to obtain an acceptable level of evidence response for that particular patient.


Eligibility Criteria:
Inclusion Criteria:

* Consultant patients at the Picasso physiotherapy practice (5 rue Nina Simone - 44 000 NANTES)
* Aged 18 to 55 years old
* Suffering from common-looking low back pain. Low back pain is defined as pain or localized discomfort under the 12th dorsal vertebrae and above the inner fold buttock, with possible irradiation to the lower limb but not exceeding the knee.
* Evolving for 4 to 12 weeks (subacute period).
* Period preceded by a period of 30 days without low back pain (in order to avoid recurrent low back pain, rather similar to the chronic phase).

Exclusion Criteria:

* Signs of specific low back pain (confirmed or highly suspected diagnosis): fracture, infection, osteoporosis, inflammatory disease, tumor
* Irradiation below the knee
* Patient knowing she is pregnant
* Protected adults
* Patient with proven cognitive impairment
* Patient with a decompensated psychiatric pathology
* Incapacity to consent
* Refusal to participate in the study
Study to Evaluate the Human Infection of the Lower Respiratory Tract in Children at High Risk

- Estimate the incidence rate of hMPV infection detected by RT-PCR from frozen nasal wash aspirates in children at high risk for severe LRI disease (hospitalized at \<2 years of age).

* A prospective, epdemiological study to estimate the incidence rate of hMPV infection as determined by RT-PCR from frozen nasal wash aspirates taken from children hospitalized with LRI who are at high risk for severe disease.
* No study drug will be administered for this study.

Eligibility Criteria:
Inclusion Criteria:

* Be premature (less than 36 weeks gestation) and less than or equal to 12 months of age, and/or
* Be less than or equal to 24 months of age with CHD (other than uncomplicated small atrial or ventricular septal defects or patent ductus arteriosus) that is judged to be hemodynamically significant, and/or
* Be less than or equal to 24 months of age with CLD of prematurity (BPD) requiring medical intervention/management (i.e., supplemental oxygen, steroids, bronchodilators, or diuretics within the previous 6 months).
* Hospital admission diagnosis referable to an acute lower respiratory tract infection or cardio/respiratory illness with a presumed respiratory infection (e.g., bronchiolitis, bronchitis, or pneumonia or cardiac decompensation associated with respiratory infection); admission must occur between October 1 and June 30 for northern hemisphere sites, and between March 1 and November 30 for southern hemisphere sites.
* Study enrollment within 2 days after hospitalization.
* Admission from the community to the Pediatric ward, Neonatal Intensive Care Unit, or the Intensive Care Unit.
* Have written informed consent obtained from the parent or legal guardian prior to study entry.

Exclusion Criteria:

* Known HIV infection or a mother with known HIV infection.
In-Use Test With a Cosmetic Product

The aim of the study is to evaluate the tolerance of the product WO 4260 by a dermatologist. Additional objectives of this clinical in-use study are to evaluate the cosmetic features and acceptance of the product by means of a questionnaire in an interview situation and by skin hydration measurements on the scalp.


Eligibility Criteria:
Inclusion Criteria:

* age: ≥ 18 years
* sex: approx. 50% male and approx. 50% female
* users of hair tonic for dry scalp
* dry, itchy scalp prone to atopic eczema / atopic dermatitis

Exclusion Criteria:

* any deviation from the above-mentioned criteria
* users of sour hair rinse
* subjects who wash their hair more than once a day
* other dermatological disorders (scars, moles) on the scalp
* known incompatibilities to cosmetics and ingredients of cosmetic test products (please see INCI)
* topical medication in the test area within 1 month prior to study start
* systemic medication with anti-inflammatory agents and antibiotics within 2 weeks prior to starting of the study
* systemic medication with retinoids, antihistamines and/or immunomodulators (e.g. cortisone, corticosterone, chemotherapeutic agents) within 4 weeks prior to starting of the study
* systemic illness of the subject at the beginning of the study
* pregnancy and period of breastfeeding
Focal HDR Brachytherapy Boost to Stereotactic Radiotherapy

To determine if fBT+sRT is superior to standard care in terms of urinary toxicity by having fewer patients experience a minimal important decline (MID) in urinary irritation/obstructive QoL

In this Phase IIR trial investigators primarily seek to determine if fBT boost (15Gy) to SBRT (35Gy/5) can be shown to be superior to standard care (whole-gland BT boost 15Gy to RT 37.5Gy/15) in terms of urinary toxicity by having fewer patients experience a minimal important decline (MID) in urinary irritation/obstructive QoL as measured by ePRO (EPIC-26) at 12 and 24 months post completion of therapy.

Eligibility Criteria:
Inclusion Criteria:

* Histological diagnosis of prostate cancer planned for curative-intent HDR brachytherapy boost to external beam radiotherapy to the prostate gland.
* ECOG 0-1
* Charlson Comorbidity Index ≤ 4
* Imaging visible disease encompassing \< 50% of the prostate gland and consistent with biopsy findings.

Exclusion - none
Treatment Study Using Depot Naltrexone (1/6) Philadelphia Coord/Data Mgmt Site

The aim of this project is to conduct a multi-site effectiveness study to determine whether the addition of a monthly injection of depot naltrexone to treatment as usual (TAU) will significantly improve outcome in parolees and probationers with a history of opioid addiction compared to TAU alone. Participants will be randomized to either treatment as usual in community programs or monthly injections of depot naltrexone for six months with treatment as usual in community programs. The effectiveness of depot naltrexone has never been studied in opioid dependent parolees. all parolee subjects will be evaluated at baseline, while in treatment, and at 6, 12 and 18 month post entry time points. The primary study outcomes are retention in treatment, drug use, re-arrests, psychosocial and medical/psychiatric functioning, and economic costs and benefit costs of naltrexone.

This site serves as the coordinating center for five sites conducting the trial under the same IND and same protocol.

Eligibility Criteria:
Inclusion Criteria:

* Be between the ages of 18 and 60;
* Have dx of opioid dependence according to DSM-IV criteria
* be in good general health as determined by complete physical and laboratory tests;
* Under some form of criminal justice supervision for at least 12 months;
* Have a negative result for urinary opioids and no sign of opiate withdrawal after IV (or IM) injection of 0.8 mg of naloxone; and
* Express a goal of opiate free treatment rather than agonist maintenance

Exclusion Criteria:

* Current drug or alcohol dependence that requires medical supervision;
* untreated psychiatric disorders that might make participation hazardous (e.g. untreated psychosis, bipolar disorder with mania, significant suicide risk). Adequately treated psychiatric disorders and appropriate psychotropic medications would be allowed.

  3. Active medical illness that might make participation hazardous (e.g., untreated hypertension, hepatitis with AST or ALT \>3 times upper limit of normal, unstable diabetes or heart disease). Adequately treated medical conditions are acceptable; 4. female subjects who are pregnant or lactating, or female subjects of childbearing potential who are not using birth control (oral contraceptives, barrier (diaphragm or condom) plus spermicide, or levonorgestriel implant); 5. Liver failure or liver function test levels greater than three times normal; 6. History of allergic reaction to naltrexone; 7. History of a drug overdose in the past 3 years; and 8. Current diagnosis of chronic pain disorder for which opioids are prescribed for pain relief.
MEDTRONIC ADAPTA, VERSA AND SENSIA nEw3 POST APPROVAL STUDY

The primary purpose of this study is to assess the long term reliability of the Medtronic Adapta®/Sensia™/Versa™ platform of devices. This study is required by FDA as a condition of approval of nEw3 devices. Patients will be followed for 5 years after implant. This study utilizes data collected from the System Longevity Study (SLS).

The rate of device malfunctions will be determined and a comparison to historical controls will be done.

Eligibility Criteria:
Inclusion Criteria:

* Subjects or appropriate legal guardians provide written informed consent and/or authorization for access to and use of health information, as required by an institution's IRB/MEC/REB.

AND one of the following must also apply:

* Subjects indicated for implant or within six months post-implant of a Medtronic market-released lead connected to a Medtronic Adapta®, Sensia™, or Versa™ IPG. The Medtronic lead must be used for pacing, sensing or defibrillation application.
* Subjects who participated in a qualifying study (IDE) of a Medtronic cardiac therapy product and: 1) have a Medtronic Adapta®, Sensia™, or Versa™ IPG 2)product is market-released 3) complete implant and follow-up data, including product-related adverse events are available and 4) subject of appropriate legal guardian authorizes release of subject study data to SLS
* Subjects implanted with a Medtronic Adapta®, Sensia™, or Versa™ IPG and Medtronic CapSure Epi Leads (model 4965 and 4968) at a minimum of three pre-selected sites to retrospectively collect data for post approval requirements.

Exclusion Criteria:

* Subjects who are, or will be inaccessible for follow-up at a SLS center
* Subjects with exclusion criteria required by local law (EMEA only)
* Subjects receiving an implant of a Medtronic device at a non-participating center and the implant data and current status cannot be confirmed within 30 days after implant
* Subjects implanted with a Medtronic device whose predetermined enrollment limit for that specific product has been exceeded
Lidocaine Before Esophageal Manometry and Ambulatory pH Monitoring

A randomized controlled trial comparing esophageal manometry and ambulatory pH monitoring test tolerance in the presence versus in the absence of topical lidocaine.

Conventionally, topical nasopharyngeal anesthesia is applied to improve the tolerance of esophageal manometry and ambulatory pH monitoring. However, there is currently no data to support this practice. This randomized controlled trial of lidocaine versus placebo applied before these tests will evaluate the benefit of topical lidocaine anesthesia.

Eligibility Criteria:
Inclusion Criteria:

Adult patients undergoing esophageal manometry or ambulatory pH monitoring at our center who are able to read and consent to participate in the study.

Exclusion Criteria:

* Patients \< 18 years
* Incapacity to provide consent
* History of lidocaine allergy
* Current pregnancy
* Previous esophageal manometry or ambulatory pH monitoring in the last 14 days
* Previous participation in the study
* Severe cirrhosis (Child-Pugh C)
* Severe chronic kidney disease (eGFR\<30 mL/min/1.73m2)
* Severe heart failure (New York Heart Association Functional Classification 3-4)
* Severe respiratory failure (dyspnea or oxygen-dependent at rest)
* Any active severe incapacitating chronic or acute medical disease
* Active hospitalization
* Ulcerated, atrophic, infected or recently burned (in the last 30 days) nasopharynx
* Recent surgery involving the nasopharynx (in the last 30 days)
* Severe chronic pain (ex. regular daily use of opioids)
* Previous stroke or any neurological lesion with resulting current sensory deficit
* Major neurocognitive disorder
* Any active severe incapacitating chronic or acute psychiatric disease