cyrilzakka/clinical-trials huggingface dataset:
Validation of the Questionnaire ASES

Questionnaires are often irreplaceable tools of collection of information in research and in the clinical practice. Coupled with other measures, they can be simple complementary tools, but questionnaires are sometimes the only way to collect data, such as self-service efficacy.

The objective of this study is a validation of the French translation of the ASES. To guarantee the comparability between the original version and the translated version, the translation of a questionnaire supposes two essential stages: a literal translation and an adaptation to the cultural context, to the habits of life and to the idioms of the target population. This new version will afterward be validated with patient's troop.

The investigators are particularly interested in the Arthritis Self-Efficacy Scale (ASES), conceived to highlight a change of the faith of the patients in their capacities to make usual thinks or behaviour in front of consequences of the degenerative osteoarthritis, further to a therapeutic education.

The ASES is an auto-questionnaire compound of 20 items, from 0 to 10 on a digital scale and distributed in three domains: control of the pain (on 50), function (on 90) and other symptoms (on 60).

This questionnaire was already translated into Swedish, Dutch and Turkish.

Translation of the ASES and cultural adaptation :

The translation of the ASES in French followed the recommendations of the literature, which recommend a double translation, then a double back - translation with synthesis of the data in every stage. A final commission deliberate then a final translation, culturally adapted.

Patients' cohort and procedure of validation :

The prospective validation will be made with patients affected by degenerative osteoarthritis who fill the questionnaire ASES. These patients arose from cures of three thermal establishments of Auvergne. One group participated in therapeutic programs centered on the physical activity; the other one followed exclusively the water cure and received at the end of the cure an explanatory notebook on the degenerative osteoarthritis with physical exercises centered on the muscular strengthening of lower limbs.

Feedback :

Assessments conducted by the using of self - questionnaires:

- Sent by mail to the patients and back at 3 and 3,5 months

Ethics:

A written consent was collected before inclusion in the study and a document intended for the information was given to the patient. The study is anonymous, indeed, index forms will be coded before IT processing to guarantee the anonymity of the patient.

Eligibility Criteria:
Inclusion criteria :

Both sexes, 50-75 years old Knee osteoarthritis Patients affiliated to a social security scheme Patients realizing a Spa Therapy Acceptance to participate in the study

Exclusion criteria :

\< 50-year-old patients or \> 75 years Inflammatory, tumoral, traumatic or infectious rheumatism Cardiac decompensation Disorders of the concentration or the compression of the written or oral French language.
Organophosphate Pesticides and Human Reproductive Health

This prospective cohort study assesses the effects of exposure to organophosphate (OP) pesticides on adverse reproductive outcomes in both male and female agricultural workers in China. We will enroll women and their spouses, who are attempting to become pregnant, and observe reproductive endpoints including (1) semen parameters (concentration, total count, motility, progression and morphology), (2) menstrual disorders (oligomenorrhea, amenorrhea, polymenorrhea, intermenstrual bleeding, prolonged menstrual bleeding, dysmenorrhea, and irregular menstruation); (3) alterations in hormone patterns including reduced estrogen excretion (REE), anovulation, abnormal luteal phase (ALP), and abnormal follicular phase (AFP) in women and abnormalities of LH, FSH, TSH, SHBG, inhibin-B and testosterone in men; (4) fecundability; and (5) pregnancy outcomes including spontaneous abortion, preterm delivery, low birth weight, and intrauterine growth retardation.


Eligibility Criteria:
Inclusion Criteria:

* it must be the first marriage for both the woman and her husband and they must currently live in the study area;
* the female's age must range from 20 to 34 years;
* the couple has no plan to leave the study area in which they live for the next two years.

Exclusion Criteria:

* those who are currently pregnant;
* those who have tried unsuccessfully to get pregnant for at least 1 year;
* those who are current or former smokers;
* those who plan to move in the coming year.
Imaging Biomarkers to Validate Response in Enzalutamide-Treated mCRPC

To determine the feasibility and success rate of tumor tissue procurement using molecular-image-directed biopsies of responding and non-responding osseous metastases, measured by NaF PET/CT, in patients with metastatic castrate-resistant prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven adenocarcinoma of the prostate.
* Identifiable prostate cancer-related osseous metastases on bone scan or NaF PET/CT in the vertebral body, pelvis or other bone. Such lesions must be amenable to serial NaF PET/CT imaging. Preference will be given to subjects with multiple lesions that can be imaged in one image acquisition session to obtain maximal information as well as locations of lesions amenable to bone biopsies.
* Patients must be starting enzalutamide for treatment of metastatic castrate-resistant prostate, with cycle 1 day 1 occurring within 14 days after the first baseline NaF PET/CT. Subjects will be allowed to receive enzalutamide treatment on a concurrent study as long as the enzalutamide treatment study does not prohibit concurrent participation.
* Men of all races and ethnic groups of age ≥18 years.
* The effects of NaF on the developing human fetus are unknown. For this reason and because radiopharmaceuticals used for diagnostic imaging and other therapeutic agents and imaging procedures used in this trial may be or are known to be teratogenic, men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while her partner is participating in this study, she should inform her treating physician immediately.
* Patients must be able to comply with all study procedures, including having both the ability and willingness to lie flat for ≥ 30 minutes during imaging and undergo bone biopsies.
* Patients must have both the ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Known bleeding diathesis or on therapeutic anticoagulants (warfarin, low-molecular heparin, heparin analogues) that would increase risk of complications from bone biopsies.
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to sodium fluoride F-18 (NaF).
PK Study to Assess Drug-drug Interaction and QTc Between Sitravatinib and a Cocktail of Substrates

Study 516-010 is an open-label Phase 1, drug-drug interaction and QTc study evaluating the effect of sitravatinib on probe substrates for CYP450 enzymes and BCRP and P-gp transporters.

Part 1 of this study is designed to evaluate the potential for drug-drug interactions and QTc effects with sitravatinib monotherapy when administered with probe drugs for specific cytochrome P450 (CYP) enzymes (CYP2C9, CYP2D6, and CYP3A4) and P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP) transporters

Part 2 allows for patients to continue sitravatinib treatment with the addition of the checkpoint inhibitor Nivolumab.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of unresectable advanced/metastatic solid tumor
* Life expectancy of at least 3 months
* Adequate bone marrow and organ function

Exclusion Criteria:

* Ongoing medical condition or need for treatment with medication that may affect the PK of study treatments during Part 1
* Immunocompromising conditions
* Impaired heart function
* Active or prior documented autoimmune disease
Mycophenolate Mofetil (MMF) Discontinuation From a Tacrolimus/MMF/Steroid Triple Regimen After Kidney Transplantation

Patients after kidney transplantation received immunosuppression by Tacrolimus, MMF and steroids. In one half of the patients after 7 weeks MMF was reduced by half, and after 12 weeks it was stopped. For the others MMF remained at initial dose.


Eligibility Criteria:
Inclusion Criteria:

* Patient has an end stage kidney disease and is a suitable candidate for primary renal transplantation or retransplantation
* Patient is receiving a kidney transplant, from a cadaveric or living donor between 5 and 65 years of age with compatible ABO blood type

Exclusion Criteria:

* Patient has an immunological high risk, defined as having a most recently measured PRA grade of \>= 50% within the previous six months
* Patient requires ongoing dosing with a systemic immunosuppressive drug at study entry for any reason other than kidney transplantation
* Patient requires initial sequential or parallel therapy with immunosuppressive antibody preparation(s)
* Patient or donor is known to be HIV positive
* Patient with malignancy or history of malignancy, except non metastatic basal or squamous cell carcinoma of the skin that has been treated successfully
* Patient has significant, uncontrolled concomitant infections and/or severe diarrhoea, vomiting, or active peptic ulcer
* Patient is receiving a graft from a non-heart-beating donor
* Cold ischemia time of the donor kidney \>= 40 hours
Orbital Floor Fracture Repair by Titanium Mesh Via Transantral Approach.

The aim of the study is to evaluate the feasibility of CAD/CAM osteosynthesis mesh through a transantral surgical approach in the Repair of orbital floor fractures by means of clinical and radiographic findings.

A CAD/CAM osteosynthesis mesh through a transantral approach should assumingly provide accurate reconstruction of the orbital volume and anatomy while eliminating the usual morbidity of lower eyelid approaches during orbital reconstruction.

Eligibility Criteria:
Inclusion Criteria:

* Patients with recent unilateral orbital floor fracture indicated for internal reconstruction -
* (isolated or in combination with other facial fractures)
* with existing or estimated enophthalmos based on radiographs and a contra-lateral healthy non-operated orbit.

Exclusion Criteria:

* Delayed cases (more than 2 weeks)
* previously operated cases
* bilateral orbital floor fracture.
Next Generation Personalized Neuroblastoma Therapy

The purpose of this research study is to match genomic aberrations in tumor cells at time of relapse to rationally designed combinations of molecularly targeted agents. This study will be done in two parts:

Part I: Tumor will be accessed at study entry via a biopsy and subjected to deep sequencing to identify protocol-specified biomarkers for therapy assignment.

Part II: If the tumor contains a genetic change defined by the study as being actionable, and other criteria are met, participants will be assigned to therapy based upon the genetic changes identified in the tumor biopsy.


Eligibility Criteria:
Inclusion Criteria:

* Aged ≥1 years to ≤ 21 years
* Relapsed or refractory neuroblastoma
* A sufficient interval between the last dose of prior anti-cancer therapy (including cytotoxic and biological therapies) and enrollment in this study, to allow recovery from the acute toxic effects of all prior anti-cancer therapy. Please contact site for specific details
* Adequate bone marrow function (bone marrow may be involved with tumor. Contact site for specific details)
* Adequate renal function, defined as Creatinine clearance or radioisotope glomerular filtration rate (GFR) ≥ 70 mL/min/1.73 m2 OR serum creatinine based on age/gender normal (contact site for details)
* Adequate liver function, defined as total serum bilirubin ≤ 1.5 times the upper limit of normal AND alanine transaminase (ALT) ≤ 110 U/L.
* Adequate cardiac function, defined as corrected QT interval (QTc) ≤ 480 msec AND shortening fraction \> 27%
* Males and females who are sexually active must agree to use effective contraception during and for 3 months after treatment

Exclusion Criteria:

* Subjects taking certain drugs or herbal medications that impact drug metabolism and/or cardiac function that cannot be discontinued (contact site for details).
* Subjects with concurrent severe and/or uncontrolled concurrent medical conditions that could compromise participation in the study (contact site for details)
* Other concomitant therapies:
* Corticosteroids initiated for tumor therapy within 7 days prior to study enrollment
* Other anti-cancer agents
* Other investigational drugs
* Hematological growth factors
* Radiation therapy
* Subjects \< 0.5m2
* Pregnant or lactating females
* Sexually active males unless they use a condom during intercourse while taking study drug/s and for 3 months after study drug discontinuation and thus do not attempt to father a child in this period.
Tele-coaching in Patients With COVID-19

Respiratory exercise training and aerobic exercise training will be given to patients who have been hospitalized in intensive care due to COVID 19 and underwent IMV, who were hospitalized in the service and underwent NIMV or high-flow oxygen inhalation, and whose respiratory symptoms persist after discharge. The patients in the study group will be called by phone once a week and a motivating conversation will be made. No control will be made to the control group. Before and after the training, 6-minute walking test, MRC dyspnea scale, SGRQ quality of life questionnaire and hospital anxiety depression scale will be applied.

Some of the patients with COVID 19 pneumonia still have respiratory symptoms despite being treated. It has been reported that pulmonary rehabilitation programs applied in various models and in a small number to relieve or reduce these symptoms reduce dyspnea, increase exercise capacity and improve quality of life. There is no study reporting the results of a pulmonary rehabilitation program applied to COVID 19 patients in our country. The main purpose of this study is to determine the efficacy of pulmonary rehabilitation applied by telecoach to patients with severe COVID 19 pneumonia or persistent respiratory symptoms. Secondly, it is aimed to present the data of Turkish society to the literature. In accordance with this purpose investigators planed a randomised control clinical study. In our study respiratory exercise training and aerobic exercise training will be given to patients who have been hospitalized in intensive care due to COVID 19 and underwent IMV, who were hospitalized in the service and underwent NIMV or high-flow oxygen inhalation, and whose respiratory symptoms persist after discharge. The patients in the study group will be called by phone once a week and a motivating conversation will be made. No control will be made to the control group. Before and after the training, 6-minute walking test, MRC dyspnea scale, SGRQ quality of life questionnaire and hospital anxiety depression scale will be applied.

Eligibility Criteria:
Inclusion Criteria:

* Being treated in intensive care unit due to COVID-19 pneumonia,
* Receiving IMV, NIMV, or high-flow oxygen therapy
* Patients whose respiratory symptoms persist despite discharge

Exclusion Criteria:

* Patients with PCR test +
* Patients without any complaints.
* Patients who are hospitalized and discharged within 10 days
* Patients with orthopedic, neurological, cognitive problems
Effectiveness of Automated Locomotor Training in Patients With Acute Incomplete Spinal Cord Injury: A Multicenter Trial

The purpose of this study is to determine whether longer locomotor training results in a mor favorable outcome in patients with incomplete spinal cord injury.

About half of patients who experience a traumatic spinal cord injury (SCI) have still motor and/or sensory function below the level of the lesion. A large proportion of these patients become ambulatory within the first six months after the SCI. In order to optimally train the walking function patients are partially unloaded from their body weight while they walk on a moving treadmill. In severe cases therapists have to assist the leg movements which is an exhaustive work limiting training time. In the last few years robotic devices have been developed which enable longer training time. Studies evaluating the training of patients with hemiparesis showed that longer training time is associated with a better outcome. The present study aims at evaluating the effect of training time within the robotic device on the recovery of ambulatory function. Subject with an acute incomplete SCI will be included. The intervention consist of a walking training which lasts at least 50min, the training of the control group last at maximum 25min. Both groups will undergo 3-5 trainings per week. Group assignment will be performed at random. The study lasts for 8 weeks. The primary outcome will be the self selected walking speed which will be assessed bi-weekly during the training period and 4 months later.

Eligibility Criteria:
Inclusion Criteria:

* patients with spinal cord injury (SCI) categorized according to the standard classification of the American Spinal Injury Association as ASIA B or C within the first two weeks after trauma
* traumatic etiology of SCI
* limited walking ability (Walking Index for Spinal Cord Injury ≤5)
* able to start training or rehab within 60 days after trauma
* motor level between cervical 4 and thoracic 12
* signed informed consent

Exclusion Criteria:

* exclusion criteria of the Lokomat:(bodyweight \> 130kg, body height \> 200cm, leg length diff \> 2cm, osteoporosis, instable fracture of lower extremity, restricted range of motion, decubitus ulcer of lower extremity)
* concomitant injury limiting walking ability (e.g. lower extremity fractures, instable spine fractures, Joint instability preventing weight-bearing, severe soft tissue lesion)
* pre-existing medical conditions interfering with unrestricted walking (e.g. total joint replacement, pain, osteoarthritis, polyneuropathy, cardiopulmonary disease)
* age older than 65 years or younger than 18 years
* conus medullaris or cauda equina syndrome
* traumatic brain injury
* passive range of motion of the hips, knees and ankles not sufficient to allow normal kinematics consistent with upright gait
* patient participates in other rehabilitation or pharmacological study
Establish the Relationship Between Shift in Prescribing Pattern and Associated Shift in Sensitivity Pattern of Causative Microbes in UTI Patients in a Closed Community

To establish a relationship between changed prescribing pattern and associated shift in sensitivity trend of causative microbes in patients of uncomplicated urinary tract infection in a closed community

Antibiotic resistance has become a startling issue in last two decades. Many strategies are being followed to combat antibiotic resistance; revival of older, effective antibiotics is one of those approaches. Urinary tract infection is one of the most common indication for which antibiotics are prescribed. Despite having published guidelines in urinary tract infection, studies show that there is wide variability in prescription. The proposed study is designed to reinforce the guideline among a group of prescribers and evaluate the associated shift in sensitivity pattern of common urinary pathogens. This study will be a double center, controlled clinical trial. In this study, the prescribers in intervention arm will be given educational intervention and in control arm no intervention will be given. When a patient is diagnosed as a case of uncomplicated urinary tract infection clinically in intervention arm, after fulfilling the study criteria the patient will be enrolled in the study. Prescription data will be collected on daily basis and sensitivity data will be collected monthly. Clinical outcome of the patients enrolled in the study will be measured over telephone, after completion of their treatment. Sensitivity pattern will be analysed monthly after collection of sensitivity data from the laboratory affiliated with the hospital. All these data will be compiled and analysed at the end of the study. In control arm, prescription data will be collected fortnightly and sensitivity data will be collected monthly. All these data will be compiled and analysed at the end of the study. After approval from the institutional review board (IRB), enrolled patient will be informed about the intervention and the study.Informed written consent will be taken from all the patients, who will take part in the study willingly. Patient's anonymity will be maintained and will be used for study purpose only.

Eligibility Criteria:
Inclusion Criteria:

* Clinically diagnosed uncomplicated urinary tract infection
* Patient agreed to participate in the study signing an informed written consent

Exclusion Criteria:

* Known hypersensitivity to Nitrofurantoin
* Known Case of Diabetes mellitus, Hypertension, glucose-6-phosphate dehydrogenase deficiency
* Suspected complicated or recurrent UTI
* Elderly Patients of 65 years or more
* Neonates ang pregnant women
Effects of Cannabis Abstinence on Symptoms and Cognition in Depression

The objective of this study is to assess the changes in symptoms and cognition that occur after a 28-day abstinence period in patients with comorbid Cannabis Use Disorder (CUD) and Major Depression (MDD). This study employs a 28-day abstinence paradigm a total of 8 visits to the CAMH Russell site (screening, training, baseline, week 1, week 2, week 3, week 4, follow-up). Participants should be between the ages of 18-55, meet criteria for moderate depression and CUD, be non-treatment seeking, and be on a stable dose of antidepressant medication. The study visits will take up a total of approximately 22.5 hours with compensation for time provided. These visits will involve multiple clinical, substance use, and cognitive assessments. Abstinence will be maintained by weekly behavioural coaching sessions and contingency reinforcement.


Eligibility Criteria:
Inclusion Criteria:

* ages 18-55
* meet DSM-5 diagnostic criteria for cannabis use disorder (cannabis use \>1 g/day, CUDIT score \>12)
* meet DSM-5 diagnostic criteria for Major Depressive Disorder as determined using the SCID
* be an outpatient receiving a stable dose of antidepressant medication(s) for at least 1 month
* have a Hamilton Depression Rating Scale (HDRS-17) baseline total score greater than 14
* have a Full Scale IQ greater than 80 as determined by the WTAR
* be a non-treatment seeking cannabis user
* evidence of sufficient motivation and effort as measure by a Test of Memory Malingering (TOMM) score greater than 45
* urinary baseline THC-COOH levels greater than 150 ng/ml

Exclusion Criteria:

* meets criteria for abuse or dependence of alcohol or other illicit substances within the part 6 months (with the exception of cannabis, nicotine, or caffeine)
* positive urine screen for illicit substances other than cannabis, nicotine or caffeine
* current suicidal or homicidal ideation
* psychotic disorder diagnosis (e.g. schizoaffective disorder, major depression with psychotic features) as determined by the SCID
* head injury with loss of consciousness greater than 2 minutes or requiring hospitalization
* neurological or medical condition determined to effect cognition
* be treatment seeking for cannabis use