cyrilzakka/clinical-trials huggingface dataset:
Observational Study With Prospective and/or Retrospective Follow-up, Without Modifying Patient Treatment and Follow-up Practices for the Initial Treatment of Hypothyroidism in France

This observational survey with prospective and/or retrospective follow-up is designed to study practices for the initial treatment of hypothyroidism in France without modifying subject treatment.

Thyroid disorder can be central, caused by a deficiency in thyroid stimulating hormone (TSH) production; or peripheral, caused by the decrease in the plasma concentration of thyroid hormones, more specifically of free thyroxine (free T4). Peripheral hypothyroidism is caused by the decrease in the production capacities of the thyroid gland.

The treatment of hypothyroidism is based on the restoration and maintenance of biological (judged on the basis of the standardised TSH and T4 values) and clinical euthyroidism.

A number of forms of thyroid hormones are available in the French market (Euthyral®, Cynomel®, L-thyroxine drops®), of which, Levothyrox® is the most frequently prescribed drug in this category.

The treatment of peripheral hypothyroidism, in particular, is well codified and almost consensual. In France, there is no published observational study, based on which one can document the manner in which subjects are treated. This observational study is set up to document these practices.

OBJECTIVES The principal objectives of this survey is to to get information on the use of Levothyrox in France

* Circumstances of diagnosis
* Record realised
* Terms and conditions of treatment by the general practitioner and/or the endocrinologist

The secondary objective is to evaluate the inclusion criteria for levothyroxine treatment.

For each subject the participating doctor will complete a follow up questionnaire form until the first control level of TSH after the diagnosis of hypothyroidism.

Eligibility Criteria:
Inclusion Criteria:

* Recently diagnosed hypothyroid subject (either during the inclusion period, or within the 6 previous months) for whom, data related to the diagnosis is available if the diagnosis was not carried out initially by the investigating doctor
* Subject, who has given his/her oral consent for participation

Exclusion Criteria:

* Subject included in clinical trial or having participated in a clinical trial during the last 3 months
* Subject presenting a major and objectifiable risk of not being able to follow-up until the next TSH level (moving, problems encountered during another study, pathology affecting the vital prognosis in the short-term)
* All contraindications to Lévothyrox
The Relationship Between Gait Velocity and Gait Parameters

Previous reports have the evidence implicating gait velocity may affect kinematic parameters. However, how the gait velocity will influence kinematic parameters remain unclear. The purpose of this research is to find out kinematic characteristics among different gait velocity. To do this, it will provide a reference for future prospective studies or investigations and make us fully understand the impact of gait velocity.


Eligibility Criteria:
Inclusion Criteria:

1. 20\< age \< 30.
2. Body mass index \< 30.
3. No history of major injury or surgery in lower limbs.
4. No symptoms of lower limbs.
5. Physical examination to test the lower limbs to be normal.
6. The habit of moderate exercise (e.g. Jogging) at least once a week for at least 30 minutes.

Exclusion Criteria:

1. Body mass index \>30.
2. Injury or surgery in hip/knee/ankle.
3. History trauma in the lower limbs (e.g. fracture).
4. Neuropathic disease.
5. Muscular disease.
6. Lack ability to finish the procedure physically or mentally.
7. Easy to fall.
8. Any other conditions that can influence gait parameters of the lower limbs.
Cranberry-lingonberry Juice Started During Acute Infection in Prevention of Urinary Tract Infections in Children

Cranberry and cranberry-lingonberry juice prevented urinary tract infections in children and in adults in our earlier clinical trials. The preventive effect was, however, observed late in the follow-up and the next recurrence was not prevented in children. The investigators hypothesize that cranberry-lingonberry juice should be started already during the antimicrobial treatment of acute urinary tract infection in order to maximize the preventive efficacy of the juice. In addition, the investigators aim to find the explanation for the efficacy of cranberry-lingonberry juice by analyzing the concomitant changes in the chemical composition of urine and feces as well as the changes of gut microbiota.


Eligibility Criteria:
Inclusion Criteria:

* Recent confirmed urinary tract infection, diagnosed in Oulu University Hospital or Oulu Health Care Center
* Age 1-16 years

Exclusion Criteria:

* Continuous antimicrobial prophylaxis
* Age \< 12 months or \> 16 years
* Severe congenital kidney or other urinary tract anomaly in ultrasound
Treatment of Non-falciparum Malaria

Patients with non-falciparum infection will be given artemether-lumefantrine for three days and will be followed up for 28 days. Besides efficacy and safety evaluations a substudy on immunology will be performed.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients between the age of 6 months and 60 years and with a minimum of 5kg bodyweight
* Presence of uncomplicated malaria confirmed by: i)fever or history of fever in the previous 4 days, and ii)positive microscopy of P. malariae or P. ovale or mixed infection with P.falciparum with parasite density \> 50-200000/μl of blood
* Written informed consent

Exclusion Criteria:

* Patients with presence of other clinical conditions requiring hospitalization
* Presence of other febrile conditions
* Presence of significant anemia, defined by hemoglobin \< 7g/dl
* Known history of hypersensitivity,allergic or adverse reactions to artemether or lumefantrine
* Intake of any antimalarial or antibiotics with known antimalarial activity in the preceding 2 weeks
* Pregnant and breast feeding females
Moderate Hypofractionated Radiotherapy for Lung Cancer

The purpose of this study is to evaluate the incidences of Grade III and above radiation-reduced esophagitis and radiation-reduced pneumonia of patients with advanced lung cancer treated with moderate hypofractionated (3Gy/f) radiotherapy, and their predictors. Efficacies are also evaluated.

Radiotherapy plays an irreplaceable role in lung cancer. However, due to the long duration of conventional fractionation irradiation, tumor cells will accelerate repopulation after 3 to 4 weeks during radiotherapy, resulting in decreased efficacy. Hypofractionated radiation is increasingly used in radiotherapy of lung cancer. It can shorten the overall treatment time, and can potentially reduce the effect of tumor accelerated repopulation. Compared with conventional radiotherapy, hypofractionated radiotherapy can theoretically obtain a higher biological effective dose (BED). The application of Stereotactic Body Radiation Therapy (SBRT) or Stereotactic Ablative Radiotherapy (SABR) in advanced or central lung cancer is restricted when the tumors are adjacent to important organs. Moderate hypofractionated radiotherapy can not only shorten the overall total treatment time, but also reduce the severe toxicities. It is widely used in lung cancer nowadays. However, most data of the tolerated doses for normal tissue and organs comes from conventional radiotherapy. Whether or not it is suitable for hypofractionated radiotherapy has not been determined. In our study, the incidences of Grade III and above radiation-reduced esophagitis and radiation-reduced pneumonia, as well as their predictors, were obtained by retrospective analysis of patients received moderate hypofractionated radiotherapy of 3Gy/f. At the same time, the efficacies of this scheme are also evaluated.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with previously untreated advanced lung cancer were recruited, who were confirmed pathologically or cytologically.
2. The Karnofsky performance status (KPS) score ≥60.
3. The expected survival time was≥3 months.
4. The laboratory examination results showed a neutrophil count ≥2.0 × 109, a hemoglobin level ≥100 g/L, a platelet count ≥100 × 109, and enough liver and kidney functions.
5. The patients did not show abnormal electrocardiogram (ECG) results.
6. They did not have other combined diseases that required hospitalization.
7. Informed consent required before enrollment.

Exclusion Criteria:

1. Patients who were pregnant or breastfeeding.
2. Patients who had another malignant tumor history (with the exception of patients with cervical carcinoma in situ and non-malignant melanoma skin cancer that had been clinically cured for at least 5 years), could not receive concurrent chemotherapy due to medical reasons.
3. Superior vena cava syndrome.
4. Syndrome and severe lung diseases that affected lung function were excluded.
Targeting CD5 CAR-T Cells in the Treatment of r/r CD5+ T-lymphoma

A Clinical Study on the Safety and Effectiveness of targeting CD5 CAR-T Cells in the treatment of r/r CD5+ T-lymphoma

In this study, 30 patients with relapsed refractory T-lymphoma were proposed to undergo CD5 CAR-T Cells therapy. Under the premise that its safety has been clarified in previous studies, further observation and evaluation of the effectiveness of CD5 CAR-T Cells therapy for relapsed refractory T-lymphoma; At the same time, on the basis of expanding the sample size, more safety data on CD5 CAR-T Cells treatment for relapsed refractory T-lymphoma were accumulated.

Eligibility Criteria:
Inclusion Criteria:

* 1. According to the 2016 WHO classification of lymphocyte tumors, histologically confirmed CD5-positive T-cell non-Hodgkin lymphoma (T-NHL),

R/R T-NHL(meets one of the following conditions) :

1. Subjects did not go into remission or relapse after receiving second-line or more chemotherapy regiments;
2. Primary drug resistance;
3. Relapse after autologous hematopoietic stem cell transplantation;

   * 2.CD5 expression rate was \>90%;
   * 3. According to Lugano 2014, there should be at least one evaluable tumor lesion;
   * 4. Total bilirubin ≤51 (mol/L), Alanine aminotransferase (ALT)/Aspartate aminotransferase (AST) ≤ 3 times the upper limit of the normal range, creatinine ≤176.8 (mol/L);
   * 5. Echocardiography showed left ventricular ejection fraction (LVEF) ≥50%;
   * 6. Refers to the pulse oxygen saturation 92% or higher oxygen (state);
   * 7. Estimated life expectancy of minimum of 12 weeks;
   * 8. ECOG 0-2;
   * 9. Pregnant/lactating women, or male or female patients who have fertility and are willing to take effective contraceptive measures at least 6 months after the last cell infusion during the study period;
   * 10. Those who voluntarily participated in this trial and provided informed consent;

Exclusion Criteria:

* 1. History of epilepsy or other central nervous system disorders;
* 2. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
* 3. Active infection of hepatitis B virus, C virus or hepatitis E virus;
* 4. Active infected persons who are not cured;
* 5. Before using any gene therapy products;
* 6. Received anti-tumor therapy before infusion, should meet the following any one should be ruled out:

  1. treated with systemic corticosteroids therapy within 72 hours (except glucocorticoid physiological replacement therapy, such as prednisone \< 10 mg/d or an equivalent dose of the drug);
  2. received within 72 hours of small molecule targeted therapy;
  3. 2 weeks received systemic chemotherapy except (pretreatment);
  4. four weeks received radiotherapy;
* 7. The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal;
* 8. Any unsuitable to participate in this trial judged by the investigator;
* 9. Any situation that researchers believe may increase the risk to the subjects or interfere with the trial results.
Evaluation of Reporting of Road Traffic Accidents With Drugs Responsible for Cognitive Side Effects (ERoADS)

Drugs responsible for cognitive and psychomotor side effects may lead to impaired driving skills and road traffic accidents. This study investigates reports of road traffic accident for different class of drugs responsible for cognitive and psychomotor sides effects (pyschotropic agents, neurotropic agents, antineoplasic agents) in the World Health Organization's (WHO) global database of individual safety case reports (VigiBase).

Some medications are responsible of a wide range of cognitive and psychomotor side effects that may make it unsafe to drive and lead to risks of road accidents .The investigators use VigiBase, the World Health Organization (WHO) database of individual safety case reports, to identify cases of road traffic accidents following treatment with different class of drugs responsible for pyschomotor sides effects.

Eligibility Criteria:
Inclusion Criteria:

* Case reported in the World Health Organization (WHO) database of individual safety case reports to 01/03/2020
* Adverse events reported were including the MedDRA terms: Road Traffic Accident (SMQ)
* Patients treated with at least one liable nervous system drugs (ATC class N) or that can induce cognitive and pyschomotor undesirable effects by crossing the blood-brain barrier (ATC class A04, C02A, L)

Exclusion Criteria:

* Chronology not compatible between the drug and the road traffic accident
A Study of Abemaciclib (LY2835219) in Combination With Other Anti-Cancer Therapies in Japanese Participants With Advanced Cancer

The purpose of this study is to see if the study drug abemaciclib in combination with other anti-cancer therapies is safe in Japanese participants with advanced cancer.


Eligibility Criteria:
Inclusion Criteria:

* Participant with histologically confirmed adenocarcinoma of the prostate.
* Participant with metastatic disease documented by positive bone scan and/or measurable soft tissue metastatic lesions by computed tomography (CT) or magnetic resonance imagining (MRI).
* Participant who has serum testosterone level is ≤1.73 nanomoles per liter (nmol/L) (50 nanograms per deciliter).
* Participant who has progressive disease at study entry demonstrated during continuous androgen-deprivation therapy (ADT)/post orchiectomy.
* Participant with adequate organ function.
* Participant with Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.

Exclusion Criteria:

* Participant who was treated with cytochrome P450 (CYP)17 inhibitors (including abiraterone acetate, TAK-700, TOK-001, and ketoconazole).
* Participant who was treated with abemaciclib or any cyclin dependent kinase 4 and 6 (CDK4 and 6) inhibitors.
* Participant who has prior cytotoxic chemotherapy for metastatic castration-resistant prostate cancer (mCRPC), prior radiopharmaceuticals for prostate cancer (PCa), or prior sipuleucel-T.
* Participant who has gastrointestinal disorder affecting absorption or inability to swallow large pills.
* Participant who has clinically active or chronic liver disease, moderate/severe hepatic impairment, ascites, or bleeding disorders secondary to hepatic dysfunction.
* Participant who has known or suspected central nervous system metastatic disease.
* Participant who was treated with drugs known to be strong inhibitors, or strong or moderate inducers of cytochrome P450 3A4 (CYP3A4) and the treatment cannot be discontinued or switched prior to starting study treatment.
Optimizing Detection and Prediction of Changes in Cognitive Function in Multiple Sclerosis (MS)

The researchers will use technology-assisted ambulatory assessment techniques to examine cognitive dysfunction in people with Multiple Sclerosis (MS).

The researchers will determine if ambulatory assessments are sensitive to subtle declines in cognitive functioning. They will also explore the impact of modifiable factors, such as sleep, physical activity, mood, and somatic symptoms on cognitive function. These efforts will uncover behavioral and medical intervention methods. Finally, they will explore whether variability in cognitive functioning predicts short- and long-term changes in other patient-centered functional domains, social participation and physical functioning.


Eligibility Criteria:
Inclusion Criteria:

1. Are able to fluently converse and read in English.
2. Multiple Sclerosis (MS) diagnosis (confirmed from neurologist, all relapsing and progressive subtypes included)
3. Ambulate either independently or with the use of a cane or walker (or similar device) for at least 50% of the time at baseline

Exclusion Criteria:

1. MS relapse within the past 30 days (may become eligible after 30 days; criteria used at T1, T2, and T3).
2. Inability to use study data collection tools (i.e., ActiGraph wrist-worn activity watch, smart phone app).
A Retrospective Study of the Effectiveness and Safety of Nivolumab in Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC) Patients in Japan

A Retrospective Study of the Effectiveness and Safety of Nivolumab in Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC) Patients in Japan


Eligibility Criteria:
Inclusion Criteria:

* Previously treated advanced/metastatic NSCLC patients treated with nivolumab at least once from 01-Apr-2016 through 31-Dec-2016

Exclusion Criteria:

Patients who meets the inclusion criteria will be included in the analysis to describe real-world clinical usage of nivolumab. However, patients treated with nivolumab falling in following criteria will be excluded for analysis for the other primary endpoint; overall effectiveness:

* History of participation in any clinical trials prior- or post-nivolumab treatment
* Patients who are a part of a Post-marketing surveillance study

Other protocol defined inclusion/exclusion criteria could apply
A Study to Observe the Safety and Efficacy of Vedolizumab in Biologically Naive Participants With Ulcerative Colitis (UC) or Crohn´s Disease (CD)

The purpose of this non-interventional study (NIS) study is to assess further knowledge on the routine use of Entyvio in inflammatory bowel disease therapy, particularly the use in participants with CD and UC naive to biologics.

The drug being tested in this prospective, observational study is called vedolizumab. Vedolizumab (Entyvio) is being used to treat people who have CD or UC. This study will look in the routine use of vedolizumab in inflammatory bowel disease therapy in participants with CD or UC who did not receive a biologic treatment before. The study will enroll approximately 150 participants. All participants enrolled in this will belong to one observational group: Vedolizumab.

Participants taking vedolizumab as per physician's prescription in routine clinical practice will be observed.

This multi-centre trial will be conducted in Austria. The overall time to participate in this study is 2 years. Participant taking vedolizumab in routine clinical practice will make multiple visits to the clinic at Baseline, Week 20 and 52. Once a participant is switched to subsequent biologic treatment upon failing treatment with vedolizumab, the switching date will be considered as new baseline followed by visits at Week 20 and 52.

Eligibility Criteria:
Inclusion Criteria

1 Initiating vedolizumab for moderately to severely active UC or CD. Exclusion Criteria

1. Participant is enrolled in a clinical trial in which treatment for UC or CD is managed through a protocol,
2. Prior treatment with a biologic agent,
3. Any other reason that, in the Investigator's opinion, makes the participant unsuitable to participate in this study.
Incorporation of AlloMaxTM in Breast Reconstruction Ver8-15-12

The purpose of this study is to measure the level of AlloMax™ incorporation (cellular infiltration, collagen production, and neovascularization) in human breast reconstruction. The hypothesis is that the AlloMaxTM will have incorporation equivalent to adjacent breast capsule at the 3-4 month time point.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (18 - 70 yrs) who require reconstructive breast surgery with AlloMaxTM implants and agree to participate will be included in this study.

Exclusion Criteria:

* Patients who do not agree to be included in the study.
A Study of the Trabecular Micro-bypass Stent in Combination With Cataract Surgery in Subjects With Open Angle Glaucoma

The purpose of this study is to evaluate the safety and efficacy of the iStent trabecular micro-bypass stent in reducing intraocular pressure (IOP) in subjects with open-angle glaucoma or ocular hypertension and co-existing cataract.

The purpose of this study is to evaluate the safety and efficacy of the iStent trabecular micro-bypass stent in reducing intraocular pressure (IOP) in subjects with open-angle glaucoma or ocular hypertension and co-existing cataract. Pre-operative unmedicated baseline pressures will be compared with post operative values in both study arms.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with open-angle glaucoma (OAG) in the study eye. Pseudoexfoliative and pigmentary glaucoma are also acceptable diagnoses.
* Subject on at least one glaucoma medication
* Able and willing to attend follow up visits for two years post operative
* Able and willing to sign informed consent

Exclusion Criteria:

* Prior glaucoma procedures (eg trabeculectomy, viscocanalostomy, ALT, SLT, shunt implant, collagen implant, cyclo destructive procedures etc)
* Angle closure glaucoma
* Fellow eye already enrolled
Infiltration or Nerve Blocks in Addition to Adductor Canal Block

The aim of this study is to evaluate the analgesic efficacy of this quadruple sensory block compared with the currently recommended procedure (adductor canal block + infiltration).

In addition to the adductor canal block, this quadruple block incorporates :

1. the block of the lateral cutaneous nerve of the thigh (or femoral-cutaneous nerve), which is a collateral sensory branch of the posterior part of the lumbar plexus.
2. IPACK (Infiltration between Popliteal Artery and Capsule of Knee), designed as a motor-sparing technique (targeting the sensory articular branches of the sciatic nerve and avoiding the motor branches of the tibial and fibular nerves), is particularly effective on posterior pain.
3. obturator nerve block, a mixed nerve originating from the anterior part of the lumbar plexus. It divides into two branches: anterior, which innervates the adductor longus, adductor brevis and gracilis muscles, and posterior, which innervates the medial part of the knee joint and the posteromedial part of the thigh. It provides sensitivity to the medial aspect of the thigh.

Eligibility Criteria:
Inclusion Criteria:

* Adult male or female
* Patient with signed consent to participate in the study,
* Patient with uni or bilateral primary gonarthrosis
* Indication for total knee arthroplasty.

Exclusion Criteria:

* History of knee fracture, arthroplasty or osteotomy
* Known or unknown contraindication to ALR or locoregional anesthesia products
* Neurological disease, stroke sequelae
* Mental deficiency or any other reason that may hinder understanding or strict application of the protocol
* Patient not affiliated to the French social security system
* Patient under court protection, guardianship or curatorship
* Pregnant or potentially pregnant women (women of childbearing age without effective contraception)
* Patient already included in another therapeutic study protocol