cyrilzakka/clinical-trials huggingface dataset:
Creation of a Clinical Database for the Study of Phenotypic Variability in Motor Neuron Diseases

Study Description: Characterization of Motor Neuron Disease Phenotypes

The goal of this observational study is to understand the clinical presentation of motor neuron disease (MND) in patients attending the Neurology Department of the Istituto Auxologico Italiano. The main questions it aims to answer are:

* What are the specific clinical phenotypes associated with MND?
* How can these phenotypes contribute to a better understanding of the disease's underlying mechanisms and improve prognostic accuracy?

Participants will undergo:

* Clinical evaluation using validated scales
* Neurophysiological and neuroradiological instrumental assessment
* Neuropsychological evaluation
* Collection of biological materials for genetic screening and biomarker assessment, if necessary.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of ALS or other motor neuron disease

Exclusion Criteria:

* refusal to participate to the study
The Initial Management in Patients With Differentiated Thyroid Cancer in the Real World in China

* To find out the gap between real-world clinical practice and guideline recommendations in initial management of DTC patients
* To observe the characteristics of patients who achieved and did not achieve TSH target value after five year follow-up
* To assess response to initial therapy in patients who undergo total or neartotal thyroidectomy and RAI remnant ablation after five year follow-up (according to an modified dynamic risk stratification system)
* To observe the recurrence status after five year follow-up

The DTCC 2nd will follow DTCC 1st and observe the long-term efficacy of initial management including surgery treatment, 131I therapy and TSH suppression therapy. It will involve nine hospitals which have participated in the first stage, and continually to observe the DTC patients who were recruited. The patients with more than 5 years long-term follow-up from the date of signing the informed consent form (ICF) in DTCC 1st to signing ICF in DTCC 2nd will be collected data retrospectively. For those follow-up less than 5 years, in addition to the retrospective data collection, one prospective visit will be conducted.

Primary endpoint(s)

1.Five-year accumulated recurrence rate

Secondary endpoint(s)

1. Disease-free survival (DFS)
2. Overall survival (OS)
3. Response to therapy
4. Re-operation rate
5. Time weighted TSH level (TW-TSH)
6. Adverse events related to L-T4 therapy (ADRs)
7. Median follow-up years

Eligibility Criteria:
Inclusion Criteria:

- Patients who had been recruited into DTCC 1st study will be enrolled.

Exclusion Criteria:

* Other malignant tumors;

  * Severe organ damage such as heart failure of New York Heart Association classes III-IV, liver failure, respiratory failure, renal failure, etc.;

    * Medical or psychological condition that would not permit the patient to complete the study or sign the informed consent; ④ Legal incapacity or limited legal capacity; ⑤ Unwilling to be followed up
Study to Compare the Safety and Efficacy of UB-851 and Eprex®

The primary objective of this study is to evaluate a 1:1 dose conversion from Eprex® to UB-851 in terms of clinical efficacy and safety in subjects with chronic renal failure receiving hemodialysis.

This is a 52-week, phase III trial consisting of two parts:

Part I is designed as a double-blind, randomized, multicenter, parallel-group study to evaluate the efficacy and safety of UB-851 in comparison to Eprex® in subjects with renal anemia on hemodialysis with a treatment period of 24 weeks.

Part II is designed as a single-arm, safety evaluation period (from week 25 to week 52) to evaluate the long-term safety and immunogenicity of UB-851.

Eligibility Criteria:
Main Inclusion Criteria:

1. Subjects signed informed consent before undergoing any study procedures.
2. Subjects aged 20 to 85 years.
3. Hemodialysis subjects with chronic renal failure and renal anemia in outpatient clinic currently on stable Eprex® treatment administered by intravenous injection (1 to 3 times per week) for at least 3 months prior to randomization.

Main Exclusion Criteria:

1. Maintenance epoetin dose \> 300 IU/kg per week.
2. Treatment with long-acting epoetin analogues.
3. Detectable anti-erythropoietin antibodies with clinical symptoms at screening visit, or history of Pure Red Cell Aplasia (PRCA).
Effects of a Walking Program in People With Mental Disorders

The purpose of this study is to investigate the short- and long-term effects of a 10-week walking program, based on the self-determination theory, in people with mental disorders. The investigators expect positive effects on:

* Physical fitness
* Physical activity
* Well-being (less feelings of anxiety, less feelings of depression) The investigators also expect underlying psychosocial processes to influence these effects.

Framework: Previous research has shown beneficial health effects of a 10-week walking program in a senior organisation. Based upon the self-determination theory, similar results can be expected in people with mental disorders and could be highly relevant, given the fact that these people:

* Are often less active
* Have mental problems and often also comorbidities
* Are often socially isolated

Participants: Psylos tries to recruit a convenience sample of at least 100 participants for an intervention group (which will undertake the walking program) and 80 participants for a control group. All of them have to sign an informed consent. Due to attrition, at least 60 participants in the intervention group and 40 in the control group can be expected. A post hoc analysis, with detailed information about the variation in this population, may give additional information about the necessary power to obtain significant results.

Data analysis: First there will be examined whether the participants in both groups are equal at baseline according to relevant parameters (due to the non-randomisation). Second, to test the main effects, the difference scores will be examined between both groups. If certain assumptions are met, by an unpaired t-test; if not, by a non-parametric test. Finally (if relevant), the underlying psychosocial processes will be examined by regression analyses.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old
* Member of Psylos
* Medically approved by a physician
High Tibial Osteotomy (HTO) With or Without Arthroscopy of the Knee Joint

Participants will be randomized to undergo a High Tibial Osteotomy (HTO) with or without a knee scope. Patients will be tested in the Gait Lab, will fill out quality-of-life questionnaires, and have a clinical evaluation done preoperative and at each follow-up visit.


Eligibility Criteria:
Inclusion Criteria:

* All patients booked for an HTO due to OA
* Grades II to IV severity of OA by radiographic evaluation (Kellgren \& Lawrence grade)
* OA of the knee primarily involving the medial compartment

Exclusion Criteria:

* Imaging evidence of significant knee joint pathology that would change the decision to do an HTO
* An arthroscopy of the knee within 2 years of planned surgery
* Active joint or systemic infection,
* Major medical illness that would preclude undergoing surgery,
* Patients who are unwilling or unable to be assessed according to study protocol for two years following surgery
* Major psychiatric illness, developmental handicap or inability to read and understand the English language
V114 and Acute Otitis Media (V114-032/PNEU-ERA)

The primary objective is to evaluate V114 in the prevention of vaccine-type acute otitis media (VT-AOM) and the safety of V114 with respect to the proportion of participants with serious adverse events (SAEs) through completion of the study. The primary hypothesis is that V114 is superior to no V114 in preventing VT-AOM as assessed by the incidence of VT-AOM.


Eligibility Criteria:
Inclusion Criteria:

* Is healthy (based on a review of medical history and physical examination)
* Is male or female, approximately 2 months of age, from 42 days to 90 days of age

Exclusion Criteria:

* Was born prior to 37 weeks of gestation.
* Has a history of invasive pneumococcal disease (IPD) (positive blood culture, positive cerebrospinal fluid culture, or other sterile site) or known history of other culture positive pneumococcal disease.
* Has a known hypersensitivity to any component of the pneumococcal conjugate vaccine (PCV), any component of the licensed pediatric vaccines to be administered concomitantly in the study, or any diphtheria toxoid-containing vaccine.
* Has any contraindication to the concomitant study vaccines being administered in the study.
* Has external auditory canal atresia/stenosis.
* Has a known or suspected impairment of immunological function.
Effects of Intra-articular Stromal Vascular Fraction Injection on Clinical Symptoms and Cartilage Health in Osteoarthritic Knees

Background: Osteoarthritis (OA) is a prevalent form of arthritis worldwide. Intra-articular stromal vascular fraction (SVF) injections are a potential therapeutic option for patients with OA. This study aims to assess the effects of intra-articular SVF injections on knee OA. Methods: Ten patients with knee OA participated in this study. After being administered intra-articular SVF injections, their outcomes were evaluated using various questionnaires. MRI T2 mapping was conducted and compared before the intervention and 6 months after. All data underwent analysis using various tests.


Eligibility Criteria:
Inclusion Criteria:

* Aged ≥ 35 years.
* Patients with degenerative knee OA confirmed via X-ray and classified according to the Kellgren Lawrence Grading Scale 2\~4.
* Persistent knee pain after nonsurgical treatment.

Exclusion Criteria:

* Arthritis caused by other systemic or local immune diseases.
* Patients who have undergone total knee replacement surgery.
* Patients who have been administered platelet-rich plasma or hyaluronic acid injections within the past three months.
* Patients with symptoms related to degenerative arthritis in the ankle, which affected the assessment of pain.
* Patients with severe heart problems and coagulation disorders.
* Patients who have taken glucosamine within the previous month.
* MRI exclusion conditions, including patients with a heart rhythm regulator who have received vascular surgery with a hemostatic clip and artificial heart valves.
Clinical Trial to Assess the Safety, Tolerability and Pharmacokinetics of Cardiotrophin-1 in Healthy Volunteers

The general aim of the study is to determinate safety, tolerability and early pharmacokinetics of cardiotrophin.1 in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Male or Female, between the ages of 18 and 55.
* Healthy condition (no suffering from known acute or chronic disease)
* No clinically important abnormal physical or laboratory findings at the screening examination.
* Normal or clinically acceptable ECG.
* Normal blood pressure (systolic: 90-140 mmHg; diastolic: 50-90 mmHg) and heart rate (40-100 bpm).
* Body Mass Index of 19.0-29.0 (kg/m2).
* Ability to communicate well with the investigator and to comply with the requirements of the entire study.
* Willingness to give written informed consent (prior to any study-related procedures being performed) and to be able to adhere to the study restrictions and examination schedule.
* For female subjects with childbearing potential: use of a known highly effective method of birth control, defined as those which results in a low failure rate: i.e. less 1% per year, (contraceptive pills, intrauterine contraceptive device, implants, vasectomized partner or sexual abstinence), for at least three consecutive months prior to the study, during the study and one month after the end of the study.
* For male subjects with partners of child bearing potential: use of appropriate contraceptive methods (vasectomy, condoms or sexual abstinence), for at least the study period and one month after the end of the study.

Exclusion Criteria:

* Administration of any investigational drug in the period within three months prior to informed consent.
* Use of any prescription medication during the period 0 to 30 days or over-the-counter medication during the 0 to 5 days before entry to the study.
* Donation or loss of greater than 400 ml of blood in the period 0 to 12 weeks before entry to the study.
* Serious adverse reaction or hypersensitivity to any drug.
* Inability to communicate or co-operate with the investigator because of a language problem, poor mental development or impaired cerebral function.
* History of drug dependence (except tobacco) or psychiatric illness within the past 2 years.
* Consumption of alcohol within 24 hours prior to dose administration.
* Presence of pain incurred by unknown causes.
* Pregnancy or nursing.
* Positive urine drug screen for drugs with a high potential for abuse and low persistence in the urine.
* Inability to refrain from smoking during study days.
* Any other condition which, in the opinion of the investigators, is likely to interfere with the successful collection of the measures required for the study.
Prenatal Microarray Follow-Up Study

The objectives of this multi-center collaborative study are to ascertain the frequency of specific copy number variants (CNVs) identified prenatally and to evaluate in detail through continued follow-up of the children the phenotypes associated with CNVs of known or uncertain clinical significance.

Specifically the aims are as follows:

1. Determine the intellectual function of the children at age 3 years
2. Determine phenotypic characteristics other than intellectual function of the children at age 3 years
3. Determine the frequency of specific copy number variants discovered during routine prenatal diagnostic testing
4. Evaluate the educational, counseling and psychosocial implications of microarray testing as it is introduced as a standard prenatal diagnostic procedure.

Eligibility Criteria:
Eligibility Criteria for Enrollment into the 3 year Follow-up Cohort

Inclusion Criteria

1. Singleton or multi-fetal pregnancy with a prenatal invasive procedure resulting in a diagnosis by microarray analysis of a microdeletion/duplication less than 10 Mbs, either pathogenic or of uncertain significance, which is reported to the patient. This includes:

   * Infants diagnosed during prenatal diagnostic studies performed at the10 pre-specified prenatal diagnostic centers
   * Infants diagnosed by analysis of microarrays performed at the collaborating laboratories
   * Infants referred through the Prenatal Microarray Resource Center website
   * Children who will be at least 3 years of age by January of 2018, and who had a prenatally detected CNV \<10 Mbs, either pathogenic or of uncertain significance OR
2. Children whose mothers were enrolled in the initial study (through July 2011) and who met inclusion criteria for follow-up in that phase, referred to as the "Index cohort". This includes:

   * CNVs of uncertain or known significance, some of which were not reported to the patient
   * Mosaic findings by karyotype and/or microarray alone.

Exclusion Criteria

1. Patient refusal to allow infant follow-up through the age of three
2. Patient not fluent in the English language
3. Patient under the age of 18
4. In surrogate pregnancies, the "rearing parents" are unavailable to give consent.
Insulin and Standard Management in Hypertriglyceridemic Acute Pancreatitis

To compare the efficacy of infusion containing insulin and infusion without insulin on reduction of triglycerides in acute hypertriglyceridemic pancreatitis


Eligibility Criteria:
Inclusion Criteria:

* acute pancreatitis
* triglycerides \> 15 mmol/l

Exclusion Criteria:

* diabetes on peroral therapy or insulin
* blood glucose \> 11 mmol/l
* pregnancy
Feedback and Psychotherapeutic Competencies

The purpose of the current study is to examine the influence of feedback on psychotherapeutic competency. The present randomized controlled study compares a feedback condition with a non-feedback condition. Therapists in the feedback condition receive feedback after every fourth session. The feedback is given by two trained and independent raters. The raters are licenced and experienced psychotherapists. Therapists in the non-feedback condition receive no feedback during the psychotherapy.


Eligibility Criteria:
Therapists

Inclusion Criteria:

* Having successfully completed the interim audit
* Having started to treat ambulant patients
* Remaining at least 6 month in the ambulance

Exclusion Criteria:

-

Patients

Inclusion Criteria:

* Meeting ICD 10 criteria for a mental disorder
* Informed consent

Exclusion Criteria:

* Currently in psychotherapy
* Suicidal tendency
* Clinical diagnosis of alcohol or drug addiction, acute schizophrenia, schizoaffective disorder or bipolar disorder
* Clinical diagnosis of personality disorder cluster A (odd disorders) and B (dramatic, emotional or erratic)
Use of a Connected Companion in Children With Cystic Fibrosis

The study will be conducted over a 6 months period. For the first three months, the child will be accompagned with a connected companion. After this period, the companion will be removed for three months in oder to prove this companion could improve treatment adherence for children suffering from cytolisis fibrosis.

This study will be conducted at the University Hospital Center of Rennes and Hospital Center of Saint-Brieuc.

In developed countries, chronic diseases with long-term therapy adherence is about 50%, according to the WHO report, and the adherence rate for regular intake of preventive therapies decreases to 28%.

For cystic fibrosis, rates are not much higher. Optimistic articles report an average compliance rate of 60%. Other articles report a rate of 50% which varies according to the age of the patient, the intake treatment complexity and burdensome drug treatment (physiotherapy achieves the lowest adherence with 38%), the disease understanding and the interest of treatment persuasion. Low adherence can also be the result of incorrect use of administration devices, for example for inhaled treatments. Technical errors are very frequent and affect around 30% of patients.

Families with children suffering from cystic fibrosis need daily support. Health professionals need to relay their recommendations at home. This is why new and funny tools dedicated to children with chronic illnesses are needed.

This trial will study the impact of connected companion named LEO® created by Ludocare company.

Study will be conducted as :

* V0 : Companion given to the child
* V1 : Companion removed after 3 months of use
* V2 : Follow-up done between 1 and 3 months after the period without companion

Eligibility Criteria:
Inclusion Criteria:

* Child volunteer from 3 to 11 years old
* Affected by cystic fibrosis
* With a prescription containing at least two medications twice a day
* Affiliation to the national health insurance
* Child and holder of the exercise of parental authority understands and speaks French
* The person exercising parental authority must have reached the age of majority.
* Collection of the written consent of one of the holders of the exercise of parental authority

Exclusion Criteria:

* Non-voluntary child, under 3 years of age or over 12 years of age
* Family reluctant to technology
* Family without smartphone and/or wifi connection
* Failure to obtain the written consent of one of the holders of the exercise of parental authority
* Child involved in research involving the human person
Trial of Foley Catheter With and Without Extra-Amniotic Saline Infusion for Labor Induction

The purpose of this study is to compare the efficacy of a transcervical Foley catheter with and without extra-amniotic saline infusion (EASI) for priming the cervix for labor.

In the United States, labor inductions have increased from 11% of all pregnancies in 1989 to 21% in 2004. Although the indications for labor induction vary, labor inductions as an obstetrical practice are associated with an increased risk of Cesarean delivery. As such, the rise in labor inductions has been paralleled by a rise in the cesarean rate to an all time high of 30%. The risk of cesarean can be mitigated with the use of cervical ripening agents in the setting of an unfavorable cervix. Both pharmacological ripening agents and mechanical methods are currently available for cervical priming. Methods available for mechanical dilation include, but are not limited to transcervical foley catheter alone and transcervical foley catheter with an extra-amniotic saline infusion or EASI. The potential advantage of EASI to transcervical foley catheter alone is the promotion of endogenous prostaglandin release by membrane stripping and supplying additional mechanical force. It may be disadvantageous by increasing the risk of chorioamnionitis or by diluting the prostaglandins that are released by membrane stripping. There have been two randomized trials comparing foley alone to foley with EASI. Because the results of these two trials are conflicting, we chose to conduct a randomized clinical trial of foley catheter compared to foley catheter with an EASI for labor induction and cervical ripening in women with an unfavorable cervix.

Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancy
* 24-42 weeks of gestation
* Cephalic presentation
* Intact membranes
* Bishop score of less than or equal to 6

Exclusion Criteria:

* Contraindications to labor
* Dead or severely anomalous fetus
* Spontaneous labor.