cyrilzakka/clinical-trials huggingface dataset:
Dysfunctions and Plasticity Mechanisms of Motor System Assessed by Cortico-cortical and Cortico-muscular Coherence Analysis in Amyotrophic Lateral Sclerosis

Amyotrophic lateral sclerosis (ALS) is characterized clinically by abnormalities of both upper motor neurons (UMN) and lower motor neurons (LMN). The presence of UMN signs is not always easy to establish. The only technique used in routine to assess the corticospinal dysfunctions is based on transcranial magnetic stimulation (TMS). However, this technique is largely dependent on LMN state and is based on artificial motor cortex activation.

The main objective of our study project is to evaluate a new method assessing functional changes in motor system in ALS patients. By using cortico-muscular and cortico-cortical coherences, it could be possible to show modifications in both cortico-muscular relationship and in cortical activity coordination which could be related to clinical state in ALS patients. We notably expect a decrease in cortico-muscular coherence in ALS patients. Furthermore, these analyses could provide new insights in motor system plasticity phenomena. We expect a partial covering of voluntary motor command by cortical areas adjacent to primary motor cortex. Lastly, the hypothesis that an increased proportion of voluntary motor control may be assumed by ipsilateral corticospinal tract could be tested by coherence analyses.

Coherence analysis might be a useful method to detect corticospinal tract dysfunctions. This method has the advantage to be painless and not to use artificial stimulations as it is used in TMS.


Eligibility Criteria:
Inclusion Criteria:

* Patient female or male, more than 18 years,
* Patien with a diagnosis of amyotrophic lateral sclerosis according to the El Escorial criteria of Brooks et al. 1994
* Patient , the beginning of the SLA date less than 12 months,
* Patient not having a familial form of ALS,
* Patient not having cancer, autoimmune disease, liver failure, severe hypertension or untreated, severe conduction disorders or uncontrolled arrhythmia
* Patient not having a chronic psychiatric disease, dementia.
* Patient with normal visual function
* Patients receiving social coverage
* Patient have read, understood and signed an informed consent after information

Exclusion Criteria:

* Patient minor
* Patient with a familial form of ALS,
* Patient associated with severe progressive disease (cancer, autoimmune disease , liver failure )
* Patient (s) with chronic mental illness, dementia ,
* Presence of atypical clinical signs such as cerebellar ataxia , extrapyramidal signs, sensory disorders , autonomic dysfunction .
* Clinical signs of chronic respiratory failure or slow and / or forced less than 70% of the theoretical value or chronic hypercapnia than 45 mmHg vital capacity .
* Patient private freedom following a judicial or administrative decision
* Patient major Trust
* Pateinte pregnant, parturient , lactating
* Patient major in legal protection ( guardianship )
* Pateinte pregnant , parturient , lactating
* Patient hospital without consent
* Patient admitted in a health or social establishment for purposes other than research
One-time Informed Consent for Research in Prison

Ethical research on detained persons remains limited, including research on informed consent. This study aimed to fill in this research gap and compared audio-visual and paper-based materials for a one-time general informed consent for research in prison, using a randomized design. The primary outcome was whether participants sign the inform consent. Secondary outcomes included understanding, evaluation, and time to read/watch the informed consent.

Detained persons constitute a very vulnerable and perhaps reluctant to share their medical data. In particular, it is crucial to ensure that these persons, deprived of their liberty, understand that their consent is voluntary and that a refusal will not have any consequence on their treatment or care. In other words, it is necessary to ensure that consent is informed. In a historical context of non-ethical research using detained persons, this is a crucial issue. However, while detained persons are now protected from various forms of abuse, this may have had the consequence of reducing research involving them, to the detriment of understanding their characteristics and vulnerabilities.

A general consent for research will encourage research on prison populations by facilitating access to their medical data in order to study and reduce health disparities, for this population with multiple somatic and psychiatric comorbidities.

Our main questions are:

Q1. What is the acceptability rate of general consent for research in detained persons? Q2. What are the characteristics (socio-demographic and medical) of detained person who refuse to give their consent? Q3. Which material (paper-based or video) is more effective?

To answer these research question, we will use an exploratory randomized cross-sectional trial, conducted in an adult pre-trial prison and a juvenile detention center. Participants will be randomly assigned to read or watch information about informed consent, stratified on the prison. In both prisons, the study will take place in the prison medical unit.

This project is aimed to improve general consent, which contributes to reducing inequalities in documentation on health status, and ultimately, health inequalities.

Eligibility Criteria:
Inclusion Criteria:

* to be18 years old or more in the adult prison and 14 years old or more in the juvenile detention center
* to be able to communicate in one of the languages of the study material
* to agree to participate in this study.

Exclusion Criteria:

* presence of an acute psychiatric problem preventing the person from participating in the study
Skin Aging in Renal Transplant Patients

Determination of collagen, pigment and haemoglobin content of sun exposed and sun protected skin by Siascopy. Immunocompromised patients (for more than seven years) compared to immunocompetent patients.

* Trial in the field of transplantation / xenotransplantation

Determination of collagen, pigment and haemoglobin content of sun exposed and sun protected skin by Siascopy. Immunocompromised patients (for more than seven years) compared to immunocompetent patients.

Eligibility Criteria:
Inclusion criteria:

* Renal transplant recipients transplanted more than seven years ago and immunocompetent probands of the same age.

Exclusion criteria:

* Refusal of informed consent, physical or psychological inability to give informed consent.
A Study to Learn How Renal Impairment Affects the Pharmacokinetics of PF-07817883.

The purpose of the study is to learn about:

* how PF-07817883 is processed in the body of adult participants.
* the safety of PF-07817883.

These participants will have different levels of kidney function loss:

* moderate
* severe
* none or healthy Participants with moderate, severe or no loss of kidney function may be taken into one of 3 groups.

This study is seeking for participants who:

* are male or female of 18 to 90 years of age.
* have different levels of damage to kidney function or for one of the groups, no damage
* are willing to follow the requirements of the study including stay at clinic for 5 nights and 6 days.

About, 8 participants may be selected in groups 2 and 3. In group 1, around 8 to 12 participants may be selected. If participants agree to take part in the study, it may take up to 4 weeks to complete all the tests to confirm if they are fit to be in the study. If they seem to be fit for the study, participants will be admitted to a clinic research unit (CRU) at least 8 hours before dosing.

On Day 1, participants will receive a single amount of study medicine (Day 1). A series of blood samples will be collected before and after giving medicines. Participants will be discharged from the CRU on Day 5. A follow-up phone call (or CRU visit, if needed), will occur 28-35 days after taking the medicine. The whole study will last for a minimum of 5 weeks and a maximum of 10 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Male or female participants aged 18 (or the minimum age of consent in accordance with local regulations) to 90 years of age at screening.
* BMI of ≥16 kg/m2 and a total body weight \>45 kg (99 lbs).
* Stable renal function, defined as the eGFR values obtained at the two screening visits should not be more than 25% different.

Exclusion Criteria:

* Positive test result for severe acute respiratory syndrome coronavirus 2 (SARS CoV 2) infection at the time of screening or Day -1.
* History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing at screening for HIV, hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C antibody (HCVAb). As an exception, a positive hepatitis B surface antibody (HBsAb) test due to hepatitis B vaccination is allowed.
* Renal transplant recipients.
* Any condition possibly affecting drug absorption
Plyometrics in the Ankle Stabilizing Muscles in Improving Balance in Ballerinas

Balance is essential for successful dance performance. The effort of salsa dancers is given by the levels of stability, produced by the muscular activation of lower limbs.

The objective of the study is to assess the effectiveness of an intervention of plyometric exercises in the improvement of balance in salsa dancers from 18 to 25 years.

Randomized clinical study. 40 dancers will be randomized to the two study groups: experimental (application of plyometric exercise protocol) and control (without intervention). The treatment will last 5 weeks, with 2 weekly sessions of 25 minutes each. The dependent variables will be: equilibrium (measured with star excursion balance). The sample distribution will be calculated using the Kolmogorov-Smirnof test. The changes after each evaluation will be calculated with the t-student test. With an ANOVA of repeated measures, the intra and intersubject effect will be observed. The effect size will be obtained with Cohen's formula.

It is expected to see improvement in the stability of the ankle and the level of balance in the dancers.


Eligibility Criteria:
Inclusion Criteria:

* Dancers
* Female
* From 18 to 25 years
* With more than a year of dance practice
* And without musculoskeletal injury at the time of starting the study.

Exclusion Criteria:

* Subjects who do not attend all training sessions
* Pregnant women or intending to remain in state during the study period
* Have not signed the informed consent
The Effect of Exercise Training on Cardiac Structure and Function

Exercise training, as part of cardiac rehabilitation, is effective in improving functional capacity and quality of life in patients with coronary artery disease. Other cardiovascular and non-cardiovascular benefits have been reported, namely in glucose metabolism, skeletal muscle function, oxidative stress, vascular function, pulmonary circulation, ischaemia-reperfusion lesion and ventricular remodelling.

However, the benefit of exercise training on systolic and diastolic function is controversial especially after acute myocardial infarction where no longitudinal study has evaluated diastolic function using modern echocardiographic parameters.

The hypothesis is that a structured program of exercise training can improve systolic and diastolic function in patients after myocardial infarction.


Eligibility Criteria:
Inclusion Criteria:

* Patients one month after myocardial infarction
* Older 18 years

Exclusion Criteria:

* Age above 75 years,
* Inability to exercise,
* Hemodinamically significant valvular disease,
* Moderate to severe chronic lung disease (vital capacity and/or forced expiratory volume in 1 s \<80% of age-dependent predicted value),
* Atrial fibrillation
* Exercise induced myocardial ischemia
* Anaemia (haemoglobin \<12 g/dl).
JCP Study of Investigation of Patient Background Characteristics

To collect the background characteristics of juvenile cerebral palsy patients aged 2-year or older prescribed BOTOX for the treatment of equines foot due to lower limb spasticity, compare them with those of patients whose deaths or adverse drug reactions (ADRs) related to the possible spread of toxin are reported through the spontaneous ADR reporting system, and discuss potential risk factors for such ADRs.

1. In each of prospective medical institutions (where BOTOX is expected to be prescribed annually to at least 10 juvenile cerebral palsy patients aged 2-year or older), the Medical Representative will explain the objectives, subjects and methods of the investigation to the prospective investigator (i.e., a physician who will prescribe BOTOX and can comply with the protocol of the investigation) and ask for his/her participation in the investigation.
2. When the physician agrees to participate in the investigation, a written agreement will be concluded between GSK and the head (e.g. director) of the medical institution prior to the start of the investigation.
3. After the completion of the investigation period, the physician will complete the case report form (CRF) for the patients prescribed BOTOX by him/her during the investigation period. The information of the patients who developed ADRs will be collected separately through the spontaneous ADR reporting system on a daily basis.

Eligibility Criteria:
Inclusion Criteria:

* Background factors:

The following background characteristics will be compared between the patients collected during the investigation and the patients whose deaths or ADRs related to the possible spread of toxin are reported through the spontaneous ADR reporting system, to discuss the potential risk factors for death or spread of toxin:

1. severity of indication (cerebral palsy) prior to use of BOTOX
2. Medical history/concurrent medical conditions (e.g., dysphagia, seizure, pulmonary disorder, neuromuscular disorder, and cardiac disorder, and others) ; Yes/No, and if yes, specify the diseases
3. Use of concomitant drugs and non-drug therapies
4. Dose per kg body weight
5. Dose per injection site (e.g., gastrocnemius muscle, soleus muscle, tibialis posterior muscle)

Exclusion Criteria:

* patients whose adverse drug reactions (ADRs)
A Study of TQB3820 in Patients With Hematological Malignancies

TQB3820 is a novel cereblon-modulating agent. Upon binding to cereblon, a substrate receptor in the cullin4 E3 ligase complex, TQB3820 promotes recruitment, ubiquitination, and subsequent proteasomal degradation of the hematopoietic transcription factors Ikaros (IKZF1) and Aiolos (IKZF3). Modulation of Aiolos and Ikaros expression has the potential to correct multiple aspects of the immune dysregulation mediated by B cells.


Eligibility Criteria:
Inclusion Criteria:

1. For Multiple Myeloma cohort

   1. Patients must have received at least 2 prior therapies;
   2. Measurable levels of myeloma paraprotein

      1. M-protein in serum \>5 g/L;
      2. M-protein in urine \>200mg/24h;
      3. Light chain Multiple Myeloma without measurable disease in the serum or urine: serum immunoglobulin free light chain ≥ 100 mg/L and abnormal serum immunoglobulin kappa lambda free light chain ratio.
2. For Indolent B-NHL

   1. Progressed after standard treatment or no standard treatment with an established survival benefit is available;
   2. Imaging in screening showing at least one measurable lesion; In patients with CLL/SLL, circulating lymphocytes \>= 5.0 × 10\^9/L or lesions greater than 1.5 cm.
3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2;
4. Life expectancy \>=3 months;
5. Adequate organ/system function;
6. Female patients of childbearing age should agree to use contraceptive measures during the study period and for at least 6 months after study is stopped; male patients should agree to use contraception during the study period and for at least 6 months after study is stopped;

Exclusion Criteria:

1. Patients received allogenic haemopoietic stem cell transplantation, or autologous stem cell transplantation within 3 months;
2. Diagnosed and/or treated additional malignancy within 3 years before the first dose;
3. With factors affecting oral medication;
4. Toxicity that is \>=Grade 2 caused by previous cancer therapy;
5. Patients with congenital bleeding or coagulopathy, or are being treated with anticoagulants;
6. Patients with uncontrolled infections;
7. Has received surgery, chemotherapy, radiotherapy or other anticancer therapies 2 weeks before the first dose;
8. Has received Chinese patent medicines with anti-tumor indications that National Medical Products Administration(NMPA) approved within 2 weeks before the first dose;
9. Pleural effusion, pericardial effusion or ascites that cannot be controlled and need repeated drainage;
10. Central nervous system metastases;
11. Has participated in other clinical studies within 4 weeks before the first dose;
12. According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.
Cryotherapy to Improve Outcomes in Lower Third Molar Surgery

This study is looking to see whether cooling the face using a special cooling device (Hilotherm®) before and during the removal of wisdom teeth will reduce the pain and discomfort patients feel after the procedure. The surgical removal of lower third molars (wisdom teeth) is arguably the most commonly performed surgical procedure worldwide. If this study shows that application of cold before and throughout the procedure is a simple way to reduce post-operative symptoms, it could benefit thousands of patients every year.


Eligibility Criteria:
Inclusion Criteria:

1. Patients 18+ years requiring surgical removal of a single (unilateral) mandibular wisdom tooth
2. Tooth requiring full mucoperiosteal flap and bone removal for removal of tooth
3. Written informed consent

Exclusion Criteria:

1. Patients refusing to give written informed consent
2. Clinically significant or unstable physical or mental disability rendering the participants incapable of complying with the study protocol as judged by the investigator
3. Pregnant women
4. Patients taking long-term anti-microbial or anti-inflammatory drugs
5. Patients requiring pre-operative antibiotics for surgery
6. Patients requiring concomitant extractions or contralateral lower 3rd molar removal
Study to Evaluate Bone and Gum Dimension Changes Around Dental Implants Placed in Different Positions in Bone.

The purpose of this study is to test two standard of care techniques of placing dental implants, and to compare how people's bones and gums respond to two different depths at which implants are placed.

The purpose of this study is to test epicrestal and subcrestal placement of dental implants, and to compare how people's bones and gums respond to two different depths at which implants are placed.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects must have read, understood and signed an informed consent form;
2. Subjects must be 18 to 70 years of age;
3. Subjects must be able and willing to follow study procedures and instructions;
4. Subjects must have indication to receive two implants in a bilateral maxillary or mandibular edentulous areas (for at least 4 months post extraction) in areas of pre-molars (first or second) and molars (first or second);
5. Sufficient width and height of bone to place at least 8mm length and any compatible in diameter Ankylos implant;
6. Sufficient vertical clearance to place a single tooth crown replacement;
7. No apical disorder/inflammation at the area of the implant site.

Exclusion Criteria:

1. Subjects participating in other clinical studies within 1 month prior to screening and/or involving therapeutic intervention (either medical or dental) that could affect bone or soft tissue healing;
2. Female subjects who are pregnant or lactating, or who intend to become pregnant during the study period following entrance into the study;
3. Subjects with parafunctional habits;
4. Subjects who have failed to maintain good plaque control;
5. Subjects with any systemic condition like uncontrolled diabetes mellitus, cancer, HIV, disorders that compromise wound healing, chronic high dose steroid therapy, bone metabolic diseases, radiation or other immuno-suppressive therapy which would preclude periodontal surgery;
6. Absence of occlusal stability in centric occlusion;
7. Subjects with the presence of acute infectious lesions in the areas intended for surgery;
8. History within the last 3 months of weekly or more frequent use of smokeless chewing tobacco, pipe or cigar smoking and cigarette smoking (greater than 10 cigarettes per day)
9. Present alcohol or drug abuse;
10. Angulation requirements of the restoration exceeding approximately 15 degrees;
11. Systemic corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration (e.g. calcium channel blocker, dilantin).
Exercise and Virtual Reality Exposure Therapy for Acrophobia

The purpose of this study is to determine whether aerobic exercise can enhance the effects of exposure therapy treatment for fear of heights.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 25
* Speaks English fluently
* Score of 80 or higher on the Acrophobia Questionnaire
* SUDS rating of 50 or higher on the Behavioral Avoidance Test or complete refusal to comply with instructions due to intensity of fear
* Passes the Physical Activity Readiness Questionnaire-Plus

Exclusion Criteria:

* Hearing or visually impaired
* Currently receiving exposure-based treatment for acrophobia
* Able to remain on floor 20 for 30 seconds during BAT with a SUDS rating \< 50
Manual Therapy for Hand Osteoarthritis

Osteoarthritis (OA) of the hand is a major cause of pain and functional limitation, central sensitization of pain can be one of the causes: this hypothesis opens avenues for research in the modulation of pain pathways. The peripherally directed therapies may modulate pain perception bilaterally. This hypothesis opens avenues for future research in the modulation of pain pathways, perhaps offering targets to optimize peripheral manual and physical therapies for pain management in hand OA.

Several studies have reported the outcomes of multimodal approach to central sensitization evaluated by generalized pressure pain hypersensitivity in patients with carpometacarpal (CMC) OA. Neurodynamic techniques are a form of manual therapy directed to the neural structures through positioning and movement of multiple joints. Recent technologies have facilitated the use of robots as tools to assist patients in the rehabilitation process thus maximizing patient outcomes. These robotic tools assist the patient with carrying out exercise protocols, optimal for the activity of the control group.


Eligibility Criteria:
Inclusion Criteria:

* Osteoarthritis of the dominant hand. To be included in the study, the subjects need to have a history of repetitive use of their dominant hand (eg, ex-factory worker) and a diagnosis of hand OA in the dominant hand, according on radiographic findings.

Exclusion Criteria:

* If they score greater than 6 points on the Beck Depression Inventory (BDI) or more than 30 points in the State Trait Anxiety Inventory (STAI). Patients with a medical history of carpal tunnel syndrome, surgical interventions to the hand, DeQuervain's tenosynovitis, or with degenerative or non-degenerative neurological conditions in which pain perception is altered will be excluded. None of the individuals in this study will have received prior interventions for hand OA.