cyrilzakka/clinical-trials huggingface dataset:
Safety and Preliminary Effectiveness of AV650 in Patients With Spasticity Due to Spinal Cord Injury

A drug called AV650 (tolperisone HCl) will be given to patients who have spasticity following a spinal cord injury. This study has three purposes:

1. To determine whether AV650 is safe for patients with spinal cord injury;
2. To assess what the body does with AV650 once it is ingested; and,
3. To gather some early evidence as to whether AV650 is effective in treating spasticity in patients with spinal cord injury.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who provide written informed consent.
* Male or female subjects aged 18 to 70 years.
* In the judgment of the Principal Investigator, able to comply with protocol requirements.
* Subjects willing and able to withdraw from other anti-spasmodic/muscle relaxant drugs for at least two weeks before randomization (including but not limited to baclofen, benzodiazepines, clonazepam, clonidine, dantrolene, diazepam, gabapentin, and tizanidine).
* Neurological level between C-4 and T-12 spinal cord levels.
* SCI duration of 6 or more months.
* Muscle tone sufficient to score at least two (2) on the Ashworth Scale for at least one of the following lower muscle groups: ankle plantar flexors (gastrocnemius), knee extensors (quadriceps), knee flexors (hamstrings) and/or hip adductors (adductors) and seven (7) for the most spastic limb.
* ASIA Impairment Scale Exam score of B, C or D.
* Female subjects of childbearing potential must be either surgically sterile or using an effective method of contraception.
* Female subjects of childbearing potential must have a negative urine pregnancy test at baseline (Study Day 0).

Exclusion Criteria:

* Subjects with a known hypersensitivity to lidocaine or non-steroidal analgesics.
* Subjects with clinically significant cardiovascular, pulmonary, endocrine, hepatic, renal, neurological, metabolic, or psychiatric disease.
* Any recent history of mental illness, drug addiction, recreational drug use, or alcoholism and/or any similar condition that the investigator feels should prohibit study participation.
* Any significant illness during the four weeks preceding Study Day 1.
* History of cancer or inflammatory arthritis of large joints.
* History of gastric or duodenal ulcer.
* Concurrent symptomatic urinary tract infections with fever.
* Severe physical injury, direct impact trauma, or neurological trauma within the last 6 months not including Spinal Cord Injury.
* ASIA Impairment Scale score of A or E.
* Uncontrolled hypertension or hypotension.
* Percussive tenderness of vertebral body or spinous process.
* Subjects with corrective surgery to or contracture of the measurable hip, knee, or ankle joints.
* Subjects known to be Hepatitis B or HIV positive.
* Female subjects who are pregnant or nursing.
* Subjects who have received an investigational drug within 30 days before Screening visit.
* Subjects with any documented episodes of seizures.
* Subjects requiring use of clinically relevant 2C19 or 2D6 inhibitors, or concomitant use of lidocaine.
* Use of rescue medication(s) within 48 hours of baseline procedures.
Clinical Investigation of the SelectSecure Pacing Lead

People who have a slow heart beat, or whose heart does not beat on its own, may be in need of an electronic device called a pacemaker. A pacemaker is implanted surgically just under the skin in the upper chest area. This device helps the heart beat at a regular rhythm by sending electrical signals (pacing) directly to the heart tissue through flexible wires called leads. The purpose of this study is to demonstrate that the SelectSecure (Model 3830) lead is safe and effective for both sensing the heart's natural rhythm and pacing the heart when it does not beat on its own. This lead will be studied in both the right atrium and right ventricle. A previously market approved Medtronic lead model will serve as a comparison to prove the safety and effectiveness of the SelectSecure Model.


Eligibility Criteria:
Inclusion Criteria:

Subjects who are in need of a pacemaker that paces in both the right atrium and ventricle.

Exclusion Criteria:

Subjects who are in need of an implantable cardioverter defibrillator (ICD).

Subjects who have a mechanical or diseased tricuspid valve (a structure in the heart, located between the right atrium and right ventricle, which allows blood to flow from the atrium to the ventricle).

Steroid contraindication
Weight Loss Study-Mechanism Underlying the Improvement of Insulin Resistance in Response to Weight Loss

The main purpose of this study is to assess factors mediating the changes in insulin sensitivity and glucose tolerance before and after 10 lbs ± or 2% weight loss reduction as well as 2, 3, 6, 12, and 24 months after initiation of a low calorie diet.

The investigators will also study the following:

1. The impact of diet induced weight loss on hormones/adipokine levels
2. The impact of diet induced weight loss on leptin tolerance


Eligibility Criteria:
Inclusion Criteria for interventional group:

1. Adult men and women, age 18-50
2. English speaking
3. Body mass index (pre weight loss) ≥30 kg/m2 but \<40 kg/m2
4. Willing to enroll in a low calorie full meal replacement weight loss program
5. Willing and able to take part in a multi year study involving visits

Inclusion Criteria for control group:

1. Adult men and women, age 18-50
2. English speaking
3. Body mass index (pre weight loss) ≥30 kg/m2 but \<40 kg/m2
4. Willing and able to take part in a multi year study involving visits
Homologous vs Heterologous Third Vaccination in Kidney Transplant Recipients Kidney Transplant Recipients

Randomized-controlled trial comparing homologous (mRNA vaccine) vs. heterologous (vector vaccine) for third SARS-CoV-2 vaccine dose in kidney transplant recipients not responding to initial prime-boost vaccination with an mRNA vaccine.


Eligibility Criteria:
Inclusion Criteria:

* patient has received a kidney transplantation
* full SARS-CoV-2 vaccination with mRNA vaccine (two doses) at least 4 weeks before screening
* \> 18 years of age
* no SARS-CoV-2 spike protein antibodies at least 4 weeks after the second dose of an mRNA vaccine

Exclusion Criteria:

* acute illness with fever
* Prior documented infection with SARS-CoV-2
* triple anticoagulation therapy
* Subject is currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug trial(s), or subject is receiving other investigational agent(s)
* Subject has known sensitivity or intolerance to any of the products to be administered for the purpose of this study
* Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with the study procedures
* Subject is pregnant or breast feeding
Effects of Seaweed Extract on Mental Performance Following a High-carbohydrate Meal

The current study will explore the impact of seaweed extract on cognitive function following a high-carbohydrate meal at a number of time-points post-consumption.

The current randomised, placebo-controlled, double-blind, parallel groups study will examine the impact of a brown seaweed extract (InSea2) on cognitive function post-prandially in 60 healthy non-elderly adults who self-report post-meal drowsiness. Computerised measures of episodic memory, attention and subjective state will be completed at baseline and for 3 hours following lunch with either seaweed or placebo consumed 30 minutes prior to a carbohydrate-rich meal.

Eligibility Criteria:
Inclusion Criteria:

* Report post-meal drowsiness

Exclusion Criteria:

Below 18 or above 65 years old at the time of giving consent

* Do not report post-meal drowsiness
* Any pre-existing medical condition/illness
* History of/current head trauma
* History of intestinal tract surgery
* History of/current diagnosis of drug/alcohol abuse
* Currently taking prescription medications (excluding the contraceptive pill)
* Habitual use of dietary/herbal supplements
* Learning difficulties, ADHD (attention deficit hyperactivity disorder), dyslexia
* Frequent migraines that require medication more than once/month.
* Visual impairment that cannot be corrected with glasses or contact lenses
* Smoking
* Excessive use of caffeine (\>500mg per day) from all dietary sources
* Not a native English speaker
* Food intolerances/sensitivities, including seafood/fish allergy
* Pregnancy, seeking to become pregnant, or current lactation
* BMI \<18.5 or \>30 kg/m2
* Any health condition that would prevent fulfilment of the study requirements
* Inability to complete all of the study assessments
G-CSF Administration in IVF in a Preferable Preceptive Endometrium Score

This is a controlled preminary trial intended to increase the implantation rate of IVF cycles, by using more than one known procedure, endometrial scratching, evaluating the status of the adhesive factors as αVβ3 integrin, L-selectin ligand MECA-79, E-cadherin and ICAM-1, as a determinant for intervention by G-CSF, according to a score that can be done on a small sample obtained during scratching, then give G-CSF for the scores less than 4 intrauterine and subcutaneously.

Placebo: CONTROL patients treated with PLACEBO (saline solution) from the day of embryo transfer through the day of beta hCG test Drug\& scratching CONTROL saline infusion every day from the day of embryo transfer through the day of beta HCG test Other Name: SALINE INFUSION Experimental: G-CSF group patients treated with G-CSF if the biopsy adhesive score 1-3 only

1. Endometrial scratching and adhesive factor score, day 21-24 cycle prior to IVF//0rv day 3 of IVF cycle not planned before.
2. Drug \&scratching : G-CSF group

1- 300 µg trans cervical intrauterine of G-CSF was administered at the oocyte retrieval day, 2- subcutaneous 300 micrograms G-CSF on the day of embryo transfer Comparative group patients not treated with G-CSF after scratching if the biopsy adhesive score 4 only

Scratching only :

Patients undergoing scratching on day 21-24 of prior IVF cycle/ and on day 5 of IVF cycle with biopsy score of 4.

Eligibility Criteria:
Inclusion Criteria:

* ALL Women aged \< 40 years who would be submitted to oocyte retrieval and embryo transfer IN IVF cycle.

Exclusion Criteria:

* • contraindications for G-CSF treatment (sickle cell disease, chronic neutropenia, known past or present malignancy, renal insufficiency, upper respiratory infection, pneumonia, and congenital fructose intolerance)
Drug Use Investigation for Cervarix®

This post-marketing study was designed to assess safety and efficacy of Cervarix® vaccine in Japanese female subjects under conditions of actual use.


Eligibility Criteria:
Inclusion Criteria:

* Subject must be female
* Subject must be aged 10 and over

Exclusion Criteria:

* Subject with obvious fever
* Subject with obvious severe acute disease
* Subject with hypersensitivity to any component of Cervarix®
* Other than above, subject who is in inappropriate conditions for vaccination
Non-invasive Screening of Fetal Trisomy 21 by Digital PCR

In France, as in many countries of the world, trisomy 21 or Down syndrome (DS) is the subject of an antenatal screening based on a risk calculation (R) including the assay of biochemical markers in the maternal blood, and the measurement of a fetal ultrasound parameter (nuchal translucency). In the population of pregnant women said to be at high risk (R\> 1/250), confirmation of the diagnosis of DS is made by invasive sampling (trophoblast biopsy or amniocentesis), which allows the establishment of fetal karyotype. In addition to limited sensitivity (80 to 85% depending on the techniques), this screening is an anxiety factor (8% false positives), and miscarriages of euploid fetuses (normal karyotype) in 1% of cases (procedures invasive).

The plasma of a pregnant woman contains a mixture of free DNA of maternal (90%) and fetal origin (cffDNA for cell free fetal DNA) (about 10%, but this proportion increases in cases of fetal trisomy 21. The proportion of cffDNA is sufficient to qualitatively and quantitatively study specific genetic markers of a pair of chromosomes. It is therefore possible to evaluate the quantity of markers chromosome of interest relative to a reference chromosome marker, and to calculate a marker / marker ratio of interest, theoretically identical for all autosomes (chromosomes 1 to 22) during euploid pregnancy. In case of fetal aneuploidy (for example, trisomy 21), this ratio is unbalanced for the chromosomal pair involved.

Advances in technology, such as high-throughput mass sequencing (MPS) and digital PCR (dPCR), now make it possible to consider the diagnosis of fetal maternal DS through the study of cffDNA. Several teams have already published on this subject with the MPS technique, applied directly to free DNA from maternal plasma, or after a cffDNA isolation step. This involves sequencing the DNA fragments present in the sample and placing them back on their original chromosome. In case of trisomy 21 fetal, one seeks to put in evidence of an excess of sequences from chromosome 21. These techniques require expensive equipment (sequencer, bioinformatic platform, servers) and a technical time and important analysis (often several days for a single run). Concerning the research of aneuploidies by digital PCR (dPCR), few publications are today due to the absence of sufficiently powerful instruments until recently. DPCR is less expensive.


Eligibility Criteria:
Inclusion Criteria:

* Women with high risk of fetal trisomy 21 with maternal screening test, who benefited of invasive sampling

Exclusion Criteria:

* women with twin pregnancies
* pregnancies with other chromosomal abnormalities
Psychophysical Aspects of Maximal Anaerobic Performance

During anaerobic exercise, the metabolic pathway of glycolysis is used in order to produces high-energy compounds adenosine triphosphate (ATP).The level of lactic acid in the blood is a marker to the increased protons concentration and acidosis.nevertheless, the increased level of protons in addition to the release of bradykinin causes pain during the exercise that limited the subject's performance. Therefore, it is assumed that the individual pain sensitivity might determine the subject's performance.

Aims: To investigate the role of the DNIC efficiency in prediction of anaerobic performance in humans (2) to study the role of peripheral pro-nociceptive processing in mediating pain during anaerobic exercise and its contribution to the subjects' performance (3) to assess the function of pain-related psychological factors in anaerobic performance.

To the best of our knowledge, no study has investigated the balance between the endogenous anti-nociceptive properties of the individual and the anaerobic-evoke pro-nociceptive activity in determining the maximal performance during anaerobic exercise. Moreover, the interaction between psychological factors and pro- and anti- nociceptive processes that are operated during anaerobic exercise, need to be investigated.

Methods: Forty healthy men and women, between the ages of 18-40 will be involved in the study. Each participant will complete 3 psychological questionnaires regarding their personality traits: Pain Catastrophizing Scale (PCS), State-Trait Anxiety Inventory and Perceived Stress Questionnaire. Pain psychophysics tests will be used for evaluating the individual pain perception, prior and subsequent to the anaerobic exercise: (1) DNIC will be tested using a paradigm of two remote noxious stimuli with one, the 'conditioning stimulus' (immersing the hand in tub containing 8°c water), inhibiting the other, the 'test pain' (pressure pain threshold) in order to assess the endogenous analgesia (EA) efficiency (2) heat and pressure pain thresholds, and (3) temporal summation of painful heat and mechanical stimuli that reflect the neuroplasticity of the central nervous system following peripheral noxious stimulation. In addition, Anaerobic performance will be evaluated during Wingate test,and blood lactate will be measured. Gene related pain ill be tested using saliva samples .

Eligibility Criteria:
Inclusion Criteria:

healthy Volunteers

Exclusion Criteria:

pregnancy
Trial Comparing Chlorambucil to Fludarabine in Patients With Advanced Waldenström Macroglobulinemia

Waldenström's macroglobulinaemia (WM) is a lymphoproliferative disorder characterized by a monoclonal IgM paraprotein and morphological evidence of lymphoplasmacytic lymphoma: the cells are IgM+, IgD+, CD19+ and CD20+ but usually CD5-, CD10- and CD23-. The treatment efficacy is difficult to assess because of the lack of clear diagnostic criteria , good response criteria, and of randomized trials.

The actual treatment is Chlorambucil, an alkylating agent. A purine analogue such as Fludarabine has proven its efficacy on 30 % to 80 % as first line therapy

This study is a phase II b open, prospective, international multicenter trial (England, Dr Johnson, Dr Catovsky, Australia: Dr Seymour) promoted by the French Cooperative Group on Chronic Lymphoid Leukemia in untreated WM, or closely related disorders ( Lymphoplasmacytic lymphoma or splenic marginal zone lymphoma). 366 patients must be included, among them 180 patients in France. Patients will be stratified according to the lymphoproliferative disorder.

The patients will receive Chlorambucil by oral route for 10 days every 28 days (12 cycles) (8 MG/M², 6 MG/M² if patient is more than 75 years old) or Fludarabine by oral route for 5 days every 28 days (6 cycles) (40MG/M², 30 MG/M² if patient is more than 75 years old).

The primary objective is to compare the efficacy (response rate) of Chlorambucil to Fludarabine in previously untreated patients. The secondary objectives are the duration of response, the improvement of hematological parameters, the toxicity, the quality of life, the event free survival and the overall survival.


Eligibility Criteria:
Inclusion Criteria:

Established diagnosis of Waldenström macroglobulinemia (the 2nd Workshop on Waldenstrom's macroglobulinemia) or Lymphoplasmacytic lymphoma or Splenic Marginal Zone Lymphoma, needing a treatment

* Life expectancy \> 6 months
* Creatinine \< 200 µmol/l
* SGPT and SGOT \< 2x ULN
* A negative direct Coombs test
* Written informed consent

Exclusion Criteria:

* Past chemotherapy/radiotherapy/immunotherapy prior to the study for Waldenström macroglobulinemia
* Previous malignancy less than 5 years ago except carcinoma in situ of the cervix and non-melanoma skin cancer
* Positive HIV serology
* Active Hepatitis B or C
* Lactation/pregnancy
* Impossible good compliance with the study protocol
* Active infection not controlled
* Psychological condition hampering understanding of the study
* Transformation into large B cell lymphoma
* Peripheral neuropathy \> grade II
Effects of Modified Otago Exercises in Individuals with Diabetic Neuropathy

The aim of the study is to investigate the effects of modified otago exercises on joint position sense, balance and physical fitness parameters in individuals with diabetic neuropathy. In addition aim of to examine the effects of exercise on metabolic variables and to gain exercise awareness in diabetic individuals.


Eligibility Criteria:
Inclusion Criteria:

* Individuals with Neuropathy Diagnosed with Type 2 Diabetes between the Ages of 40-65 Years
* Cooperative, able to take instructions (Mini Mental Test score of 24 and above)
* Able to walk independently
* With a Body Mass Index Below 40 Kg/M2
* Not Doing Regular Physical Activity for the Last 6 Months
* Voluntarily participated in the research

Exclusion Criteria:

* Additional neurological problem other than neuropathy
* Any orthopedic or systemic problems that will prevent him from performing the exercises
* The presence of pathology related to the lower limb that occurred within the last 6 months (surgery, fracture, soft tissue injuries, etc.)
* Pregnant
* Vision problem that cannot be corrected with glasses or lenses
* Hearing loss that cannot be corrected with hearing aids
* Foot ulcer
* Patients who have been diagnosed with cancer and are receiving chemotherapy in this context
* With limitation of the range of motion of the joints of the lower extremities
Reliability and Responsiveness of One Questionnaire Used on a Low Back Pain Population

The purpose of this study is to determine the reliability and responsiveness of the Pain Self-Efficacy Questionnaire (PSEQ) in a chronic low back pain (CLBP) population referred to The Danish Rheumatism Associations´ rehabilitation centre Sano Aarhus.

Chronic low back pain (CLBP) is a highly prevalent health condition, and the leading cause of years lived with disability both globally and in Denmark. In the majority of patients with CLBP, no underlying pathology or cause can be identified and CLBP is acknowledged to be multifactorial. CLBP is defined by symptoms lasting for a period longer than three months. The high prevalence of CLBP causes a substantial impact on patients and their families, communities and health-care systems, as well as a financial burden. Besides pain and disability people with CLBP often experience psychosocial consequences with signs of anxiety and depression and effects on social, leisure, and work life.

An important component in rehabilitation is documentation of treatment outcomes. This demands that a change over time can be measured. To determine effect, the measurement tool must detect real or important change over time. This requires the measurement tool is reliable, and therefore will show no real or important change in periods where the patient is stable. If the measurement tool shows real or important change, in periods where there is no change in the patient state, the results can not be predicted as an effect from an intervention, but due to uncertainty of measurement tool.

The measurement tool is selected by the recommendation of literature and involvement of clinicians and patients at sano, and examines patient with CLBP.

It is found necessary to determine the reliability and responsiveness of the PSEQ on the CLBP population referred to Sano Aarhus. Data will be electronically entered in, stored in and collected from Sanos internal database (SanoBasen).

Eligibility Criteria:
Inclusion Criteria:

• referred to The Danish Rheumatism Associations' rehabilitation centre Sano

Exclusion criteria:

* a rated physical status of \> 3 according to the American Society of Anesthesiologists Physical Status Classification System
* axial spondyloarthritis
* spinal fracture within the last 3 months
* severe osteoporosis
* active cancer
* active psychiatric pathology assessed by general practitioner before referral
* pregnancy
* low Danish language skills
* no e-mail address