cyrilzakka/clinical-trials huggingface dataset:
CLINICAL EFFECT OF BOTULINUM TOXIN TYPE A IN TREATMENT OF SPASTICITY

Spasticity has been defined as a disorder of the sensorimotor system characterized by a velocity-dependent increase in tonic stretch reflexes (muscle tone) with exaggerated tendon jerks, resulting from hyperexcitability of the stretch reflex.

The treatment goal of spasticity is Medical treatment generally combines physiotherapy with medications, depending on spasticity distribution. Systemic treatments such as oral or intrathecal baclofen are generally considered in case of generalized spasticity, whereas local treatments are considered in case of focal spasticity.

Local treatments such as Botulinum Toxin type A, phenol, and alcohol present several advantages, allowing to treat of selected muscles without the risk of sedation. As stated above, they are indicated for focal spasticity but might be helpful even in the presence of generalized spasticity with identified focal goals (Bethoux et al., 2015).

In particular, Botulinum Toxin type A (BoNT-A) is considered the gold standard treatment for focal spasticity, showing a level A evidence for spasticity reduction in upper- and lower-limb spasticity (Simpson et al., 2016).

However, current evidence is mainly focused on post-stroke spasticity (Franceschini et al., 2014), whereas it is still limited in spasticity as a consequence of other aetiologies, such as spinal cord injury (SCI), traumatic brain injury (TBI), or multiple sclerosis (MS).

Interestingly, spasticity is a major concern for the rehabilitation of these patients.

The aim of this observational study is the evaluation of the clinical efficacy of BoNT-A in spasticity reduction in patients affected by neurological conditions different from post-stroke spasticity, such as SCI, TBI, and MS.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Spasticity as a consequence of traumatic brain injury, spinal cord injury or MS (documented by clinical records)
* Muscle tone graded at least 1+ on the modified Ashworth scale in the relevant joints of the affected limb(s), which requires medical intervention
* BoNT naïve or pre-treated with any BoNT product. If previously treated with any BoNT, at least a 4 months interval between last injection and inclusion

Exclusion Criteria:

* Presence of fixed contractures or bony deformities in the affected limb
* Changes in any oral antispastic medications or specific physiotherapy regimen \<4m before study entry or during the study.
* Other neurological or orthopaedic conditions involving the affected limbs.
* Sensitivity to BoNT-A or to its excipients
* Other contraindications as given in the local SmPC for BoNT-A
Safety and Tolerability of SYNB1020-CP-001

A Phase 1, First-in-human, Oral Single and Multiple Dose-Escalation, Randomized, Double-blinded, Placebo-controlled Study of SYNB1020 in Healthy Adult Volunteers to Evaluate Safety, Tolerability, Dosing, and Pharmacodynamics

This Phase 1, dose-escalating, randomized, double-blinded study will evaluate SYNB1020 in placebo-controlled cohorts within the following 2 study parts:

Part 1: A single-ascending dose (SAD) study conducted in an inpatient setting over 6 days in healthy volunteer male and female subjects evaluated in up to 7 dose cohorts to identify the maximum tolerated dose (MTD) within the single dose range studied; and Part 2: A multiple-ascending dose (MAD) study conducted in an inpatient setting over 22 days in healthy volunteer male and female subjects evaluated in up to 4 dose cohorts that were proven tolerable in the SAD part of the study to identify the MTD of SYNB1020 within the multiple-dose range studied. Up to 48 subjects may be enrolled in this part of the study.

Subjects will be screened for eligibility within 30 days prior to enrollment, with evaluations of exercise habits, gastrointestinal (GI) signs and symptoms, fecal patterns (frequency, consistency), recent or current antibiotic exposure, and laboratory measurements. Eligible patients will be admitted to an inpatient facility for investigational product (IP) administration, safety monitoring, and collection of blood, urine, and fecal samples for pharmacokinetic and pharmacodynamic evaluations.

Eligibility Criteria:
Key Inclusion Criteria:

* Age 18 to 64 years
* Healthy volunteer Males and Females; Females must be of non childbearing potential
* Able and willing to complete informed consent process
* Available for and agree to all study procedures
* Screening Labs within normal range

Key Exclusion Criteria:

* Acute or chronic medical, surgical, psychiatric, social or laboratory abnormality
* Body mass index \< 18.5 or ≥ 30 kg/m2
* Intolerance of or allergic reaction to E. coli Nissle or any of the ingredients in SYNB1020 or placebo formulations; allergies to common foods (e.g., eggs, milk, soy, nuts).
* Prior participation in a study with SYNB1020
* Evidence or history of clinical signification hematological, renal, endocrine, pulmonary, GI cardiovascular, hepatic, psychiatric, neurologic or allergic disease
* Personal or family history of UCD
Five-year Recurrence After LCME

A register-based study is conducted to examine clinical outcomes following a population-based, multi-centred implementation of Laparoscopic Complete Mesocolic Excision (LCME) in the Central Denmark Region, Denmark.

This study was conducted as a population-based "before-and-after" cohort study following the implementation of LCME in the Central Denmark Region (CDR), Denmark, in 2017. The IDEAL framework (Idea, Development, Evaluation, Assessment, Long-term) was used for examining the outcome of a training program on the LCME adoption.

Training programme A LCME training program was conducted from March 2017 to October 2017 in the CDR, inspired by the National English Laparoscopic Colorectal Surgery Course.

Patients This study included all colon cancer patients undergoing a curative-intent bowel resection in the defined timeframe. Exclusion criteria comprised: 1) another synchronous colon cancer; 2) metastatic disease at the time of surgery; 3) non-curative procedures or local resections only; 4) Danish residency \<10 years preoperatively; and 5) non-colon primary cancer.

Data sources The DCCG database, a national registry of newly diagnosed colon cancer patients, was used to identify the primary cohort. For follow-up data beyond 30 days after surgery, the cohort was linked to the following registries: 1) the Danish Civil Registration System (DCRS), 2) the Danish Cancer Registry (DCR), 3) the Danish National Patient Registry (DNPR), 4) the Danish Pathology Registry (DPR) and the Danish Pathological Data Bank (DPDB).

Outcome The primary outcome was the cumulative incidence of colon cancer recurrence 5 years after surgery. A validated algorithm was used to identify recurrence.

The secondary outcome was postoperative complications within 30 days graded by the Clavien- Dindo Classification (CDC) (minor: I-II, major: III-V).

Eligibility Criteria:
Inclusion Criteria:

* newly diagnosed colon cancer patients.

Exclusion Criteria:

1. another synchronous colon cancer
2. metastatic disease at the time of surgery
3. non-curative procedures or local resections only
4. Danish residency \<10 years preoperatively
5. non-colon primary cancer.
Phase I Study of BI 831266 in Patients With Advanced Solid Tumours

The main objective of this trial is to provide safety data in terms of drug-related adverse events for the recommendation of the dose for further trials in the development of BI 831266.

Secondary objectives are the collection of antitumour efficacy data and the determination of the pharmacokinetic and pharmacodynamic profile of BI 831266.


Eligibility Criteria:
Inclusion criteria:

1. Patients with confirmed diagnosis of advanced, non-resectable and/or metastatic solid malignant tumours, who have failed conventional treatment or for whom no therapy of proven efficacy exists or who are not amenable to established treatment options
2. Secure central venous access
3. Measurable and/or non-measurable tumour deposits
4. Recovery from toxicities of prior anti-cancer therapies at least to CTCAE grade 1
5. Age \>= 18 years
6. Life expectancy \>= 3 months
7. Written informed consent in accordance with International Conference on Harmonisation guideline for Good Clinical Practice and local legislation
8. Eastern Cooperative Oncology Group performance score \<= 2

Exclusion criteria:

1. Serious illness, concomitant non-oncological disease (e.g. active infectious disease), or ongoing toxicity of prior therapies considered by the investigator to potentially compromise patients' safety in this trial
2. Pregnancy or breastfeeding
3. Symptomatic brain metastases and/or leptomeningeal disease requiring therapy
4. Second malignancy requiring therapy
5. Left ventricular ejection fraction (LVEF) \< 50% in echocardiography
6. Clinically significant (i.e. active) cardiovascular disease: CVA/stroke (\<= 6 months prior to randomisation), myocardial infarction (\<= 6 months prior to randomisation), unstable angina, New York Heart Association Grade II or greater congestive heart failure, or serious cardiac arrhythmia requiring medication
7. Absolute neutrophil count less than 1500 / mm3
8. Platelet count less than 100 000 / mm3
9. Bilirubin greater than 1.5 mg / dl (\> 26 micromol / L, SI unit equivalent)
10. Aspartate amino transferase (AST) and / or alanine amino transferase (ALT) greater than 2.5 times the upper limit of normal (if related to liver metastases greater than five times the upper limit of normal)
11. Serum creatinine greater than 1.5 mg / dl (\> 132 micromol / L, SI unit equivalent)
12. Women and men who are sexually active and unwilling to use a medically acceptable method of contraception
13. Treatment with other investigational drugs or in another clinical trial within the past two weeks before start of therapy or concomitantly with this trial
14. Chemo-, hormone, radio- or immunotherapy within the past two weeks before start of therapy or concomitantly with this trial
15. Patients unable to comply with the protocol
16. Active alcohol or drug abuse
Tolerance of a Motorized Orthosis Reproducing Walking Movement vs Conventional Standing-up Devices in Child With CP

Cerebral palsy (CP) includes all the sensorimotor development disorders leading to balance, gait and movement disruptions. These disorders are related to lesions of the central nervous system (CNS) that occurs at birth or during the early childhood. The therapeutic management of CP is essentially based on reeducation, but may also require specific medical treatments, orthopedic devices and sometimes bone surgery. Therefore, CP children are very often placed in specialized institutions with a significant socioeconomic impact. CP children suffer from various sensorimotor impairments, which may evolve into orthopedic deformations, justifying the implementation of restrictive devices. The French High Authority of Health (HAS) estimates that 50 % of CP children have pains when using contention or verticalization devices. These pains are mainly nociceptive and are caused by the passive constraint applied on contact points. Many clinical trials evaluating the physiotherapy benefits on CP patients have led to controversial results regarding the duration of the effect of this therapeutic approach. However, the improvement is more important when neuromuscular facilitation techniques are added to the reeducation program. Human neuronal adaptation and plasticity mechanisms are now understood, with the possibility of a potential partial recovery. Non-invasive stimulation methods and neurorehabilitation techniques could participate in the CNS re-calibration. Automated assisted movements have already been used and these processes showed an increase joint range of motion, bone density and decreased spasticity.

In recent years, "exoskeleton" devices have been used on subjects with spinal cord injuries allowing motor performances improvement.

This pilot study aims evaluating CP children's tolerance to motorized orthosis reproducing walking pattern compared with conventional passive standing-up devices. For this clinical trial, the investigators compare the behavior of CP children using a motorized orthosis reproducing walking pattern (Innowalk Pro Small) to the behavior of same children placed in their usual conventional passive device. The investigators hypothesis is that the Innowalk improves joints range of motion, enhances selective motor control, decreases the medium-term spasticity and offers at least the same tolerance as conventional passive devices.


Eligibility Criteria:
Inclusion Criteria:

* CP children from 6 to 16 years old, and being less than 150 cms, able to receive a 30 minutes verticalization session (standard practice) without sign of discomfort or intolerance
* Communicating children
* Children who had never walked

Exclusion Criteria:

* Children presenting uncontrolled epileptic seizures
* No social insurance affiliation
* Refuse to participate in the study
* Orthopaedic surgery in 6 months which precede the inclusion.
* Injection of botulinum toxin in the 6 months which precede the inclusion.
* Previous neurotomy
Rare Inherited Bleedig Disorders in Children at Sohag University Hospital

The RBDs are autosomal disorders, which can be manifested in homozygotes or compound heterozygotes by a severe bleeding tendency caused by a severe deficiency or dysfunction of a clotting factor . (1) During the haemostatic response the formation of primary platelet plug limits bleeding and provides a surface for clotting factors to assemble and become activated .the initial platelet plug is stabilized by fibrin monomers ,covalently cross-linked by fXIII, forming a platelet fibrin thrombus .(2-5) Defect in platelets as well as inherited deficiencies of coagulation factors including fibrinogen ,FII,fV , FVII,FX, fXI and factor FXIII deficiencies , generally lead to lifelong bleeding disorders whose severity of bleeding symptoms is heterogeneous in platelet abnormalities but generally inversely proportional to the degree of the factor deficiency in rare bleeding disorders (RBDs). (4) the prevalence of platelet defects among the general population has not been established , whereas for RBDs it range from approximately 1in 2 million to 500,000, being higher in countries where consanguineous marriages are diffused .(6)

* As a consequence of the rarity of these deficiencies ,the type and severity of bleeding symptoms ,the underlying molecular defects and the actual management of bleeding episodes are not well established . (1) Platelet defects can alter circulating platelet numbers, function or both. These conditions are typically manifested by symptoms of excessive mucocutaneous bleeding and rapid onset, excessive bleeding following invasive surgical and dental procedures or trauma. There is considerable heterogeneity in the severity of bleeding problems associated with these defects. (7) Treatment of patients with RBDs during bleeding episodes or surgery is a challenge because of the lack of experience, paucity of data, non-availability of factor concentrates for some deficiency states and the possible occurrence of severe complications .(8) Patients who are homozygotes or compound heterozygotes for a RBD frequently present with spontaneous and or injury-related bleeding. Therapy during such episodes usually includes fresh frozen plasma or specific plasma-derived factor concentrates, which potentially carry significant risks and have adverse effects. (9,10)


Eligibility Criteria:
Inclusion Criteria:

* This study included children, aged 0-18 years, attending to pediatric department at Sohag university hospital for evaluation of bleeding symptoms, family history of a bleeding disorder and/or abnormal coagulation studies, previously diagnosed to have RBDS or recent diagnosed
* Bleeding questionnaire is done during patients' clinic visit Symptoms included in this questionnaire are epistaxis , cutaneous bleeding , minor cutaneous wound , oral cavity bleeding , hematemesis , melena and hematochezia , hematuria , tooth extraction , surgical bleeding , menorrhagia , muscle hematomas or hemoarthrosis and CNS bleeding

Exclusion Criteria:

1. Patients older than 18 years.
2. Other acquired bleeding disorder
3. common inherited bleeding disorders
The Characterization of Small and Diminutive Colonic Polyps in LCI

Colorectal cancer is a maior cause of morbidity and mortality worldwide.Colonoscopy and removal of all adenomas is the most efficient method to prevent colorectal cancer.The most colorectal polyps detected are small(\<10mm) and diminutive(≦5mm) during colonoscopy.At that size,the are overwhelmingly hyperplastic or adenomatous,and rarely harbour high-grade dysplasia,cancer or sessile serrated adenoma/polyp.Traditional white-light endoscopy cannot reliably distinguish between small adenomatous and hyperplastic polyps,thus,real-time recognition of the polyp histology during colonoscopy has the potential to minimize both the costs and complications associated with endoscopic biopsy and polpectomy.Linked color imaging(LCI),a new system for endoscopy modality,creates clear and bright endoscopic images by using short-wavelength narrow-band laser light combined with white laser light on the basis of magnifying blue laser imaging(BLI) technology. it is easier to recognize a slight difference in color of the mucosa. This is a study to investigate the impact of Linked color imaging endoscopes on the in vivo histology prediction of colonic polyps.

This is a prospective study comparing the accuracy of linked color imaging(LCI) and standard white light colonoscopes in the diagnosis of small and diminutive colorectal polyps.

Eligibility Criteria:
Inclusion Criteria:

- 1.ability to provide written informed consent and undergoing colonoscopy. 2.The patient is undergoing colonoscopy for screening, for surveillance in follow-up of previous polypectomy or for diagnostic work-up.

3.detection and retrieval for histologic examination of at least one polyp\< 10mm in size and/or 5mm in size

Exclusion Criteria:

* Patients were previous colon resection
* Patients were a diagnosis of inflammatory bowel disease,familial polyp syndromes or poor bowel preparation
* suspected chronic stricture potentially precluding complete colonoscopy
* Patients had polypectomy or had coagulopathy/thrombocytopenia
* Patients had diverticulitis or toxic megacolon;previous radiation therapy to the abdomen or pelvis;severe cardiovascular,pulmonary,liver,or renal disease;and coagulation disorders or use of anticoagulants.
* all of polyps could influence surface pattern or/and color assessment
Descartes-08 for Patients With Systemic Lupus Erythematosus

This is a Phase II study to evaluate the safety, tolerability and manufacturing feasibility of Descartes-08 CAR T-cells in patients with Systematic Lupus erythematosus (SLE).


Eligibility Criteria:
Inclusion Criteria:

* Patient must be at least 18 years of age.
* Patient must have systemic lupus erythematosus (SLE) at the time of screening.
* Active symptoms despite recent or ongoing immunosuppressive therapy with glucocorticoids and at least 2 other immunosuppressive medications being tried for at least 12 weeks within 24 months of screening.
* At least one of: anti-dsDNA, anti-histone, anti-chromatin, and/or anti-Sm antibodies detectable at screening as assessed by a CLIA-certified laboratory.

Exclusion Criteria:

* Active severe lupus nephritis, active severe CNS lupus, and/or neurological symptoms of SLE including headache, seizure, psychosis, and organic brain syndrome (a patient with an incidental headache, deemed unrelated to SLE, may re-screen by telephone upon resolution of the headache);
* Major chronic illness that is not well managed at the time of study entry and in the opinion of the investigator may increase the risk to the patient.
* Patient is pregnant or lactating.
AIDS and Cancer Specimen Bank (ACSB)

The purpose of this study is to obtain clinical specimens from pathologists and physicians involved in the diagnosis and care of patients with AIDS and non-AIDS associated malignancies.

The National Cancer Institute has set up a Bank for tissues and biological fluids from HIVpositive and HIV-negative individuals in order to have specimens available for scientists studying malignancies associated with HIV disease.

The overall goal of the AIDS and Cancer Specimen Bank is to obtain clinical specimens from pathologists and physicians involved in the diagnosis and care of patients with AIDS and non- AIDS associated malignancies. These specimens will be banked and linked to a clinical data set so that experimental results obtained by analysis of specific specimens can be linked to relevant clinical data. Contents of the ACSB will be made available to researchers through an application to the National Cancer Institute. Strict patient confidentiality protection guidelines are in place for all specimens in the ACSB. The objective of this protocol is to obtain clinical specimens from potential participants in clinical trials conducted by the AIDS Malignancies Consortium, and from other patients with and without HIV infection, who have AIDS-Associated malignancies.

Eligibility Criteria:
Inclusion Criteria:

* Patient \> 18 years of age
* Suspected or confirmed AIDS-Associated malignancy with or without HIV infection
* Will obtain fresh tissue and/or biological fluids
* Patient signed the correct version of the informed consent

Exclusion Criteria:

* N/A
Cyclophosphamide and Cryoablation in Treating Patients With Advanced or Metastatic Epithelial Cancer

RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Cryoablation kills cancer cells by freezing them. Giving chemotherapy together with cryoablation may kill more cancer cells.

PURPOSE: This clinical trial is studying how well giving cyclophosphamide together with cryoablation works in treating patients with advanced or metastatic epithelial cancer.

OBJECTIVES:

* Document radiologic and/or tumor marker response to cryotherapy of tumor lesions followed by cyclophosphamide.

OUTLINE: This is a pilot study.

Patients undergo percutaneous biopsy of the targeted lesion prior to cryoablation. Patients then undergo percutaneous or open cryotherapy of the largest or most accessible lesion on day 0. On day 3, patients receive cyclophosphamide IV over 1 hour.

Tumor markers (if applicable) are assessed at baseline and monthly during study until marker progression.

After completion of study therapy, patients are followed periodically for up to 3 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of epithelial solid tumors of any of the following sites or types:

  * Lung (closed to accrual as of 4/2/2009)
  * Renal
  * Prostate
  * Breast (closed to accrual as of 4/2/2009)
  * Sarcoma (closed to accrual as of 4/2/2009)
  * Colon (closed to accrual as of 4/2/2009)
  * Liver(closed to accrual as of 4/2/2009)
  * Pancreatic (closed to accrual as of 4/2/2009)
  * Bone (closed to accrual as of 4/2/2009)
  * Head and neck (closed to accrual as of 4/2/2009)
  * Melanoma (closed to accrual as of 4/2/2009)
  * Carcinoma of unknown primary (closed to accrual as of 4/2/2009)
* Advanced or metastatic disease
* Ineligible for or unwilling to undergo surgical resection
* Eligible for cryotherapy but not expected to be cured by cryotherapy alone

PATIENT CHARACTERISTICS:

* ECOG performance status 0-2
* Life expectancy \> 3 months
* Creatinine \< 2.5 mg/dL
* Platelet count \>75,000/mm³
* INR\< 1.5
* No known HIV positivity
* No active, uncontrolled infection
* Not pregnant
* Negative pregnancy test
* Women of childbearing potential must practice adequate contraception
* No debilitating medical or psychiatric illness that would preclude giving informed consent or receiving optimal treatment and follow-up

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics