cyrilzakka/clinical-trials huggingface dataset:
Extension Study of AGT-181-102 to Evaluate Long Term Safety and Activity of AGT-181

AGT-181 is a fusion protein containing alpha-L-Iduronidase that is intended to deliver the enzyme peripherally and to the brain, when administered intravenously. This study is an extension of a safety and dose ranging study to obtain long term safety and exposure data, as well as information on the biological activity of the investigational drug


Eligibility Criteria:
Inclusion Criteria:

* Must have completed clinical trial AGT-181-102
* Voluntary written consent by patient or legally responsible representative
* All women of childbearing potential and sexually mature males must be advised to use a medically accepted method of contraception throughout the study.
* Negative pregnancy test (females)

Exclusion Criteria:

* Refusal to complete screening evaluations.
* Any medical condition or other circumstances that may significantly interfere with study compliance
* Patient is pregnant or lactating
* Clinically significant spinal cord compression, evidence of cervical instability.
* Subject developed clinically relevant hypersensitivity to AGT-181
Trochanter Fixation Nail Advanced (TFNA) Weight Bearing

This study documents real life weight bearing in patients treated with a TFNA, who are allowed for immediate weight bearing as tolerated.

Prospective data will be collected from 30 patients presenting a per- or inter-trochanteric fracture of the femur treated with the TFNA. Post-operatively patients will be asked to wear a sensor insole in their shoes for up to 3 months after surgical treatment. The sensor insole will be used in both feet and will not have any impact in patient's activities of daily living while allowing real time measurements of weight bearing.

In addition to weight bearing measurements, perceived pain (numeric rating scale), mobility (Parker Mobility Score and Time Up and Go Test) will be assessed at 6 and 12 weeks after surgical treatment and in conjunction with the standard (routine) of care follow up schedule. In order to investigate the relationship between these variables and the weight bearing measurements, patients or their care takers or assisting family members will be asked to document the daily use of the insole in a diary.

Finally, over the course of the study, anticipated adverse events (AE) that may affect the healing process will be collected. Special attention will be given to implant- or bone-related AEs. Images from patients with implant- or bone related AEs will be collected as per standard of care

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years and older
* Patients treated with the TFNA; i.e. according to the technique guide and the indications for use, patients who presented any of the following conditions:

  * Stable or unstable pertrochanteric fractures
  * Intertrochanteric fractures
  * Basal neck fractures
  * Combinations of pertrochanteric, intertrochanteric, and basal neck fractures
* Patients who were able to walk before the fracture and are prescribed full weight bearing as tolerated post-surgery
* Ability to understand the content of the patient information / informed consent form
* Willingness and ability to participate in the study according to the clinical investigation plan
* Signed and dated ethical committee approved written informed consent according to the local regulations

Exclusion Criteria:

* Patients who are not allowed to full weight bearing as tolerated post-surgery
* Any condition, which impairs weight bearing (e.g. additional acute fracture on the ipsilateral and/or contralateral side, pain)
* Patients, who due to their condition, are in opinion of the Prinicipal Investigator (PI) unable to complete a reliable assessment
* Pregnancy or women planning to conceive within the study period
* Participation in any other medical device or medicinal product registry within the previous month that could, in opinion of the PI, influence the results of the present study
Preclinical Project on the Traitment of Acute Lymphoblastique Leukemia With NVP-BEP800, an Inhibitor of the Heat Shock Protein HSP90

NVP-BEP800, a new HSP90 inhibitor, has particularly interesting therapeutic potential and represents hope in cancer pathologies. While it is currently being tested for solid cancers, no preclinical study has yet demonstrated its effectiveness in acute lymphoblastique leukemia (ALL). The investigators wish to study the effects of NVP-BEP800 on two different types of ALL (T and B-ALL).


Eligibility Criteria:
Inclusion Criteria:

* Patient suffering from acute lymphoblastic leukaemia whose biological samples are kept at the Biology Technical Platform.

Exclusion Criteria:

* Patient over 80 years of age
Neuroimaging the Effects of Intravenous Anesthetic on Amygdala Dependent Memory Processes

This study involves 60 healthy volunteers aged between 18 and 50 recruited from the general community. It involves doing a set of simple memory tests while inside a fMRI machine. The subject is given a very low dose of an anesthetic drug intravenously while in the scanner. The subject then sees a sequence of pictures on a screen, and presses a button if they remember seeing the picture before. While this is happening, the scanner will be capturing images that tell us what parts of the brain are active. Hypothesis: patterns of hippocampal and amygdala activation during the encoding and retrieval of memory,as measured by fMRI, will be altered by intravenous anesthetics such that suppression of hippocampal and amygdala activities will be dissociable. This dissociation pattern will be different between the drugs propofol and thiopental.

Background: Subclinical doses of propofol produce anterograde amnesia, characterized by an early failure of memory consolidation. It is unknown how propofol affects the amygdala-dependent emotional memory system, which modulates consolidation in the hippocampus in response to emotional arousal and neurohumoral stress. We present an event-related functional magnetic resonance imaging study of the effects of propofol on the emotional memory system in human subjects.

Methods: Sixty healthy subjects were randomized to receive propofol, at an estimated brain concentration of 0.90 μgml-1, thiopental, at an estimated brain concentration of 3.0 μgml-1, or placebo. During drug infusion, emotionally arousing and neutral images were presented in a continuous recognition task, while blood-oxygen-level-dependent activation responses were acquired. After a drug-free interval of 2 h, subsequent memory for successfully encoded items was assessed. Imaging analysis was performed using statistical parametric mapping and behavioural analysis using signal detection models.

Eligibility Criteria:
Inclusion Criteria:

* age b/w 18 and 50
* right-handed
* minimum of high school education
* fluent in English
* normal vocabulary

Exclusion Criteria:

* any significant medical/psychiatric comorbidity
* deficit in vision or hearing that would impede the study
* allergies to any of the study drugs, to soybeans, or eggs.
* history of head trauma
* family history of major psychiatric illness
* body mass index \> 30 kg/m2
* claustrophobia
* prior exposure to IAPS pictures
* pregnancy
* permanent metal objects anywhere in the body
* a personal/family history of any porphyria
PS-341 and Doxorubicin in Treating Patients With Advanced Solid Tumors

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of combining PS-341 and doxorubicin in treating patients who have advanced solid tumors.

OBJECTIVES:

* Determine the maximum tolerated dose of PS-341 in combination with doxorubicin in patients with advanced solid tumors.
* Determine the qualitative and quantitative toxic effects of this regimen in these patients.
* Determine the antitumor activity of this regimen in these patients.

OUTLINE: This is a dose-escalation study of PS-341.

Patients receive PS-341 IV over 3-5 seconds on days 1, 4, 8, and 11; and doxorubicin IV on over 3-5 minutes on days 1 and 8. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of PS-341 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

PROJECTED ACCRUAL: A total of 3-31 patients will be accrued for this study within 1 year.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed advanced solid tumor for which no curative treatment exists
* Measurable or evaluable disease
* No brain metastases or primary brain tumors

PATIENT CHARACTERISTICS:

Age:

* Over 18

Performance status:

* ECOG 0-2

Life expectancy:

* Not specified

Hematopoietic:

* Absolute neutrophil count greater than 1,500/mm\^3
* Platelet count greater than 100,000/mm\^3

Hepatic:

* Bilirubin normal

Renal:

* Creatinine no greater than 1.5 mg/dL OR
* Creatinine clearance at least 60 mL/min

Cardiovascular:

* MUGA at least 45%

Other:

* No serious active infection
* No pre-existing neuropathy grade 2 or greater
* No other concurrent illness that would preclude study participation
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* At least 4 weeks since prior chemotherapy
* No prior cumulative dose of doxorubicin exceeding 280 mg/m\^2

Endocrine therapy:

* Not specified

Radiotherapy:

* At least 4 weeks since prior radiotherapy

Surgery:

* Not specified

Other:

* No other concurrent investigational or commercial agents for treatment of this malignancy
Study of Carotid Occlusion and Neurocognition

To determine the relationship between cognitive functioning and blood flow in the brain among patients randomized to either extracranial-intracranial (EC-IC) bypass or medical therapy alone in the Carotid Occlusion Surgery Study (COSS).

The Carotid Occlusion Surgery Study (COSS) evaluates whether a surgical operation, EC-IC bypass surgery, can reduce the chance of a stroke in someone who has complete blockage in one main artery in the neck that supplies blood to the brain (the carotid artery). The operation bypasses the blockage so more blood can flow to the brain. Only people with decreased blood flow to the brain, as demonstrated on a PET (positron emission tomographic) scan, are randomized into the COSS study. Among patients randomized into the COSS study, RECON will evaluate whether restoring the blood flow to the brain (with EC-IC bypass surgery) will also improve mental functioning. Participants in both the surgical and medical groups of the COSS study will participate in the RECON study. By comparing the mental functioning of the participants in both treatment groups over the course of 2 years, the investigators hope to determine whether the EC-IC bypass operation also helps improve or maintain mental functioning.

Eligibility Criteria:
Inclusion Criteria:

* Enrollment into Carotid Occlusion Surgery Study

Exclusion Criteria:

* Prior diagnosis of dementia
A Study to Evaluate the Relative Bioavailability and Tolerability of Bimekizumab in Healthy Subjects

The purpose of the study to determine the relative bioavailability of bimekizumab in healthy subjects


Eligibility Criteria:
Inclusion Criteria:

* Subject is male or female aged ≥18 years and ≤65 years at the Screening Visit
* Female subjects of child bearing potential must have a negative serum pregnancy test at the Screening Visit, which is confirmed to be negative by urine testing prior to the first dose of the Investigational Medicinal Product (IMP). Female subjects of childbearing potential must agree to use a highly effective method of birth control during the study and for a period of 20 weeks after their last dose of the IMP
* Subject must be in good health (physically and mentally) as determined by the Investigator on the basis of medical history (any chronic and acute illness), physical examination, vital signs, 12-lead ECG, and laboratory screening tests during the Screening Period
* Subject has a body weight of 45 to 90 kg (inclusive) and body mass index (BMI) between 19 and 28 kg/m\^2 (inclusive)

Exclusion Criteria:

* Female subject who is pregnant, or plans to become pregnant during the study, or lactating, or sexually active with childbearing potential who is not using a medically accepted birth control method. Male subjects who are planning a partner pregnancy during the study
* Subjects receiving any live (includes attenuated) vaccination within the 8 weeks prior to Baseline (eg, inactivated influenza and pneumococcal vaccines are allowed but nasal influenza vaccination is not permitted). Live vaccines are not allowed during the study or for 20 weeks after the last dose of study drug
* Subject has received any investigational drug or experimental procedure within 90 days or 5 half-lives, whichever is longer, prior to IMP administration
* Subject has a known hypersensitivity to any components of the IMP as stated in this protocol
* Subject has a current or past history of gastrointestinal ulceration or other gastrointestinal disease
* Subject has cardiovascular or cerebrovascular disease, including hypertension, angina, ischemic heart disease, transient ischemic attacks, stroke, peripheral arterial disease sufficient to cause symptoms, and/or requires therapy to maintain stable status
* Subject has an active infection (eg, sepsis, pneumonia, abscess) or has had a serious infection (resulting in hospitalization or requiring parenteral antibiotic treatment) within 6 weeks prior to IMP administration
* Study participant has a history of a positive tuberculosis (TB) test or evidence of possible TB or latent TB infection at the Screening Visit
* Subject has concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection
* Subject has 12-lead ECG with changes considered to be clinically significant at Screening Visit and Day -1
* Subject has active neoplastic disease or history of neoplastic disease within 5 years of Screening Visit (except for basal or squamous cell carcinoma of the skin or carcinoma in situ that has been definitively treated with standard of care)
The Efficacy of Amino Acid Supplementation in Treating Environmental Enteric Dysfunction Among Children At Risk of Malnutrition

A randomised controlled open label clinical trial to determine whether addition of indispensable amino acids (IAA) to standard complementary food will reduce occurrence of Environmental Enteric Dysfunction (EED) compared with provision of standard complementary food without IAA in healthy Malawian children aged 18-36 months with or without stunting.


Eligibility Criteria:
Inclusion Criteria:

* All children identified from the Mangochi DSS whose guardian/parent desires screening will be eligible for screening. This will first include age, weight, length, and MUAC assessment. If a participant meets age and anthropometric criteria, they will be invited to undergo full inclusion/exclusion criteria assessment, consent, and randomization.

In order to be eligible to participate in the study, an individual must meet all of the following criteria:

1. 18-36 months old (now agreed to by all countries)
2. Stunted (LAZ\&lt;-2)
3. Of either sex
4. Able and willing to undergo HIV testing
5. Parent, carer, or guardian able and willing to give written, informed consent
6. A positive HIV test result will not be an exclusion criterion.

Exclusion Criteria:

* An individual who meets any of the following criteria will be excluded from participation in this study:

  1. Under 18 months of age
  2. Over 36 months old
  3. Wasted (weight-for-length Z-score less than -2)
  4. Overweight (weight-for-length Z-score greater than 2)
  5. Have had diarrhea (by self-report) in the preceding month
  6. Sibling or twin of another participating study child (2 children of different families in the same household are both eligible)
  7. Have any underlying condition other than HIV, which in the opinion of the investigator would put the subject at undue risk of failing study completion or would interfere with analysis of study results
The Effect of Therapeutic Touch on Pain and Comfort After Cesarean Section

This study was conducted as randomized controlled study to evaluate the effect of Therapeutic Touch on acute pain and comfort level in women who delivered by cesarean section. Personal information form was used as data collection form, VAS was used to assess pain, and PPCQ was used to assess comfort. When power analysis was performed, the sample size was calculated to be at least 45 participants for each group (45 experiments, 45 controls). Experimental group received deep Therapeutic Touch by investigators two time at 10th and 40nd hours after cesarean section.

Cesarean section rate is increasing in the world and in our country, and it might bring other problems with it. Pain, breastfeeding problems and decrease in comfort problems have high chance to happen after cesarean section. The insufficiency of pharmacological methods in reducing the problems experienced after cesarean section and having many side effects increase the using percentage tendency to non-pharmacological methods.

This study was conducted as randomized controlled study to evaluate the effect of Therapeutic Touch on acute pain and comfort level in women who delivered by cesarean section. Personal information form was used as data collection form, VAS was used to assess pain, and PPCQ was used to assess comfort. When power analysis was performed, the sample size was calculated to be at least 45 participants for each group (45 experiments, 45 controls). Experimental group received deep Therapeutic Touch by investigators two time at 10th and 40nd hours after cesarean section.

Eligibility Criteria:
Inclusion Criteria:

* • Those between the ages of 18 and 45

  * Multiparous women
  * At the 8th postoperative hour
  * Women who have not developed any complications during pregnancy, birth and postpartum for themselves or their newborns.
  * Having a single, healthy newborn at term,
  * Does not react negatively to any attempt to touch,
  * Able to speak and communicate in Turkish
  * Agreeing to participate in the study

Exclusion Criteria:

* Those with any problems diagnosed before or at birth (such as oligohydramnios, preeclampsia, heart disease, diabetes, placenta previa)
* Those who develop any complications related to mother and baby in the postpartum period (bleeding, hypertension, babies taken to the neonatal intensive care unit, etc.).
* Those who receive different analgesics other than routine post-operative analgesics (75 mg diclofenac sodium in the first 30 minutes post-op).
Effects of Balance Training Exercises on Mobility in Open and Closed Environment in Children With Visual Impairments.

Visual impairment is used to describe any kind of vision loss, whether it's someone who cannot see at all or someone who has partial vision loss. Visual impairment is classified on the basis of visual acuity like mild, moderate, severe, profound, near total visual impairment, no light perception (NLP). Balance is defined as the ability to maintain one's equilibrium as the center of gravity when the COG shifts called (dynamic balance), as in walking and running, and while the center of gravity remains stationary (static balance). Mobility is the ability of a patient to change and control their body position. Physical mobility requires sufficient muscle strength and energy, along with adequate skeletal stability, joint function, and neuromuscular synchronization. This will be a randomized controlled trial. Approval will be gained from the Ethical committee of the Riphah international university Lahore, Pakistan prior to the commencement of study. Written informed consent will be taken from all the patients and all information and data will be confidential. Subjects will be informed that there is no risk of study and they will be free to withdraw any time during process of study. 24 patients will be divided into two Groups. Group A will be the Control Group that will be given the baseline treatment of static balance training (static exercises like standing on balance board, bounce on one foot, heel rises/toe rises, standing on one foot, jumping on trampoline) and Group B will be the Experimental Group that will be provided with baseline treatment along with dynamic balance training (cross, side and tandem walking, step up and down, jumping and hopping on floor). Exercises will be given the 40 minutes with 2 sessions per week over the period of 8 weeks. Pre and Post treatment values will be evaluated. The tools used will be Time Up and Go Test, GMFM-88, Wee FIM. Data will be analyzed using SPSS 22.0 and mean and standard deviation will be calculated.


Eligibility Criteria:
Inclusion Criteria:

* Both gender
* 08-14 Age
* Visual acuity is 20/70 with possible correction
* All participants are label with legally blind by an ophthalmologist.
* Able to follow the commands

Exclusion Criteria:

* Those who were unable to complete follow-up tests.
* No other neurological or orthopedic problems that could affect balance, and who could understand the instructions during the implementation of the exercises and tests.
Circular RNA and Chemerin in Breast Cancer Patient

This study aimed to evaluate the role of serum chemerin as a biomarker of breast cancer.

and To investigate the diagnostic value of hsa_circ_0001785 (Circ-ELP3) and hsa_circ_100219 (Circ-FAF1) in serum samples of breast cancer patients to find out whether these circRNAs can utilize as a diagnostic and prognostic biomarker for human breast cancer assessment and make Correlation between serum chemerin levels , serum Circ-FAF1 , serum CircELP3 and classical tumor markers (CEA + CA15-3).

andTo elucidate if there is a difference between metastatic and non-metastatic cases as regard serum chemerin levels, serum Circ-FAF1 or Circ-ELP3.

Breast cancer is the most common cancer among women and despite advances in therapy over the past few decades, drug resistance, recurrence, metastasis and the heterogeneity of the cancer continue to be a problem in successful management of the diseases(Hong et al ,2019) .

Circular RNAs (CircRNAs) are single-stranded, covalently closed RNA molecules that are ubiquitous across species ranging from viruses to mammals(Zhou et al 3 .,2020). circRNAs can be divided into two categories including coding and noncoding circRNAs(Li et al., 2019) A new subtype of RNAs is circular RNAs, single-strand RNA molecules with less than 100 to more than 4,000 nucleotides (Lu et al., 2016) and a covalently closedloop structure. These molecules are produced through a backsplicing mechanism, in which the downstream 5'-end of the splice donor joins the upstream 3'-end splice acceptor and forms a product with a circular structure (wang et al., 2017).

Chemerin is a leukocyte chemoattractant widely expressed in many tissues and is known to recruit innate leukocytes.

Recently, more and more studies focus on the relationship between chemerin and cancers and found that chemerin acts an essential role in cancers.(Shin et al,2018) Chemerin expression is different depending on the tumor type (Zhang Y et al, 2013) the clinical significance of chemerin in breast cancer has been only reported by a very limited number of studies (EL Sagheer et al,2018).

Eligibility Criteria:
Inclusion Criteria:

* histopathological diagnosis of breast cancer

Exclusion Criteria:

* history of other types of cancers
* history of HIV
* history of any therapeutic interventions in form of chemo or hormonal therapy before specimen collection