cyrilzakka/clinical-trials huggingface dataset:
Intrabone Infusion of Cord Blood in Adults With Hematological Malignancies

The purpose of this study is to evaluate the engraftment of donor hemopoiesis (proportion of transplanted patients with successful engraftment at day +42) in adult patients affected by high risk hematological malignancies after intrabone infusion of cord blood.

For many hematological malignancies, hemopoietic stem cell (HSC) transplant is the only possible treatment. The source of HSC is often bone marrow (BM) or, in the past 10 years, peripheral blood cell (PBSC) mobilized by granulocyte growth factor. Transplant needs a HLA compatible (related or unrelated) donor. Around 10-30% of patients with indication for allogeneic HSC transplant are not able to undergo the procedure because of the lack of a HLA compatible donor. Cord blood (CB) cells represent another possible source, which needs a lower degree of HLA compatibility, this type of transplant, however, offers a lower number of HSC. For this reason, adult patients, until now, could not use this source, because of the not suitable number of cell per kg, of recipient body weight. Recently, in experimental animal models it was observed that intrabone HSC transplant allows, in the recipient, engraftment of donor hemopoiesis by using a 1Log (10-1) lower number of cells compared to the intravenous way (Yahata 2003, Castello 2004). Safety and feasibility of intrabone infusion was verified by two clinical studies on humans: the first was conducted by Ringden O. et al. in 18 patients without any evidence of collateral effects and with complete engraftment of donor hemopoiesis with BM as a source of HSC (Hagglund 1998); the second one was conducted by Frassoni et al. (Frassoni 2008) with CB as the source of HSC.

The aim of this study is to evaluate the intrabone infusion instead of the intravenous one, for the HSC transplant from CB in patients with haematological malignancies when it is not possible to find a HLA matched donor.

We will perform:

* evaluation of the engraftment kinetics;
* evaluation of the chimerism degree at 30, 60, 100 days, 6 months and 1 year after transplant;
* studies on immunological reconstitution and the role of the NK compartment.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 65 years.
* Patients affected by hematological malignancies without a HLA identical sibling donor or unrelated donor.
* Informed consent.

Exclusion Criteria:

* Patients with ECOG \< 2.
* Patients with blood creatine \> 2 mg/dl or with transaminase or cholestase index \> 5 times compared to normality upper limits.
* Patients with Cardiac Fraction Ejection \< 40%.
* Patients with DLCO \< 60% or Diffusing Lung Capacity of carbon monoxide attesting a severe pulmonary insufficiency.
* Patients with peripheral blast cell count over 10%.
* Second neoplasia diagnosed no more than 2 years before.
* Patients with active or suspected infection by fungi for which a therapeutic treatment is ongoing.
* HIV positive patients.
* HCV-RNA and HBV-RNA positive patients (it is possible to enrol them after discussion with the Principal Investigator).
* Pregnant or lactating women.
* Severe mental diseases.
Changes in Pulpal Blood Flow of Teeth During Leveling and Alignment Stages of Orthodontic Treatment Using Clear Aligners

The aims of this study were to: -

* Evaluate PBF in upper and lower teeth during orthodontic alignment using fixed appliances (0.014" super elastic NiTi arch wire) at different time intervals (20min, 48h, 72h and 1 month) of initial arch wire placement.
* Evaluate the PBF in upper and lower teeth during orthodontic teeth alignment using clear aligners at different time intervals (20min ,48h, 72h and 1 month) of fitting the second aligner (first active aligner).
* Compare the PBF changes between the above two different types of orthodontic appliances (fixed appliances and the clear aligners).

Aims: to evaluate the pulpal blood flow (PBF) during orthodontic teeth alignment and leveling using clear aligners (second aligner) and fixed orthodontic appliance at different time intervals of orthodontic force application.

Materials and Methods: A total of 45 subjects were subdivided in two groups: group 1: 25 subjects treated with pre-adjusted edgewise fixed appliance with 0.014 inch NiTi as the alignment arch wire and group 2: 20 subjects treated using clear aligner. In both groups, PBF was measured for the upper right and the lower left using Laser Doppler Flowmetry at different time interval (20 minutes, 48 hours, 72 hours, 1 month) after the fitting of the arch wire in group one and after the delivery of the second aligner in group two.

Eligibility Criteria:
Inclusion Criteria:

* Both male and female subjects
* 16 or more years old
* Class I skeletal malocclusion
* mild upper and lower arches crowding. Exclusion Criteria:-
* Poor oral hygiene
* Previous orthodontic treatment
* Active periodontal disease
* Missing teeth
* Deep carious teeth
* Teeth with root resorption
* Endodontically treated teeth
* History of previous trauma
* Restoration on measured teeth
* Medical conditions affecting blood vessels
* Smoking
Reliability and Versatility of Supraclavicular Artery Flap in Reconstruction of Head and Neck Soft Tissue Defects

This is a case series study conducted at plastic surgery department Sohag University including 20 patients The aim of this thesis is to evaluate reliability and versatility of Supraclavicular artery flap in the reconstruction of traumatic and non-traumatic defects of head and neck.With adequate documentation of functional, aesthetic outcome and patient satisfaction through; clinical examination , photographic documentation and doctor and patient satisfaction charts


Eligibility Criteria:
Inclusion Criteria:

* Patients with head and neck soft tissue defect either traumatic or non-traumatic
* Available healthy donor site

Exclusion Criteria:

* Trauma or conditions affecting donor site or with possible compromise of vascular pedicle.
* Patients with a major uncontrollable medical illness, chronic heavy smokers.
Markers of Pubertal Suppression During Therapy for Precocious Puberty

The best way to measure whether treatment of children with central precocious puberty is working is to do a hormone stimulation test (leuprolide stimulation test) that requires injection of a medication and multiple blood draws to see if the hormonal response is suppressed (blocked). The hypothesis of this study is that random measurement of the free alpha subunit of pituitary glycoprotein, a protein related to the pituitary hormones that stimulate puberty, will provide an adequate alternative to the leuprolide stimulation testfor monitoring efficacy of pubertal suppression with Supprelin LA®.

During clinical trials of Supprelin LA®, leuprolide stimulation tests were performed to determine adequacy of suppression. However, the use of this stimulation test to monitor suppression requires an expensive medication and collection of multiple blood samples. Alternative methods of monitoring pubertal suppression during gonadotropin releasing hormone receptor agonist (GnRHa) therapy have included both random and trough levels of Luteinizing Hormone (LH), estradiol or inhibin B. Recently, the free alpha subunit of pituitary glycoprotein (FASPG) has also been shown to be a potentially useful marker of hormonal suppression (Hirsch HJ, et al, JCEM 95:2841, 2010) as it undergoes a paradoxical rise following initiation of therapy, and reverts to baseline upon completion.

In this investigator-initiated pilot study we will evaluate novel markers of pubertal suppression in children receiving standard of care gonadotropin releasing hormone receptor agonist therapy for the treatment of central precocious puberty. Children with central precocious puberty who have selected treatment with Supprelin LA will undergo hormonal testing of markers of pubertal activity before and after placement of the Supprelin LA insert.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Age: 3 to 9 years old, inclusive
* Diagnosis of Central Precocious or Rapidly Progressive Puberty
* Bone Age more than 1 year advanced (obtained within 6 months of screening) AND
* Breasts Tanner II or greater AND
* One of the following:
* Random LH \> 1 mIU/mL
* Leuprolide-stimulated LH \> 4 mIU/mL
* Random estradiol \> 20 pg/mL
* Leuprolide-stimulated 24 hour estradiol \>20 pg/mL
* Naïve to GnRHa therapy
* Approved to receive Supprelin LA® therapy
* Have an acceptable surrogate capable of giving consent on the subject's behalf.

Exclusion Criteria:

* Previous GnRHa therapy
* Presence of peripheral precocious puberty including CAH
A Relative Bioavailability and Food Effect Study of HDM1002 in Healthy Subjects

The main purpose of this study is to evaluate the effect of formulation on relative bioavailability of HDM1002, and the food effect on pharmacokinetics of HDM1002.


Eligibility Criteria:
Inclusion Criteria:

1. According to the medical history, clinical laboratory test results, vital sign measurements, 12 lead ECG results, and physical examination results during the screening period, the investigator considers the subject to be in good general health.
2. Age range of 18-45 years old (including range), no limit to gender.
3. Male subject weighed ≥50.0 kg, female subject weighed ≥45.0 kg, and a body mass index (BMI) within the range of 19.0 - 30.0 kg/m2 (including cut-off values).
4. Female subject of childbearing potentiaafter last dose, who have no childbearing plans and agrl during signature ICF to 30 days after last dose and male subject during signature ICF to 90 days ee to use highly effective contraception and consent not to donate sperm and oocyte during this period.

Exclusion Criteria:

1. Subject has a history or family history of medullary thyroid cancer, thyroid C-cell hyperplasia, or multiple endocrine neoplasia type 2 (MEN2), or calcitonin≥50 ng/L during the screening period.
2. History of chronic pancreatitis or an episode of acute pancreatitis within 3 months prior to screening.
3. History of acute cholecystitis attack within 3 months prior to screening.
4. Subject judged by investigator has dysphagia, diseases or conditions that affect gastric emptying, or affect the absorption of gastrointestinal nutrients, such as bariatric surgery or other gastrectomy, irritable bowel syndrome, dyspepsia, etc.
5. History of previous surgery that will affect the absorption, distribution, metabolism, and excretion of drugs or plan to undergo surgery during the study period.
6. During screening period, any abnormalities in physical examination, electrocardiogram, laboratory tests, and vital signs which are of clinically significant .
7. Taken or planned to take any drug that effect liver enzyme or transporter activity within 28 days prior to taking the investigational drug.
8. History of clinically significant cardiovascular and cerebrovascular disease within 6 months prior to screening or at the time of admission.
9. Presence of clinically significant ECG results judged by the investigator at screening.
CoolCap Followup Study-Coordination of Participating Centers

This observational study will assess long-term functional outcome of survivors from neonatal encephalopathy who were previously treated with either head cooling or with conventional care in a randomized clinical trial. Children's parents will be interviewed by phone by trained staff using the WeeFIM questionnaire to ascertain the childrens' functional performance on a set of skills basic to daily life. This instrument is able to assess a very wide range of abilities, from independently functioning to needing total assistance. The ratings will be used to examine the relationship between the outcome previously measured at 18 months age and functional outcome at school age and to triage the children into those who clearly could not be tested on standardized exams of cognitive functioning, those who potentially could, even if at a low level of cognitive ability, and those who appear to be functioning at an age-appropriate level.

Previous studies have demonstrated that hypothermia for hypoxic-ischemic encephalopathy in the neonatal period is generally safe and feasible, and can improve intermediate term survival without handicap. There is, however, no information on whether cooling improves longer term (school-age) outcomes in non-handicapped survivors. The current observational trial is designed to help obtain additional followup information on children who participated in the initial randomized clinical trial of head-cooling for neonatal encephalopathy. A first step is to collect information on the current status (at 7-8 years of age) of participants in the original study using a standardized telephone questionnaire. This will allow the investigators to more appropriately target children for whom further, more detailed, in-person neurodevelopmental testing would be appropriate. Given limited resources, identification of children for whom such testing would be helpful and instructive is a necessary goal.

Eligibility Criteria:
Inclusion Criteria:

* Previous participation in the CoolCap study
* Survivors to 7-8 years of age
* Parental consent to participation

Exclusion Criteria:

* Lack of parental consent
The Effect of Mindfulness Compassionate Living Practice on Hemodialysis Patients

There are studies evaluating the effects of mindfulness-based practices on individuals receiving HD treatment. No studies have been found on how Mindfulness Compassionate Life application reduces stress, increases self-efficacy and quality of life in individuals receiving HD treatment. Considering the stress situations experienced by individuals receiving HD treatment, it is thought that the evidence-based effect of Mindfulness Compassionate Living application on individuals\&#39; stress, self-efficacy and quality of life is important.

The population of the research will consist of 90 Hemodialysis patients who were treated in Bingöl State Hospital Dialysis Unit during the specified date range. Sample size of the research; Calculated using the GPower computer program. With the power analysis, it was calculated that at the α = 0.05 level, the effect size would be strong 150, 153 (d = 0.8) and the power of the study would be 90%, and that at least 68 patients should be included in the sample. Patients who meet the research criteria and agree to participate in the research will be randomly assigned to one experimental and one control group.

Introductory information form prepared by the researcher in line with the literature and containing the socio-demographic data of hemodialysis patients, Perceived Stress Scale (PSS) to evaluate stress, Self-Efficacy-Efficacy Scale (SEES) to evaluate self-efficacy, SF-12 Quality of Life Scale to evaluate quality of life. , Self-Compassion Scale Short Form (PSS-K) will be used to evaluate self-compassion, and Conscious Mindfulness Scale (BIPS) will be used to evaluate conscious mindfulness.

Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed with chronic renal failure
* Being over 18 years of age,
* Being willing to participate in the study
* Being open to communication and collaboration

Exclusion Criteria:

* Having a diagnosis of acute renal failure,
* Having a current hospital stay,
* Lack of openness to communication and collaboration,
A Prospective Clinical Outcomes Registry

This is a prospective non-interventional 24 month post implant registry. Any patient that receives a St. Jude Medical FDA approved implantable neuromodulation system is eligible for enrollment. A minimum of 600 patients will be enrolled from a minimum of 30 sites.

Patients will be enrolled post-implant and followed for 24 months. Data are collected at enrollment (within 30 days of device implant), and routine care follow-up visits at 3 months, 6 months, 12 months, 18 months and 24 months.


Eligibility Criteria:
Inclusion Criteria:

1. Patient has signed and received a copy of the Informed Consent form;
2. Patient has been implanted with a St. Jude Medical Neuromodulation system, including battery and/or SCS leads;
3. Patient is 18 years of age or older.
4. Patient is not currently participating in another clinical trial.

Exclusion Criteria:

* None
Repeat Dose Nasal Allergen Challenge

What happens in the nose during an allergic reaction? Are there changes that a new drug could treat? What is the best way to test new drugs?The response of the nose to being exposed to cat allergen in someone who is allergic to cats. Symptoms, level of nasal blockage and cell and chemical changes that occur in the nose will be studied before and after being exposed to cat allergen. The investigators will also to see if giving repeated doses of allergen increases the response.Allergic rhinitis is a very common illness. There are over 500 million patients worldwide. It can increase the severity of associated asthma. Currently available drugs do not completely treat the symptoms. New treatments need to be found. A way of testing these drugs is very important. This study will investigate causes of the symptoms that occur in allergic rhinitis. It will also validate a proposed model to test new drugs. the Study Hypothesis is that a model of nasal allergen challenge shows an increased response (priming) with repeat challenges as determined by changes in nasal peak inspiratory flow.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female subjects aged over 18 able to understand and sign the written consent form.
2. Able to comply with study procedures and protocol.
3. Positive skin prick test (wheal difference ≥ 3mm compared to negative control) to cat at or within 12 months preceding the screening visit.
4. Clear history of nasal symptoms on exposure to cats.
5. Otherwise healthy with no other health problems, other than mild asthma controlled by intermittent β2-agonist use, that may prevent the subject participating in the study.

Exclusion Criteria:

1. Presence of perennial rhinitis or seasonal allergic rhinitis.
2. TNSS \< 2 at screening
3. Viral URTI within the 2 weeks prior to screening.
4. Current smoker or history of smoking within the previous 3 months.
5. Presence of any structural nasal abnormalities or nasal polyps on examination, a history of frequent nose bleeding, nasal surgery within the previous 3 months.
6. Use of concomitant medication that could affect responses to nasal challenge (e.g. corticosteroids, decongestants, anti-histamines) or any other nasally applied medication within 2 weeks prior to screening.
7. Participation in any other clinical trials within the previous 3 months.
8. Use of inhaled corticosteroids within the 2 months prior to screening.
Evaluation of a Program to Improve the Life Quality of Elderly

Older people belong to an age group that has been increasing in recent decades, leading to a progressive ageing of the population. With the aim of reducing the generational digital divide, the use of technology in retirement homes was proposed. To this end, virtual reality glasses were used to allow the visualization of an external virtual world and, subsequently, it was evaluated whether their application improved the quality of life of the elderly by reducing the difficulties they have in participating in recreational activities outside these centers. A prospective quasi-experimental longitudinal study was carried out in the centers belonging to the basic health area of Valls, with a study period from May 2023 to March 2024. Quality of life was measured using the ad hoc "Escala de Calidad de Vida Rivas-Bordas".


Eligibility Criteria:
Inclusion Criteria:

* Age 65 or older.
* Resident of a geriatric home in the Valls area.
* Individuals with slight, moderate, fair, or total impairment of social resources, as assessed by the Duke University Center (1978) Social Resources Scale (OARS).

Exclusion Criteria:

* Individuals with a history of frequent migraines or motion sickness.
* Individuals with moderate or severe cognitive impairment (≥ 5 errors on the Abbreviated Pfeiffer test).
* Inability to communicate in Spanish and/or Catalan.
* Individuals with advanced visual and/or hearing impairments.
Efficacy of Tranexamic Acid in Reducing Myomectomy Associated Blood Loss in Federal Teaching Hospital Abakaliki.

to determine safety and efficacy of Tranexamic Acid in reducing blood loss during Myomectomy in our institution.

A double blinded randomized controlled trial in which cases were given 1000mg intravenous tranexamic acid into 1L of intravenous normal saline and control were given 10mls of placebo water for injection into same amount of intravenous fluid. outcome of both groups in terms of intraoperative blood loss, duration of surgery, postoperative packed cell volume and total blood loss with risk of blood transfusion were then determined.

Eligibility Criteria:
Inclusion Criteria:

* non-pregnant women with symptomatic myomas women with no known contraindication to tranexamic acid

Exclusion Criteria:

* past history of thromboembolic disorder, ischaemic heart disease, malignancy or liver disease
Assessment of Efficacy and Safety of Tegaserod Treatment and Placebo in Women With Dyspepsia

This study is being done to evaluate the safety, tolerability and satisfactory relief of dyspepsia symptoms in females excluding those with predominant stomach pain. Tegaserod will be evaluated at 6mg twice daily and placebo.


Eligibility Criteria:
Inclusion Criteria:

* Female, 18 years or older
* Self-reported presence of persistent or recurrent adverse digestive symptoms consistent with dyspepsia for at least 12 weeks, not necessarily consecutive, during the previous 12 months.

Exclusion Criteria:

* Abnormal upper GI endoscopy findings such as esophageal, gastric erosions or ulcers and/or duodenal ulcers/erosions.
* Any of the following symptoms: heartburn, epigastric pain, nausea or vomiting.

Other protocol-defined inclusion/exclusion criteria may appl
COVID-19-Study of Immune Responses Following Vaccination Against SARS-CoV-2

T-cell adaptive immunity is known to be required to sustain a long term immunoglobulin production and a long term memory against several infections. Previous results suggest a lack in the generation of T-cell responses against CoV-N, M and S proteins among cancer patients exposed to SARS-CoV-2 virus highlighting that cancer patients failed to mount a protective T-cell immunity. Given this context, our hypothesis is that COVID-19 vaccine candidates are not immunogenic in some cancer patients. Thus, the monitoring of CD4 and CD8 T-cell responses before and after vaccination might provide information related to the correlation between induction of CD4 T-cells (including helper follicular T-cells) by the vaccine and long-term IgG production (serological index). Additionally, the failure of COVID-19 vaccines in some patients should be monitor carefully in order to provide specific recommendations to avoid COVID-19 infections. The main objective is to assess humoral immune responses following COVID-19 vaccination in a population of cancer patients.


Eligibility Criteria:
\*Inclusion Criteria:

* Male or female patients
* Age ≥ 18 years
* Not having developed a symptomatic form of COVID-19 within the last 3 months before inclusion
* Eligible to the vaccination against SARS-CoV-2
* Affiliation to French social security or receiving such a regime,
* Signed informed consent
* Ability to comply with the study protocol, in the Investigator's judgment

Cancer patients

* Patients under active anticancer treatment: in adjuvant or neoadjuvant setting or in first line of treatment in metastatic setting. Except for prostate cancer (until metastatic castration-resistant prostate cancer); and breast cancer hormonal receptor positive/HER2 negative (until apparition of hormonal resistance).
* Patients in follow-up (active treatment \< 3 months).

Elderly:

Age ≥ 70 years old

Healthy person:

Age ≥ 18 years old and \< 70 years old

\*Exclusion Criteria:

* Patient under guardianship, guardianship or under the protection of justice
* Receipt of a live, attenuated vaccine within 4 weeks prior to the initiation of treatment or anticipation that such a live, attenuated vaccine will be required during the study.