cyrilzakka/clinical-trials huggingface dataset:
A Pilot Study Investigating the Effects of Acetyl-L-Carnitine and Vincristine-Induced Neuropathy in Pediatric Patients With ALL

The purpose of this study is to see if a drug called Acetyl-L-Carnitine can help prevent painful nerve damage and nerve pain which is caused by vincristine, a drug used in chemotherapy in children being treated for newly diagnosed ALL. Acetyl-L-Carnitine is a drug available for purchase as a nutritional supplement but for the purpose of this study is experimental.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must meet the following inclusion criteria.

  * The subject must have a confirmed diagnosis of acute lymphoblastic leukemia within 1 week of starting therapy
  * Currently being treated on a standard ALL induction regimen
  * Subjects must be greater than or equal to 5 and less than 18 years old
  * Signed informed consent

Exclusion Criteria:

* Subjects will be excluded for the following:

  * Preexisting neurologic disease, including grade II, III, or IV neurological status by NCI Common Toxicity Criteria v3.0 on clinical exam
  * History of hypersensitivity to vincristine
  * History of hypersensitivity to Acetyl-L-carnitine
  * Previous use of Acetyl-L-carnitine
  * Concurrent anti-convulsant use
  * Concurrent Gabapentin use
  * Concurrent Glutamine use
  * Liver Function: Total bilirubin greater than 1.3 mg/dL and serum glutamic-pyruvic transaminase (SGPT) (ALT) greater than 5 x upper limit of normal for age and serum albumin less than 2 g/dL
  * Patients who are pregnant
PSYCHE (Personalised Monitoring SYstems for Care in Mental Health)

For the moment, the detection of a mood episode in Bipolar Disorder (BD) relies on the appearance of the first clinical signs that the clinician detect or that the patient becomes aware of and reports to the clinician. Since physiological parameters such as cardiac rhythms, respiratory rate, voice characteristics and actigraphy seem to be related to the onset of a mood episode, information collected through the combined monitoring of multiple selected physiological parameters (such as cardiac rhythms, respiratory rate, movements, voice) during wake and sleep time, using wearable user friendly systems included into garments as well as with a smartphone, may offer a new perspective in the long-term treatment of BD.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female individuals aged from 18 to 65 years old (both ages included).
2. Participants meeting DSM-IV-TR criteria for bipolar disorder I or II subtypes or Participants meeting DSM-IV-TR criteria for rapid cycling BD, which is defined by a pattern of presentation accompanied by 4 or more mood episodes in a 12-month period, with a typical course of mania or hypomania followed by depression or vice versa. The episodes must be demarcated by a full or partial remission lasting at least 2 months or by a switch to a mood state of opposite polarity.
3. Female participants must agree to use efficient contraceptive methods during the study duration.
4. Participants must have signed informed consent documents indicating that they understand the purpose and procedures required for the study and are willing to participate in the study and comply with the study procedures and restrictions.
5. Patients must be affiliated with or a beneficiary of a social security system.

Exclusion Criteria:

1. Any clinically relevant acute or chronic diseases which could interfere with the participants' safety during the trial, or expose them to undue risk or which could interfere with the study objective. This last perspective includes :- Attention deficit and hyperactivity disorder (ADHD)- Borderline personality disorder (BPD)
2. Current MDD episode or manic episode, according to the DSM-IV-TR criteria
3. Current major suicidal ideation (suicidal thoughts several times a day)
4. History of recent (less than 1 year preceding inclusion) substance abuse or dependence (tobacco dependence excepted)
5. Pregnant women as determined by the patient or breast-feeding women
6. Any history of significant allergy.
7. No legal capacity or limited legal capacity or unable to give an informed consent.
8. Participants unlikely to co-operate in the study, and/or poor compliance anticipated by the investigator
9. Participants being in the exclusion period according to the French National File for participants participating in a biomedical research.
10. Total annual amount of compensation earned from participating in clinical studies exceeding 4500 Euros.
11. Patients with pacemaker, defibrillator, or any implanted electronic device (to avoid any hazard - see section 7.3.2 of the Psyche device User Manual).
Comparison of a Needle-free Injection Method With a Needle-syringe Injection Method

The purpose of this study is to obtain psychological response and user preference information on the use of the T jet® device versus the traditional subcutaneous injection administration of Tev Tropin®.

This study will compare subject-reported injection anxiety immediately before the administration of each dose of Tev-Tropin® between a needle-syringe injection method and a needle-free injection method (T-jet®)

The primary efficacy endpoint was the difference in mean subject-reported injection anxiety between the two injection methods as recorded on a 5-point FIS immediately before administration. A higher score denoted greater anxiety.

The injection anxiety score was to be reported by the subject from a row of five faces with values ranging from 5 (the face with the most negative affect) to 1 (the face with the most positive affect).

Eligibility Criteria:
Inclusion Criteria:

* Subjects must require a routine Tev-Tropin® dose that does not exceed 2.5 mg in one injection (0.5 mL) using the dosing schedule individualized for each patient by their prescribing physician
* Male, age 7-17 years, with the capability to provide assent, as determined by the investigator and/or parent or legal guardian
* Clinically definite growth hormone deficiency as previously diagnosed by the investigator or other physician
* Subjects must be using Tev-Tropin® prior to enrollment for 28 days
* Informed consent signed by parent(s) or legal custodian of patient prior to study entry and patient assent as determined by the investigator and/or subject's parent or legal custodian

Exclusion Criteria:

* More than one subcutaneous injection per Tev-Tropin® dose
* Female gender
* Use of any other needle-free injection device at any time
* Current use of another human growth hormone product other than Tev-Tropin®
* Concurrent treatment with other routine injectable medications
* History of benign intracranial hypertension
* Significant communication difficulties, or medical or psychiatric condition, that affects the subject's and/or caregiver's ability to perform the necessary functions to complete the study, or any condition which the investigator in their medical judgment thinks may interfere with participation in the study
* Use of an investigational drug within 30 days prior to randomization
* Contraindications related to routine use of Tev-Tropin® as per investigators' medical judgment (e.g., subjects with closed epiphyses, active proliferative or severe non-proliferative diabetic retinopathy, active malignancy, acute critical illness, or Prader-Willi syndrome who are severely obese or have severe respiratory impairment)
* Current participation in another pharmaceutical or device study
* Previous participation in this study
Effect of a Combination of Local Steroid Injection With Oral Steroid Administration for the Prevention on Esophageal Stricture After Endoscopic Submucosal Dissection for Early Esophageal Neoplasm

The method of esophageal endoscopic submucosal dissection (ESD) to remove superficial esophageal neoplasms has gained widespread acceptance as an alternative to surgery recently these years especially in Asian countries. However, besides of perforation and bleeding, another complication postoperative esophageal stricture is frequently observed after the removal of large-sized esophageal neoplasms by ESD. Dysphagia caused by postoperative stricture substantially decreases the patient's quality of life, requiring further therapy. Although the exact incidence is unknown, esophageal stricture is supposed to be related to the extent of the circumference being resected. In previous study by Ono et al，it is reported that 90% of patients with lesions of circumferential extension of more than three-fourths experienced postoperative stricture after esophageal ESD. There were some reported studies exploring new ways to prevent esophageal stricture after ESD, such as oral prednisolone and local corticosteroid injection. Corticosteroids can inhibit not only collagen synthesis but also enhance collagen breakdown, thereby inhibiting stricture formation. Some studies reveled that just oral prednisolone oral is effective option for the prevention of post-ESD stricture. However, most of the reported studies were non RCTs with small sample. In the primary study, the investigators search a new method of combination of both oral and local injection to prevent esophageal stricture，as a result，stricture at 8 weeks after ESD was found in 19 of 36 patients in the no corticosteroid group but only 4 of 34 in the corticosteroid group. Unfortunately，the study was also retrospective. So, the investigators plan to undertake a prospective, randomized controlled trial to evaluate the prophylactic effects of combination of local steroid injection with oral steroid administration for esophageal stenoses complicating extensive ESD.


Eligibility Criteria:
Inclusion Criteria:

1. Patients who has undergone esophageal ESD
2. Histologically confirmed early squamous cell carcinoma or high grade intraepithelial neoplasia of the esophagus
3. ESD resulted in a mucosal defect involving more than two-thirds of the esophageal circumference.

Exclusion Criteria:

1. Severe circulatory or respiratory disease，severe renal impairment
2. Women in pregnancy and lactation
3. Patients with steroid contraindications
4. Patients refuse to join in this study
Effects of Alcohol History on Effects of Nitrous Oxide - 9

The purpose of this study is to conduct experiments to examine subjective and reinforcing effects of nitrous oxide. Mood altering and psychomotor effects will be tested on non-drug abusers and preference procedures will be used to assess reinforcing effects. Comparisons between nitrous oxide, opiates, and benzodiazepine antagonists will be made. To determine effects of alcohol history on the reinforcing, subjective and psychomotor effects of nitrous oxide in healthy volunteers.


Eligibility Criteria:
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Invasive Infections in Children With Hemoglobinopathies

Patients diagnosed as having hemoglobinopathies are exposed to serious bacterial infections, principally those patients that underwent splenectomy. Since the introduction of anti pneumococcal vaccine the incidence decreased significantly but other bacteria besides encapsulated bacteria takes place as principal cause of invasive infections. The purpose of this study is to analyse in a retrospective study the incidence of those infections in a group of patients suffering from thalassemia and sickle cell anemia treated in our clinic.


Eligibility Criteria:
Inclusion Criteria:

* All patients treated in the Pediatric Hematology Unit.
Non-surgical Treatment of Chronic Periodontitis With an Adjunctive Vitamin E and Coenzyme Q10 Supplementation

Non-surgical treatment of chronic periodontitis with vitamin E and coenzyme Q10 supplementation

This research was structured as a double-blind, randomized clinical trial to assess the effectiveness of CoQ10 and Vitamin E supplements on periodontal health in patients with chronic periodontitis. A total of 120 patients from the Department of Periodontics at Boroujerd Dental School of the Islamic Azad University of Medical Sciences were chosen for the study. Before the commencement of the trial, various clinical periodontal parameters such as plaque index, bleeding on probing, gingival index, probing depth, and clinical attachment level were measured in six different areas of the tooth surface. Subsequently, scaling and root planning were carried out, and oral hygiene practices were enhanced for all participants. The participants were then randomly divided into three groups: Group A received 30 mg of CoQ10, Group B received 400 mg of Vitamin E supplements daily, and Group C did not receive any medication. After two months, the clinical periodontal parameters were reevaluated. Furthermore, to compare the total antioxidant capacity in saliva before and after the administration of these supplements, as well as in patients who did not receive any medication, 2 ml of non-stimulated saliva was collected from each participant at the beginning and end of the study for analysis using UV-spectrophotometric methods. The selection criteria for eligible participants in this study were also clearly defined.

Eligibility Criteria:
Inclusion Criteria:

healthy individuals, between the ages of 28 and 35, there is a presence of chronic initial periodontal disease, now categorized as Stage-I, with a maximum pocket depth of 5 mm, specifically affecting the mandibular molar teeth in every quadrant.

Exclusion Criteria:

Conditions that may affect orthodontic treatments include systemic diseases, ongoing orthodontic treatments, pregnancy and breastfeeding, and the use of medications that can impact the periodontium, such as antibiotics, within the past 6 months. Additionally, recent malignancy, radiotherapy, or chemotherapy within the past 5 years can also have an impact. It is important to consider factors such as plaque index and bleeding scores, which should be below 25%, as well as any history of periodontal surgery at the desired treatment site within the past 6 months. Furthermore, the use of medicinal supplements within the past 6 months and cigarette smoking or tobacco use should also be taken into account.

Eligibility Criteria:

The study population consisted of 80 eligible individuals who were enrolled in this research project, which was specifically designed to conduct Randomized Double-Blind Clinical Trials.
Topical Tranexamic Acid After Intravitreal Injections

We aim to investigate whether topical administration of Tranexamic acid can reduce the occurence of subconjunctival hemorrahge after routine intravitreal injections for retinal conditions.


Eligibility Criteria:
Inclusion Criteria:

Subjects receiving intravitreal injections as part of their routine ophthalmological care

Exclusion Criteria:

Pregnancy, Oral contraceptives/HRT use, Known systemic autoimmune disease, Renal failure, active/suspected infection or inflammation in the treated eye, subconjunctival hemorrahge prior to inclusion, History of subarachnoid hemorrahge, thromboembolic events, increased risk for thromboembolic events, known sensitivity to the study drug
Effect of Texting and Writing on Grip and Pinch Strength

Texting and writing are common hand activities among college students. Students tend to spend increasing hours of texting and writing for every day activities in addition to the academic assignments that are mainly on line and through distance education. The effect of such daily activities on hand grip and key pinch strength has not been studied among college students.

Students will be recruited from physical therapy department of college of medical rehabilitation sciences after satisfying the inclusion and exclusion criteria. Participants will be randomly assigned to one of the four groups (texting 10 minutes, texting 15 minutes, writing 10 minutes and writing 15 minutes). Participants will be blinded to the outcome measures and the evaluator will be blinded to the participants assigned group. Hand grip strength and key pinch strength will be the main outcome measures. Participants demographics will be gathered in addition to recreational status, risk factors, pain body diagram and number of hours spent for texting and writing in every day life.

Eligibility Criteria:
Inclusion Criteria:

* Active college student
* Healthy
* Willing to participate
* Using smart phones\& electronics
* Hand writing for \> 10 minutes/day

Exclusion Criteria:

* Recent upper limbs injury (sprain\& strain)
* Chronic neurological disorder
* Carpal tunnel syndrome
* De Quervain's disease
* Diabetic neuropathy
Examining of Occupational Balance, Executive Functions, and Quality of Life of Adolescents with Internet Gaming Disorder

Internet gaming disorder leads to social problems and isolation, neglect of daily responsibilities, behavioral disorders, and cognitive and physical impairments. It is thought that assessing the occupational profiles and cognitive functions of adolescents with internet gaming disorder will bring a new perspective to the occupational therapy literature. The aim of the present study is to examine the occupational balance, executive functions, and quality of life of adolescents with internet gaming disorder.

The study, planned to be conducted with individuals aged 12-18 who are followed up in the Child and Adolescent Mental Health and Diseases outpatient clinic of Bezmialem Vakif University and diagnosed with internet gaming disorder according to DSM-V diagnostic criteria, will include a total of 62 participants, with 31 in the study group and 31 in the healthy control group. All individuals who provide written consent will be administered the Sociodemographic Data Form, Internet Gaming Disorder Scale, Teenage Executive Function Inventory, Pediatric Quality of Life Inventory-Adolescent Form, and Adolescent Occupational Balance Scale, and the results will be recorded. The obtained results will be statistically analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Internet Gaming Disorder
* Aged between 12 and 18
* Proficiency in Turkish
* Open to communication and cooperation
* Willing to participate in the study
* No reported cognitive impairment

Exclusion Criteria:

* Additional psychiatric diagnosis
* Having a neurological problem that would impair communication and collaboration
C-myc Biomarker Study for Diabetic Foot Ulcers

This is a multi-center observational cohort study of patients with diabetic foot ulcers (DFU) to develop and validate potential tissue-based biomarkers that predict complete wound healing. Eligible and consented participants will begin standard of care treatment after collection of tissue specimens from the wound's edge. An additional tissue specimen is collected at 4 weeks if clinically indicated. Tissues will be tested for c-myc and phosphorylated glucocorticoid receptor (p-GR) levels using validated protocols at a central laboratory. Participants will be followed weekly for up to 12 weeks or until complete wound healing (whichever occurs first). One final assessment 2 weeks after complete wound healing will occur to confirm healing.


Eligibility Criteria:
Inclusion Criteria:

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

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female, aged 18 years or older.
4. Clinically diagnosed with diabetes or meeting the American Diabetes Association (ADA) criteria.
5. Foot ulcer of diabetic etiology, with all of the following characteristics:

   1. Ulcer size \> 0.5 cm2 and \< 12 cm2 at least 2 cm from any other ulcer, and
   2. Ulcer with Wagner grade 1 or 2 In case of multiple ulcers, select the largest ulcer that meets inclusion criteria.
6. Patients with neuropathic or neuro-ischemic ulcers with adequate circulation to allow healing to the affected extremity as demonstrated by at least 2 of the following within 6 months of Visit 1:

   1. Ankle brachial index (ABI) ≥ 0.6 with Doppler Waveforms, or
   2. Absolute ankle pressure ≥ 70 mm Hg, or
   3. Toe pressure ≥ 40 mmHg, or
   4. TcPO2 ≥ 40 mmHg
7. Willingness to comply with standard of care which includes an initial surgical debridement of the wound.

Exclusion Criteria:

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

1. Patient participating in an interventional clinical trial within 1 month of Visit 1
2. Currently receiving radiation to target area or chemotherapy
3. Participants with Charcot's foot or other foot deformities that prevents adequate targeted ulcer offloading
4. Participant with active severe infection or osteomyelitis at the time of screening
5. History of cancer within last 3 years, other than non-melanoma skin cancer
6. Known or suspected malignancy of current study ulcer
7. Use of adjunctive therapy within previous 30 days
8. Currently receiving medication considered to be systemic glucocorticoids
9. Plan to perform a vascular intervention, such as surgical bypass, angioplasty or stenting, or \< 1 month from a prior ipsilateral vascular intervention
10. Any history of concomitant medical condition that, in the opinion of the investigator(s), would compromise the participant's ability to safely complete the study
Clinical Evaluation of Composite-ceramic Implant-supported Posterior Crowns (Cerasmart)

The objectives of the present study are to analyze and to compare the survival rates and possible biological and technical complications arising from the use of composite-ceramic posterior implant-supported crowns with those obtained when using their counterparts prepared using monolithic zirconia restorations. The null hypothesis is that no differences would be found between the parameters studied for each type of restoration.

Eighty patients in need of posterior implant-supported crowns (n=80) were recruited from the Master of Buccofacial Prostheses and Occlusion, Faculty of Odontology, University Complutense of Madrid, Madrid, Spain. Before treatment, all participants were informed of the purpose of the study, the clinical procedures, the material to be used, and the advantages and risks of the restorations. They were asked to give their written informed consent to participate in the study.

Eighty posterior implant-supported crowns were produced and allocated in parallel an randomly to either monolithic zirconia or composite-ceramic restorations by means of a randomization list. A total of 40 implant-supported crowns were placed using monolithic zirconia and 40 composite-ceramic. The clinical procedures were performed by two experienced clinicians. Full-arch impressions were taken using addition silicone. The restorations were cemented using a resin-based cement. The occlusion was adjusted and the surfaces polished after cementing. All restorations were prepared by an experienced technician. The restorations will be examined at one week (baseline), 1, 2, and 3 years by two researchers who were not involved in the restorative treatment. Each assessor evaluated the restoration independently, and the worst assessment will be used in the event of discrepancies.

Eligibility Criteria:
Inclusion Criteria:

* One posterior tooth (molar or premolar) to restore, and with opposing tooth

Exclusion Criteria:

* unacceptable oral hygiene
* bruxism