cyrilzakka/clinical-trials huggingface dataset:
A Pilot Study of the Effects of Isotretinoin on Cognition, Learning and Memory

This prospective study tested the effects of isotretinoin in a cohort of patients receiving standard therapy for acne vulgaris. Subjects completed questionnaires and standardised computer based cognitive testing using CANTAB to test for cognitive effects particularly on learning and memory. Test were conducted before starting isotretinoin, after 3 months and again a month after finishing therapy. This was carried out as a pilot study to

1. Test the hypothesis that oral isotretinoin, over its 4-month treatment time, will result in a decline in learning and memory as measured using the CANTAB series of test.
2. Generate data for sample size calculation for a larger study to determine the changes in memory over time in drug and control group
3. Test of CANTAB, questionnaires and data collection forms
4. Select most appropriate outcome measures
5. Identify therapy sensitive cognitive tasks which would be used in future functional brain imaging studies It was not considered to randomise subjects to placebo.


Eligibility Criteria:
Inclusion Criteria:

1. Adult subjects age 16 and over with acne vulgaris
2. Cases should be candidates for isotretinoin therapy should have severe acne not responding to treatment and at risk of scarring and have discussed the risks, pregnancy prevention program and benefits of this treatment according to normal clinical practise

Exclusion Criteria:

1. Subjects already on treatment with isotretinoin
2. Subjects with below normal intelligence who would not understand the CANTAB psychological tests
3. Subjects with neurological disease e.g. epilepsy or pre-existing mental health problems
4. Pregnant females or females not taking preventive precautions
5. Subjects on sedative or psycho-active medications that could interfere with the outcomes tested
Study of Combination Docetaxel and Radiotherapy With or Without Cisplatin to Treat Local Advanced Head and Neck Cancer

To evaluate the efficacy of the concomitant combination of radiotherapy and docetaxel with or without cisplatin in terms of objective response rates (WHO criteria).


Eligibility Criteria:
Inclusion Criteria:

* Patients with locally advanced head and neck cancer (T3 and T4 tumors), epidermoid, histologically proven without metastasis; the primitive site of which is the oral cavity, the oropharynx, the hypopharynx or the larynx.
* Locally advanced tumors which are inoperable, or operable but the patient refuses surgery.
* Age ≥ 18 years and ≤ 70 years.
* PS \< 2.
* Satisfactory hematological, hepatic and renal functions: (PN ≥ 2000/mm3, platelet count ≥ 100,000/mm3, hemoglobin ≥ 10g/dl, serum creatinine ≤ 120 µmol/l or creatinine clearance ≥ 60 ml/mn, normal total bilirubin, AST (SGOT) and ALT (SGPT) ≤ 2.5 x the upper limit of normal (ULN) of each center, PAL ≤ 5 x LNS; patients with AST or ALT \> 1.5 x LNS combined with PAL \> 2.5 x LNS will not be eligible for this trial.

Exclusion Criteria:

* Any metastases (other than cervical ganglia).
* Cancer of the cavum and the facial structure.
* Any previous chemotherapy or radiotherapy, irrespective of the reason.
* Any surgery for epidermoid carcinoma in the upper aerodigestive tracts.
* Weight loss ≥10% of total body weight during the last 3 months.
* Any other previous cancer excepting in situ or cutaneous cervical cancer (spinocellular or basocellular).
* Pregnant or nursing women; women of childbearing potential must use an appropriate method of contraception.
* Poorly controlled progressive infection.
* Peripheral neuropathy with NCI grade ≥ 2.
* Neurological or psychiatric disease (dementia, seizures, etc.) that is not compatible with good understanding and sufficient compliance with treatment.
* Any other poorly controlled progressive disease, such as heart failure, symptomatic cardiac rhythm disorders, progressive angina pectoris, or respiratory impairment.
* Any other concomitant investigational treatment.
* Any other concomitant anticancer treatment.
* Allergy to polysorbate 80.
* Definitive formal contraindication to corticosteroids.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Combination Chemotherapy in Treating Patients With Acute Promyelocytic Leukemia

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving combination chemotherapy works in treating patients with acute promyelocytic leukemia.

OBJECTIVES:

* Determine, preliminarily, the safety of incorporating arsenic trioxide (ATO) into cytarabine and daunorubicin hydrochloride-based consolidation therapy followed by tretinoin maintenance therapy in patients receiving induction tretinoin and daunorubicin hydrochloride with acute promyelocytic leukemia (APL) induced into remission with tretinoin and daunorubicin hydrochloride.
* Determine, preliminarily, the efficacy of this strategy in inducing and maintaining molecular remissions in patients treated with this regimen.

OUTLINE: This is a pilot, multicenter study.

* Induction therapy: Patients receive oral tretinoin twice daily on days 1-60 and daunorubicin hydrochloride IV on days 4, 6, and 8. Patients are evaluated between days 60-67 and proceed to consolidation therapy.
* Consolidation therapy: Patients receive cytarabine IV continuously on days 1-3, daunorubicin hydrochloride IV on days 1-3, and arsenic trioxide IV over 1-2 hours once daily, 5 days a week, beginning on day 8 and continuing for 6 weeks. Patients with clinical and/or cytogenic, but not molecular, remission receive additional arsenic trioxide once daily, 5 days a week, for 30 doses (6 weeks). Patients achieving clinical and molecular remission after completion of 6 or 12 weeks of arsenic trioxide proceed to maintenance therapy.
* Maintenance therapy: Patients receive oral tretinoin once daily on days 1-15. Treatment repeats every 3 months for 8 courses (2 years).

After completion of study treatment, patients are followed periodically for up to 5 years.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of acute promyelocytic leukemia (APL) by morphologic and flow cytometric documentation (high orthogonal light scatter, lack of HLA-DR expression)

  * Patients with classical APL as well as the microgranular variant (M3V) are eligible

    * In cases where the diagnosis is unclear, consultation with a hematopathologist is required before enrolling the patient in the study
* Patients found to have cytogenetic abnormalities that do not produce the PML-RARα gene rearrangement will be removed from study and will not be included in data analysis

PATIENT CHARACTERISTICS:

* Patients will not be excluded because of performance status or comorbid disease
* Premenopausal female patients must have a negative pregnancy test

PRIOR CONCURRENT THERAPY:

* No prior chemotherapy for APL except hydroxyurea
Comparison of QoL for Sutureless Thyroidectomy

Patients underwent thyroidectomy filled an computer or paper based QoL questionnaire before and after operation.

Patients who have consent to undergo to total thyroidectomy with sutureless technique (regardless of attending to study or not) for benign thyroid diseases in the institution are asked to participate to this study. Patients are informed that participating to this study will not alter their treatment method. Patients were operated either with Ligasure SmallJaw or Harmonic Focus according to result of label picked from bag. Same surgical team performed all operations and they did not know if the patient was participated in study or not.

Patients willing to participate in this study are being questioned for their quality of life (QoL) with a patient-reported outcome (PRO) questionnaire before surgery and 4 weeks after surgery. For assessment of quality of life Thy-PRO-39 questionnaire is being used. Responses of patients to QoL questionnaire is being recorded to a secure online database. After data completion answers of patients will be exported as anonymous to principal investigator for analysis. Effect of two energy based devices (EBD) on QOL will be compared.

Eligibility Criteria:
Inclusion Criteria:

* Sutureless thyroidectomy for benign conditions

Exclusion Criteria:

* Known neck malignity,
* History of neck operation
* Ligation use during surgery
* Refusal of patient
* Non-capable patient
* Non-euthyroid patient
* Pregnancy
* Having rheumatic diseases
* Having connective tissue diseases
Photobiomodulation on Major Salivary Glands in Children With Caries Activity

The purpose of this trial is to evaluate the efficacy of photobiomodulation of the major salivary glands on salivary parameters in children with caries activity.

Dental caries represents one of the most prevalent diseases among children around the world. Saliva plays a preponderant role in the process of demineralization- remineralization of the dental surface. Patient salivary characteristics, such as flow rate, pH, and buffering capacity, provide relevant information about patient's risk for developing carious lesions. Photobiomodulation has shown promising results to improve salivary flow rate, as well as buffer capacity in the adult population. The purpose of this trial is to evaluate the efficacy of photobiomodulation of the major salivary glands on salivary parameters in children with caries activity.

Methods: This protocol details a randomized, double-blind, parallel-group, controlled trial evaluating salivary parameters through photobiomodulation in children. Seventy-eight 6- to 12-year-old participants will be randomly divided in two groups: 1) the photobiomodulation experimental group (G1) (n=39), 2) the photobiomodulationn placebo group (G2) (n=39). Infrared light will be applied in 16 intra and extraoral points and the placebo, respectively. The unstimulated salivary sample will be taken before and immediately after the application once a week, for three consecutive weeks. Salivary samples will be analyzed for flow rate, pH and buffering capacity. The primary outcomes are difference in salivary flow rates between the G1 and the G2. The secondary outcomes are difference in salivary pH and buffering capacity between the G1 and the G2 group.

Eligibility Criteria:
nclusion criteria

* Individuals of both sexes, between 6 and 12 years old with mixed dentition.
* Participants diagnosed with the presence of at least one active caries lesion
* Good general health, without systemic or local diseases that affect salivary secretions.

Exclusion criteria

* Participants with severe active cavitated lesions with pulpal symptoms.
* Plans of the family nucleus to move for the duration of the study.
* Patients with a diagnosis of hyposalivation or xerostomia
* Presence of fixed appliances.
* Physical disability that interferes with oral or intellectual hygiene to answer the questionnaire.
Effect of Zinc Carnosine on Intestinal Permeability in Healthy Volunteers

Zinc carnosine is a food supplement which is available in the health food shops. The investigators wish to see if it can reduce intestinal swelling in people who take non-steroidal anti-inflammatory (anti-swelling) drugs (NSAIDs: non-steroidal antiinflammatory drug.).

The study was about exploring the influence of zinc carnosine (ZnC) on changes in small bowel permeability caused by indomethacin.

Healthy volunteers (n = 10) participated in this double-blind randomised controlled crossover protocol. Each arm comprised two baseline urine collections, followed by a third at the end of that study period. In each arm, volunteers took ZnC (37.5 mg twice daily, orally) or placebo for 7 days, with indomethacin for the final 5 days.

Results were expressed as lactulose:rhamnose (L:R) ratios and mean values for each stage were therefore estimated: when taking placebo, volunteers had a threefold increase in L:R ratios in response to indomethacin administration (p,0.01), whereas no increase was seen if ZnC was also being taken.

All 10 participants completed the study without protocol violations. Two of ten participants developed mild nondescript upper abdominal discomfort while taking the indomethacin (control) arm, but completed the course. None reported symptoms during the ZnC (plus indomethacin) arm, and no side effects due to ingestion of ZnC were reported.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18-35 years

Exclusion Criteria:

* Conditions known to alter intestinal permeability, eg previous bowel surgery, celiac disease
* Conditions where NSAIDs are contraindicated, eg asthma, renal failure, heart failure
* Diabetes
* Any other serious illness
Sentinel Lymph Node Procedure in Testicular Germ Cell Tumour

Assessment of accuracy of sentinel node biopsy, defined as the false negative rate.

Current practice in patients with Clinical Stage I (CS I) testicular germ cell tumour is active surveillance after orchiectomy, with relapses occurring in 15-20% of patients. The majority of relapses occur in the lymph nodes as lymphogenic spread is the dominant route of dissemination. A sentinel node procedure, in which the sentinel lymph node is resected and pathologically examined, could be more reliable to identify patients who are likely to relapse.

Early identification of patients with micro-metastases in the sentinel node makes it possible to treat these patients at the earliest possible moment. Absence of metastases could lead in the future to a less intensive follow up protocol than the present one.

Eligibility Criteria:
Inclusion Criteria:

* Patients suspected of testicular germ cell tumour, based on physical examination, ultrasound imaging, and tumour markers
* Patients 18 years and older
* No evidence of metastases on first staging (thoraco-abdominopelvic CT)
* Written and signed informed consent

Exclusion Criteria:

* Patients with evidence of metastases at first staging
* Patients with a second primary tumour
* Patients with recent (\< 6 months before diagnosis) surgical treatment to the external genitals or recent surgical intervention in the inguinal or retroperitoneal regions
* Patients with previous abdominal surgery, necessitating open surgical approach for the sentinel node biopsy
Neural and Behavioral Outcomes of Social Skills Groups in Children With Autism Spectrum Disorder (ASD)

The purpose of this study is to compare two different treatment approaches to social skills groups for high-functioning children with Autism Spectrum Disorder (ASD). This project will examine changes in both behavior and the brain following treatment.

Despite the fact that social skills impairments are the most persistent and pervasive symptoms affecting individuals with ASD, treatments targeting social skills have been the subject of few controlled investigations. The available literature suggests that cognitive behavioral techniques are commonly used and may improve targeted social skills in individuals with ASD. However, drawing firm conclusions about the efficacy of social skills treatment remains difficult, particularly with respect to maintenance of skills and generalization to natural settings, owing to methodological limitations of extant studies (e.g., small sample size, lack of manual-based curricula, minimal assessment of generalization or maintenance).

Several neuroimaging studies have found that individuals with ASD underactivate key brain regions involved in social cognition. However, there is also evidence to suggest that factors that increase attention to or interest in social stimuli are associated with more normal brain activity.

The purpose of this investigation is to examine the acute and sustained effects of social skills treatment on social cognition and the neural architecture that supports it. High-functioning children with ASD will be randomly assigned to a 12-week cognitive behavioral social skills group or a social play-based therapy group. For both types of groups, a parent session will be held concurrently. Functional MRI scans as well as behavioral assessments of social cognition, adaptive functioning, and symptom severity will be acquired at baseline, immediately following treatment, and at a 3-month follow-up.

Eligibility Criteria:
Inclusion Criteria:

* 8 to 11 years of age
* Meets criteria for ASD according to psychiatric interview (DSM-IV), the Autism Diagnostic Observation Schedule-Generic, and the Autism Diagnostic Interview-Revised
* Verbal IQ ≥ 70, as measured by the Wechsler Intelligence Scale for Children-Fourth Edition or Wechsler Abbreviated Scale of Intelligence

Exclusion Criteria:

* History of psychiatric or neurological disorders other than ASD (e.g., schizophrenia, depression, seizure disorder)
* Within 30 days prior to the initial evaluation, beginning any new psychotropic medication or other therapeutic intervention (e.g., behavior, speech, physical/occupational, cognitive, nutritional therapy) that would confound the evaluation of the social skills groups
* Gross structural abnormality present in the brain (e.g., aneurysm)
* History of head trauma or loss of consciousness
* For any reason the child or parents appear unable to participate in study procedures
Use of Nitrous Oxide Donor for Labor Induction in Women With PreEclampsia

A randomized controlled trial (RCT) of nitric-oxide donor (NOD) isosorbide mononitrate (IMN) versus placebo as an adjuvant to misoprostol/ intra-cervical Foley bulb for induction of labor to decrease rate of cesarean deliveries in pregnancies complicated by preeclampsia (≥24/0 weeks' gestation)

The investigators are proposing a double blinded, placebo controlled, randomized clinical trial of patients undergoing induction of labor for preeclampsia. Once the decision to induce will be taken, the participants will be randomized to receive either intravaginal IMN (40mg) or identical appearing placebo placed every 4hrs in the posterior vaginal fornix X 3 doses. IMN or placebo will be discontinued when active labor occurs or when the physician decides to proceed with augmentation with oxytocin or AROM. Participants will be induced using the investigators routine induction agents, Misoprostol (25 mcg every 4 hrs for maximum of 6 doses) and an intra-cervical foley bulb will be inserted with 2nd dose of IMN or placebo. Regarding management of labor, physician decides when to proceed with augmentation with oxytocin or AROM.

Eligibility Criteria:
Inclusion Criteria:

* Women older than 18 years at the time of induction of labor with the ability to give informed consent
* Induction of labor for clinical diagnosis of preeclampsia
* Unfavorable cervix (Bishop's score of less than 6)
* Cervical dilation 2cm or less
* Singleton
* Gestational age ≥ 24 weeks
* English speaking

Exclusion Criteria:

* • Contraindication to vaginal delivery

  * Contraindication to misoprostol
  * Fetal Demise
  * Major fetal anomaly
  * Non-english speaking women
  * HIV
  * Medical conditions requiring assisted second stage
  * Category III tracing
  * Eclampsia
  * Hemolysis Elevated Liver enzymes Low Platelets syndrome
  * DIC or active hemorrhage before randomization
  * Hypersensitivity to isosorbide mononitrate
  * Isosorbide mononitrate should not be used in cases of acute myocardial infarction with low filling pressure, acute circulatory failure (shock, vascular collapse), or hypertrophic obstructive cardiomyopathy (HOCM), constrictive pericarditis, low cardiac filling pressures, aortic/mitral valve stenosis and diseases associated with a raised intra-cranial pressure e.g following a head trauma and including cerebral hemorrhage.
  * Isosorbide mononitrate should not be used in patients with severe anemia, severe hypotension, closed angle glaucoma or severe hypovolaemia.
  * Isosorbide mononitrate tablets contain lactose and therefore patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
To Determine if a Lower Extremity Strengthening Program Improve Quadriceps Muscle Strength

The purpose of this study is to determine if a lower extremity strengthening program as part of pulmonary rehabilitation will improve quadriceps muscle strength, endurance and functional status as well as overall quality of life.

Hypothesis:

1. Lower extremity resistance training as part of a pulmonary rehabilitation program will improve quadriceps strength, endurance and functional capacity.
2. Lower extremity resistance training as part of a pulmonary rehabilitation program will improve quality of life in patients awaiting lung transplant.

Objectives:

1. To determine if a lower extremity strengthening program as part of pulmonary rehabilitation is effective at increasing quadriceps strength when measured with a hand held dynamometer.
2. To determine the effectiveness of a lower extremity strengthening program as part of pulmonary rehabilitation for improving endurance and functional capacity as measured by the six minute walk test.
3. To determine if the lower extremity strengthening program as part of pulmonary rehabilitation improves overall quality of life as measured by the St. George's Respiratory Questionnaire.
4. To provide a basic framework for a larger randomized control study evaluating if a lower extremity strengthening program as part of a pulmonary rehabilitation program is more effective than a pulmonary rehabilitation program alone at improving quadriceps strength, endurance, and functional level.

Eligibility Criteria:
Inclusion Criteria:

* Patients preparing for lung transplant
* Diagnoses included are: Chronic Obstructive Pulmonary Disease, Idiopathic Pulmonary Fibrosis, Sarcoidosis, Cystic Fibrosis, or Bronchiectasis

Exclusion Criteria:

* Primary Pulmonary Hypertension
* Multi-organ transplant patients
* Re-transplant patients
* Patients requiring intubation greater than or equal to 7 days prior to transplant
* Any orthopedic condition which will prevent from participation in a lower extremity strengthening program