cyrilzakka/clinical-trials huggingface dataset:
Effects of Sensory Diets on Children's Sensory Processing Skills, Psychosocial Skills, and Classroom Engagement

This study investigated the effects of a sensory diet intervention program on five children with a sensory processing disorder. The effect was investigated on children's sensory processing skills, psychosocial skills, and classroom engagement.

Sensory diets are one of the interventions occupational therapists use in school-based settings to manage manifestations of sensory processing disorder. However, very few studies have investigated the effectiveness of sensory diets, and the results of these studies were mixed. Past studies also had methodological limitations. Therefore, this study investigated the effect of sensory diets on children's sensory processing skills, psychosocial skills, and engagement in classroom activities. This study used a single-subject ABCA design. Five children between the ages of five and eleven years participated in the study. The study consisted of an initial baseline phase A1, the control intervention phase B, sensory diets intervention phase C, and the second baseline phase A2. Each phase lasted for seven days. The PI videotaped each participant for fifteen minutes each school day during all phases to collect the data. The participants were videotaped during classroom group activities. Visual analysis of the data showed that sensory diets had a positive effect on participants' sensory processing, psychosocial skills, and classroom engagement.

Eligibility Criteria:
Inclusion Criteria:

- Children between the ages of four and eleven years and attending pre-kindergarten through fourth grade

* Children eligible for occupational therapy services under the special education eligibility criteria or under section 504 of the Rehabilitation Act of 1973-subpart D. This subpart of section 504 ensures children with disabilities who do not meet the eligibility criteria for special education services and are placed in general education classrooms receive the necessary support and related services (such as occupational therapy) to fully participate in general education classrooms.
* Children who scored in the Definite Difference range (+ 2 SD) or Probable Difference (+ 1 SD) ranges on two or more sections or quadrants on the Sensory Profile-2, Teacher Questionnaire (SP-2 Teacher Questionnaire; Dunn, 2015) were included in this study

Exclusion Criteria:

Children with medical concerns, such as cardiac conditions, posing risk to participate in resistive (strenuous) gross motor activities or children who used mobility devices were excluded from the study as these conditions may have hindered their participation in sensory diet activities.

* Children who were on medications, such as stimulants, anti-anxiety or anti-convulsive medications were excluded from the study as these medications may influence the clinical representation of SPD and interfere with the study outcomes.
* Children who were currently receiving sensory diets or received sensory diets six months prior to the beginning of the study were excluded from the study to control for confounding.
Omalizumab Use and Asthma-Related Quality of Life in Patients With Severe Persistent Allergic Asthma

This study investigated asthma-related quality of life in Brazilian patients using omalizumab.


Eligibility Criteria:
Inclusion criteria:

* 12 to 75 years-old during screening visit.
* Body weight \> 20 kg and \< 150 kg.
* Daily or persistent asthma symptoms.
* Night symptoms at least once a week.
* Forced expiratory volume in 1 second (FEV1) \> 40% and \< 80% of predicted normal value and continuing asthma symptoms.
* FEV1 increased \> 12% from baseline within 30 minutes of inhaled (up to 400 mcg) or nebulized (up to 5 mg) salbutamol.
* Subject taking more than 500 mcg/day of fluticasone or equivalent associated to a long-acting β2-agonist.
* Inhaled corticosteroid and long-acting beta-2 adrenergic agonist (LABA) doses that remained fixed during the last 12 weeks prior to screening.
* Medical history of at least two episodes of asthma exacerbation treated with systemic corticoid or at least one severe asthma exacerbation treated with systemic corticoid and hospitalization or emergency room visit in the last 12 months prior to screening.
* Positive skin prick test (diameter of wheal \> 3mm) to at least one perennial aeroallergen (dust mite, cat/dog dander, cockroaches), to which the subject was likely to be exposed during the study.
* Subject capable to read and understand asthma related quality of life questionnaire (Juniper's questionnaire).

Exclusion criteria:

* Pregnant, nursing female subjects.
* Female subjects without current acceptable contraceptive method.
* Previous history of allergy or hypersensitivity to omalizumab.
* Subjects with prior treatment with omalizumab.
* Subjects with medical history of psychiatric disorder.
* Subject had been treated with systemic corticosteroid for any reason other than asthma.
* Subject took β2 antagonist medication in the last 3 months prior to screening visit.
* Subject took protocol prohibited medication prior to screening.
* Medical history of food or drug related severe anaphylactoid reactions.
* Medical history of antibiotics allergy. Patients were included if the antibiotics to which they were allergic to were to be avoided for the entire duration of the study.
* Asthma related to non-steroidal anti-inflammatory drug (NSAID).
* Treatment of exacerbation in the 4 weeks prior to randomization.
* Other active lung diseases.
* Medical history of others uncontrolled diseases 3 months prior randomization (eg, infections, coronary heart diseases and metabolic diseases).
* Any history of cancer.
* Abnormal electrocardiogram (ECG), laboratory exams (clinically significant abnormalities), and chest X-ray (CXR).
* Evidence or history of drug or alcohol abuse.
* Airway infection (eg, pneumonia, acute sinusitis) 4 weeks prior to screening visit.
* Smokers or smoking history of \> 10 pack-years.
* Subject that had been treated with investigational drugs over the past 30 days or during the course of the trial.
* Subject had elevated IgE levels for reasons other than allergy.

Other protocol-defined inclusion/exclusion criteria applied to the study.
Erythrocytes and Skeletal-muscle Fatty Acids Are Positively Correlated After Caloric Restriction and Exercise

The aim is compare and correlate skeletal muscle and erythrocytes fatty acids (FAs) profiles in adult healthy human after caloric restriction and acute exercise in order to validate erythrocyte FAs profile as marker of changes in muscle fatty acid composition.

The study was performed with 11 healthy sportsmen participating in a caloric restriction trial for 1 month. The participants follow a caloric restriction, 30-40% respect to the usual diet of each participant, three alternate days weekly along 4 weeks. After the caloric restriction period the participants realized an exercise stress test. For each participant one blood sample and muscular biopsy were obtained after acute exercise and caloric restriction intervention. All the participants were informed of the purpose and demands of the study before giving their written consent to participate. The study protocol was in accordance with the Declaration of Helsinki for research on human participants and was approved by the local Ethics Committee of the Consell Català de l'Esport.

Eligibility Criteria:
Inclusion Criteria:

* age (18-50 years old),
* sex (male),
* equilibrate diet and physical activity of 3 days weekly.

Exclusion Criteria:

* sex (female),
* smokers.
Study of Congenital Orofacial Clefts by Implementing Optical Genome Mapping

Orofacial clefts, the most common congenital craniofacial malformations, have a complex etiology involving an interaction between genetic and environmental factors.

Chromosomal abnormalities, including structural variations, represent a major cause of human pathology. Recently, technological developments and the introduction of next-generation sequencing (NGS) technologies have revolutionized the field of medical genetics.

Optical genome mapping (OGM) is an innovative, high-resolution "long read" technique that enables the identification of all classes of chromosomal variation, consisting in the direct visualization of long, labeled DNA molecules throughout the genome. This technology is gradually becoming an essential tool for studying onco-hematology and constitutional genetic pathologies The purpose of this study is to search for structural chromosomal variants (SV) or copy number variants (CNV) not identifiable either by cytogenetic methods nor by "short read" NGS "short read, in individuals with oral-facial clefts with no genetic diagnosis.


Eligibility Criteria:
Inclusion Criteria:

* Individuals with syndromic, complex or familial oral-facial clefts
* With no established genetic diagnosis
* Followed up at the Amiens-Picardie University Hospital

Exclusion Criteria:

* genetic diagnosis of oral-facial cleft
* No health insurance affiliation
* Patient under guardianship or curatorship, under safeguard of justice or deprived under public law
* Pregnant, parturient or breast-feeding woman
His Bundle Pacing Versus Right Ventricular Pacing

This study will randomize cross-over periods of 6 months of right ventricular pacing and His bundle pacing in patients with baseline left ventricular ejection fraction (LVEF)\>40%. The primary outcome measure is LVEF.

Monocentric, randomized, double-blind comparative crossover clinical study.

Patients with a standard pacing indication with \>20% ventricular pacing, with a baseline LVEF \>40%, implanted with a functioning His bundle lead and a backup right ventricular lead, will be randomized to 6-months periods of right ventricular pacing and of His bundle pacing. The primary outcome is LVEF assessed by gated Equilibrium Radionuclide Angiography. Secondary outcomes are diastolic function, New York Heart Association (NYHA) functional class, quality of life, 6-minute walk test, heart failure hospitalisations and device electrical parameters.

Eligibility Criteria:
Inclusion Criteria:

* Baseline LVEF\>40%
* Standard pacing indication with \>20% VP
* Functional His bundle lead with confirmed His capture
* Functional right ventricular lead with myocardial capture

Exclusion Criteria:

* Unable to sign an informed consent form
Correlation Between PET/CT Parameters and Tumor Markers in Recurrent Breast Cancer

Worldwide, breast cancer (BC) is the most frequent type of cancer in women yet, it is associated with relatively lower mortality rates, as it ranks fifth in cancer-related deaths overall, which is attributed to evolution in the treatment of recurrent and metastatic lesions, especially when these lesions were detected early . BC recurrence can occur even 15 years after primary treatment.

life-long routine monitoring is mandatory. Although histopathologic confirmation is the definitive diagnostic method for BC recurrence, it is not always easy to perform as in cases with deeply located or very small-size lesions, or lesion too close to organs or great vessels, making sampling either inaccessible or hazardous. BC recurrence can be assessed using morphological imaging studies or tumor markers. Mammography, ultrasound (US), computed tomography (CT), and magnetic resonance imaging (MRI) are currently the most commonly used morphological imaging methods for detecting breast cancer recurrence. However, both of the two modalities have some restrictions.

Cancer antigen 15-3 (CA 15-3) and carcinoembryonic antigen (CEA) are two tumor markers that are frequently used in the monitoring of BC patients . However, the findings of many studies on these markers in BC follow-up are conflicting.

The introduction of integrated 2-deoxy-2-\[18 F\] fluoro-D-glucose (18FDG) positron emission tomography (PET) computed tomography (CT), known as PET/CT, has become a helpful tool for this purpose.

PET/CT is the functional imaging tool that can measure increased glucose metabolism in cancer cells by using 18F-FDG. Its ability to identify tumor recurrence before detection of morphologic changes in conventional imaging reflecting its importance in detecting BC recurrence in asymptomatic patients with high tumor markers and negative results of radiological imaging. 18F-FDG PET/CT is frequently used for BC evaluation. However, data on its value in evaluating BC recurrence in patients with elevated tumor markers are limited and unclear

Eligibility Criteria:
Inclusion Criteria:

* female patient with pathologically proved breast cancer who will be referred to do PET\\CT imaging at the nuclear medicine unit, Assiut university hospital due to suspicion of recurrence based on elevated level of tumor marker in the period between October 2021 until the end of the study .

Exclusion Criteria:

* patients with newly diagnosed BC patients with early stages of BC BC patients with normal serum level of tumor markers
The Efficacy and Safety Study of Tung's Acupuncture for Polycystic Ovarian Syndrome

This study evaluates the efficacy and safety in improving ovarian function of polycystic ovarian syndrome in adults. Half of patients will receive Tung's acupuncture therapy, while the other half will receive Diane-35(CPA/EE) as the control group.

Both Tung's acupuncture therapy and Diane-35(CPA/EE) could improve the symptom of patients with polycystic ovarian syndrome, but until now there is no definite evidence to indicate acupuncture could play the same role in improving ovarian function. So we design this study to observe the change of follicular development, ovary size and sex hormone( testosterone, follitropin, luteinizing hormone) before and after the treatment, and evaluate the efficacy and safty of acupuncture.

Eligibility Criteria:
Inclusion Criteria:

1. Chinese;
2. 18-45 years old;
3. to meet the diagnostic criteria for polycystic ovary syndrome;
4. no need for pregnancy in the next six months;
5. volunteering to join this research and give informed consent prior to receiving treatment.

Exclusion Criteria:

1. hypertensive patients with blood pressure exceed 160/100 mmHg;
2. a history of thrombosis,cerebrolvascular diseases, cancer, liver disease or liver dysfuction, hyperlipidemia, mental disorder, and severe infection;
3. having taken any pharmacological treatments affecting reproductive endocrine system;
4. having received acupuncture in the previous three months;
5. smoking more than 15 cigarettes per day;
6. having pacemakers, metal allergies or severe fear of acupuncture.
A Randomized, Controlled Study of Intravenous Ganciclovir Therapy for Peripheral Cytomegalovirus Retinitis in Patients With AIDS

To provide information about the usefulness and safety of giving injections of ganciclovir (DHPG) for treating peripheral cytomegalovirus (CMV) retinitis.

CMV retinitis is an important sight-threatening opportunistic infection which affects 1 to 2 out of every 10 patients with AIDS. Results from an earlier study suggest that about 80 percent of patients with CMV retinitis will be helped by receiving intravenous doses of DHPG.

CMV retinitis is an important sight-threatening opportunistic infection which affects 1 to 2 out of every 10 patients with AIDS. Results from an earlier study suggest that about 80 percent of patients with CMV retinitis will be helped by receiving intravenous doses of DHPG.

Patients are randomly placed in one of two treatment groups. In one group, patients receive DHPG twice a day, intravenously, for 14 days, followed by a daily dose for 14 weeks. Patients in the other group (the delayed-treatment group) do not receive immediate treatment with DHPG. Patients in both groups have regular ophthalmologic (eye) evaluations with retinal photographs to see if the retinitis is getting worse. Patients in the delayed treatment group receive DHPG if this occurs.

Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* Zidovudine (AZT) for patients in delayed treatment group and not receiving ganciclovir.
* Didanosine (ddI) may be continued or initiated in any patient during the study.
* Topical acyclovir.
* Topical ophthalmics.
* Aerosolized pentamidine.

Patients must have:

* AIDS as defined by the CDC criteria or have had confirmation of HIV infection by ELISA, p24 antigen assay, or culture of HIV.
* Retinal lesions greater than 1500 microns from edge of optic disc outside major temporal vascular arcades, and greater than 3000 microns from fovea.
* Understanding of study provisions, and willingness to sign informed consent form approved by the appropriate Institutional Review Board and Syntex.
* Life expectancy of at least 4 months.

Exclusion Criteria

Co-existing Condition:

Patients with ocular conditions requiring immediate surgical correction are excluded.

Concurrent Medication:

Excluded during first 4 weeks of ganciclovir treatment:

Zidovudine (AZT).

Excluded:

Other investigational drugs and antimetabolites, alkylating agents, nucleoside analogs (topical ophthalmics are permitted), acyclovir, interferon, foscarnet (non-nucleoside pyrophosphate analog), cytomegalovirus (CMV) hyperimmune globulin, and cytokines.

Patients with the following are excluded:

* Immediately sight-threatening retinitis (= or \< 1500 microns from edge of optic disc, or inside major temporal vascular arcades, or = or \< 3000 microns from the fovea).
* Ocular media opacities (corneal, lenticular, or vitreal) preventing ophthalmologic and photographic retinal assessment.
* Demonstrated hypersensitivity to acyclovir.

Prior Medication:

Excluded:

- Previous treatment with anti-cytomegalovirus therapy.
Corticospinal Excitability and Rehab in Knee Osteoarthritis

To determine differences in thigh muscle function in individuals with and without knee arthritis, and also determine the effectiveness of common physical therapy interventions on clinical and patient oriented outcomes.

The primary objective of the proposed research evaluates the concurrent changes in corticospinal excitability and central sensitization of pain pathways for their influence on quadriceps voluntary activation. A secondary objective is to establish the feasibility of an intervention study to determine if changes in the excitability of these supraspinal motor and sensory processes can be modified by physical therapy interventions targeting pain and muscle strengthening. We hypothesize that patients with knee osteoarthritis will show measurable deficits in quadriceps voluntary activation that can be explained by lower levels of corticospinal excitability and increased pain sensitization. A 1 week physical therapy intervention will improve voluntary activation and reduce pain with concurrent changes in underlying motor and sensory processes. We further hypothesize that part of this improvement will be attributed to positive treatment expectation.

Eligibility Criteria:
Inclusion Criteria:

* Age 19-65
* Grade I or II knee Osteoarthritis confirmed by radiographs or other imaging and at least one of the following:

  * Age \> 50 years old
  * Morning stiffness \< 30 minutes
  * Crepitus
* Meet at least 3 of 6 diagnostic criteria for osteoarthritis:

  * Age \> 50 years old
  * Morning stiffness \< 30 minutes
  * Crepitus
  * Bony tenderness
  * Bony enlargement
  * No palpable warmth

Exclusion Criteria:

* BMI \> 30
* History of traumatic spine or lower extremity injury within the last 6 months
* Previous adverse reaction to electrical stimulation (i.e. burns or hypersensitivity)
* Cardiac pacemaker
* Metal implants in head
* Current pregnancy
* Neurological disorders
* History of seizures
* Unable to give consent or understand the procedures of this study
Resting Heart Rate in Chronic Obstructive Pulmonary Disease

110 COPD patients who were participated in the PR program were included in the study. Resting Heart Rate , pulmonary functions, functional capacity, perception of dyspnea, quality of life and psychological symptoms compared before and after PR.

In many studies, it has been reported that baroreceptor activity and heart rate variability decrease and resting heart rate (RHR) increases in COPD patients due to changes in cardiac autonomic function. Among the recommendations regarding pulmonary rehabilitation (PR) and exercise training in COPD patients, approaches such as including practices targeting RHR and developing implementation strategies that improve the cardiovascular system are recommended. The primary aim of our study is to examine the effect of comprehensive exercise training consisting of breathing, aerobic and strengthening exercises on RHR in COPD patients, and secondarily to determine the factors that affect RHR change after PR in COPD patients.

110 COPD patients who were participated in the PR program were included in our retrospective study. Resting Heart Rate , pulmonary functions, functional capacity, perception of dyspnea, quality of life and psychological symptoms compared before and after PR.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with COPD according to GOLD and completed the 2-day / 8-week PR program

Exclusion Criteria:

* With cardiovascular disease
* With additional diseases such as diabetes
* Receiving medical treatment that affects the autonomic nervous system
* Patients receiving long-term oxygen therapy
A Prospective Study of Apatinib Plus Concurrent Neoadjuvant Chemoradiotherapy for Siewert II ，III of Locally Advanced HER-2 Negative Adenocarcinoma at Gastroesophageal Junction

The purpose of this study is to assess the efficacy and safety of patients who receive concurrent neoadjuvant chemoradiotherapy for Siewert II ，III of locally advanced HER-2 negative adenocarcinoma at gastroesophageal junction.


Eligibility Criteria:
Inclusion Criteria:

1. Age:18 to 70 years old (man or female);
2. Conﬁrmed to Siewert II , III of locally advanced adenocarcinoma at gastroesophageal junction and tumor long diameter ≤8 cm by gastroscopy and CT, The her-2 negative was detected by immunohistochemistry;
3. Patients with Stage for Ⅲ by CT/MRI (According to the eighth edition of AJCC );
4. Patients with measurable lesions(measuring≥10mm on spiral CT scan, satisfying the criteria in RECIST1.1);
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
6. Major organ function has to meet the following certeria:

   HB≥80g/L; ANC≥1.5×109/L; PLT≥90×109/L; ALT and AST≤2.5×ULN, but\<≤5×ULN if the transferanse elevation is due to liver metastases； TBIL\<1.5×ULN； Serum creatinine ≤1.5×ULN;
7. Life expectancy greater than or equal to 6 months;
8. Women of childbearing age must have contraceptive measures or have test pregnancy (serum or urine) enroll the study before 7 days, and the results must be negative, and take the methods of contraception during the test and the last to have drugs after 8 weeks. Men must be contraception or has sterilization surgery during the test and the last to have drugs after 8 weeks;
9. Participants were willing to join in this study, and written informed consent, good adherence, cooperate with the follow-up.

Exclusion Criteria:

1. Allergic to apatinib, capecitabine and oxaliplatin;
2. The cytological examination of the abdominal cavity washing fluid showed that the tumor shedding cells were positive;
3. Have high blood pressure and antihypertensive drug treatment can not control (systolic blood pressure \> 140 mmHg, diastolic blood pressure \> 90 mmHg), Uncontrolled coronary heart disease and arrhythmia ,classⅢ-Ⅳcardiac insufficiency;
4. A variety of factors influencing oral drugs (such as unable to swallow, nausea, vomiting, chronic diarrhea and intestinal obstruction, etc);
5. Patients with tendency of gastrointestinal bleeding, including the following: a local active ulcerative lesions, and defecate occult blood (+ +); Has melena and hematemesis in two months;
6. Coagulant function abnormality (INR \> 1.5 ULN, APTT \> 1.5 ULN), with bleeding tendency;
7. Pregnant or lactating women;
8. Patients with other malignant tumors within 5 years (except for curable skin basal cell carcinoma and cervical carcinoma in situ);
9. History of psychiatric drugs abuse and can't quit or patients with mental disorders;
10. Less than 4 weeks from the last clinical trial;
11. The researchers think inappropriate.