cyrilzakka/clinical-trials huggingface dataset:
Nutrient Intake in Children With Attention Deficit Hyperactivity Disorder

Specific nutrient deficiencies have been described in children with ADHD including zinc, magnesium, calcium, and essential fatty acids. In addition, children with ADHD have been noted to behave and concentrate better in some studies when the ratio of protein compared with carbohydrate in their diets was increased, however, this was anecdotal information noted from studies designed to study other factors, so its not clear if the increased protein is actually the cause of the improved behavior. In our clinical practice, we have noted a high incidence of what appears to be carbohydrate "craving" among children with ADHD, which can put children at risk for obesity, diabetes type II, and additional dysregulation of mood and concentration. Carbohydrate craving is a well-documented phenomenon in adults, particularly those with certain patterns of obesity, mood disorders, or those undergoing smoking cessation programs. It has not been studied in children, however. Thus, this initial study was designed to determine 1) whether or not children with ADHD have different patterns of nutrient intake compared with children in the same family and children in families without a child with ADHD, 2) if the described nutrient deficiencies are due to decreased intake, and 3) whether there is an increased occurrence of carbohydrate craving, based on parents' perceptions, eating patterns, and actual intake, among children (or certain subgroups of children) with ADHD. The information gained from this study will be used to design additional studies to test causative hypotheses and intervention strategies.

Three day prospective diet records will be completed on 25 children aged 5-13 with ADHD, their sibling controls, and 25 children from control families without ADHD in order to assess their protein, carbohydrate, fat, calorie, and multiple specific nutrient intakes. In addition, a questionnaire will be completed on each child describing several aspects of eating behavior, food choices, and gastrointestinal, allergic, and infectious concomitants.

Eligibility Criteria:
Children with ADHD (combined or hyperactive-impulsive subtype) by Parent and Teacher Rating Scales, history, and interview who do not have a medical or neurologic problem that influences eating, who are not on medication for ADHD or another medication that may influence eating, aged 5-13 years with a sibling in the same age range meeting the same criteria but without ADHD. This sibling must have a normal Parent Rating Scale and not have been held back in school or been on medication or diagnosed with a learning, developmental, or neuropsychiatric disorder. Controls must meet the same criteria, and may not have a first-degree relative with ADHD. All participants must have a normal intellect, and may not have an autistic spectrum disorder or major depression.
Pulmonary Hypertension, Quality of Life and Psychosocial Factors

The investigators aim to :

* describe and analyse psychological characteristics, cognitive factors and representations in patients with Pulmonary Hypertension, a rare disease.
* assess the psychological characteristics impact on quality of life, check the association between disease and QoL evolution, and the variability of QoL parameters over severity class changes and follow-up

PAH is a rare, and severe disease, potentially mortal, affecting preferentially young subjects. The knowledge and the international literature, as regards the quality of life, the expectations, the needs and the psychosocial characteristics of patients with PAH, are non-existent. But it is known that the persons affected by rare diseases are more vulnerable, on the psychological, social, economic and cultural planIn all the stages of the treatment, patients with PAH are confronted with heavy psychosocial situations, in a context of vital risk, with exceptional medicinal treatments (intravenous administration at home).

* QoL might be differently affected by these changes according to situational and dispositional psychological dimensions.
* the predictive role of these characteristics on the current and later quality of life, as well as the impact of diverse cognitive mediators and strategies to cope with the disease, should be investigated.The respiratory diseases department of the Montpellier hospital is regional competence center for PAH in Languedoc-Roussillon, under the aegis of the national reference center (the respiratory diseases department of Antoine Béclère hospital, Le Petit-Clamart).

Eligibility Criteria:
Inclusion Criteria:

* Patients with PAH
* Patients stable since 3 months
* Patients with a severity of class I to IV
* Patients aged between 18 and 80 years
* Patients no psychological follow-up at the competence center.

Exclusion Criteria:

* Patients unable to give his accordance
* Patients unable to understand the aim of the study
* Patients with recents psychiatrics disorders
* Patients with problems of understanding the tests of the study
* Drug users or drinkers
* Pregnant or women without efficacy contraception
* Patient without freedom by administration decision
* Patient in exclusion period
* Patient without french insurance
* Adult protected by the law
A Phase 1b/2 Study of MEDI4736 With Tremelimumab, MEDI4736 or Tremelimumab Monotherapy in Gastric or GEJ Adenocarcinoma

This is a randomized, multicenter, open-label, dose-exploration and dose-expansion study to evaluate the safety, tolerability, antitumor activity, PK, pharmacodynamics, and immunogenicity of MEDI4736 in combination with tremelimumab, MEDI4736 monotherapy or tremelimumab monotherapy in participants with metastatic or recurrent gastric or gastroesophageal junction adenocarcinoma.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female participants
2. 18 years and older
3. Histological or cytological confirmation of metastatic or recurrent gastric or gastroesophageal junction adenocarcinoma
4. Participants must have received and have progressed, or are refractory to standard regimens
5. Participants must have at least one lesion amenable to biospy

Exclusion Criteria:

1. Any concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment
2. Previous immunotherapy
3. Concurrent or prior use of immunosuppressive medication with 14 days
4. Active or prior documented autoimmune or inflammatory disease within 3 years with some exceptions
Shared Care Follow-up After Chemotherapy for Testicular Cancer

The aim of this study is to develop and evaluate a shared care survivorship care plan (SCP) to follow-up patients with metastatic testicular cancer after completion of chemotherapy that resulted in complete remission.

Rationale: Since the introduction of cisplatin, metastatic testicular cancer (TC) has become a highly curable disease. Successfully treated TC patients have a small chance of a relapse. In case of a relapse, early treatment will improve outcome. This stresses the need for a frequent and stringent follow-up scheme. Although chemotherapy is a very effective treatment, a downside of this treatment has now become apparent: chemotherapy-related complications such as the increased risk for cardiovascular disease (CVD) and secondary malignancies. CVD can manifest during treatment, but also years or decades thereafter. We recently observed early development of cardiovascular risk factors in TC patients, clustered into the metabolic syndrome. Monitoring and treatment of cardiovascular risk factors during follow-up is important to lower the chance of developing CVD.

Since TC survivors are discharged from follow-up after 10 years, collaboration between oncologists and general practitioners (GPs), in other words shared care, will ensure monitoring of cardiovascular risk factors and timely detection and treatment of late effects (cardiovascular risk management). Survivorship care plans for cancer survivors, GPs and oncologists facilitate care for long-term survivors. The testicular cancer survivor himself is the key person, who can be empowered to participate in follow-up programs and make lifestyle adjustments to decrease the risk of late effects and improve quality of life and life expectancy. However, data are scarce on the design of an evidence based effective follow-up schedule. For childhood cancer survivors a detailed guideline has been developed that can serve as a framework for adult cancer survivor follow-up.

Objective: To examine the safety and feasibility of a shared care survivorship care plan (SCP) to follow-up patients with metastatic testicular cancer after completion of chemotherapy that resulted in complete remission.

Study population: Patients that achieved a complete remission after chemotherapy for metastatic testicular cancer who are starting with follow-up or are currently in active follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Patients with disseminated testicular cancer;
* Complete remission after chemotherapy with or without adjunctive surgery and in active follow-up;
* Age 18 years or older;
* Started with chemotherapy after January 1st 2003;
* Written informed consent.

Exclusion Criteria:

•Mental disability
Clinical Evaluations and Laboratory Studies to Study the Disease Course in Patients With Cutaneous T-Cell Lymphoma

RATIONALE: Gathering information about patients with cutaneous T-cell lymphoma over time may help doctors learn more about the disease.

PURPOSE: This natural history study is collecting disease-related health information over time from patients with cutaneous T-cell lymphoma.

OBJECTIVES:

Primary

* Follow the disease course of patients with cutaneous T-cell lymphoma.
* Provide a patient population for study by proteomic and molecular analysis.
* Develop a mechanism for screening by a Tumor Board for enrollment of patients in therapeutic clinical trials.

Secondary

* Develop a tissue bank for future disease study using specimens from these patients.
* Provide community outreach by offering a second opinion regarding treatment of this disease in these patients and, in limited cases, provide standard-of-care treatment to these patients.
* Develop an algorithm for screening and evaluating this disease in these patients.

OUTLINE: Patients undergo disease assessment by physical examination, full-body photographic documentation of skin disease, biopsy, and blood sampling at baseline and then at least annually thereafter. Proteomic and molecular methods are used to analyze samples. Biopsies may be examined using histologic and immunohistochemical methods. Blood may be analyzed by polymerase chain reaction for clonal T-cell gene rearrangements or by flow cytometry.

PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study within 5 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of 1 of the following:

  * Histologically confirmed stage IA-IVB cutaneous T-cell lymphoma (CTCL) (mycosis fungoides or Sézary syndrome)
  * Other histologically and clinically confirmed primary or secondary CTCL
  * Histologically and clinically confirmed pre-CTCL skin condition, including large plaque parapsoriasis and lymphomatoid papulosis
* Measurable disease by skin lesion assessment or Sézary cell count

PATIENT CHARACTERISTICS:

Age

* Over 18

Performance status

* Not specified

Life expectancy

* Not specified

Hematopoietic

* Not specified

Hepatic

* Not specified

Renal

* Not specified

Other

* Human T-cell lymphotrophic virus (HTLV) I/II negative
* Not pregnant
* Negative pregnancy test

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* Not specified

Endocrine therapy

* Not specified

Radiotherapy

* Not specified

Surgery

* Not specified
Botulinum Toxin A for Emotional Stabilization in Borderline Personality Disorder (BPD)

The main objective of the trial is to test whether a single application of botulinum toxin A into the glabellar region will lead to emotional stabilization in borderline personality disorder through paralysis of facial muscles/attenuation of negative emotions.

Afferent feedback from facial muscles is believed to enhance emotional states (facial feedback theory). The facial expression of negative emotions involves facial muscles of the glabellar region. It has been shown that paralysis of facial muscles in the forehead using botulinum toxin A leads to the improvement of depressive symptoms. It is believed that the limited ability to express these emotions alleviates depressive symptoms. As Borderline personality disorder is characterized by negative emotions expressed via facial muscles in the forehead, it is hypothesized that BPD patients could profit from botulinum toxin treatment.

Eligibility Criteria:
Inclusion Criteria:

1. female
2. 18-40 years
3. diagnosed BPD according to ICD-10 (F60.31) and SKID II
4. stable treatment
5. mastery of the German language
6. effective contraception
7. willingness to and acceptance of treatment with either botulinum toxin A or acupuncture

Exclusion Criteria:

1. Comorbid disorders of all ICD-10 groups o F0,

   * F1 (with exception of F1x.1),
   * F2,
   * F3 (with exception of 32.0 and F33.0),
   * F7 and disorders essentially defining the clinical picture from sections
   * F4,
   * F5,
   * F6.
2. Contraindication for treatment with botulinum toxin A according to the IMP's SmPC (e.g. myasthenia gravis, Lambert Eaton-syndrome or other impairments in neuromuscular function)
Study to Evaluate the Abuse Potential of ACT-541468 in Healthy Recreational Drug Users

This placebo- and active controlled study will investigate the abuse potential of ACT-541468 in healthy recreational drug users


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent prior to any study-mandated procedure
* Male or female healthy subjects, 18-55 years of age (inclusive) at Screening
* Body mass index of 18.0-33.0 kg/m2 (inclusive) at Screening and a minimum weight of 50.0 kg at Screening
* Current sedative users who have used sedatives (e.g., benzodiazepines, zolpidem, eszopiclone, gamma-hydroxybutyrate, barbiturates) for recreational (non-therapeutic) purposes (i.e., for psychoactive effects) at least ten times in their life and at least once in the 12 weeks before Screening
* Women of childbearing potential must consistently and correctly use a reliable method of contraception with a failure rate of \< 1% per year, be sexually inactive, or have a vasectomized partner
* Women of non-childbearing potential
* Male subjects are required to use a medically acceptable method of contraception throughout the entire study period and for at least 90 days after last study drug administration

Exclusion Criteria:

* History of major medical or surgical disorders which, in the opinion of the investigator, are likely to interfere with the absorption, distribution, metabolism, or excretion of the study treatment(s)
* Positive HIV or hepatitis B/C test at Screening
* Female subjects who are currently pregnant or lactating or who are planning to become pregnant within 1 month of the last study treatment administration
* Modified Swiss Narcolepsy Scale total score \< 0 at Screening or history of narcolepsy or cataplexy
* Substance or alcohol dependence within 2 years prior to Screening or prior participation in a substance or alcohol dependence rehabilitation program
* Subjects who have a positive urine drug screen at admittance to the qualification or core phase
* Any sleep-disorder including self-reported insomnia disorder, breathing-related sleep disorders, restless legs syndrome (RLS), nightmare disorder, non-rapid eye movement (REM), sleep arousal disorders, REM sleep behavior disorder, circadian rhythm sleep-wake disorders, or narcolepsy
* Any of the following SLEEP-50 Questionnaire scores at Screening:

  * ≥ 15 on Apnea subscale;
  * ≥ 7 on Narcolepsy subscale;
  * ≥ 7 on RLS or Periodic limb movement disorder subscale;
  * ≥ 8 on Circadian Rhythm subscale;
  * ≥ 7 on Sleepwalking subscale;
  * ≥ 3 on Item 32 and ≥ 9 on Items 33 to 35 (i.e., on nightmare subscale);
  * ≥ 15 on Impact subscale.
* Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol
Role of Paclitaxel in Stricture Urethra

Stricture urethra is a common disease and has various causing factors. The most common performed procedure is direct visual internal urethrotomy (DVIU), but unfortunately has a high recurrence rates. Multiple trial were performed to improve the outcomes of DVIU. Various intralesional injections were used. in this trial we will evaluate intralesional paclitaxel injection following DVIU.


Eligibility Criteria:
Inclusion Criteria:

* Anterior urethral stricture
* Short strictures (less than 2 cm)
* International Prostate Symptom Score less than 11 and maximum flow rate \< 15 ml per second.
* No previous treatment for stricture disease

Exclusion Criteria:

* Recurrent cases
* Prior pelvic radiation
* Associated other pathology or unresolved confounding etiologies (e.g. bladder neck contracture, neurogenic bladder, benign prostatic hyperplasia) were excluded.
Diagnosis and Treatment of Co-infection With Human Immunodeficiency Virus /Latent Tuberculosis Infection (HIV/TBL)

The purpose of this study is to determine of once identified to the subjects infected with human immunodeficiency virus (positive VIH), to diagnose latent Tuberculosis, and to treat her with isoniazid for six months, measuring the production of Interferon range pre and posttreatment, to evaluate this way the result of the treatment on the immune response

A descriptive analysis of the data will be made. Means and standard deviations for continuous data frequencies for categorical data will be performed. Wilcoxon test Mann-Whitney U test Chi square will be used for frequency analysis of responders Data Analysis and Statistical Software(STATA).

Eligibility Criteria:
Inclusion Criteria:

* Accept to participate. Informed consent.
* Human Immunodeficiency Virus positive test, documented by Western Blot
* Have not received treatment for latent tuberculosis
* Have not been diagnosed pulmonary tuberculosis (Tbp)
* Normal two chest X-rays, Postern-anterior and left lateral.

Exclusion Criteria:

* Active tuberculosis
* Previous diagnosis of tuberculosis
* Antecedent of treatment for active o latent tuberculosis
* Contact with TB patient harboring Multidrug resistance or isoniazid resistant isolates of Mycobacterium tuberculosis.
* Abnormal liver enzyme levels
* Hemoglobin below 8 gr/dl
* Allergy or intolerance to isoniazid
* Peripheral neuropathy
* Ingestion of drugs interacting with isoniazid
Bioequivalence of Dotilavir Sodium Tablets in Healthy Subjects in the Fasting and Fed State

The primary purpose of this study is to evaluate the bioequivalence of two dotilavir sodium tablets in the fasting and fed state. The secondary purpose of this study is to observe the safety of the test and reference preparations. An open-label, randomized, single-dose, crossover study in healthy Chinese volunteers was performed. A single oral dose of 50 mg of two dotilavir sodium tablets was administered to 64 healthy volunteers, with 36 in the fasted group and 28 consuming a high-fat diet. The evaluated pharmacokinetic parameters, including maximum concentration (Cmax), the area under the concentration-time curve (AUC0-t and AUC0-∞) were assessed for bioequivalence.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female subjects ≥18 years of age, with appropriate sex ratio
* The body mass index is in the range of 19.0-27.0 kg/m2 (including the critical value). The weight of male is not less than 50.0 kg, and that of female is not less than 45.0 kg
* The subjects have no family planning within 3 months and could select contraceptive method.
* Before the study, all subjects have been informed of the study's purpose, protocal, benefits, and risks, and signed the informed consent voluntarily

Exclusion Criteria:

* Subjects with allergic constitution.
* Being allergy to the study medications, smoking, alcohol abuse.
* Participation in another clinical trial within 3 months.
* Blood donation, massive blood loss (#400mL) or enrolled in other clinical trials 3 months prior to screening;
* Hepatitis (including hepatitis B and C), positive screening results for AIDS or syphilis;
Changes in Pulpal Blood Flow Between Conventional and Self-ligating Fixed Orthodontic Brackets During Leveling and Alignment Stage

- Evaluate and compare initial changes in PBF between conventional and self-ligating fixed orthodontic brackets during leveling and alignment stage using 0.016" Nickle titanium (NiTi) and 0.016X0.022" NiTi archwires at different time intervals (20min, 24h, 72h, 1 week and 1 month) of initial arch wire placement.

Objectives: to evaluate and compare the initial changes in pulpal blood flow (PBF) between conventional and self-ligating fixed orthodontic brackets during leveling and alignment stage.

Materials and Methods: A total of 22 patients (16 females and 6 males) aged 19± 2.53 years who presented with mild lower arch crowding were selected to participate in the study. A split mouth study design was applied for each patient. Two different fixed appliance brackets were used in the lower arch (self-ligating brackets on one side and conventional brackets on the other side of the same patients). PBF was measured for the lower right and left sides using Laser Doppler Flowmetry at different time intervals (20min, 24h, 72h, 1 week and 1 month) after the fitting of 2 alignment archwires; 0.016" NiTi and 0.016X0.022" NiTi. A repeated measures analysis of variance test and a Bonferroni post-hoc comparison test were applied to detect differences in PBF between the 2 groups.

Eligibility Criteria:
Inclusion Criteria:

* Both male and female subjects
* 6 or more years old
* Class I skeletal malocclusion
* mild lower arch 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 and
* smoking