cyrilzakka/clinical-trials huggingface dataset:
Pharmacogenomics of Mood Stabilizer Response in Bipolar Disorder (PGBD)

This is a prospective pharmacogenomics study of mood stabilizer response. The goal of this work is to identify genes associated with good response of patients with bipolar disorder to two commonly used mood stabilizing agents, lithium and valproate.

All subjects meeting study inclusion criteria will be started on lithium. Those that fail lithium will be crossed over to valproate (VPA). Those that also fail VPA will be again crossed-over to a standardized treatment as usual (TAU) arm. Subjects who are eligible for the study must be at least 18 years of age and have been diagnosed or are thought to have bipolar I disorder with at least one episode of mood instability in the last 12 months. They must also be eligible to take lithium and, if female and of child bearing age, agree to use adequate birth control methods and to inform their doctor of their plans to become pregnant.

Eligibility Criteria:
Inclusion Criteria:

* Any phase of bipolar I disorder including, depressive, manic, hypomanic, mixed, or baseline/euthymic/not symptomatic;
* Lithium naïve patients and inadequately past lithium treated patients will be required to have had at least one affective episode in the last 12 months meeting DSM-IV criteria. Current lithium treated patients (CLTPs) will be stable on lithium monotherapy and will be exempted from this criterion if they have had no mood episodes meeting DSM-IV criteria in the last 6 months;
* Both outpatients and inpatients will be permitted to enroll into this study;
* Able to give informed consent, in the judgment of the investigator;
* Age greater than or equal to 18 years;
* Women of child bearing potential agree to inform their doctor at the earliest possible time of their plans to conceive, and to use adequate contraception (e.g. oral contraceptives, intrauterine device, barrier methods, or total abstinence from intercourse), and to understand the risks of lithium to the fetus and infant. Depo Provera is acceptable if it is started 3 months prior to enrollment.

Exclusion Criteria:

* Unwilling or unable to comply with study requirements;
* Renal impairment (serum creatinine \>1.5 mg/dL);
* Thyroid stimulating hormone (TSH) over \>20% above the upper normal limit (participants maintained on thyroid medication must be euthyroid for at least 3 months before Visit 1;
* Other contraindication to lithium;
* Currently in crisis such that inpatient hospitalization or other crisis management should take priority;
* Subjects with alcohol/drug dependence who meet criteria for physical dependence requiring acute detoxification;
* Pregnant or breastfeeding;
* Women of child-bearing potential who aren't able to agree to the requirements specified above;
* Those who have participated in a clinical trial of an investigational drug within the past 1 month;
* Inability to agree to comply with the visit schedule or study procedures;
* History of lithium toxicity, not due to mismanagement or overdose that required treatment;
* Current unstable medical condition.
Ovarian Response Prediction in In Vitro Fertilization (IVF) Patients

The aim of the study is to explore ovarian response in terms of oocyte numbers after ovarian stimulation in a fixed gonadotropin dose GnRH-antagonist protocol by endocrine (AMH, FSH), demographic (age), sonographic (antral follicle count) and genetic factors (polymorphisms of gonadotropin receptors and secreted gonadotropins).

Assisted reproduction by in-vitro fertilisation plays a pivotal role in the treatment of infertility, the understanding of reproductive biology, and future population dynamics. The success of assisted reproductive technologies (ART) is critically dependent on optimizing protocols for controlled ovarian stimulation which aim at providing an adequate number of good quality oocytes for in-vitro laboratory procedures. Interindividual variation in response to follicle-stimulating hormone (FSH) is a widespread problem with clinical and economical implications. A group of patients (9%-24%) tend to respond poorly to controlled ovarian stimulation (COS) whereas other patients tend to overrespond (2.5%) and thus run at risk of developing ovarian hyperstimulation syndrome, a potentially life-threatening disease. Polymorphisms of gonadotropin receptors seem to have an influence on the outcome of controlled ovarian hyperstimulation treatment, e.g. contributing to the variation in ovarian response to exogenous FSH between individuals. Other predictive factors include demographic (age), sonographic (follicular count in the ovaries, ovarian volume), endocrine (serum gonadotropin levels and Anti-Muellerian Hormone) and life-style factors (smoking, obesity). Such factors are routinely obtained prior to a treatment cycle, and are used to determine the optimal FSH starting dose or the best treatment regimen. The identification of gonadotropin receptor polymorphisms and variants in secreted gonadotropins prior to an ovarian stimulation treatment should allow the clinicians to tailor the starting dose of rFSH, especially for patients undergoing their first treatment cycle, as such ovarian response prediction will prevent cycle cancellations due to too low or too high ovarian response and reduce the risk of OHSS. The aim of the present study is to identify the prevalence of FSH and LH receptor polymorphisms and hormonal variants of LH and to study the variation attributable to these genetics factors when controlling for already established predictors of ovarian response to exogenous FSH in a multi-variate analysis.

Eligibility Criteria:
Inclusion Criteria:

Female patients for who the treating physician decides that treatment with long acting FSH 150µg in a GnRH-antagonist protocol is indicated.

Exclusion Criteria:

Contraindications for the use of gonadotropins (e.g., tumors, pregnancy/lactation, undiagnosed vaginal bleeding, hypersensitivity, ovarian cysts) Use of hormonal preparations within one month prior to inclusion
Hand Hygiene of Kindergarten Children

Randomized controlled trial to further assess the impact of a digital intervention on hand hygiene of young children. Children in intervention kindergartens will see live instructions and feedback on their hand washing activity in reals-time / while washing hands. Aim of the study is to better understand behavior change of young children.


Eligibility Criteria:
Inclusion Criteria:

* children attending kindergarten

Exclusion Criteria:

* none
Bone Healing at Non-submerged Implants Installed With Different Insertion Torques.

The objective of the study is to evaluate histomorphometrically the healing at implants installed with standard or very low insertion torque values.

Very high insertion torque values have been recommended when immediate loading is applied to implants.1 However, it has been shown that similar clinical outcomes may be achieved even with insertion torque values ≤15 Ncm when implants are splinted together. Due to the contradictory outcomes on the influence of the torque on osseointegration and a lack of histological data in humans, there is a need of more evidences that may support the clinicians in the decision making when an unintentional low insertion torque occur at implants during the daily practice. So the aim of the study i evaluate histomorphometrically the healing at implants installed in Twelve volunteer patients that will be recruited. Two screw-shaped titanium devices will be installed in the distal segments of the mandible using insertion torque values of either \<10 Ncm or \~30 Ncm. The implants were left to heal in a non-submerged fashion. After 8 weeks, biopsies will be retrieved and ground sections will be prepared for histological evaluation.

Eligibility Criteria:
Inclusion Criteria:

* presence of at least two edentulous zone in the posterior segment of the mandible
* ≥ 25 years of age
* smoking ≤ 10 cigarettes per day
* Good general health
* No contraindication for oral surgical procedures.
* Not being pregnant.

Exclusion Criteria:

* Presence of systemic disorders
* Chemotherapy or radiotherapy;
* Smokers \>10 cigarettes per day
* Previous bone augmentation procedures in the region
Nanodropper Use in Primary Open-Angle Glaucoma Patients: A Non-Inferiority Trial

This randomized, single-masked, crossover, non-inferiority trial aims to evaluate the safety and efficacy of Nanodropper-mediated microdrops of ocular hypotensive topical treatments (experimental intervention) compared to standard drops of the same medication(s) (active comparator) in Wilford Hall Ambulatory Surgical Center (WHASC) primary open-angle glaucoma (POAG) and ocular hypertension (OHTN) patients.

The primary objective of this study is to compare changes in intraocular pressure (IOP) in a population of POAG and OHTN patients in response to administration of 1) standard drops of IOP lowering medications and 2) Nanodropper-mediated microdrops of IOP-lowering medications. The hypothesis is that Nanodropper-mediated microdrops of IOP-lowering medications will not result in a significant difference in IOP relative to standard drops of IOP-lowering medications after three months of daily eyedrop administration with each delivery system. The primary outcome measure for this efficacy endpoint will be mean IOP (mm Hg) ± SEM. A secondary objective of this trial is to evaluate Nanodropper's safety and usability. Surveys that have been designed to gain an understanding of the differences in side effects and usability between using Nanodropper-mediated microdrops compared to standard eyedrops will be administered to patients at the enrollment visit and at each follow-up visit.

Eligibility Criteria:
Inclusion Criteria:

* POAG/OHTN patients above the age of 18 years.
* On a maximum of 2 IOP lowering medications.
* Stable disease without progression in IOP, optic disc cupping, RNFL changes, and visual field changes within the previous 1 year.

Exclusion Criteria:

* Glaucoma not of the POAG or OHTN variety or other retinal diseases.
* Progression of disease within the preceding 1 year (IOP elevation, optic disc cupping, visual field changes).
* Using more than 2 IOP-lowering medications.
* IOP-lowering surgical interventions or lasers except for SLT. SLT may have been completed 6+ months prior to study start date.
Effect of Antacids on the Pharmacokinetics of Raltegravir

The purpose of this study is to test whether there is a drug interaction between raltegravir (a medicine used to treat the human immunodeficiency virus or HIV) and antacids.

This study will determine if an interaction occurs between the HIV medicine raltegravir and an antacid. A prior study found an interaction with another medicine like raltegravir called elvitegravir and an antacid. The elvitegravir levels were reduced by half. The same interaction may occur with raltegravir and an antacid based on the structure of this medicine and how it works. When the levels of HIV medications are reduced, people with HIV can "fail" their treatment. The virus can multiply when the drug levels are too low and the medications can stop working. We need to be sure that antacids will not cause this problem with raltegravir.

Eligibility Criteria:
Inclusion Criteria:

* Absence of HIV-1 infection as documented by any licensed ELISA test kit within 21 days prior to study entry.
* Age greater than or equal to 18 but less than or equal to 60 years.
* Ability and willingness to give written informed consent.
* Within 30% (+/-) of ideal body weight and total body weight of ≥ 50 kg.
* Hematology, Metabolic Profile, Renal, and Hepatic Function tests all within normal limits.
* Creatine kinase (CK) less than 3 times the upper limit of normal

Exclusion Criteria:

* Pregnancy or breast-feeding.
* Women and men of reproductive potential who are actively engaging in sexual activity or assisted reproductive technology with the intent of pregnancy.
* Allergy/sensitivity to raltegravir.
* Allergy/sensitivity to antacids.
* Active drug or alcohol abuse or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements. While on study, subjects will be instructed not to consume alcohol for 48 hours prior the screening visit, and for the 24 hours preceding the intensive pharmacokinetic (PK) study visits and for 24 hours following the completion of the study visits.
* Any medical condition that, in the opinion of the investigator, would interfere with the subject's ability to participate in this protocol.
* Participation in any investigational drug studies within 30 days prior to study entry.
* History of or active cardiovascular, renal, hematologic, hepatic, neurologic, gastrointestinal, psychiatric, endocrine, or immunologic disease(s). This is inclusive of chronic illnesses such as hypertension, coronary artery disease, arthritis, diabetes, any chronic gastrointestinal conditions that might interfere with drug absorption.
* Use of investigational, prescription, and over-the-counter medications within 14 days of study entry with the following exceptions: aspirin, acetaminophen, ibuprofen, and oral contraceptives
Efficacy of Topotecan and Lapatinib in Early Recurrent Ovarian or Peritoneal Cancer

The objective of the trial was to evaluate the efficacy of the association of topotecan and lapatinib in patients who failed first line platinum-based chemotherapy within 12 months.


Eligibility Criteria:
Inclusion Criteria:

* Age superior or equal 18 years
* primitive ovarian adenocarcinoma histologically confirmed
* or peritoneal or fallopian tube adenocarcinoma histologically confirmed
* Progression or relapse within 12 months after the end of first line of platin based chemotherapy
* association in first line with other anticancer agent is allowed (taxanes, anthracyclines, alkylants or gemcitabine) and with an anti-angiogenic (bevacizumab, sunitinib).
* intra-peritoneal chemotherapy in first line is possible
* No previous treatment with HER inhibitors (ex : gefitinib)
* HER status not necessary
* measurable lesions (RECIST criteria). and/or CA125 value higher than 2 fold the normal value or CA125 higher than 2 fold nadir value (if no normalized) proved by two samples distant of 1 month
* OMS inferior or equal 2.
* biological parameters as follow: creatininemia ≤ 150 µmol/L or clearance ≥ 50 mL/min,bilirubin ≤ 1,5 LNS,transaminases and or alcalin phosphatases ≤ 2 LNS without hepatic metastasis or ≤ 3 LNS if hepatic metastasis,neutrophils ≥ 1,5.109/L,plaquettes ≥ 100.109/L.
* normal FEV
* No previous treatment by chemotherapy, hormonotherapy, immunotherapy or radiotherapy within 4 weeks before inclusion
* No concomitant treatment forbidden with lapatinib.
* No previous treatment by Amiodarone in 6 months before inclusion
* signed informed consent

Exclusion Criteria:

* Previous treatment with :

  * intensive chemotherapy with autograft
  * two lignes of chemotherapy
  * previous total abdominal irradiation
  * previous chemotherapy with anti-HER treatment
* History of brain or meningitis metastasis uncontrolled.
* Malignancies except for adequately treated carcinoma in situ of the cervix and/or basal cell skin cancer.
* uncontrolled infectious pathology
* uncontrolled cardiovascular disease
* Patients with an active intestinal occlusion not permit oral treatment
* known hypersensibility to topotecan and its excipients
* Woman of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period
* Individual deprived of liberty
A Study to Evaluate Efficacy and Safety of HS-10374 for Mild-to-moderate Plaque Psoriasis

This study has been designed to explore the clinical efficacy and safety of HS-10374 in the treatment of mild-to-moderate plaque psoriasis.

This is a 12-week, multi-center, randomized, double-blind, placebo-controlled, Phase II study. The study duration includes a 4-week screening period, a 12-week placebo-controlled treatment period, and a 4-week follow-up period. All eligible subjects will be randomly assigned in a 2:2:1 ratio to receive HS-10374 Dose 1, HS-10374 Dose 2, or placebo.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects between the ages of 18-70 years
2. Diagnosis of plaque psoriasis for at least 6 months
3. sPGA score of 2-3, BSA 2-15%, PASI score 2-15
4. Subject must be inadequately controlled with, or intolerant of at least one topical therapy

Exclusion Criteria:

1. Diagnosis of non-plaque psoriasis or drug-induced psoriasis
2. Recent history of infection, history or risk of serious infection
3. Any major illness or evidence of unstable condition of major organ systems including psychiatric disease
4. Any condition possibly affecting the PK process of the study drug
5. Evidence of other skin conditions that would interfere with the evaluation of psoriasis
6. History of hypersensitivity to the ingredients of study drugs, history of anaphylaxis
7. Prior exposure to TYK2 inhibitors
8. Have received the prohibited treatment during the protocol required washout period
9. Any significant laboratory or procedure abnormalities that might place the subject at unacceptable risk during this study period
Effects of Brain Breaks on Educational Achievement in Laboratory Settings: The Break4Brain Project

Advancement in teaching methods, together with the frenetic change in the lifestyles of the school population, provides a unique opportunity to advance scientific knowledge. The current project, called "The Break4Brain Project", aims to examine the acute (transient) effects of physical activity on brain function, cognition, and academic performance in children with and without Attention Deficit Hyperactivity Disorder (ADHD). Specifically, a total of 60 children between 10 and 12 years old will be included with (n=30) and without (n=30) ADHD. The study will use an intra-subject design of isolated conditions with four measurement moments where the children will perform three different experimental conditions lasting 10 minutes, which will be randomized in a counterbalanced manner. These experimental conditions will be based on physical activity engaging cognitively, physical activity without engaging cognitively, and cognitively engaging control condition. This project could have a significant impact in the educational field, since, if brain function, cognition, and academic performance prove to be favorably stimulated, acutely, by physical activity through active breaks, these could be prescribed as an effective teaching strategy for children with and without ADHD in the school setting.


Eligibility Criteria:
Inclusion Criteria:

* Children aged 10-12 years diagnosed with ADHD by a recognized diagnostic procedure.
* Children aged 10-12 years without any neurodevelopmental impairment.

Exclusion Criteria:

* Children who have serious physical or mental disorders.
Assessment of the Psychological Impact of the COVID19 (SARS-CoV-2) Pandemic on Patients With Chronic Inflammatory Rheumatism

Patients with chronic inflammatory rheumatism (RIC) or autoimmune diseases, rheumatoid arthritis and spondyloarthritis, are regularly monitored in consultation as part of a "treat to target" strategy with rapid adaptation of treatments to the activity of their disease. according to French recommendations.

They are treated with immunosuppressive drugs: disease-modifying treatments with very often methotrexate, associated with biotherapies or targeted therapies (JAK inhibitors) They can also be treated transiently or over the long term with corticosteroids. These treatments expose them to greater infectious risks, especially with regard to COVID19.

The objective is on the one hand to assess the impact of the Covid 19 pandemic on general state of health of these patients and the evolution of their disease and on the other hand to prioritize the optimal care of these patients by including in the context of maintaining the pandemic reduction rules, modern telemedicine technologies.


Eligibility Criteria:
Inclusion Criteria:

All patients with chronic inflammatory rheumatism followed in the rheumatology department of the CHU de Limoges.

Exclusion Criteria:

Patients who object to the use of their data.
Effect of Kinesiotaping on Ankle Stability

Ankles sprains are the most popular injuries in basketball players. They are traumatic injuries, which happen most of the time in specific situations, like landing on another player's foot, or during changes of direction.

Neuromuscular exercises are very important to improve ankle stability and reduce risks of sprains. However various external support such as ankles braces and rigid tape, are also used in order to prevent injury.

The kinesiotape (KT) is a new but broadly used method in the world of athletes. Created by KenzoKase, in 1980, this kind of tape has a tremendous success with athletes and is today commonly used during practices and/or competitions. The main property of this tape is its elasticity, which is supposed to improve proprioception and, thus ankle stability, but these aspects have not been investigated yet.

Aim: Compare the effects of a kinesiotape (KT) with a sham treatment (KT put with no effects) and a control condition (absence of tape) in basketball players from the Swiss national league through balance tests on an unstable surface.

Hypotheses: A KT positioned on the lateral side of the leg improves ankle stability in basketball players while balancing on an unstable surface.

Method: 30 subjects will be recruited from different basketball teams affiliated to the Swiss national league. They will have to perform some postural stability tests on both unstable ("Delos") and stable surfaces ("Single Les Stance", "Star Excursion Balance Test", "Cross Over Hop Test for Distance") under three different conditions. The three condition will be as followed : with a KT positioned on the lateral side of the leg, with a sham tape or without tape. The three sessions will be spaced in time (7 days of wash out). The order of the three interventions (KT, Sham tape, no tape) will be randomized (cross over) to avoid the bias of learning processes. Neither the subjects nor the examiner will be aware of the "tape condition" (double blind); a physiotherapist will be in charge of positioning the tape according to the tested condition.

The sequence of the tests will be the same for all subjects and breaks are scheduled to avoid the effect of the fatigue. An anamnesis of all subjects will be done in order to evaluate history of injuries. At the end of each session, a visual analogical scale will be completed by the athlete to obtain a personal feeling of stability . The subject will be also asked to determine which condition was tested.

Expected results: the application of a KT on the lateral side of the leg improves postural stability on instable surfaces in elite basketball players.

Field's importance: the application of KT may reduce the risk of ankle sprains and the recurrence of sprains in a population of athletes at risk.

Eligibility Criteria:
Inclusion Criteria:

* active elite basketball players

Exclusion Criteria:

* no history of ankle sprain in the last 6 weeks
* no history of any other lower limbs lesion in the last 6 weeks