cyrilzakka/clinical-trials huggingface dataset:
Mapping Personality Traits to Genes

Previous research involving families, twins, and adoption all support the idea that there is a substantial heritable aspect to personality.

The goal of this research study is to determine how genetics influence heritable personality traits. The work will focus on how genetics affect the chemical messengers which brain cells use to communicate with each other (neurotransmitters).

The study involves collecting personality data and DNA samples from related individuals, primarily male siblings and female siblings, but also including parents. Genetic tests performed on these samples will continue to focus on variations in genes, which potentially effect brain neurotransmission.

This research has the potential to advance knowledge of genetic influences on human behavior that may be relevant both to normal personality and to psychopathology.

Building on family, twin and adoption studies suggesting that substantial aspects of personality are heritable, research under this protocol explores potential genetic influences on normal personality dimensions. We have previously reported associations between variation in neurotransmitter system genes and variation in personality traits, both across and within families, in a sample of the general population. This study involves collecting personality data and DNA samples from related individuals, primarily male siblings and female siblings, but also including parents. Genetic tests performed on these samples will continue to focus on variations in genes, which potentially affect brain neurotransmission. In some cases, participants are recontacted to specifically investigate whether identified variations in neurotransmitter system genes actually affect neurotransmission. Large population samples are needed in this research, particularly since a new epidemiologically standard population sample will be obtained. This research has the potential to advance knowledge of genetic influences on human behavior that may be relevant both to normal personality and to psychopathology.

Eligibility Criteria:
Personality data and DNA samples will be collected from related individuals, primarily pairs of male and pairs of female siblings, but also including parents.
Pediatric-inspired Regimen Combined With Venetoclax for Adolescent and Adult Patients With de Novo Philadelphia Chromosome-Negative Acute Lymphoblastic Leukemia

The pediatric-inspired regimen has greatly improved the prognosis of adult patients with with Philadelphia chromosome-negative acute lymphoblastic leukemia (Ph- ALL), but relapse remains a great challenge. Venetoclax (Ven) is an oral, selective inhibitor of B-cell lymphoma 2 (Bcl-2). Although this drug is currently used primarily for acute myeloid leukemia, in vitro as well as small cohort studies suggest a effect in acute lymphoblastic leukemia. This study proposes to combine pediatric-inspired regimen with venetoclax for the treatment of adult patients with Ph- ALL, aiming to improve the MRD-negative complete remission rate measured by flow cytometry after induction and to reduce relapse, thus further improving patients overall survival.


Eligibility Criteria:
Inclusion Criteria:

* De novo and primary Ph/BCR-ABL1 negative acute lymphoblastic leukemia diagnosed by the bone marrow cytomorphology, immunophenotyping, cytogenetics and molecular biology according to WHO classification
* Age: 14 -60 years
* Male or female
* ECOG Performance Status 0-2
* Adequate end organ function as defined by: Total bilirubin ≤ 1.5 x upper limit of normal（ULN）; serum alanine aminotransferase (ALT) and serum aspartate aminotransferase (AST) ≤ 2.5 x ULN or ≤5 x ULN if leukemic involvement of the liver is present; Creatinine ≤ 1.5 x ULN; Serum amylase and lipase ≤ 1.5 x ULN; Alkaline phosphatase ≤ 2.5 x ULN unless considered tumor related; normal electrolytes: Potassium ≥ LLN; Magnesium ≥ LLN; Phosphorus ≥ LLN; Cardiac color Doppler ultrasound ejection fraction ≥ 45%;
* Subject has provided written informed consent prior to any screening procedure

Exclusion Criteria:

* Burkitt lymphoma/leukemia
* Acute Leukemia of Ambiguous Lineage
* Female patients who are pregnant or breast feeding
* Uncontrolled active serious infections that could, in the investigator's opinion, potentially interfere with the completion of treatment
* History of pancreatitis
* Poorly controlled diabetes, defined as glycosylated hemoglobin (HbA1c) values of \>7.5%. Patients with preexisting, well-controlled diabetes are not excluded
* History of active gastrointestinal bleeding within the last 6 months
* History of arterial/venous thrombosis within the last 6 months
* Known HIV seropositivity
* Any serious psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment
Pilot Prospective CGM Quality Improvement (QI) Project in Pregnancy

A single-center, prospective, 'open-label,' investigator-initiated pilot study evaluating the role of continuous glucose monitor (CGM) use either alone or with remote monitoring capabilities during pregnancy associated with T1DM.

A single-center, prospective, 'open-label,' investigator-initiated pilot study evaluating the role of continuous glucose monitor (CGM) use either alone or with remote monitoring capabilities that enable subjects to share CGM data with family and friends (whom the investigators will call "followers" in this protocol) among women with T1DM associated with pregnancy.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent before any study-related activities
* Female aged 18 years and older
* T1D duration \>1 year
* Pregnancy with confirmation of gestational age 13 weeks or less
* Willingness to routinely practice at least 3-7 blood glucose measurements per day
* Using MDI or CSII therapy
* Willingness to provide an A1C level
* Ability and willingness to adhere to the protocol including scheduled study visits for the duration of the pregnancy
* Able to speak, read, and write English

Exclusion Criteria

* Extensive skin changes/diseases that inhibit wearing a sensor on normal skin
* Known allergy to adhesives
* Any other condition, as determined by the investigator, which could make the subject unsuitable for the trial, impairs the subject's suitability for the trial, or impairs the validity of the informed consent
Evaluating the Safety of the SPECTRALIS CENTAURUS Device

The objective of this clinical trial is to evaluate the safety of the SPECTRALIS CENTAURUS device (HuCE-optoLab, BFH TI, Biel, CH) in a clinical setting on patients with retinal diseases.

Optical microsurgery of the retinal pigment epithelium (RPE) requires reliable real-time dosimetry to prevent unwanted overexposure of the neuroretina. The SPECTRALIS CENTAURUS device implements optical coherence tomography (OCT) to detect intentional elimination of RPE cells caused by a prototype laser for selective retina therapy (SRT).

Within this clinical trial the safety of the SPECTRALIS CENTAURUS device and its ability to detect RPE cell damage towards selective real-time laser microsurgery will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Written Informed Consent
* For Stage 1, any patient aged \>18 years with the need for conventional laser retina ablation
* For Stage 2, will be restricted to people aged 50 to \<95 years with lesion characteristics that meet the criteria for intermediate AMD

Exclusion Criteria:

* Presence of reticular pseudodrusen
* Any manifestation of late-stage AMD
* Known hypersensitivity or allergy to fluorescein or uncontrolled hypertension
* Concomitant systemic corticosteroid treatment for continuous period longer than 2 weeks
* History of any vitreous haemorrhage within 4 weeks prior to screening or current haemorrhage in the study eye
* Inability to obtain fundus photographs or fluorescein angiogram of sufficient quality
* Photosensitive epilepsy
* Insufficient retinal pigmentation (albinism)
* Corneal opacity / lens opacity
* Women of child-bearing potential
* Contralateral eye is at an advanced stage of disease and has poor visual acuity
* Inability to follow the procedures of the study
* Participation in another study with investigational drug within the 30 days preceding and during the present study - Inability or lack of willingness to commit to return for all clinical visits and complete all study-related procedures
Investigation of Factors Associated With Preserved Cognitive Function in Bipolar Disorder

Bipolar disorder (BD) ïs the fourth leading cause of disability worldwide among young people. Differences in demographic and clinical characteristics between patients do not influence educational achievement and receipt of disability pension, indicating that there are other factors such as neurocognitive function that are of importance for maintaining occupational and social function. Research has shown that at the group level, cognitive deficits are present in euthymic BD patients, while approximately 30%-50% of BD patients is not different from healthy controls when it comes to cognitive function. There is however little knowledge of risk and resilience factors for cognitive impairment in BD. Factors likely to contribute to cognitive and functional outcomes in BD, such as sleep, obesity, biological rhythms, comorbid medical and psychiatric conditions are also understudied. While it has been customary to focus research on factors related to the negative illness trajectories, the overarching aim of the current project is to explore factors associated with favourable outcomes. This shift in research focus is essential to elucidate factors related to more preserved function since this represents a clear gap in knowledge today.

This is an observational and prospective study aimed at identifying risk and resilience factors for cognitive impairment in BD. The investigators will enrol 85 participants with bipolar disorder. The assessment period is from one up to two weeks. At inclusion, the investigators will examine other psychiatric conditions, known somatic diseases and symptom levels of depression and hypo-/mania. Insomnia severity and risk factors for metabolic syndrome will also be assessed. Secondly, the investigators will examine sleep and Activity extensively with both subjective and objective measures for one to two weeks. Third, a newly developed web-based neuropsychological test protocol will be used shortly after assessment of sleep and activity to test cognitive function. Fourth, alcohol use, substance use and biological rhythms will be assessed. Lastly, the investigators will retest cognitive function and symptom levels up to five years after enrolment.

Eligibility Criteria:
Inclusion Criteria:

* Individuals aged \>=18 years who score \<= 16 on the MADRS or \<= 8 on the YMRS.
* Willing and able to give online informed consent.

Exclusion Criteria:

* Symptom level above inclusion criteria will be put on a waiting list, and if informed consent is given, will be included when symptom level is reduced.
* No Norwegian fluency.
A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes on Metformin With or Without Sulfonylurea (SURPASS-AP-Combo)

The main reason for this study is to compare the study drug tirzepatide to insulin glargine in participants with type 2 diabetes on metformin with or without a sulfonylurea.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus
* Treated with stable metformin with or without a sulfonylurea (metformin ≥1000 milligrams/day; sulfonylurea should be at least half the maximum dose) for at least 2 months
* Are insulin-naive (except for the use of insulin for treatment of gestational diabetes or short-term use \[≤14 consecutive days\] for acute conditions)
* HbA1c ≥7.5% to ≤11.0% at screening
* Stable weight (±5%) ≥3 months, and agree to not initiate a diet and/or exercise program during the study with the intent of reducing body weight other than the lifestyle and dietary measures for diabetes treatment
* Body mass Index (BMI) ≥23 kilograms per meter squared

Exclusion Criteria:

* Type 1 diabetes mellitus
* Have history of chronic or acute pancreatitis
* Have history of proliferative diabetic retinopathy; or diabetic maculopathy; or non-proliferative diabetic retinopathy that requires acute treatment
* Have a history of severe hypoglycemia and/or hypoglycemia unawareness within the 6 months
* Have a history of ketoacidosis or hyperosmolar state/coma
* Have a known clinically significant gastric emptying abnormality, have undergone or plan to have during the course of the study, or chronically take drugs that directly affect GI motility
* Have acute myocardial infarction (MI), stroke or hospitalization due to congestive heart failure (CHF) within 2 months
* Have family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
* Have been treated with prescription drugs that promote weight loss or similar other body weight loss medications including over the counter (OTC) within 3 months
HIV Vertical Transmission in Vietnam

Prevention of HIV-1 transmission from mother-to-child by non-breast-feeding is complicated by increased infant mortality in developing countries. However, extensive counselling about formula feeding turned out safe in Vietnam, a middle-income country.Extensive counselling together with formula feeding and antiretroviral therapy reduced vertical transmission of HIV-1 considerably.

Observation 135 HIV mother to check up and delivery in the Obstetric and Gynecology in two big city in Northern Vietnam (Hanoi and Haiphong)and follow up their children from the birth to 18 months. They were provide the antiretroviral by the National program for prevention of mother-to-child transmission of HIV, also the counseling estimates 6 hours for each mother-child pair while study progressing. Using the Nested PCR to diagnosis HIV infected in the children in difference time point before 18 months. Our Outcome are

* The rate of HIV transmission form mother to child in our study is 6,7%(9?135). In utero is 1,5% and 5% in gestation.
* Sixty-nine percent of HIV pregnant women were get antiretroviral. Most of them (84%) get nevirapine at delivery (6 children HIV infected). The rest get triple antiretroviral(2 infected child).
* Selective cesarean section not comment for HIV pregnant women.
* Non breast feeding were recommended and all mothers chose formula feeding to their child so that we had no data for transmission by breast milk.
* Two HIV infected child die before 18months versus non die in uninfected child.
* CD4 T cell count lower than 200/microliter were observed dominate in mother infected child.

Eligibility Criteria:
Inclusion Criteria:

* HIV Mother willing to enroll to study and their child For mother: Their HIV status was diagnosed by at least one quick test and two different ELISA serological tests.

For their child: the child had tested HIV at list 3 time one at birth, one at 12 or 18 months and one in between.

Exclusion Criteria:

* The child had less than 3 time to test.
A Study Evaluating Hypotension and Autonomic Nervous System Dysfunction in Multiple Myeloma (MM) Patients

The purpose of this study is to determine whether the orthostatic hypotension reported among subjects during bortezomib-containing regimen is caused by a dysfunction of the autonomic nervous system (ANS).

1. To gather pilot data on the incidence of autonomic dysfunction in patients with Multiple Myeloma prior to treatment with Bortezomib.
2. To characterize the changes in the ANS including the fluctuations in blood pressure (hypotension /hypertension) associated with bortezomib.
3. To determine the duration of the ANS dysfunction if present.

This is not a treatment study, only an evaluation of the autonomic nervous system (ANS) among subjects receiving antimyeloma therapy which includes bortezomib (Velcade).

Eligibility Criteria:
Inclusion Criteria:

* Subjects with Active Multiple Myeloma who are scheduled to be treated with Bortezomib-containing regimens.
* Subjects must have signed an IRB-approved informed consent indicating their understanding of the proposed treatment and understanding that the protocol has been approved by the IRB.

Exclusion Criteria:

* Subjects with unstable cardiovascular disease. Recent (\< 6 months) myocardial infarction, unstable angina, difficult to control congestive heart failure, uncontrolled hypertension, or difficult to control cardiac arrhythmias.
* Subjects unable to perform the Valsalva maneuver such as patients with clinically significant aortic stenosis, glaucoma or retinopathy.
* Subjects receiving Selective Serotonin Reuptake Inhibitors.
Effects of Angeliq and Prempro on Blood Pressure and Sodium Sensitivity in Postmenopausal Women With Prehypertension

The main purpose of this study is to compare the effects of treatment of two different formulations of Angeliq® and Prempro on blood pressure in post-menopausal women with prehypertension.

This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.Bayer HealthCare Pharmaceuticals, Inc. is the sponsor of the trial.

Eligibility Criteria:
Inclusion Criteria:

- Postmenopausal women 45 - 65 years old with prehypertension

Exclusion Criteria:

- Hormone therapy (estrogen/progestin)
Non-thermal Plasma for Sebum Reduction in Oily Facial Skin

The aim of this study is to evaluate the efficacy and safety of argon-and nitrogen- non-thermal, atmospheric-pressure plasma (NTAPP) for reduction of sebum excretion in healthy volunteers with oily facial skin.

Excessive secretion of sebum contributes to several skin diseases associated with sebum glands, including acne. Excessive sebum secretion can damage the skin barrier function by changing the composition of skin surface lipids, leading to the abnormal keratinocyte differentiation and hyperkeratosis in the follicular ostia. Follicular hyperkeratosis can create anaerobic environment, leading to the proliferation of Propionibacterium acnes.

Recently, several energy devices targeting sebaceous glands have been developed, but there is still a need for an effective and safe therapeutic tool for hyperseborrhea. Non-thermal, atmospheric-pressure plasma (NTAPP) has various biological effects. A recent study demonstrated NTAPP-induced microscopic tissue reactions in the sebaceous glands from rat skin in vivo, suggesting that the potential effect of NTAPP on the human sebaceous gland physiology, but the relevant data are lacking. In this study, investigators aim to assess the safety and efficacy of argon- and nitrogen-NTAPP for reduction of sebum excretion in oily human facial skin.

Eligibility Criteria:
Inclusion Criteria:

1. Persons aged 19 to 40 years who are determined to have oily skin type. Skin types were classified based on the sebum measurements by using measured using a Sebumeter® (SM815; Courage+Khazaka Electronic GmbH, Cologne, Germany) according to the manufacturer's guidelines as follows: \> 220 μg/cm2 on forehead and \> 180 μg/cm2 on cheeks, oily type; 100-220 μg/cm2 on forehead and 70-180 μg/cm2 on cheeks, normal type; \< 100 μg/cm2 on forehead and \< 70 μg/cm2 on cheeks, dry type.
2. People with mild acne-like skin whose upper limit is Grade 1 (Few lesions; No nodules, papules/pustules less than 1, few comedones) and Grade 2(Mild; No nodules, papules/pustules less than 5, some comedones) of the Korean acne severity system
3. Persons who skin color of type I to III according to Fitzpatrick skin type
4. Persons who do not have inflammatory skin diseases on the facial skin
5. Persons who have heard the purpose and contents of a clinical trial and voluntarily signed the consent form prior to the clinical trial
6. Persons who can be monitored during a clinical trial period

Exclusion Criteria:

1. Persons who do not want this study or do not write a consent form
2. Persons who have a history of hypertrophic scars, keloids, etc.
3. Persons who have been using retinoid formulations within the last 1 month due to excessive sebum secretion or acne
4. Persons who have a history of receiving treatments such as lasers or fillers on your face within the last 1 month
5. Persons who is pregnant or lactating, or have a pregnancy plan within the expected trial period
6. Other cases in which the study is considered difficult due to the judgment of the principal investigator
Safety and Pharmacokinetics of ASA404 When Given Together With Fluvoxamine, a Selective Serotonin Receptor Reuptake Inhibitor and CYP1A2 Inhibitor

This trial is designed to study the drug-drug interaction between ASA404 and fluvoxamine, an inhibitor of its metabolic pathway (CYP1A2). The study will consist of two phases. The purpose of the Core Phase is to study the drug drug interaction between fluvoxamine and ASA404. The purpose of the Extension Phase is to provide continued treatment for those patients that have not progressed during the Core Phase and to collect safety data on ASA404 when given in combination with paclitaxel, docetaxel or the paclitaxel plus carboplatin chemotherapy regimen.


Eligibility Criteria:
Inclusion Criteria:

1. Patients having a histologically-proven and radiologically-confirmed advanced or metastatic solid tumor.
2. WHO Performance Status of 0-2.
3. A minimum of 4 weeks must have elapsed since the last treatment with other cancer therapies.
4. Laboratory values within the ranges, as defined below:

   * ANC ≥ 1.5 X 109 /L
   * Platelets ≥ 100 X 109 /L
   * Hemoglobin ≥ 10 g/dL
   * Serum total bilirubin is within normal range

Exclusion Criteria:

1. Patients having CNS metastasis or evidence of leptomeningeal disease.
2. Patients with any of the following:

   * any clinical or electrocardiographic evidence of cadiac ischemia
   * poorly controlled hypertension
   * family history of unexplained sudden death
   * long QT syndrome
   * history of ventricular fibrillation or torsade de pointes
   * congestive heart failure (NYHA class III or IV)
   * myocardial infarction within 12 months of starting study treatment
3. History of neuroendocrine tumors (e.g. carcinoid tumor, pancreatic islet cell tumor).
4. Significant neurological or psychiatric disorder.
5. Smokers (use of cigarettes within the last 3 months).
6. Concomitant use of drugs that are associated with QTc interval prolongation or have a risk of causing torsade de pointes.
7. Concomitant use of serotonin reuptake inhibitors (SSRIs), 5-hydroxytryptamine (5-HT) receptor agonists or selective serotonin / nor-epinephrine reuptake inhibitors (SNRIs) within 30 days prior to starting study treatment.
8. Concomitant use of somatostain analogues (i.e. octreotide, lanreotide within 30 days prior to starting study treatment.

Other protocol-defined inclusion/exclusion criteria may apply