cyrilzakka/clinical-trials huggingface dataset:
Mapping the Human HIV Chronobiome

Individuals infected with HIV have a high risk of developing metabolic comorbidities not traditionally associated with the immune dysregulation and deficiency associated with HIV infection and AIDS. Many of these comorbidities in HIV uninfected individuals have been linked to a disordered circadian clock function. The study investigators will further evaluate the circadian clock in HIV infection as a mechanism underlying the metabolic dysregulation in this population.


Eligibility Criteria:
Inclusion Criteria:

* Cohort 1: Diagnosis of HIV infection with CD4+ counts \<500 cells/mm3 while untreated;
* Cohort 2: Diagnosis of HIV infection with CD4+ counts \<300 cells/mm3 on ARV;
* Cohort 3: Volunteers must be in good health as based on medical history, physical examination, vital signs, and laboratory tests as deemed by PI;
* Volunteers are capable of giving informed consent;
* 25-50 years of age;
* Own a smartphone which installs the remote sensing applications;
* Non-smoking;
* Male subjects only if feasible during recruitment; and
* In case female volunteers are invited to enroll: non-pregnant, female subjects must consent to a urine pregnancy test.
* Females of child bearing potential will be asked to use a medically accepted method of birth control (such as oral contraceptives, intra-uterine device (IUD), or condom with spermicide) while you participate in the study.
* The use of contraception will NOT be required for male participants.

Exclusion Criteria:

* Recent travel across more than two (2) time zones (within the past month);
* Planned travel across more than two (2) time zones during the planned study activities;
* Volunteers with irregular work hours, e.g. night shifts or becoming a parent;
* Use of illicit drugs;
* High dose vitamins (Vitamin A, Vitamin C, Vitamin E, Beta Carotene, Folic Acid and Selenium), alcohol and any over-the counter NSAID in the (2) two weeks before the start of the 48 hour deep phenotyping period (Females who are taking birth control pills can continue so for the duration of this study).;
* History of abdominal surgery;
* Subjects, who have received an experimental drug, used an experimental medical device within 30 days prior to screening, or who gave a blood donation of ≥ one pint within 8 weeks prior to screening;
* Subjects with any abnormal laboratory value or physical finding that according to the investigator may interfere with interpretation of the study results, be indicative of an underlying disease state, or compromise the safety of a potential subject.
* Women who are breastfeeding.
Masked Comparison of a New PEG Based Artificial Tear and Optive for Comfort, Vision & Wear Time in Patients Wearing Contact Lenses

The objective of this study is to evaluate the effect of a new PEG based artificial tear as compared to Optive on comfort, wear time, and vision in patients wearing contact lenses.


Eligibility Criteria:
Inclusion Criteria:

* Use of soft contact lenses (e.g. silicone hydrogel lenses, daily disposables etc.) and multipurpose solution for cleaning, including enzyme-based cleaners (ClearCare etc.)
* Able to wear contact lenses for approximately 10-12 hours/day
* Willingness to complete entire length of trial and comply with subjective questionnaire.

Exclusion Criteria:

* Patients taking topical cyclosporine (Restasis)
* Patients currently using Optive for dryness relief.
* Patients wearing hard or rigid gas permeable lenses
* Patients with uncontrolled systemic disease which may confound the results of the trial.
A Trial Comparing the Efficacy and Tolerability of Faslodex With Nolvadex in Postmenopausal Women With Advanced Breast Cancer

The purpose of this study is to compare the efficacy of Faslodex (fulvestrant) to Nolvadex (tamoxifen) as first-line treatment for postmenopausal women with advanced breast cancer. Patients will be treated until disease progression or until the investigator has determined that treatment is not in the best interest of the patient, whichever occurs first.


Eligibility Criteria:
Inclusion Criteria:

* Biopsy confirmation of breast cancer. Evidence of breast cancer that is not considered amenable to curative treatment.

Postmenopausal women. Written informed consent to participate in the study.

Exclusion Criteria:

* Previous treatment with hormonal therapy unless that therapy was tamoxifen for adjuvant breast cancer. The use of tamoxifen must have ceased at least one year before this study.

Previous treatment with Faslodex. Any existing serious disease, illness, or condition that will prevent participation or compliance with the study procedures.

Treatment with an investigational or non-approved drug within one month of then start of the study.
Human MATER and Idiopathic Infertility

Approximately 15 percent of couples experience infertility, yet no abnormalities can be detected in the man or the woman. In a number of couples, their embryos unexpectedly slow down growth or stop growth completely. Some of these situations may be genetically determined. For instance, a portion of cases may be caused by poor egg quality related to genetic or functional deficiencies in heretofore unidentified human maternal effect genes. A model has been developed of such unexplained fertility by creating a mouse line lacking a critical maternal effect gene. (Maternal effect genes produce mRNA or proteins that accumulate in the egg and are required for normal early embryonic development.) This pilot project will test the hypothesis that a similar defect may be a cause of human infertility.

Thirty cubic centimeters of blood will be collected from 40 women who have a clinical history consistent with a defective maternal effect gene. DNA from these blood cells will be examined and stored. Some of the blood cells will be treated so that they can be frozen and grown in the laboratory to produce more DNA in the future. If certain mutations are not found, that means that the prevalence of such mutations is less than 10 percent, and investigators may initiate another study with 100 women. If a common mutation is found in at least four patients, the investigators will seek to collect DNA from 150 normal fertile control women for comparison.

This project is purely investigational; therefore, findings will not be shared with participants.

...

The pilot investigation will examine the hypothesis that human infertility may be caused by mutations in the human MATER gene. We will determine the prevalence of these mutations in a select group of women who have a clinical infertility history consistent with a possible defect in a maternal effect gene. After obtaining informed consent and DNA from 100 women, relevant mutations in the MATER gene will be searched for by single strand conformation polymorphism analysis.

Eligibility Criteria:
* INCLUSION CRITERIA:

Women to be included in this study will have a clinical infertility history that would be consistent with a possible defect in a maternal effect gene.

This includes women who meet the following criteria:

1. a clinical diagnosis of infertility,
2. never been pregnant, and
3. undergone treatment by in vitro fertilization and had at least 8 fertilized eggs as part of at least one in vitro fertilization cycle that failed to lead to a clinical pregnancy.

Women who have subsequently achieved a pregnancy by egg donation will be included.

Women of any age are eligible as long as they have otherwise met the inclusion criteria.
Non-invasive Brain Stimulation for People With Stroke

Every five minutes someone in the UK has a stroke. It is the main cause of long-term disability among adults in the UK despite a fall in age-specific stroke incidence, with a growing number of survivors remaining dependent for activities of daily living. While most people with stroke regain walking ability, upper limb problems with no voluntary arm and hand activity, affecting a third of people after stroke, has a poor prognosis. Transcranial direct current stimulation (tDCS) is a non-invasive procedure used to polarise brain regions through the application of weak direct currents and has the potential to develop into a useful aid to treatment strategies in neurorehabilitation. Recent literature into the application of tDCS in people with arm and hand impairments after stroke has shown promising results on upper limb function measures like the Jebsen-Taylor hand function test. Furthermore, a recent pilot study evaluated a six-week training programme combining tDCS with robot-assisted hand training and reported significant improvements in upper limb function. However, the robot in the latter study focused on single-plane distal movements only and long-term effects of the tDCS were not assessed. Recent robotic developments included robots with three rotational degrees-of-freedom for the upper limb, but the effectiveness of this type of robot combined with tDCS in early stroke settings is unknown. Ethical Approval was sought from NHS NRES Committee South Central- Southampton B (Ref: 11/SC/0345) to conduct this study.


Eligibility Criteria:
Inclusion Criteria:

1. Have a confirmed clinical diagnosis of a haemorrhagic or an ischaemic stroke confirmed clinically or by CT, PET or MRI Scan
2. Experienced a single (first) stroke or multiple strokes
3. In the acute, sub-acute or chronic phase of their recovery (the first three to seven days are referred to as the acute phase. The first two weeks to six months are defined as the sub-acute phase, and the chronic phase begins after three or six months (Teismann et al. 2011, Duncan et al. 2003a)
4. Have had a subcortical or cortical stroke
5. Be over the age of 18 years
6. Have any level of upper limb impairment

Exclusion Criteria:

1. A history of epilepsy (TMS studies) due to the fact that TMS could cause an epileptic fit
2. Impaired gross cognitive function; score of less than 24 of the Mini-Mental State Examination (Folstein et al. 1975)
3. Any metal implants in the head including cochlear implants
4. Any another neurological condition apart from stroke
5. Are currently participants in another intervention study using TMS/tDCS
Sarcopenia Studies for the Elderly Population in Taiwan

Health promotion in the elderly has been a major recent public health concern. Sarcopenia is a term utilized to define the loss of muscle mass and strength that occurs with aging. It has been demonstrated to be associated with decreased functional capacity among the elderly. The magnitude of the public health problem posed by sarcopenia is not yet established. The purposes of this study are to investigate sarcopenia and its relationship with functional status in elderly Taiwanese community-dwellers, and to develop the preventive strategy for sarcopenia in the elderly. Firstly, the investigators will recruit 100 volunteers (aged 18-90 years old) to participate in this study. All of the participants will receive bioelectric impedance analysis (BIA), muscle strength and endurance assessment, physical activity level assessment by a seven-day recall questionnaire, protein intake assessment, cognition evaluation (Mini-Mental State Examination) and functional status assessment by the Functional Independence Measurement (FIM) questionnaire. A multiple regression model will be used for statistical analyses. Then, this project will be used to evaluate the efficacy of a 12-week supervised resistance strengthening exercise program for sarcopenia in the elderly. Participants who are defined as having sarcopenia from the previous examination will be randomized into either the exercise or control groups. Subjects in the exercise group will receive resistance strengthening exercises 3 times per week for 12 weeks. All measurements will be performed as described above. The investigators expect that resistance exercises are effective in offsetting age-related decline of muscle mass and strength in the elderly.


Eligibility Criteria:
Inclusion Criteria:

* 18-90 year old healthy adults

Exclusion Criteria:

* No systemic diseases
A Dose-ranging Study of Fluticasone Furoate (FF)

This is a Phase IIb, multi-centre, stratified, randomised, double-blind, double-dummy, parallel-group, placebo and active controlled study in children aged 5-11 years with persistent uncontrolled asthma. Subjects meeting all of the inclusion criteria and none of the exclusion criteria at the screening visit (Visit 1) will enter a four week run-in period during which time they will continue their current medications. Visit 2 will occur two weeks into the run-in period to allow a review of compliance with daily diary and run-in medication. At Visit 3 (end of run-in/randomization visit), subjects meeting the eligibility criteria who remain uncontrolled despite baseline therapy will be stratified based on pre screening inhaled corticosteroid (ICS) use. Once stratified, subjects will be randomised to the treatment phase of the study where they will receive one of five treatments for 12 weeks. Approx 1200 subjects ages 5 to 11 will be screened to achieve 575 randomized for a total of 115 randomized/evaluable subjects per treatment arm. Subjects will attend on-treatment visits at 2, 4, 8 and 12 weeks (Visits 4, 5, 6 and 7 respectively). A follow-up contact will be performed one week after completing study medication. All subjects must attempt spirometry measurements at Visits 1 and 3. For all subjects, a timed 24-hour urine collection for urinary cortisol and creatinine excretion will be performed prior to randomization at Visit 2 and within 7 days prior to Visit 7. All subjects must perform PEF daily between visits 1 and 7. The primary endpoint will be change from baseline in pre-dose (i.e. dosing trough) PM PEF from patient hand held electronic daily diary at Endpoint (Endpoint is defined as the mean over the last 7 days of treatment). Safety assessments include adverse events, oropharyngeal examinations, clinical chemistry, urinary cortisol, and vital signs.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent from at least one parent/ legal guardian to take part in the study.:
* Diagnosis of asthma
* pre-bronchodilator PEF between ≥50% to ≤90% of their best post-bronchodilator value
* Receiving therapy of short acting beta-agonist (SABA) alone, LTM, or ICS (total daily dose \<FP 200mcg or equivalent)Exclusion :

Exclusion Criteria:

* history of life-threatening asthma
* history of asthma exacerbation for asthma within 6 months prior to screening.
* Culture-documented or suspected bacterial or viral infection
* significant abnormality or medical condition
* Present use of any tobacco products
Mutational Oncology in Clinical Practice

The study of biological profiling is of fundamental importance in the diagnosis and treatment of many diseases, particularly oncological ones, and for this reason, the integration of molecular characterization into clinical practice becomes essential. NGS allows a high number of samples to be sequenced simultaneously, generating a great deal of genomic information in a short time and at reasonable cost. This information is of fundamental importance for the study of oncogenic drivers and gene alterations that may have a prognostic and/or predictive role in response to new molecularly targeted drugs.

Policlinico A. Gemelli has begun a process of internal reorganization of the research infrastructure following its recognition in 2018 as an Institute of Hospitalization and Treatment with Scientific Character (IRCCS) for its commitment to the disciplines of "Personalized Medicine" and "Innovative Biotechnology." In particular, with regard to genomics, will be equipped with a state-of-the-art technological asset that includes a fully automated process for sample preparation and the highest gene sequencing power available today. This condition makes it possible to perform extensive genomic profiling for large numbers of patients at low cost and in reasonable time.


Eligibility Criteria:
- Patients with neoplasm of the lung, breast, ovary, pancreas, prostate, colorectum, melanoma, GIST, thyroid neoplasm, endometrium, and cholangiocarcinoma:

1. BREAST Locally advanced or metastatic, hormone-responsive, HER2-negative breast neoplasm, progressing after endocrine therapy.
2. LUNG Metastatic disease.
3. OVARY Any stage of nonmucinous, non-borderline epithelial carcinoma of the ovary, fallopian tube, or primary peritoneal carcinoma.
4. PANCREAS Metastatic disease.
5. PROSTATE Metastatic castration-resistant disease.
6. COLORECTUM Metastatic disease.
7. MELANOMA Stage IV or stage III undergoing surgery.
8. GIST Profiling of c-KIT in case of metastatic disease or for patients undergoing surgery and of PDGFRα for all patients with inoperable or metastatic disease.
9. THYROID
10. ENDOMETRIUM
11. CHOLANGIOCARCINOMA
The Efficacy of Sodium-glucose Co-transporter 2 Inhibitor or Dipeptidyl Peptidase-4 Inhibitor in Type 2 Diabetes Patients With Premix Insulin

The population of type 2 diabetes increased enormously worldwide. As disease progression, uncontrolled type 2 diabetes patients need multiple daily insulin injections, but the risk of body weight gain and hypoglycemia will increase. In recent years, the newly oral anti-hypoglycemic agents developed, such as dipeptidyl peptidase-4 inhibitors (DPP4i) and sodium-glucose co-transporter 2 inhibitors (SGLT2i). The former indirectly stimulate insulin secretion and suppress glucagon through increase incretin. The later inhibit re-absorption of blood glucose in proximal renal tubule to improve hyperglycemia. According to the guideline published in 2017 by American diabetes Associations, if patients received premix insulin injections twice daily and their glycemic control can't meet the target, increase the frequency of injection such as basal bolus would be considered. However, it is difficult for some patients and it may cause more hypoglycemia and gain of body weight. Because previous report revealed dipeptidyl peptidase-4 inhibitors or sodium-glucose co-transporter 2 inhibitors added to insulin resulted in better glycemic control, but there was no direct comparison, so we design this study to observe the efficacy of these two drugs in uncontrolled diabetes patient received twice daily insulin injections.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes patient received premix insulin twice daily and HbA1c\>7%
* \>20 years old

Exclusion Criteria:

* Type 1 diabetes and gestational diabetes
* Diabetic ketoacidosis in previous 6 months
* Urinary tract infection in previous 6 months
* Pancreatitis in previous 6 months
* estimated GFR\<45 mL/min/1.73m2
* Patient whom already received DPP4 inhibitor or SGLT2 inhibitor
The European Paediatric Network for Haemophilia Management ( PedNet Registry)

Rationale:

Haemophilia is a rare disease; to improve knowledge international collaboration is needed. Well-defined clinical data will be collected from complete cohorts in order to prevent selection bias.

Objective:

To collect data on bleeding during neonatal period, endogenous (genetic) and exogenous (treatment-related) determinants of inhibitor development and long term outcome.

Design: Multicenter Prospective Observational Birth Cohort Study

Population:

Patients with haemophilia A and B with FVIII/IX levels of \<1 to 25% born between 1-1-2000 and 1-1-2030.

Intervention:

No intervention; only documentation of patient characteristics and parameters of routine patient care and outcome

Main outcome parameters:

Outcome: clinically relevant inhibitor development, bleeding pattern and joint status on physical examination and imaging.

Determinants: baseline FVIII/IX levels, measurement of inhibitory antibodies, family history, FVIII/IX gene mutation, details on replacement therapy (according to each infusion for the first 50 treatment days, and annually thereafter) and surgeries.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:

* No burden for the patients. Well-defined clinical data will be collected from the medical files. Participating in this registry will not change the number of visits to the clinic. All outcome parameters that are collected (including laboratory results) are part of routine clinical care.
* Direct benefit is not to be expected. However, the direct interaction between centres that treat patients with rare diseases improves both clinical care and will result in better guidelines and as such may provide indirect benefit.
* Multicentre participation: haemophilia is a very rare condition. Therefore, collecting data on a multi-centre observational cohort is the only way to study this specific population.
* The registry concerns young boys and girls with haemophilia and cannot be performed in older patients, as \>90% of inhibitors occur develop during the first 50 exposure days, and the results of prophylactic replacement therapy are highly dependent on the initiation of this treatment.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Haemophilia A or B
* Factor VIII/ IX activity of \<1 to 25%
* Complete records of Factor treatment and bleeds
* Treated in one of the participating centres

Exclusion Criteria:

* Patients referred because of an inhibitor\*
* Informed consent not obtained
Energy Deficiency and Athletic Performance

Energy availability (EA) refers to the balance between daily energy intake and exercise energy expenditure. Athletically inadequate EA is defined as low energy availability (LEA). Energy deficits occur throughout life, from young athletes with a relative lack of energy in sports or the female athlete triad to older adults struggling with weight loss. Acute and/or chronic LEA can cause negative athletic and health outcomes in athletes.

It is known that LEA, as an energy saving mechanism, suppresses the reproductive system and causes disruption of the menstrual cycle, as well as causing many interrelated endocrine-related physiological consequences by changing other hormonal pathways. Menstrual dysfunction due to LEA causes various risks as it can disrupt the EC during training and competition. Therefore, low EA may contribute to poor sports performance due to detrimental endocrine effects.

Various parameters such as body mass and nutritional intake affect the performance of athletes, and LEA is frequently reported among athletes with intense training programs. LEA combined with high training volumes; It can cause negative consequences such as impaired protein synthesis/degradation rate, impaired hormonal and training response, increased risk of fatigue, and these can lead to decreased performance. Resting metabolic rate, which indicates the energy expended for basic body functions, is considered a potential objective indicator of energy availability.

Regulation of dietary energy intake in the management of LEA in athletes covers a wide area in the literature. However, LEA is caused not only by a deficiency in energy intake but also by an excess in energy expenditure. In the light of this information, the aim of the study is to examine the acute period effects of the training program in which exercise energy expenditure is reduced in terms of energy availability and athletic performance.

Voluntary participants who have been diagnosed with energy deficiency will be included in the study. Signed voluntary consent will be obtained from participants. Participants will be divided into two groups. Study groups will be as follows: a) Modified Training, b) Routine Training.

Eligibility Criteria:
Inclusion Criteria:

* 18- 35 years old female gender
* Body mass index being less than 18.50-24.99 kg/m2
* Having a energy deficiency
* Been interested in basketball professionally for at least one year
* Must be training with the team at least 3 days a week
* Performance levels should be 3-4

Exclusion Criteria:

* Having a history of any fracture in the last year
* Having had a sports injury in the last 8 months
* Having had an infectious disease in the last 6 months being a smoker
* Getting 2 or more points from the SCOFF survey
* Having been using any medication regularly for the last 6 months