cyrilzakka/clinical-trials huggingface dataset:
A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood

This study aims to investigate the effect of multiple doses of BI 1358894 on pharmacokinetics of ethinylestradiol (EE) and drospirenone (DRSP) (Yasmin®)


Eligibility Criteria:
Inclusion Criteria:

1. Healthy premenopausal female subjects according to the assessment of the investigator, as based on a complete medical history including a physical and gynaecological examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
2. Age of 18 to 35 years (inclusive)
3. Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive)
4. Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
5. Female subject who meet any of the following criteria for a highly effective contraception from at least 30 days before the first administration of trial medication until 30 days after trial completion:

   * Use of an oral hormonal contraception method in combination with a barrier contraception method and willing to stop the hormonal method and to continue using the barrier method plus Yasmin® for the duration of the trial
   * Use of non-hormonal intrauterine device (IUD)
   * Sexually abstinent
   * Female subject who underwent tubal ligation
   * A vasectomised sexual partner who received medical assessment of the surgical success (documented absence of sperm) and provided that partner is the sole sexual partner of the trial participant

Exclusion Criteria:

1. Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator (e.g. pronounced varicosis, thrombophlebitis, and evidence of peripheral circulatory disturbances)
2. Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimetre(s) of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 beats per minute (bpm)
3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
4. Any evidence of a concomitant disease assessed as clinically relevant by the investigator
5. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
6. Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
7. Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
8. History of relevant orthostatic hypotension, fainting spells, or blackouts

Further exclusion criteria apply
Use of Silodosin to Treat Moderate to Severe Abacterial Chronic Prostatitis/Chronic Pelvic Pain Syndrome.

The primary objective is to compare the efficacy of silodosin 4 and 8 mg once daily with placebo in the treatment of subjects with moderate to severe abacterial chronic prostatitis/chronic pelvic pain syndrome during a 12 week treatment period. The secondary objective is to compare the safety of silodosin 4 and 8 mg once daily with placebo.

A Multi-Center, Double-Blind, Placebo-Controlled Investigation of Silodosin in the Treatment of Subjects With Moderate to Severe Abacterial Chronic Prostatitis/Chronic Pelvic Pain Syndrome.

Eligibility Criteria:
Inclusion Criteria:

* Male, at least 18 years of age
* Has a total NIH-CPSI total score of 15
* Has a NIH-CPSI pain score of 8
* Has had pain in the pelvic region for at least 3 months prior to screening

Exclusion Criteria:

* Has previously participated in a Watson study with silodosin
* Has previously received α-blocked therapy for chronic prostatitis/chronic pelvic pain syndrome or is currently receiving α-blocked therapy for any condition
* Has experience ≥2 urinary tract infections within the previous 12 months
* Has any medical condition that in the opinion of the investigator precludes safe participation in the study
* Has any medical condition that could confound the efficacy evaluation
* Is receiving ketoconazole, or other known potent inhibitors of cytochrome P450 3A4 or any medication in the opinion of the investigator that precludes safe participation in the study
* Is receiving any medication that in the opinion of the investigator that could confound the efficacy evaluation
* Has participated in a study involving the administration of an investigational agent within the past 30 days
Arterial Stiffness and Decreased Bone Buffering Capacity in Hemodialysis Patients

Renal patients have an increased risk for cardiovascular complications. There is also increased vascular calcification and bone metabolism is similarly abnormal in patients with chronic kidney disease.

In dialysis patients frequent episodes of hypercalcaemia occur. In a healthy bone structure those episodes of hypercalcemia are buffered by the bone. The absence of bone buffering capacity in dialysis patients can be a mechanism for vascular calcifications.

Study hypothesis.

Patient with a higher ∆ Calcium (Calcium post - Calcium pre) have a diminished bone buffering capacity indicative for adynamic bone disease compared with patients with smaller ∆ Calcium.

This may result in higher extraosseous calcification and higher pulse wave velocity

∆ PTH/∆ Calcium may reflect the sensitivity and density of the calcium receptors; this may reflect parathyroid "health"

Eligibility Criteria:
Inclusion Criteria:

* maintenance hemodialysis patients

Exclusion Criteria:

* dialysis \<3 months
* aortobifemoral graft
* calcium level predialysis \>10.5 mg/dl
OMILQ: Osteopathic Manipulation to Increase Lactation Quantity (OMILQ)

This study is designed to investigate whether using osteopathic manipulation can increase the milk supply in lactating women.

The short and long-term benefits of breastfeeding to both the mother and infant are well established. Benefits for the child range from protection against common childhood infections, decreased rates of type-2 diabetes and systolic hypertension, lower rate of sudden infant death syndrome, increased performance on intelligence tests, and possible reduction in obesity. Maternal benefits include a reduction in the risk of breast cancer, diabetes, hyperlipidemia, hypertension, myocardial infarction, obesity, and ovarian cancer. Given this evidence the World Health Organization (WHO) and the American Academy of Pediatrics recommend, exclusive breastfeeding of infants for the first six months. WHO goes on to recommend breastfeeding to 2 years and beyond if mutually agreeable to both the mother and child. Despite these benefits and recommendations, according to the Centers for Disease Control and Prevention (CDC) in the United States 81% of infants were started breastfeeding and only 51% continued at 6 months. Perceived or actual low milk supply is one of the most common reasons for discontinuing breastfeeding.

This protocol is designed to investigate scientifically our current osteopathic standard of care. There is no available research data to date specifically on using osteopathic manipulation as an intervention to increase milk supply in lactating women.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 - 40
2. Between 2 and 28 weeks postpartum from a live infant birth weighing at least 2500g
3. Desire to exclusively breastfeed
4. Able to provide informed consent
5. Available for the duration of the study
6. 1 hour milk volume of less than 1oz (or 2oz for twins)
7. All current nurslings are the same age

Exclusion Criteria:

1. Current use of domperidone
2. Current use of metoclopramide
3. Current use of silymarin
4. History of breast surgery
5. Current malignancy
6. Current pulmonary embolism or deep vein thrombosis
7. Current medical condition resulting in increased intra-cranial pressure
8. History of insufficient glandular tissue (IGT)
Cerebral Infarction and White Substance in Angiopathy Cerebral Amyloid

The cerebral amyloïd angiopathy ( AAC) is a disease characterized by deposits of beta-amyloid peptids in the walls of the arteries of young and average calibre of the brain and the leptomeninx. The incidence of the AAC increases strongly with the age and represents a major cause of spontaneous brain haemorrhage to people over 60. The main demonstration is the lobar brain haemorrhage, the other ones are bleedings under arachnoid cortical and microbleedings leading to cognitive decline.

Anatomical studies reported the presence of cortical infarcts in patients having amyloïd deposits suggesting an association between asymptomatic cortical cerebral infarcts and AAC.

However prevalence and meaning of these infarcts in patients having an AAC remain badly known because of studies on low number of patients and the rarity of radiological analyses of these infarcts .A better knowledge of these asymptomatic cortical infarcts would allow to dread better cognitive disorders(confusions) presented by these patients, and to develop preventive strategies.

Besides, the risk factors of severity of the AAC are little studied.


Eligibility Criteria:
Inclusion Criteria:

* age\>55
* hospitalized in CAEN hospital and Paris St Joseph Hospital between 1st january 2011 and 31 december 2015 for cerebral haemorrhage with MRI images diagnosing cerebral amyloid angiopathy.

Exclusion Criteria:

* Insufficient MRI images quality without FLAI sequence, T2 GRE
* disease with same radiologic and clinical signs that cerebral amyloid angiopathy.
OCT Angiography Software Evaluation Study

Comparisons for vascular structure visualization in the retina and choroid.

Evaluate the clinical performance of the Maestro2 OCTA for the visualization of the vascular structures of the retina and choroid.

Eligibility Criteria:
Pathology Population Inclusion Criteria

1. 22 years of age or older on the date of informed consent
2. Able to understand the written informed consent and willing to participate by signing the informed consent
3. Current diagnosis of one or more of the following pathologies in the study eye in two subgroups:

   1. Vascular pathologies primarily visualized in Superficial and Deep en face OCTA slabs, including but not limited to Diabetic Retinopathy (DR), Branch Retinal Vein Occlusion (BRVO), Central Retinal Vein Occlusion (CRVO), Central Retinal Arterial Occlusion (CRAO), Macular Telangiectasia (MacTel), Sickle Cell Retinopathy (SCR)
   2. Vascular pathologies primarily visualized in Outer Retina and Choriocapillaris en face OCTA slabs, including but not limited to Neovascular Age-Related Macular Degeneration ("wet" AMD) and Polypoidal Choroidal Vasculopathy (PCV) Exclusion Criteria

1. Subjects previously enrolled in Maestro2 OCTA feasibility study 2. Subjects who are pregnant or lactating\* 3. Unable to complete the required clinical examinations 4. Contraindication to pupil dilation 6. Known allergy or other contradictions to fluorescein and/or to indocyanine green or iodides

Normal Population Inclusion Criteria

1. 22 years of age or older on the date of informed consent
2. Able to understand the written informed consent and willing to participate by signing the informed consent
3. BCVA 20/40 or better in the study eye Exclusion Criteria

1. Subjects previously enrolled in Maestro2 OCTA feasibility study 2. Subjects who are pregnant or lactating\* 3. Unable to complete the required clinical examinations 4. Clinically significant findings in the study eye in clinical examination 5. Contraindication to pupil dilation 7. Known allergy or contradictions to fluorescein and/or to indocyanine green or iodides
Study of Safety and Efficacy of MY008211A in Patients With Residual Anemia Despite Anti-C5 Antibody Treatment

The main purpose of this study is to evaluate the efficacy of MY008211A in PNH patients with residual anemia despite treatment with anti-C5 antibody.

This is a multicenter, single-arm, open-label phase III clinical trial. The purpose of this study is to determine whether MY008211A is efficacious and safe for the treatment of PNH patients Who Are Still Anemia After Anti-C5 Antibody Treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Male and female participants ≥ 18 years of age and BMI ≥ 18.0 kg/m2 with a diagnosis of PNH confirmed by high-sensitivity flow cytometry with clone size ≥ 10%.
2. Stable regimen of anti-C5 antibody treatment for at least 6 months before treatment, and Hb was still \< 100 g/L.
3. The average hemoglobin level of at least two tests in 4 months before screening \< 100 g/L.
4. The average hemoglobin level of two tests in the central laboratory during screening \< 100 g/L.
5. Vaccination against Neisseria meningitidis infection is required prior to the start of study treatment. If not received previously, vaccination against Streptococcus pneumoniae and Haemophilus influenzae infections should be given.

Exclusion Criteria:

1. Patients with reticulocytes \<100x10\^9/L; platelets \<30x10\^9/L; neutrophils \<0.5x10\^9/L.
2. History of recurrent invasive infections caused by encapsulated organisms,e.g. meningococcus or pneumococcus.
3. Known or suspected hereditary complement deficiency.
4. Previous bone marrow or hematopoietic stem cell transplantation.
5. Previous splenectomy.
6. A history of malignancy within 5 years before screening, except cured local basal cell carcinoma of the skin and carcinoma in situ of the cervix.
Neurobehavioral Functioning in Pediatric Brain Tumor Patients After Proton Beam Radiation Treatment

The aim of this study is to follow up with all of the pediatric brain tumor patients who received proton beam radiation therapy at Massachusetts General Hospital (MGH) for which there is baseline neuropsychological testing in order to measure changes, if any, in neurobehavioral functioning (executive skills, emotional/behavioral functioning, and adaptive abilities) and their use of special education services at one year or more post-treatment. The investigators will also correlate neurobehavioral data with pertinent clinical information. Participation will be maximized through the use of mail-in, parental- and self-report questionnaires.

The purpose of this study is to longitudinally examine neurobehavioral functioning outcomes and use of special education services in brain tumor and CNS tumor patients treated with proton radiation at MGH. Furthermore, we seek to correlate neurobehavioral data with pertinent clinical information. We anticipate better neurobehavioral functioning to be associated with use of protons (vs. photons, as reported in the literature). We also anticipate the need and utilization of special education services to be lower in brain and CNS tumor patients treated with protons (vs. photons, as reported in the literature). Lastly, we anticipate greater neurobehavioral deficits in patients whose proton radiation treatment involved the craniospinal axis compared to those who received proton radiation to the involved field.

Eligibility Criteria:
Inclusion Criteria:

1. Children diagnosed with brain or CNS tumors and treated with proton radiation therapy at the MGH Francis H. Burr Proton Center since September 2002
2. Patients received baseline neurocognitive testing at MGH
3. Patients ≤25 years at the time of diagnosis
4. Tumor location in the brain or CNS
5. Radiation treatment consisted of only proton radiotherapy
6. No prior radiation exposure or chemotherapy

Exclusion Criteria:

1. Patients receiving treatment with palliative intent
2. Patients who do not wish to participate
3. Patient is deceased at ≥1 year follow-up
Outcomes of Patients Who Had an Incomplete Colonoscopy After a Positive Fecal Immunological Test

In France, colorectal cancer (CRC) is the second leading cause of cancer death. Its organized screening (Organized ColoRectal Cancer Screening: DOCCR), now carried out by immunological test for occult blood in the stool, has proven its effectiveness. When the immunological test is positive, the Haute Autorité de Santé recommends a total colonoscopy. In 5 to 10% of cases, this colonoscopy is incomplete. The renewal of the endoscopic procedure or the performance of additional second-line examinations are then recommended. At present, however, the respective place of second-line examinations to be performed in this situation is not the subject of specific and validated recommendations.


Eligibility Criteria:
Inclusion criteria:

* Age between 50 and 75 years old at the time of the colonoscopy
* With incomplete colonoscopy performed in 2018 after a positive fecal immunological test as part of the DOCCR
* Patient whose follow-up has ended
* Patient living in the Grand-Est region and in the department of the site concerned
* Examination carried out by a gastroenterologist from the Grand-Est region
* Subject not having expressed, after information, his opposition to the reuse of his data for the purposes of this research

Exclusion criteria:

* Age ≥ 76 years at the time of colonoscopy
* Colonoscopy performed after a positive Hemoccult® test (screening technique older than the immunological test and different sensitivity / specificity)
* Colonoscopy performed before the fecal immunological test
* Gastroenterologist performing the examination practicing outside the Grand-Est region
* Subject not able to understand the objectives of this research
* Subject under judicial control
* Subject under tutorship or curatorship
Effects of Muscle Fatigue and Kinesio Taping on Shoulder Position Sense

The purpose of this study is to investigate the effects of Kinesio Taping on the position sense of shoulder after muscle fatigue.


Eligibility Criteria:
Inclusion Criteria:

* Healthy participants

Exclusion Criteria:

* prior shoulder surgery
* shoulder injury that required rehabilitation in the last 2 years
* shoulder dislocation
* ligamentous laxity
HEARTS R34 Feasibility Study, Autistic Participants

The goal of this randomized clinical trial is to test whether the 6 sessions HEARTS Healthy Relationships classes increases the satisfaction that autistic adults feel about their friendships and dating relationships compared to a 6 weeks online discussion group. The 6 HEARTS sessions cover: healthy and unhealthy relationships, launching new relationships, neurohealth, meeting and reconnecting, boundaries, and healthy endings.

Participants who take part in this research study will be in this research study for three months. During this time, participants will be asked to complete two 30-minute and six 10-minute online surveys, and participate in two 20-minute interviews over Zoom.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with autism by a healthcare provider or other professional
* Willing to be randomized to either HEARTS or the active control condition (ACC)
* Have not already participated in the study, nor in the HEARTS class previously
* English speaking

Exclusion Criteria:

* unwilling or unable to provide informed consent by themselves
* have participated at any time previously in HEARTS research or the HEARTS class
* are unable to understand English
Equivalence of Resorption of Empagliflozin/Metformin Administered as Combination Tablet Compared With Empagliflozin/Metformin as Single Tablets Administered Together

Bioequivalence of an empagliflozin/metformin (FDC) tablet compared with single tablets of two strength of empagliflozin and metformin (Part I) under fasted and under fed conditions and bioequivalence of empagliflozin/metformin (FDC) tablet compared with single tablets empagliflozin and metformin under fed conditions (Part II).


Eligibility Criteria:
Inclusion criteria:

1. Healthy male and female subjects

Exclusion criteria:

1. Any relevant deviation from healthy conditions
Stepped Care for Depression in Heart Failure

This study evaluates stepped care for depression in patients with heart failure (HF). The stepped care intervention consists of individualized cognitive behavior therapy (CBT). Half of the participants will receive stepped care and half will receive usual care for depression; all participants will receive heart failure self-care education and support. The primary aims are to determine whether stepped care is superior to usual care for depression, and whether treating depression improves heart failure self-care outcomes.

Depression is associated with poor heart failure self-care. Good self-care practices, including following dietary recommendations, taking prescribed medications, monitoring symptoms, and regular light exercise have been shown to improve quality of life and survival in persons with heart failure.

Both CBT and antidepressant medications have been used in previous studies to treat major depression in patients with heart failure. Participants in the intervention arm in this trial will start with CBT. Those who do not improve very much within the first 5-10 weeks of CBT may also be referred to their own physician to discuss antidepressant medications.

Heart failure self-care education and support will be provided after the first 8 weeks of the depression intervention. The study will determine whether people with heart failure benefit more from self-care education and support after their depression has been treated with a stepped care intervention, as compared to usual care for depression as provided by primary care providers.

Eligibility Criteria:
Inclusion Criteria:

1. Stable, clinically-documented New York Heart Association (NYHA) Class I-III heart failure.
2. Current major depressive episode.
3. Baseline Beck Depression Inventory (BDI-II) score 14 or greater

Exclusion Criteria:

1. Dementia or other significant cognitive or communication deficits
2. Terminal illness other than HF
3. Insurmountable logistical barriers to participation
4. Age less than 25 years
5. Current clinically significant substance abuse, bipolar disorder, schizophrenia, or other psychotic disorder
6. High risk of suicide
7. Current participation in non-study psychotherapy for depression or other psychiatric conditions
8. Initiation or modification of antidepressant medication treatment within past two months
9. Renal or hepatic conditions that would preclude the use of antidepressants.