cyrilzakka/clinical-trials huggingface dataset:
Viral Infection of HSPC Impacts Hematopoiesis

We propose to demonstrate that HIV-1 and SARS-CoV-2 are capable of targeting long-lived HSPC with self-renewal capacities. These progenitors, thus transformed into host cells, can give rise to a durable source of infected cells with an impact on hematopoiesis.

Virus-induced immunosuppression is the transient or persistent decline of immune cell counts and/or function caused by a virus, favouring its persistence in the host organisms. When sustained, triggered by acute viral replication or maintained by chronic viral infections, virus-induced immunosuppression is a life-threatening condition. It is notoriously observed in chronic HIV-1 infection and even in a considerable fraction of antiretroviral-treated HIV-infected individuals. It is also observed in some individuals recovering from severe and mild-to-moderate COVID-19. Its mechanisms are elusive and efficient therapeutic options are not available. Virus-induced immunosuppression may occur in the periphery (affecting circulating immune cells) or in the bone marrow, affecting hematopoietic stem and progenitor cells (HSPC) and hematopoiesis. Several viruses can infect HSPCs. HIV-1 can directly infect HSC, negatively impacting HSC function and the whole stem cell environment of the bone marrow. Whether HSC can be productively infected by SARS-CoV-2 or just targeted and modulated by it remains uncertain and further studies are required to determine HSPC susceptibility or viral sensing for SARS-CoV-2. Therefore, we will i) Evaluate which hematopoietic stem and progenitor cells (HSPC) are targeted by HIV-1 (in vivo and ex vivo) and SARS-CoV-2 (ex vivo); ii) Evaluate whether these infected HSPC would modulate the bone marrow environment by upregulating inflammatory cytokines detrimental to lymphopoiesis.

Eligibility Criteria:
Inclusion Criteria:

HIV patients :

* HIV-positive patients with a negative or positive viral load.
* managed at Ambroise Paré Hospital.
* patients with a bone marrow biopsy or myelogram performed as part of their care.

Healthy subjects without HIV - patients with a BM biopsy or myelogram performed as part of their care for a suspected hematological pathology.

Management at Ambroise Paré Hospital.

Exclusion Criteria:

-
Primary Prevention of Major Depression in Later Life

The Institute of Medicine has called for studies of "indicated" preventive interventions to reduce the incidence of mental illness in persons already symptomatic but not yet presenting with fully developed clinical syndromes.

The investigators' Advanced Center for Interventions and Services Research in Late Life Mood Disorders has embraced the development and testing of preventive interventions as one of its key objectives. The investigators propose to test the following hypotheses related to primary prevention of major depressive episodes in old age, focusing on elderly patients who have symptoms of emotional distress but who are not yet presenting with the full syndrome of a major depressive episode.

Hypothesis 1: Problem solving therapy (PST) will be superior to an attention-only control (dietary education) in lowering the two-year incidence of episodes of syndromal major depression in already symptomatic elderly primary care patients.

Hypothesis 2: PST will also prevent higher levels of depressive symptoms and associated disabilities, over a two-year period of follow-up.

306 participants will be randomly assigned to either problem solving therapy or to a dietary education control. PST will consist of 6 to 8 sessions, distributed over 6 to 16 weeks, teaching participants a structured process of problem definition, generation of potential solutions, evaluation and choice of solution, and its implementation. The dietary education control will consist of 6 to 8 sessions also, distributed over 6 to 16 weeks. Subjects assigned to the DIET condition will receive education in healthy eating practices (e.g., food pyramid, types of food and calories recommended for people age 60 and above, tips on shopping for healthy food, food preparation, and healthy eating behavior). Subjects will be followed up to 2 years. Length of study is 24 months.

Eligibility Criteria:
Inclusion Criteria:

* Age 50 or greater
* Center for Epidemiological Studies of Depression Scale (CES-D) score of 11 or higher
* Folstein Mini-Mental State score of 24 or higher
* Not currently receiving antidepressant medication or participating in other mental health treatment

Exclusion Criteria:

* Episode of major depression within the past 12 months
* Episode of alcohol or other substance abuse within the past 12 months
* Life time history of bipolar disorder or other psychotic disorder
* Diagnosis of any neurodegenerative disorder or of dementia (Alzheimer's, vascular, or frontotemporal dementia, etc.)
A Study of LY3015014 in Otherwise Healthy Participants With High Low-density Lipoprotein (LDL) Cholesterol

This is a phase 1 study in otherwise healthy participants with high LDL cholesterol. Following multiple doses of LY3015014, the safety and tolerability of the drug, how the body handles the drug, and the drug's effect on the body will be evaluated. Participants will participate in the study for approximately 3 months not including screening. Screening is required within 42 days prior to the start of the study.


Eligibility Criteria:
Inclusion Criteria:

* Participants must be healthy males or females without childbearing potential as determined by medical history and physical examination, including first-generation Japanese participants
* Have body mass indexes of 18 to 35 kilograms per meter square (kg/m\^2), inclusive, at screening
* Have screening low-density lipoprotein cholesterol (LDL-C) of between 100 and 180 milligrams per deciliter (mg/dL), inclusive

Exclusion Criteria:

* Have known allergies to compounds related to LY3015014 or any components of the formulation or known clinically significant hypersensitivity to biologic agents
* Have a history of atopy, significant allergies to humanized monoclonal antibodies, clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe posttreatment hypersensitivity reactions \[including but not limited to erythema multiforme major, linear immunoglobulin (Ig)A dermatosis, toxic epidermal necrolysis, or exfoliative dermatitis)
* Have significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs, of constituting a risk when taking the study medication, or of interfering with the interpretation of data
* Have received any vaccine(s) within 1 month of LY3015014 dosing or intend to do so during the study
* Have received treatment with biologic agents (such as monoclonal antibodies) within 3 months or 5 half-lives (whichever is longer) prior to dosing
4 Week Combination of BI 207127 NA With Peg-IFN and Ribavirin in Chronic HCV Patients

The main purpose of this clinical trial with BI 207127 is to see the effect of 4 week combination of BI 207127 with Peginterferon alfa (Peg-IFN) and Ribavirin (RBV) on hepatitis C virus (HCV) virus load and how safe BI 207127 is in this combination in HCV infected patients.


Eligibility Criteria:
Inclusion criteria:

1. HCV genotype 1
2. HCV viral load \>100,000 IU/mL
3. histology or fibroscan to rule out cirrhosis
4. Absence of retinopathy
5. treatment naive patients and treatment experienced patients
6. Age 18 - 70 years
7. Male OR female with documented hysterectomy OR postmenopausal

Exclusion criteria:

1. Fertile males not willing to use an adequate form of contraception
2. Pretreatment with any HCV-polymerase inhibitor
3. Any concurrent disease if clinically significant based on the investigator's medical assessment
4. Current alcohol or drug abuse, or history of the same
5. Positive test for HIV or HBs
6. History of malignancy
7. Planned or concurrent usage of any other pharmacological therapy including any antiviral therapy or vaccination
8. Usage of any investigational drug within thirty (30) days prior to enrolment or 5 halflives, whichever is longer
9. Any clinically significant laboratory abnormalities based on the investigator's medical assessment at screening
10. Patients treated with any interferon (approved or investigational) or Peg-IFN and/or Ribavirin within 3 months prior to screening
11. Known hypersensitivity to drugs or excipients; Further exclusion criteria apply
Enhanced Safety Laser Hair Removal System

The purpose of this study is to determine whether a new laser system provides better safety and efficacy in hair removal than existing lasers.

Lasers are a well-established, popular modality for removal of unwanted hair. The existing lasers are based on a wavelength that is specifically absorbed by the pigment melanin found in the hair follicle, where the energy is converted to heat resulting in a thermal injury.

However, lasers for hair removal are not without limitations. A laser based long-term hair removal treatment is based on thermal destruction of the hair shaft and follicle using wavelengths that are specifically absorbed by the pigment melanin found in the hair follicle. The heating of hair follicle is done through heat dissipation from the hair shaft. One of the significant limitations of this approach is the fact that the epidermis through which the light energy must penetrate is rich in melanin and therefore absorbs a major portion of the energy, resulting in inadequate heating of the hair follicles. The purpose of the study is an evaluation safety and efficacy of a new laser based device.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 75 years old
* Fitzpatrick skin types I to VI

Exclusion Criteria:

* Age below 18 or above 75 year old
* Use of photosensitive medications
* Photosensitive diseases
* Active infection of any type and active infection or or a history of Herpes Simplex in the treated site
* Exposure to sun or artificial tanning during the last 3-4 weeks
A Phase 1 Study in Patients With Solid Tumors

The primary objective of this study is to determine the maximum tolerated dose (MTD) regimen for the combination therapy of LY573636 and pemetrexed that may be safely administered to patients with a solid tumor that is not amenable to curative therapy.


Eligibility Criteria:
Inclusion Criteria:

* You must have a diagnosis of a solid tumor malignancy that is not amenable to curative therapy
* You must have a serum albumin level greater than or equal to 3.0 grams per deciliter (g/dL) \[30 grams per liter (g/L)\]
* You must have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale
* You must be reliable and willing to make yourself available for the duration of the study and are willing to follow study procedures
* Patients with reproductive potential should use medically approved contraceptive precautions during the trial and for 6 months following the last dose of study drugs
* Your test results assessing the function of your blood, kidneys, liver, and heart are satisfactory
* You must be willing to take folic acid, Vitamin B12, or prophylactic steroids
* You must able to interrupt the use of aspirin (other than an aspirin dose less than or equal to 1.3 grams per day) and/or other nonsteroidal anti-inflammatory agents for 2 days before, the day of, and 2 days after the dose of pemetrexed (5 days prior for long-acting agents, such as piroxicam)
* You must have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, immunotherapy, hormone therapy, or other investigational therapy for at least 4 weeks (6 weeks for mitomycin-C or nitrosoureas) before study enrollment and recovered from the acute effects of therapy (except alopecia). Patients who have received whole-brain radiation must wait 90 days before starting study therapy.
* You must sign an informed consent

Exclusion Criteria:

* You cannot have received other investigational drugs within the last 30 days
* You cannot have other on-going serious illnesses including active bacterial, fugal, or viral infections
* You cannot require regular, periodic paracentesis or thoracentesis
* You cannot have active brain metastasis
* You cannot currently be receiving warfarin (Coumadin®) therapy
* You cannot be pregnant or lactating
* You cannot have received prior pemetrexed or LY573636
* You cannot have a second primary malignancy that could affect interpretation of the study results
Multimodal Biopsychosocial Teleprehabilitation for Total Knee Arthroplasty

Knee replacement surgeries are one of the most frequently performed elective surgeries, with approximately 29,000 such procedures carried out annually in Belgium. Although these surgeries have been increasingly refined over the years, leading to better surgical outcomes, there is still room for improvement in terms of pre-surgical biopsychosocial patient preparation. Such preparation aims to optimally inform patients before their surgery and to start preparing them for rehabilitation and resumption of activities after surgery. Therefore, we aim to assess the added value and feasibility of prehabilitation within the knee replacement care pathway.

The primary objective is to investigate the feasibility, acceptability and safety of multimodal biopsychosocial teleprehabilitation (BPS-teleprehab) for people undergoing total knee arthroplasty (TKA).

The secondary objective is to explore the effect of BPS-teleprehab versus best-evidence preoperative advice for people undergoing TKA on activity outcomes, functioning, pain, symptoms of central sensitization, quality of life, cognitive-emotional factors, joint awareness, satisfaction with the surgery, healthcare and medication use and productivity loss.

The tertiary objective is to explore baseline associations between the collected outcome measures, demographics and medical data in people scheduled for TKA.

Furthermore, this pilot trial will inform potential protocol modifications in prepara- tion of an eventual fully powered randomized controlled trial to investigate the ef- fectiveness of BPS-teleprehab in people undergoing TKA.


Eligibility Criteria:
Inclusion Criteria:

* People scheduled for elective primary TKA at one of the participating hospitals;
* Being over 18 years old;
* Dutch speaking/reading

Exclusion Criteria:

* Doing activities that make them feel out of breath for 300 minutes or more per week on average;
* Orthopedic, neurological, cardiovascular or any other condition/comorbidity that leads to an overall contraindication for moderate physical activity;
* Cognitive impairment (≥11 on 6-item Cognitive Impairment Test and/or unable to understand the study instructions);
* Presence of uncontrolled inflammatory arthritides (e.g., rheumatoid arthritis, gout);
* Uncontrolled psychiatric disorders;
* Active cancer and/or active cancer treatment ((hormonal) maintenance therapy is allowed);
* People undergoing emergency (non-elective) TKA.
Immune Responses to BCG Vaccination in Malawi and the UK

BCG vaccination has been found to provide greater protection against TB in the UK than in Malawi. This study compares immune responses in BCG-vaccinated and unvaccinated teenagers and young adults in Malawi and in the UK.


Eligibility Criteria:
Inclusion Criteria:

* BCG unvaccinated
* HIV negative
* Not pregnant
* Informed Consent

Exclusion Criteria:

* HIV positive
* Pregnant
* Seriously ill
Improving Person-Centered Care for Family Planning in India

To evaluate the impact of a training to ASHAs on person-centered care (PCC) for family planning (FP).

ASHAs will be provided with a training on family planning (FP) counseling and method options. Half of the group will receive additional trainings on person-centered care (PCC) principles and respectful care while the other half of the group will not receive this additional training. Women working with both the control ASHAs (FP trained) and Interventions ASHAs (FP+PCC trained) will be surveyed following their interactions with the ASHA to understand the quality of their experience with the ASHA and whether the woman has taken up a FP method of her choice following interaction with the ASHA.

Eligibility Criteria:
Inclusion Criteria:

* Women aged 18-49
* Consented/agreed to participate
* Has met with a control or intervention ASHA at least once in the previous three months

Exclusion Criteria:

* Not a women aged 18-49
* Did not consent/agree to participate
* Has not met with a control or intervention ASHA at least once in the previous three months
An Open-Label Study of YM155 + Docetaxel in Subjects With Advanced Hormone Refractory Prostate Cancer and Other Solid Tumors

To determine the feasibility and safety of administering YM155 in combination with docetaxel

This clinical trial is designed to include two parts:

Part 1: Assessment of feasibility and safety of administering YM155 in combination with docetaxel and prednisone in subjects with hormone refractory prostate cancer (HRPC) \[ ENROLLMENT COMPLETED \]

Part 2: Assessment of feasibility and safety of administering YM155 in combination with docetaxel in subjects with solid tumors (except HRPC).

This registration has been updated to reflect the design requirements of PART 2.

Eligibility Criteria:
Inclusion Criteria:

Part 1:

* Male subjects with histologically or cytologically confirmed adenocarcinoma of the prostate with clinical or radiological evidence of metastatic disease.

Part 2:

* Subjects with histologically and cytologically confirmed solid tumors with measurable disease (except HRPC).

Exclusion Criteria:

* Radiation therapy within 4 weeks of the start of study drug
Pioglitazone/Glimepiride (Sonias) Combination Tablets Special Drug Use Surveillance Survey in Patients With Type 2 Diabetes Mellitus Who Respond Poorly to Pioglitazone

The purpose of this study is to evaluate the safety and efficacy of long-term use of pioglitazone/glimepiride combination tablets (Sonias Combination Tablets LD) in patients with type 2 diabetes mellitus who respond poorly to pioglitazone hydrochloride monotherapy (pioglitazone at 15 mg/day) in the routine clinical setting.

This is a special drug use surveillance on long-term use of pioglitazone/glimepiride combination tablets (Sonias Combination Tablets LD) designed to investigate the frequency of adverse drug reactions in patients with type 2 diabetes mellitus who respond poorly to pioglitazone hydrochloride monotherapy (pioglitazone at 15 mg/day).

The usual adult dosage is one tablet (15 mg/1 mg of pioglitazone/glimepiride) administered orally once daily before or after breakfast.

Eligibility Criteria:
Inclusion Criteria:

* Patients with type 2 diabetes mellitus for whom treatment with pioglitazone hydrochloride monotherapy (pioglitazone at 15 mg/day) is considered inefficacious as per physician's assessment and for whom long-term treatment with pioglitazone/glimepiride combination tablets is considered necessary

Exclusion Criteria:

* (1) Patients with cardiac failure or a history of cardiac failure (2) Patients with serious hepatic or renal impairment (3) Patients with severe ketosis, diabetic coma or precoma, or type 1 diabetes mellitus (4) Patients with severe infection, severe trauma, or pre- and post-operative patients (5) Patients with gastrointestinal disorders such as diarrhea and vomiting (6) Pregnant or potentially pregnant women (7) Patients with a history of hypersensitivity to the ingredients in Sonias Combination Tablets or sulfonamides
Impact of Dexmedetomidine on Acute Kidney Injury Following Living Donor Liver Transplantation

Acute kidney injury (AKI) following liver transplantation (LT) is associated with increased costs, morbidity, and mortality. Dexmedetomidine has known to have anti-inflammatory effect and has been shown to ameliorate IRI in several organs. However, the impact of Dexmedetomidine on AKI after LT is not determined yet. Therefore, this study aims to observe the renal protective effects of Dexmedetomidine after LT.

Acute kidney injury (AKI) following liver transplantation (LT) has shown a wide range of incidence between 17% and 95% and is associated with increased costs, morbidity, and mortality. The etiology of AKI after LT is multifactorial. Among these factors, renal ischemia-reperfusion injury (IRI) caused by perioperative renal hypoperfusion is considered as one of the most important independent risk factors and recent reports have indicated that IRI is associated with an inflammatory cascade. Dexmedetomidine which is a highly selective agonist of α2-adrenergic receptors has known have anti-inflammatory effect and has been shown to ameliorate IRI in several organs. However, the impact of Dexmedetomidine on AKI after LT is not determined yet. Therefore, this study aims to observe the renal protective effects of Dexmedetomidine after LT.

Eligibility Criteria:
Inclusion Criteria:

* living liver transplantation recipients

Exclusion Criteria:

* preoperative renal dysfunction
* dual living donor liver transplantation
* severe cerebral artery disease
* severe cardio-pulmonary disease
A Study Of Inotuzumab Ozogamicin Versus Investigator's Choice Of Chemotherapy In Patients With Relapsed Or Refractory Acute Lymphoblastic Leukemia

This study will compare the efficacy, in terms of complete responses and overall survival, of inotuzumab ozogamicin versus investigator's choice of chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* CD22 expression
* Adequate liver and renal functions

Exclusion Criteria:

* Isolated extramedullary disease
* Active Central Nervous System \[CNS\] disease
Computer Tomography (CT) Trial of Acute Abdomen

The purpose of this study is to determine the impact of routinely performed early CT scanning in terms of diagnostic accuracy, patient management and cost-effectiveness compared to current imaging practice in patients suffering from acute abdomen.


Eligibility Criteria:
Inclusion Criteria:

* age \> 18
* abdominal pain \> 2h and \< 7 days

Exclusion Criteria:

* pregnancy
* acute abdominal trauma
* allergy to iodinated contrast media
* severe renal insufficiency
* metformin medication combined with elevated plasma creatinin level
* lack of cooperation (if informed consent is not possible)
* abdominal pain combined with bleeding shock
Agonist Trigger With HCG Luteal Supplementation vs HCG Trigger With Progesterone Luteal Supplementation in Antagonist Controlled HyperstimulationCycle

The aim of the current study is to compare agonist trigger and HCG luteal support vs standard HCG trigger and progesterone luteal supplementation in antagonist controlled hyperstimulation cycle as regards to clinical pregnancy rate.

Prospective Interventional randomized pilotstudy on patients undergoing controlled ovarian hyperstimulation.

All patients will receive a fixed dose of 150-300 IU recombinant FSH (Gonal-F; Sereno Laboratories,Madrid, Spain) for ovarian stimulation according to age, BMI and antral follicle count (AFC).

After 6 days of stimulation, FSH will be adjusted according to ovarian response.

Premature LH surge will be prevented with 0.25 mg of a GnRH antagonist (Cetrotide; Serono International, Geneva, Switzerland) starting on day 6 when two or more follicles reach a size of 18-20 mm, trigger of ovulation will be done and followed by luteal phase support according to the protocol assigned for each group.

Group 1:

A single dose of 0.2 mg triptorelin (Decapeptyl® Ipsen Pharmaceutical Company, France) and follow up with daily 125 IU HCG injections

Group 2:

A single dose of HCG 10000 IU was given followed by progesterone supplementation with 100mg IM (Prontogest®).

Eligibility Criteria:
Inclusion Criteria:

* Age between 20 and 39 years.
* Body mass index between 18 and 30.
* Unexplained infertility or male factor infertility

Exclusion Criteria:

* Endocrinological disorder eg.:hyperprolactenemia, Hypo or hyper thyrodism
* More than 2 previous attemptsof IVF
* Any uterine anatomical anomaly.