cyrilzakka/clinical-trials huggingface dataset:
New Strategies to Detect Cancers in Carriers of Mutations in RB1

Rationale: Individuals with a cancer predisposition due to a mutation in the paradigm tumor suppressor gene RB1, have a high risk to develop the childhood cancer retinoblastoma (Rb). Biopsies are not possible in Rb, before treatment selection. Heritable Rb patients have also a high risk to develop other types of second primary, either childhood or adult, malignancies (SPMs), notably sarcomas and melanomas. Remarkably, SPMs are now the leading cause of death in heritable-Rb-survivors. Unfortunately, there are no well-developed regular surveillance protocols for SPMs in Rb survivors available right now. Recently, new non-invasive cancer test have been developed, based on either RNA-sequencing data from platelets (ThromboSeq), or on extracellular membrane vesicles (EVs) derived from tumor cells present in blood.

Objective:

* Determine the non-cancerous baseline in adult RB1-mutation carriers (heritable-Rb-survivors).
* Contribute to the biobanking of blood and cancerous tissues from RB1-mutation carriers with SPMs.
* The development of blood-based tests, either platelet or EV-based, for the detection of (the type of) tumors in RB1-mutation carriers.

Study design: Cross-sectional multicenter trial.

Study population:

* 40 Rb patients (children),
* 40 controls (children),
* 153 Rb survivors (adults),
* 153 controls (adults),
* 10 Rb survivors with SPM (children/adults).

Main study parameters/endpoints:

* Determine the non-cancerous baseline in adult RB1-mutation carriers (heritable-Rb-survivors).
* Contribute to the biobanking of blood and cancerous tissues from RB1-mutation carriers with SPMs.

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

Two blood samples totalling 10ml blood will be collected for every participant. Additionally, a short questionnaire has to be filled in concerning their and their family's cancer history. Blood draws will be done, when participants are already present in the hospital for other appointments, and thus no extra visits are required. For all children, blood will be collected through an already present IV, and so no extra venepuncture is required. Children have to be included because Rb is a tumor only present in this patient group.


Eligibility Criteria:
Inclusion Criteria:

Adult (16 years and older):

* Group 1: germline mutation RB1.
* Group 2 (control): no germline mutation RB1.

Pediatric (until 6 years of age):

* Group 1: somatic or germline mutation RB1 and retinoblastoma.
* Group 2 (control): no mutation RB1.

Exclusion Criteria:

Adult (16 years and older):

* Group 1: concomitant heritable (inherited) disorder other than caused by monoallelic mutation of RB1.
* Group 2 (control): cancer or already known cancer predisposition syndrome.

Pediatric (until 6 years of age):

* Group 1: concomitant heritable (inherited) disorder other than caused by monoallelic mutation of RB1.
* Group 2: cancer or already known cancer predisposition syndrome.
FACBC Prostate Therapy Response

The purpose of this study is to assess if using anti-1-amino-3-\[18F\]fluorocyclobutane-1-carboxylic acid (FACBC or fluciclovine) PET scan will be useful in determining if participants are responding to chemotherapy treatment. Investigators will enroll participants whose cancer has been treated with hormone therapy and now the cancer is not responding to the treatment (castration -resistant), and so therefore will be started on chemotherapy. Investigators aim to enroll thirty participants in this study.

The goal of the investigation is to examine therapeutic monitoring of chemotherapy in castrate resistant prostate carcinoma with anti-3-\[18F\]FACBC in prostate carcinoma to determine if anti-3-\[18F\]FACBC amino acid imaging can serve as an accurate and efficient imaging biomarker.

Investigators will perform a baseline anti-3-\[18F\]FACBC PET-CT of the whole body. All participants will also undergo conventional staging including 99mTc methylene diphosphonate (MDP) bone scanning and computed tomography scan (CT) or magnetic resonance imaging (MR) of the abdomen and pelvis which are standard of care at the enrolling institution. This study will not interfere with standard patient evaluation or delay therapy.

All 30 participants will receive chemotherapy every 3 weeks for 6 cycles. Participants will undergo a repeat anti-3-\[18F\]FACBC PET-CT after 1 and 6 cycles and also repeat conventional imaging including bone scanning CT or MR of the abdomen and pelvis after 6 cycles. At the end of the study, the study team will then record the response (or lack thereof) on anti-3-\[18F\]FACBC PET-CT and correlate that response with response per standard clinical criteria including bone scan uptake for skeletal lesions, CT or MR for soft tissue and skeletal lesions, prostate-specific antigen (PSA) progression or regression, and other clinical parameters such as declining performance status.

Eligibility Criteria:
Inclusion Criteria:

* Primary or recurrent castration resistant prostate carcinoma with skeletal and/or nodal involvement not currently undergoing systemic chemotherapy who are about to commence therapy with docetaxel/prednisone. (Note that systemic hormonal targeted therapy including luteinizing hormone-releasing hormone (LHRH) agonists (Lupron or Trelstar), other anti-androgens, and/or Abiraterone or Enzalutamide may be in use.)
* Ability to lie still for PET scanning
* Ability to provide written informed consent

Exclusion Criteria:

* Age less than 18 years
* Inability to lie still for PET scanning
* Inability provide written informed consent
* Currently undergoing chemotherapy for organ confined or systemic disease. This does not preclude patients who had previously received upfront docetaxel in the hormone sensitive setting.
Bortezomib With or Without Hormone Therapy in Treating Patients With Relapsed Prostate Cancer

RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Androgens can cause the growth of prostate cancer cells. Drugs, such as goserelin, leuprolide, flutamide, or bicalutamide, may stop the adrenal glands from making androgens. Giving bortezomib with hormone therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving bortezomib with or without hormone therapy works in treating patients with relapsed prostate cancer.


Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed adenocarcinoma of the prostate
* Relapsed disease after definitive local therapy, as documented only by a rise in prostate-specific antigen (PSA)

  * Experienced PSA relapse after definitive local therapy
  * Rising PSA (≥ 1.0 ng/mL after nadir \< 1.0 ng/mL)

    * PSA increase of ≥ 0.3 ng/mL (increase occurred between 2 separate measurements taken ≥ 4 weeks apart)
  * The first of these two PSA values must rise above a previously recorded post-therapy nadir value
* Ineligible for curative therapy
* No clinical evidence of local recurrence (i.e., palpable induration or mass in the prostatic fossa) other than PSA elevation
* No evidence of palpable disease in the prostatic bed
* No metastatic disease (M0)

  * No non-nodal (\> N1) metastasis
  * No evidence of osseous metastasis on bone scan within the past 28 days

PATIENT CHARACTERISTICS:

Age

* Over 18

Performance status

* ECOG 0-1

Life expectancy

* At least 1 year

Hematopoietic

* Platelet count ≥ 30,000/mm\^3
* Absolute neutrophil count ≥ 1,000/mm\^3

Hepatic

* No known hepatitis B or C positivity

Renal

* Creatinine clearance ≥ 30 mL/min

Immunologic

* No known human T-cell lymphotropic virus positivity
* No hypersensitivity to bortezomib, boron, or mannitol
* No known HIV 1 or 2 positivity
* No active, ongoing bacterial, viral, or fungal infection

Other

* Fertile patients must use effective contraception
* No peripheral neuropathy ≥ grade 2
* No other disease, condition, or social or geographic constraint that would preclude study participation
* No other malignancy within the past 5 years except basal cell or squamous cell skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* No concurrent chemotherapy

Endocrine therapy

* See Disease Characteristics
* At least 6 months since prior hormonal therapy combined with radiation therapy as definitive therapy
* Neoadjuvant hormonal therapy prior to definitive therapy (e.g., surgery, radiation therapy, brachytherapy, or cryoablation) allowed
* No other concurrent hormonal therapy

Radiotherapy

* See Disease Characteristics
* More than 12 months since prior radioactive seed therapy
* No concurrent radiotherapy

Surgery

* See Disease Characteristics
* More than 4 weeks since prior surgery
* No concurrent surgery

Other

* No concurrent second-line herbal preparations, including PC-SPES
* No other concurrent investigational agents
A Randomized Trial to Study Combined Pulsed Dye Laser and Rapamycin Treatment of Port Wine Stain Birthmarks.

The researchers want to collect data on safety and efficacy of combined pulsed dye laser and rapamycin to improve fading/blanching of port wine stain birthmarks as compared to pulsed dye laser alone, which is the current standard of care.

This single center pilot and feasibility study will have a target enrollment of 40 port wine stain subjects at the Beckman Laser Institute and Medical Clinic, University of California, Irvine.

The study will offer two different approaches to the treatment of port wine stain birthmarks.

Study Group Number 1: Port wine stain treated by the pulsed dye laser alone, which is the current standard of care: 20 subjects.

Study Group Number 2: Port wine stain treated by combined pulsed dye laser and rapamycin: 20 subjects.

The researchers want to collect data on safety and efficacy of combined pulsed dye laser and rapamycin to improve fading/blanching of port wine stain birthmarks as compared to pulsed dye laser alone, which is the current standard of care. Twenty subjects will have their entire port wine stain birthmark treated by pulsed dye laser alone. Twenty subjects will have their entire port wine stain birthmark treated by combined pulsed dye laser and rapamycin, which is a drug that prevents the formation of blood vessels in the skin. Safety will be evaluated by searching for any local effects such as injury to the skin or systemic effects such as abnormal blood and/or urine studies. Efficacy will be determined by objectively measuring and comparing the port wine stain fading/blanching responses for the two study groups.

Eligibility Criteria:
Inclusion Criteria:

* Port wine stain suitable for comparison testing.
* Age \> 13 years of age or older; minor will be accompanied in the room by parents or guardians during laser treatment.
* Apparent good health as documented by medical history.
* Ability to understand and carry out subject instructions.
* Women of childbearing potential must have a negative urinary pregnancy test prior to being started on rapamycin.
* Women of child bearing potential must agree to use a medically acceptable method of contraception throughout the study and for 3 months following discontinuation of rapamycin.

Exclusion Criteria:

* Inability to understand and carry out instructions.
* Pregnancy.
* Abnormal blood or urine tests
* History of cancer.
* History of high cholesterol, lipids or liver disease.
* Allergy to macrolide drugs (e.g., erythromycin).
* Any therapy within the previous two months to the proposed port wine stain treatment sites.
* Current participation in any other investigational drug evaluation.
* Concurrent use of known photosensitizing drugs.
* Concurrent use of immunosuppressive drugs or steroids.
* Concurrent use of any of the following medications: antifungals, antiepileptics, protease inhibitors, cimetidine, cisapride, clarithromycin, dannzol, diltiazem, erythromycin, metoclopramide, rifabutin, rifampin, rifapetine, troleandomycin, or verapamil.
Dysbiosis and Immune Reconstitution After Allo-HSCT

Preliminary (proof of concept), monocentric, interventional, prospective, non-randomized and analytic trial designed to simultaneously explore intestinal microbiota changes and early post-transplant immune reconstitution, and to correlate biological data with clinical data (antibiotics use, stress level, GVHD).

Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is the major curative therapeutic approach for hematologic neoplasms. After HSCT, patients have a compromised GI mucosal barrier and an altered microbiota, also called dysbiosis. The later could be due to conditioning or use of broad-spectrum antibiotics, and could be accentuate by stress encountered by patients during their therapy management. Recent data have shown that alterations in the intestinal flora are associated with bad outcome, particularly with graft-versus-host disease (GVHD), bacteremia, and reduced overall survival post-transplantation. How intestinal bacteria can modulate the risk of relapse after HSCT is yet unknown. The scientists hypothesize that the variation of some bacterial taxa may influence post-transplant immune reconstitution, particularly invariant Natural Killer T cells.

Eligibility Criteria:
Inclusion Criteria:

* Patients \> 18 years affiliated to a social security system
* Patients followed at the hospital of Nancy for a allogeneic hematopoietic cell transplantation (HLA matched donor)
* Graft of peripheral blood stem cell
* GVHD prophylaxis by ciclosporin and antilymphocyte serum +/- mycophenolate mofetil or methotrexate.

Exclusion Criteria:

* HIV+ patients
* Patients with active HBV or HCV
Zoledronic Acid to Maintain Bone Mass After Denosumab Discontinuation

In contrast with bisphosphonates,discontinuation of denosumab results in gradual loss of bone mineral density gains. The investigators aim to evaluate whether in patients treated with denosumab, a single zoledronic acid infusion would prevent the anticipated bone loss.

Discontinuation of denosumab results in a rebound rise of bone turnover markers and gradual loss of the achieved bone mineral density gains. In contrast, bisphosphonates, such as zoledronic acid, remain within the skeleton acting for several months or even years after discontinuation while maintaining bone mineral density despite the cessation of treatment. In this study, the investigators aim to evaluate changes in bone mineral density of the lumbar spine and the femoral neck, as well as in bone turnover markers one year after treatment discontinuation both in denosumab-treated women and in denosumab-treated women who switched to zoledronic acid infusion one year before treatment discontinuation.

Eligibility Criteria:
Inclusion Criteria:

* postmenopausal women
* osteopenic (T-score \> -2.5 but \< -1.0) after treatment with denosumab

Exclusion Criteria:

* secondary osteoporosis;
* diseases that could affect bone metabolism;
* medications that could affect bone metabolism;
* history of any antiosteoporotic treatment other than denosumab prior to randomization
* severe liver or kidney disease (creatinine clearance \< 60ml/min/1.73m2)
An Experimental Medicine Study to Evaluate Serum Biomarkers of Lipid Metabolism

The purpose of this study is to validate novel assays for serum biomarkers of lipid metabolism (PCSK9 and LDL receptor) and to obtain information about how these biomarkers differ in subjects with normal or high cholesterol levels


Eligibility Criteria:
Inclusion Criteria:

* Hypercholesterolemia
* Statin monotherapy

Exclusion Criteria:

* Significant acute or chronic illness
* Secondary causes of hypercholesterolemia
Phase II Study of TRK-820 Soft Capsules - Intractable Pruritus in Patients With Chronic Liver Disease -

The efficacy and safety of TRK-820 are to be evaluated in the treatment of intractable pruritus in patients with Chronic Liver Disease by administering 2.5, 5 and 10 microg of this drug or placebo for 28 days in four groups with a design of randomized, double-blind, parallel-group comparison. In addition, the plasma concentrations of TRK-820 and its primary metabolites are to be determined.


Eligibility Criteria:
Inclusion Criteria:

* Chronic Liver Disease is present; and the patient's general condition is judged by the physician to be stable with no prospect of an abrupt change in pathophysiology.
* It can be confirmed by either of the following that treatment of pruritus with antihistamines or antiallergics has not been adequately effective in such patients:

Exclusion Criteria:

* Malignant tumors
* Depression, integration dysfunction syndrome (schizophrenia), or dementia
* Hepatic encephalopathy, or hepatic cirrhosis in which ascites or esophageal or gastric aneurysm cannot be controlled
* Alcoholic liver disease
* Atopic dermatitis, chronic urticaria, or other skin disease producing generalized pruritus that is judged by the physician to affect the assessment of pruritus associated with Chronic Liver Disease in this study
* Allergy to opioid drugs
* Drug dependence or alcohol dependence
* Chronic renal failure
Interface Selection for Adaptive Servo Ventilation

The purpose of this study is to compare the effects of nasal and oronasal interfaces during ASV treatment on sleep efficiency and sleep architecture. Therefore, patients starting treatment with ASV, will be randomized between two groups. In the first group, patients will use a nasal interface during the first night and an oronasal interface during the second night. In the second group, patients will use an oronasal mask first and a nasal mask during the second night. The results of this trial will have major impact on future clinical practice as it would deliver prediction rules to choose the correct interface immediately.


Eligibility Criteria:
Inclusion Criteria:

* Patients with central sleep apnea, not responding to treatment with CPAP
* Indication for treatment with ASV

Exclusion Criteria:

* Patients \< 18 years old
Bioequivalence of BIBR 277 Tablet (Mannitol Based) Compared With Capsule Formulation in Healthy Male Volunteers

Study to investigate the bioequivalence of BIBR 277 tablet (Mannitol based) vs. BIBR 277 capsule


Eligibility Criteria:
Inclusion Criteria:

1. Age \>= 20 and \<= 35 years
2. Weight: BMI \> 17.6 and \< 26.4 (Weight (kg) / Height (m)2)
3. Subjects judged by the investigator to be eligible as study subjects, with no clinically significant findings after screening
4. Subjects who volunteer to participate and are able to fully understand and agree with this study by written informed consent

Exclusion Criteria:

1. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
2. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
3. Chronic or relevant acute infections
4. History of hepatic disorder (e.g., biliary cirrhosis, cholestasis)
5. History of serious renal disorder
6. History of or present bilateral renal artery stenosis or lack of unilateral kidney accompanying arterial stenosis
7. History of or present cerebrovascular disorder
8. History of hyperkalemia
9. History of hypersensitivity to active ingredient (Telmisartan) or other angiotensin II receptor antagonists
10. History of or present orthostatic hypotension or faint
11. Surgery of gastrointestinal tract (except appendectomy)
12. History of alcohol or drug abuse
13. Participation to another trial with an investigational drug within 4 months prior to the trial
14. Whole blood donation more than 400 mL within 3 months prior to the trial
15. Whole blood donation more than 100 mL within 1 month prior to the trial
16. Donation of constituent of blood of more than 400 mL within 1 month prior to the trial
17. Any medication which might influence the result of the trial within 10 days prior to the trial
18. Excessive physical activities within 7 days prior to the trial
19. Alcohol drinking within 3 days prior to the trial
20. Inability to comply with restriction of protocol
21. Other than above, those who are judged by the investigator to be inappropriate as the subjects of the study
Psilocybin for the Treatment of Migraine Headache

The purpose of this study is to investigate the effects of oral psilocybin in migraine headache. Subjects will each receive a dose of placebo and a dose of psilocybin approximately 14 days apart. Subjects will be randomized to the order of treatment and they will be randomized to receive either low or high dose psilocybin. Subjects will maintain a headache diary prior to, during, and after the treatments in order to document headache frequency and intensity, as well as associated symptoms. This preliminary study will inform on the basic effects of psilocybin in migraine headache and inform on the design of larger, more definitive studies.

The number of arms reflects the design of the enhanced blinding method. The final enrollment number reflects the number of subjects participating in study procedures.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of migraine headache per ICHD-3beta criteria
* Typical pattern of migraine attacks with approximately two migraines or more weekly
* Attacks are managed by means involving no more than twice weekly triptan use
* Age 21 to 65

Exclusion Criteria:

* Axis I psychotic disorder (e.g. schizophrenia, bipolar I, depression with psychosis)
* Axis I psychotic disorder in first degree relative
* Unstable medical condition, severe renal, cardiac or hepatic disease, pacemaker, or serious central nervous system pathology
* Pregnant, breastfeeding, lack of adequate birth control
* History of intolerance to psilocybin, LSD, or related compounds
* Drug or alcohol abuse within the past 3 months (excluding tobacco)
* Urine toxicology positive to drugs of abuse
* Use of vasoconstrictive medications (i.e. sumatriptan, pseudoephedrine, midodrine) within 5 half-lives of test days
* Use of serotonergic antiemetics (i.e. ondansetron) in the past 2 weeks
* Use of antidepressant medication (i.e. TCA, MAOI, SSRI) in the past 6 weeks
* Use of steroids or certain other immunomodulatory agents (i.e. azathioprine) in the past 2 weeks
Trial Comparing Laparoscopic Vs Robotic-assisted Colposacropexy for Pelvic Organ Prolapse Repair

The aim of the study is to perspectively compare the anatomical and functional outcomes of Pelvic Organ Prolapse (POP) repair after Laparoscopic or Robotic-assisted Colposacropexy.

Female pelvic floor disorders rank amongst the most common disorders affecting women and include conditions such as urinary incontinence and pelvic organ prolapse (POP). POP is estimated to affect 30% of women aged 50- 89 years, and the lifetime risk of requiring surgery is 11%. Open abdominal sacrocolpopexy is the established gold standard procedure and is indicated when there is prolapse of the anterior and/or apical vaginal wall compartments. Laparoscopic sacrocolpopexy (LSCP) has not been widely adopted as it demands skill and motivation and it is associated with a long learning curve. So the hypothesis is that robot-assisted laparoscopic approach for sacrocolpopexy (RALSCP) could be an alternative to a pure laparoscopic technique.

In the study design 62 patients will be randomly enrolled (31 in the laparoscopic arm and 31 in the robotic assisted one). The primary outcome will be the anatomic one, secondary outcomes will be functional in terms of storage or voiding dysfunctions, sexual dysfunctions, bowel dysfunctions, QoL, post operative complications.

For continuous variables will be used the Mann-Withney test, for categorical data will be used McNemar test and X2 test.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic POP \>2 stage according to POP Q system

Exclusion Criteria:

* Obesity
* Heart failure (NYHA III-IV)
* High stage COPD (Chronic Obstructive Pulmonary Disease)
* Patients who underwent more than 2 previous abdominal surgical procedures