cyrilzakka/clinical-trials huggingface dataset:
Pre-approval Access Single Patient Request for Niraparib / Abiraterone Acetate Combination (Nira/AA Combination)

The purpose of this pre-approval access is to provide Niraparib plus Abiraterone Acetate (Nira/AA combination) in the treatment of (a) participant(s) with first line metastatic castration-resistant prostate cancer with specific Homologous Recombination Repair (HRR) gene alterations.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with metastatic castration-resistant prostate cancer (mCRPC)
* A confirmed homologous recombination repair (HRR) gene alteration as identified by a genomic assay through use of a validated test
* Eastern Cooperative Oncology Group Performance Score (ECOG PS) Grade of 0 or 1
* Willing to receive concomitant prednisone/ prednisolone 10 milligrams (mg) (not provided by Janssen) daily while receiving niraparib/abiraterone acetate (Nira/AA) combination treatment
* Willing to continue treatment with gonadotropin-releasing hormone (GnRH) analogue if not surgically castrated

Exclusion Criteria:

* Prior treatment with a Poly ADP-ribose Polymerase (PARP) inhibitor
* Prior systemic therapy for mCRPC (that is, taxane-based chemotherapy, androgen signaling inhibitors). Ongoing androgen deprivation therapy (ADT), prior systemic treatment (example, apalutamide, enzalutamide, darolutamide, docetaxel) for earlier disease settings (example, hormone sensitive disease, non-metastatic castration-resistant disease); and treatment recently initiated with abiraterone acetate for mCRPC less than or equal to (\<=) 60 days is permitted
* Other treatment options available or participant eligible or able to participate in a clinical trial for first line mCRPC with HRR gene alterations
* Moderate-severe pain
* History or current diagnosis of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML)
Comparison of the Efficacy of Different Nerve Stimulation Methods in Individuals With Chronic Consipation

Consipation is the most common digestive complaint in the general population. The normal frequency of defecation ranges from a minimum of three times a week to a maximum of two times a day.

Constipation is one of the most common health problems in the geriatric population, negatively affecting the physical and emotional status of individuals. Constipation can be classified into three main groups: normal transit time constipation, slow transit time constipation and dyssynergic defecation disorders .

Treatment in chronic constipation should be directed towards the underlying cause. In the treatment of chronic constipation, lifestyle modifications and physiotherapy are the first, pharmacologic treatment is the second, and surgical treatment is the third. Physiotherapy modalities such as defecation training, classical massage, electrical stimulation, anorectal biofeedback and exercise training can be used in the treatment of chronic constipation.

Eligibility Criteria:
Inclusion Criteria:

* 18-65 ages Female
* Rome III diagnostic criteria

Exclusion Criteria:

* Severe heart or kidney diseaseprevious gastrointestinal, spinal or pelvic surgery other than cholecystectomy, hysterectomy or appendectomy neurological diseases such as multiple sclerosis, stroke, Parkinson's disease or spinal injury,
* Impaired awareness (mini-mental score \< 15),
* Legal blindness, pregnancy,
* Rectal prolapse
* Anal fissure and altered constipation and diarrhea pattern.
Protective Effect of Intraoperative Parathyroid Gland Auxiliary Recognition System in Thyroid Malignant Tumor Operation

This intraoperative parathyroid gland auxiliary recognition system uses the principle of parathyroid gland autofluorescence to assist surgeons in accurately identifying and protecting parathyroid glands during surgery, reducing the possibility of postoperative hypoparathyroidism. This study will explore the protective effect of the parathyroid gland auxiliary recognition instrument on parathyroid function during thyroid malignant tumor surgery through reasonable grouping.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with unilateral thyroid malignancies who require surgical treatment between the ages of 20-50.
2. No history of neck surgery and radiotherapy.
3. There is no evidence of parathyroid tumor invasion in preoperative imaging assessment.
4. No abnormal calcium metabolism disease.
5. No abnormalities in blood calcium and blood PTH before operation.
6. No allergy to contrast agents.
7. The patient or his agent signs an informed consent statement.

Exclusion Criteria:

1. Does not meet the entry criteria;
2. Parathyroid glands were found to be invaded by tumor during operation and the parathyroid glands could not be preserved.
Survivin Peptide Vaccination for Patients With Advanced Melanoma, Pancreatic, Colon and Cervical Cancer

This study evaluates the safety, the immunological response and the clinical outcome of a vaccination with survivin peptides for patients with advanced melanoma, pancreatic, colon and cervical carcinoma.

As prognosis of advanced melanoma, pancreatic, colon and cervical cancer remains gloomy, new therapeutic modalities have to be developed to improve the patient´s clinical outcome. Immunotherapy, which targets tumor associated antigens of tumor cells or tumor stroma, is currently an intensively investigated, novel therapeutic option. As survivin is expressed both by neoplastic cells as well as by endothelial cells of the tumor vasculature, this antigen is an intriguing target molecule. Spontaneous cytotoxic T-cell responses against different survivin epitopes in cancer patients underline the relevance of survivin-directed immunological trials. This study is comprised of a peptide vaccine with HLA-A1, -A2 and -B35 restricted survivin epitopes in Montanide ISA-51 for patients with stage IV melanoma, advanced pancreatic, colon and cervical carcinoma. The vaccine is applicated as a deep subcutaneous injection. Vaccination is administered for the first 2 months weekly, afterwards every 4 weeks. Standard staging examinations are performed every three months. Clinical, laboratory and immunological monitoring is done every month.Diagnostic leucapheresis is performed before first vaccination and afterwards every 2 months.

Eligibility Criteria:
Inclusion Criteria:

* Advanced melanoma, pancreatic, colon and cervical cancer
* At least 1 prior postoperative conventional therapy (chemotherapy, radiation, immunotherapy)
* HLA-A1, -A2, -B35
* More than 4 weeks since last chemo-, immune- or radiotherapy
* ECOG-PS (Eastern Cooperative Oncology Group- Performance Status) of 0-1
* Sufficient renal, hepatic and bone marrow function: thrombocytes \> 75.000/ul; hb \> 9 g/dl; leucocytes \> 2.500/ul; creatinine \< 2 mg/dl; GOT/GPT \< twice the normal value
* negative for HIV and Hbs
* Older than 18 years
* Informed consent

Exclusion Criteria:

* Acute/chronic infections
* Positive for HIV, Hbs
* Autoimmune disorders
* Pregnancy, breast feeding
Characteristics and Results of Patients Treated by Therapeutic Intensification

Many studies have focused on patients treated with allogeneic peripheral stem cell transplantation; few studies have until now been carried out to describe the characteristics and results of autografted patients and to attempt to determine possible prognostic factors. However, it is estimated that nearly 5% of autograft patients require MIR care. The investigators therefore wish to conduct a retrospective study including patients treated by therapeutic intensification followed by autograft of hematopoietic stem cells and admitted to the MIR department of the Hautepierre hospital of the University Hospitals of Strasbourg (HUS) within thirty days following initiation of chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient (≥18 years old)
* Gender indifferent
* Admitted to the Intensive Care Unit within thirty days following therapeutic intensification and autograft of peripheral stem cells for the treatment of a hematologic malignancy between 01/01/2013 and 12/31/2022

Exclusion Criteria:

- Subject having expressed his opposition to the reuse of his data for scientific research purposes
NAFLD: Independent Effects of Western Dietary Pattern Profile and Sedentary Life

Investigators perform a counseling intervention study (6 months) in adult subjects with evidence of Fatty Liver by Ultrasound, graded 0-3 according to the Bright Liver Score (BLS); exclusion criteria are diabetes, renal insufficiency (glomerular filtration rate \< 90 ml/min), cancer, heart failure \> II NYHA ( New York Heart Association) Class), chronic virus hepatitis, and cirrhosis. Insulin resistance was assessed as homeostasis model assessment-insulin resistance (HOMA-IR) . Suggestions and advice on individual "healthy" food purchase, storage, and cooking were given. Reliable feedback and evidence of patients' adherence were obtained by scheduled dietician's interviews. Investigators will challenge the predictive effects of the Adherence to Mediterranean Diet, of Western dietary profile score and of increased physical activity at 6 months in a body mass index changes-balanced model to detect independent effects, if any, of the studied variable on NAFLD persistence, amelioration or disappearance. Threshold and odds of Mediterranean and Western dietary profile score will be calculated by contingency tables and receiver operator characteristic curve (ROC) analysis..

Dietary and physical exercise counseling.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of fatty liver

Exclusion Criteria:

* type I or type II diabetes,
* no alcohol, cancer, malnutrition, severe obesity, renal insufficiency, viral hepatitis, other chronic disease
Delirium in Covid-19: Germany-wide Covid-19 Intensive Register

The global pandemic caused by the SARS-CoV-2 virus is confronting the German health system with a novel pathogen. This means that a timely evaluation of all available results is required. In the field of intensive care in particular, there are significant gaps in knowledge, particularly with regard to delirium. In this respect, this study also serves directly to investigate the pathways of delirium outcome in COVID-19 patients.


Eligibility Criteria:
Inclusion Criteria:

All patients with SARS-CoV-2 positive Covid-19 disease

* Age≥18 years
* Proven by positive PCR tests from nasal/ throat swabs as well as samples from the deep respiratory tract.
* Period 01.01.2020 to 21.02.2022

Exclusion Criteria:

* NONE
Physical Activity and Fall Prevention in Geriatric Inpatients in Acute caRe: Feasibility Study

This study aims to evaluate the feasibility and the impact on physical performance and falls occurence among geriatric inpatients hospitalized in acute care unit.

Having developed many tools to determine fall risk of 65 years and older patients, Angers University Hospital plans to develop a corrective action to prevent the occurrence of falls in this population.

This study aims to assess the feasibility of a physical activity program with 3 difficulty levels (depending on the patient's risk of falling): easy (low fall risk), moderate (average fall risk) and difficult (high fall risk).

The implementation process should be simply and fastly applicable in practice for routine care by paramedics.

Eligibility Criteria:
Inclusion Criteria:

* Being 65 years old and older
* Being hospitalized in geriatric acute care unit of Angers University Hospital.
* No contraindications to physical activity practice.
* No contraindications to standing station and sitting station.
* Participants having given and signed an informed participation consent. If the participant is unable to answer, we will retain the disagreement expressed by a trusted person.
* Being affiliated to French social security

Exclusion Criteria:

* Refusal of participation
* Persons aged under 65.
* Topics including hospitalization at the entrance should not exceed 3 days.
* Participation in concomitant clinical trial.
* Civil Protection Measures such as trusteeship, guardianship or backup justice underway.
SkIn, Muscle and Bone Aging Determinants in HIV Infected-patients.

this study consists of the study of markers of skin, muscular, neurocognitive and bone aging in HIV infected adults and to compare the frequency of these signs to the general population of same gender and age.

Nowadays, the elevated frequency of cancers as well as cardiovascular, neurocognitive and bone diseases seems to denote a process of accelerated aging in the treated HIV-infected population of western countries, who are 40 to 50 years old in median. Markers of age-related alterations should be compared to the distribution among the general population whenever possible, to disentangle the effect of HIV and "normal" ageing or ageing due to other conditions. Common mechanisms should be better understood, more specifically those related to the impact of tobacco, antiretroviral treatments, and nutritional components. For markers of skin, muscle, neurocognitive function and bone ageing, the distribution of the general population is available and, in addition, alteration of these markers might have common mechanisms, such as insufficiency in 25 hydroxy vitamin D or nutritional parameters. Therefore, a joint study of these three organs seems particularly relevant.

This aim is to study markers of skin, muscular, neurocognitive and bone aging in HIV infected adults and to compare the frequency of these signs to the general population of same gender and age.

Eligibility Criteria:
Inclusion Criteria:

* HIV-1 infected patients included in the TISSOS-VIH substudy of the ARNS CO3 Aquitaine Cohort or who had a DXA measurement of the lumbar spine, femoral neck, and total body between 2004 and 2011 at the University Hospital of Bordeaux,
* \> 18 years
* Affiliated to the medical insurance
* Having had at least one DXA measurement prior to the SIMBAD study visit
* Written informed consent for the SIMBAD study

Exclusion Criteria:

* Hepatitis C virus co-infection
* Pregnancy
Rituximab and Fludarabine Followed by CAMPATH-1H in Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

In this multicenter trial, we will investigate the use of fludarabine plus rituximab, followed by Campath-1H, in previously untreated patients with CLL/SLL. Patients who are elderly, or who are considered unlikely to tolerate this combination therapy well, will receive single agent rituximab followed by Campath-1H.

Upon determination of eligibility, all patients will receive:

Fludarabine + Rituximab + CAMPATH-1H

Patients who are judged by the investigator not to be candidates for fludarabine due to advanced age, marginal performance status or coexistent medical conditions will receive rituximab alone followed by CAMPATH-1H.

Eligibility Criteria:
Inclusion Criteria:

To be included in this study, you must meet the following criteria:

* Histologically proven B-cell CLL/SLL
* Positive staining for CD20 antigen
* No systemic chemotherapy.
* Measurable or evaluable disease
* Able to perform activities of daily living with minimal assistance
* Age \> 18 years
* Life expectancy \> 12 weeks
* Adequate liver and kidney function
* Must be accessible for treatment and follow-up
* Must give written informed consent prior to entering this study.

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

* Female pregnant or lactating
* Unstabilized active infection on the basis of neutropenia
* History of previous severe opportunistic infections
* Serious underlying medical conditions
* Central nervous system involvement
* History of other neoplasms, either active or treated within five years

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
L-arginine add-on Therapy in Patients With Schizophrenia

This study evaluates the addition of L-Arginine to the usual regimen in the treatment of schizophrenia in adults. As a requisite of crossover design, half of the participants started with L-Arginine and the other half with placebo and switched over after a three weeks use and one week of a washout period.

L-arginine is the precursor of nitric oxide (NO), a neuromodulator of dopamine, gamma-aminobutyrate (GABA) and glutamate systems. Nitric oxide donors which increase NO levels at the cellular level could improve N-methyl-D-aspartate (NMDA) receptor dysfunction. Using L-arginine could bypass the blocked NMDA receptors and improve the therapeutic efficacy by reversing the dysfunction.

The investigators proposed that using L-Arginine, a dietary supplement in most cultures, might constitute a safe option as an add-on treatment which may display beneficial effects on positive, negative, cognitive and affective symptoms associated with schizophrenia.

Eligibility Criteria:
Inclusion Criteria:

* Schizophrenia-Schizoaffective Disorder
* Clinical Global Impression \>4
* Able to take oral medication and likely to comply the required evaluations
* On stable medication regimen for 8 weeks
* Competent and willing to give informed consent

Exclusion Criteria:

* Uncontrolled medical illness (renal disease, hepatic, cardiac diseases, gout, asthma, diabetes, sickle cell anemia, low-high blood pressure)
* History of Myocardial Infarction (MI)
* History of genital herpes infections/ receiving lysine containing treatments
* Pregnancy/ lactation
* Substance related and Addictive Disorders
* Drugs that might induce hypotension
* Intolerance to L-arginine and ingredients of placebo or L-arginine capsule
Chiropractic Treatment of Arthrogenic Torticollis in Infants; a Retrospective Study on Outcome in 1000 Infants

Patient data is collected from previously treated patients and entered into the Research Electronic Data Capture (REDCap).

Already collected patient data (1995-2013) from a privat practice, is screened and entered into a individually design REDCap form.

Eligibility Criteria:
Inclusion Criteria:

* arthrogenic torticollis
* male or female age 3-12 month
* treatment was conducted between 01/1995-12/2013

Exclusion Criteria:

* uncompleted record
* decline of further use of patient data
Benefits of Microcor in Ambulatory Decompensated Heart Failure

To assess investigator engagement of μCor system data in the context of heart failure management. The μCor system includes a sensor and wearable patch for fluid management.

Subjects meeting the inclusion/exclusion criteria will wear the μCor for up to 90 days.

During the study, face to face follow up will occur every 30 days. For all subjects, each scheduled clinic visit will include assessment of cardiac signs, symptoms, and any relevant clinically actionable events.

The subject will be given a daily diary to track symptoms, hospital visits, medication changes, and all other heart failure related clinical events.

Weekly phone calls to the subject will be given throughout the duration of the study to remind the patient to use the subject diary and to collect and record heart failure related clinical events.

The subject's health care provider team will receive the μCor data through access to a clinical tool interface. The clinical tool will send data updates that are dependent on the μCor data trends. The data updates will allow the health care provider team to take action when the data indicate worsening heart failure, within the context of standard of care medical practice and patient specific parameters. Weekly data reports will be delivered to the investigators.

Subjects will be contacted six months and one year from initial enrollment to assess the vital status of the subject, any heart failure related clinical events since the end of μCor wear, and any health care utilization since the end of μCor wear.

Eligibility Criteria:
Inclusion Criteria:

* 4.1.1 Subjects hospitalized for acute decompensated heart failure and enrolled in the study within 10 days post-hospital discharge.
* 4.1.2 Subjects who have had an acute heart failure event requiring medical management in the previous 180 days of index hospitalization admission. This acute heart failure event admission must be at least 2 weeks apart from the event admission in 4.1.1
* 4.1.3 Subjects 21 years of age or older on the day of screening.

Exclusion Criteria:

* 4.2.1 Subjects who are wearing the wearable cardioverter defibrillator (WCD)
* 4.2.2 Subjects not expected to survive one year from enrollment from non-cardiac disease.
* 4.2.3 Subjects with skin allergy or sensitivity to medical adhesives.
* 4.2.4 Subjects anticipated to start dialysis within 90 days.
* 4.2.5 Subjects currently implanted with an subcutaneous implantable cardio defibrillator (S-ICD) system.
* 4.2.6 Subjects who received a percutaneous coronary intervention (PCI) less than 24 hours after onset of heart failure related symptoms during index hospitalization.
* 4.2.7 Subjects who are unable to participate in all follow up visits.
* 4.2.8 Subjects participating in research other than a registry at the time of enrollment.
* 4.2.9 Subjects currently implanted with a Left Ventricular Assist Device (LVAD).
* 4.2.10 Subjects with self-reported pregnancy.
* 4.2.11 Subjects currently being actively managed with any device based remote HF monitoring.
Local Anesthesia and Tuberculin Skin Test in Infants and Children

The use of local anaesthesia efficiently reduces pain due to needle puncture. However, when tuberculin skin test is performed it is the skin reaction to tuberculin injection that is studied. It is a quantitative skin reaction measured in millimiters. From the study of literature it is not known whether local anaesthetic modify skin reaction to tuberculin. Therefore, before recommending the use local anaesthesia for tuberculin intradermal injection we have to rule out a potential effect of local anaesthetic on the result of the test. This is particularly important in children, since there are more sensitive to pain than adults


Eligibility Criteria:
Inclusion Criteria:

hospitalized or non hospitalized infant or child (3 months-15 years)requiring a tuberculin skin test, in our hospital. hospitalized 1 to 3 months old infants requiring a tuberculin skin test, in our hospital.

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Exclusion Criteria:

* child with contra indication to the use of Lidocaine / prilocaine
* child with evolutive dermatitis on forearms
* premature or newborn (less than 1 month of age)
* infants (1 - 24 months of age)who has yet received repeated local anaesthesia (at least 2)during the 24 previous hours
* infants (1 - 24 months of age)who is treated with a drug that could enhance the risk of methhaemoglobinemia
* child with previous evere local reaction to tuberculin injection (necrosis,ulceration)
* child with history of tuberculosis disease
* child with hepatic failure
* parents or the child himself if lod enough, have not given their agreement for the study