cyrilzakka/clinical-trials huggingface dataset:
Immunomodulatory Therapy in Women With Autoimmune Premature Ovarian Insufficiency

Title: Effects of immunomodulatory therapy on gonadal function in women with autoimmune premature ovarian insufficiency (POI)

Trial objectives and purpose: To study if rituximab therapy can improve ovarian response to gonadotropin stimulation and menstrual function in women with autoimmune POI.

Treatment: Controlled ovarian hyperstimulation before and four months after an infusion of 1-gram rituximab (Mabthera®) twice with two weeks interval. Follow-up period 12 months after infusion.

Primary outcome: Number of antral follicles and the size of the largest follicle in response to ovarian stimulation.

Secondary outcomes:

1. Reestablishment of spontaneous menstrual bleedings during the 12 months' study period
2. Ovulation during the 12 months' study period
3. Change in B-cell count, autoantibody indices and immunoglobulin levels (IgG) after treatment

Safety outcomes: All adverse events. Of particular relevance are any hospital admissions, infections and allergic reactions.

Study population: Fifteen women with autoimmune POI defined as absence of menstruation \> 6 months and elevated serum level of follicle stimulation hormone \> 40 International units (IU)/L.

Inclusion criteria: Autoimmune POI defined as presence of autoantibodies against 21-hydroxylase (OH), side chain cleavage enzyme (SCC), 17-OH and/or neuronal apoptosis inhibitory protein (NACHT) leucine-rich-repeat protein 5 (NALP5) or other relevant autoantibodies; 18-35 yrs of age; body mass index 19-30.

Exclusion criteria: Hypersensitivity to rituximab; severe infection; severe immunosuppression; cardiac disease; cancer; benign tumours of the hypothalamus, pituitary, or ovary; ovarian enlargement or ovarian cyst; vaginal bleeding of unknown aetiology.

Time plan: The study is expected to start the spring 2017. It is expected to be closed spring 2023.


Eligibility Criteria:
Inclusion Criteria:

1. Autoimmune premature ovarian insufficiency defined as presence of autoantibodies against 21-OH, SCC, 17-OH and/or NALP5 or other relevant autoantibodies
2. 18-35 yrs of age
3. Body mass index 19-30.
4. In fertile females, willingness to comply with effective contraceptive methods.
5. Ability to provide informed consent

Exclusion Criteria:

1. Documented hypersensitivity or intolerance to rituximab
2. Active, severe infection
3. Severe immunosuppression
4. Severe cardiac disease
5. Cancer
6. Benign tumours of the hypothalamus, pituitary, or ovary; ovarian enlargement or ovarian cyst
7. Vaginal bleeding of unknown aetiology
8. Hormone replacement therapy (HRT) within four weeks prior study entry.
9. Pregnant or lactating women
10. Concurrent treatment with other immunosuppressive drugs
11. Vaccination within 4 weeks of infusion of study medication
12. Severe psychiatric disorder
13. Patient with any condition or any circumstance that in the opinion of the investigator would make it unsafe to undergo treatment with Rituximab.
Analysis of the Effects of Vocal Conditioning Through Semi-occluded Vocal Tract Exercises in Choir Singers

This research aims to evaluate the effects of vocal conditioning through two semioccluded vocal tract exercises (SOVTE) in choir singers.

This research aims to evaluate the effects of vocal conditioning through two semioccluded vocal tract exercises (SOVTE) - Finnish tube and phonation in high strength straw - in vocal parameters, vocal extension profile and maximum phonation time for a period of four months in a group of singers. acoustic analysis will be performed of the average parameters of the fundamental frequency (F0), jitter, shimmer and glottal to Noise Excitation (GNE) by VoxMetria program and perceptual analysis through Consensus Assessment Perceptual Hearing the Voice Protocol (CAPE-V) three times: before the vocal conditioning, after the last meeting of the technical realization and a week after the vocal conditioning period.

Eligibility Criteria:
Inclusion Criteria:

* signing of the Informed Consent (IC).

Exclusion Criteria:

* voice disorders diagnosed by otolaryngologist physician;
* smokers;
* presence below 75% in the meetings.
Impact of a Computer-Assisted SBIRT Program in an HIV Care Setting

The goal of this research is to assess the impact of the "screening, brief intervention, and referral to treatment" (SBIRT) intervention strategy for harmful substance use among HIV-positive people.

The specific aims of the study are:

1. To assess the feasibility of conducting SBIRT using (1) a patient self-administered intervention embedded in a web-based Personal Health Record (PHR) compared to (2) a provider-administered SBIRT intervention guided by the Electronic Medical Record (EMR) during clinic appointments.
2. To examine the acceptability of web-based PHRs to conduct and communicate SBIRT compared to EMR-activated SBIRT conducted by clinic staff, from the perspective of the patient and the provider.
3. To assess the impact of SBIRT on risky drug and alcohol use in an HIV/AIDS population and subsequent effects on sexual risk behaviors and antiretroviral therapy (ART) adherence.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age
* confirmed prior HIV+ serostatus
* ability to provide informed consent to be a participant over a 6 month period
* English or Spanish speaking

Exclusion Criteria:

Inability to answer questions with interviewer assistance. Not receiving primary care in clinic.
Montelukast in Parkinson Disease

Parkinson's disease (PD) is the second most common neurodegenerative disorder after Alzheimer's disease (AD). Clinical manifestations of PD can vary, but a formal diagnosis relies on the presence of bradykinesia with rigidity and/or rest tremor according to Movement Disorder Society (MDS) criteria for PD. Non-motor symptoms, such as hyposmia, constipation, depression, and rapid eye movement (REM) sleep behavior disorder, are common and can in many cases manifest before classical motor symptoms. In later years, more emphasis has been put on non-motor symptoms, especially in the early stages of PD and which is evident in the proposed prodromal PD criterion by MDS.

Leukotrienes are along with prostaglandins, lipoxins, and thromboxanes included in a group of long-chain fatty acids known as eicosanoids. They are known to play important parts in the inflammatory response such as leukocyte chemotaxis, vascular leakage, and astrocyte proliferation, and were first described by Bengt Samuelsson and colleagues in 1983. Leukotrienes (LT) are synthesized from free arachidonic acid (AA) by the enzyme 5-lipoxygenase (5-LOX) into LTA4, which is then further metabolized into LTB4, C4, D4, and E4. LTC4, D4, and E4 are grouped by their molecule structure to form the cysteinyl leukotrienes and they mainly activate two receptors, CysLT1 and CysLT2. CysLT1 is a Gq/11 family G-protein-coupled receptor with signaling through phospholipase C and Ca2+ mobilization

Eligibility Criteria:
Inclusion Criteria:

- Age ≥ 18 years Both male and female will be included Negative pregnancy test and effective contraception. Diagnosed Parkinson's disease patient taking Levodopa

Exclusion Criteria:

- Secondary causes of parkinsonism Patients taking anti-inflammatory drugs Atypical parkinsonian syndromes Prior stereotaxic surgery for Parkinson's disease Pregnancy and lactation Suffering from active malignancy Addiction to alcohol and / or drugs Known allergy to the studied medications
Coronavirus Response - Active Support for Hospitalised Covid-19 Patients

The CRASH-19 trial is a multinational, open-label, factorial, randomised trial in adults hospitalised with suspected or confirmed acute COVID-19 infection.

We will evaluate the effect of aspirin (150mg once daily), losartan (100mg once daily), and simvastatin (80mg once daily) in patients with COVID-19 infection.

Eligible patients will be randomly allocated to one of eight study arms (aspirin only; losartan only; simvastatin only; aspirin and losartan; aspirin and simvastatin; losartan and simvastatin; aspirin, losartan and simvastatin; standard care only). Trial treatments are given in addition to the usual standard of care at the study hospital.

Treatment will be started as soon as possible after randomisation and will continue until death, discharge or 28 days after randomisation, whichever occurs first.

Eligibility Criteria:
Inclusion Criteria:

* Adults age 40 years and older
* with suspected or confirmed acute COVID-19 infection. Acute COVID-19 infection is suspected in the presence of a fever and at least one symptom of respiratory disease e.g. cough, difficulty breathing, signs of hypoxia. The clinician may suspect COVID-19 infection if i) the patient lives in or has recently travelled to an area with COVID-19 transmission; ii) the patient had recent contact with a confirmed or probable COVID-19 case, or iii) no alternative diagnosis fully explains the clinical presentation
* requiring hospitalisation

Exclusion Criteria:

* Women known to be pregnant
* Patients hospitalised without symptoms of acute COVID-19 infection should not be recruited even if they test positive for COVID-19
* Patients already receiving mechanical ventilation
* Patients with a definite indication or contraindication for any of the trial treatments.
* Patients who are very severely frail (completely dependent and approaching end of life who typically they could not recover even from a mild illness) or terminally ill should not be recruited.
Therapeutic Confirmatory Clinical Trial to Evaluate the Safety and Efficacy of "AG NPP709 Syrup"

The purpose of this study is to assess therapeutic confirmation of AG NPP709 syrup to evaluate the safety and efficacy in patients with acute upper respiratory tract infection and chronic inflammatory bronchitis.


Eligibility Criteria:
Inclusion Criteria:

1. Parent s or patient who decided to participate in this clinical trial at his (her) own will and agreed in written letter of consent
2. Patient ages between 24months and 75years
3. Patient with a clinical diagnosis of acute upper respiratory tract infection or chronic inflammatory bronchitis should has any combination of at least two of following symptoms including sputum: cough, sputum, dyspnea and chest pain when breathing
4. Females of child-bearing age should have nagative pregnancy test or have sufficient contraceptive protection

Exclusion Criteria:

1. Patient whose the following severe respiratory disease: pneumonia, uncontrolled asthma, pancreatic fibrosis viral influenza, tuberculosis
2. Patient whose the following disease: malignant tumors, severe central nervous system disorders, medication needed severe metabolic disorders
3. Patient whose fructose intolerance
4. Patient who has hypersensitivity anamnesis of Prospan syrup
5. Patient whose heart function is abnormal: cardiac insufficiency, including the case of showing abnormal EKG test value that is clinically significant
6. Patient whose liver or kidney function is serious abnormal: including the cases of ALT, AST, bilirubin and blood creatinine value exceeding three times of their upper limit, severe liver disorders, chronic kidney disease
7. Patient who has uncontrolled diabetes or uncontrolled hypertensions
8. Patient who has experience to have participated in other clinical trial within two months before starting the trial
9. Pregnant women, lactating women
Chemotherapy Via an Implantable Pump Compared With a Subcutaneous Port for Unresectable Liver Metastases in Patients With Resected Colorectal Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug or giving the drugs in different ways may kill more tumor cells.

PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy administered via an implantable pump with a subcutaneous port for unresectable liver metastases in patients with resected primary colorectal cancer.

OBJECTIVES: I. Compare the efficacy of 2 schedules of fluorouracil/leucovorin given as a continuous intra-arterial infusion via an implantable pump vs. a subcutaneous port for unresectable liver metastases in patients with colorectal cancer. II. Compare the effect of each treatment on response rate, quality of life, and rate of technical complications in these patients.

OUTLINE: Randomized study. The following acronyms are used: CF Leucovorin calcium, NSC-3590 5-FU Fluorouracil, NSC-19893 Arm I: Single-Agent Chemotherapy with Drug Modulation. 5-FU; with CF. Weekly infusion via an implantable pump. Arm II: Single-Agent Chemotherapy with Drug Modulation. 5-FU; with CF. Weekly infusion via a subcutaneous infusion port. Arm III: Single-Agent Chemotherapy with Drug Modulation. 5-FU; with CF. Monthly infusion via an implantable pump. Arm IV: Single-Agent Chemotherapy with Drug Modulation. 5-FU; with CF. Monthly infusion via a subcutaneous infusion port.

PROJECTED ACCRUAL: A total of 336 patients will be entered in this multicenter study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Primary colorectal cancer with unresectable liver metastases Less than 75% involvement of the liver Radical resection of primary colon or rectal tumor required No local recurrence or extrahepatic metastases No portal vein thrombosis, ascites, or cirrhosis

PATIENT CHARACTERISTICS: Age: 18 to 76 Performance status: Karnofsky 70%-100% Hematopoietic: WBC greater than 3,000 Platelets greater than 100,000 Hepatic: Bilirubin no greater than 4 mg/dL Alkaline phosphatase no greater than 1,200 U/L Coagulation tests normal Renal: Creatinine no greater than 2.5 mg/dL Other: No prior malignancy

PRIOR CONCURRENT THERAPY: See Disease Characteristics No prior intra-arterial chemotherapy for liver metastases No prior hepatic chemoembolization At least 3 months since fluorouracil
Comparison of Outcomes of Multiple Platforms for Assisted Robotic - Prostate

The object of this exploratory clinical trial is to evaluate post-operative complications in a population that underwent Robotic Assisted Radical Prostatectomy (RARP) made with multiple platforms:

* DaVinci;
* Hugo;
* Versius.

The questions it aims to answer are:

* Does the estimation of the post-operative complications suggest something?
* Are differences (intra-operative, post-operative, oncological, functional, technical, and economic) among the three intervention approaches observable?

Participants will be invited to fill out questionnaires and join one of these three groups:

1. surgery with the daVinci platform;
2. surgery with the Hugo platform;
3. surgery with the Versius platform.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 and \< 90 years;
* Organ-localized prostate cancer with a surgical indication of radical prostatectomy;
* Informed consent provided.

Exclusion Criteria:

* Age \< 18 and \> 90 years;
* Contraindication to radical prostatectomy procedure;
* Non-organ confined prostate cancer;
* Refusal to participate.
Measuring Core Body Temperature Using TempuRing

This study evaluates the safety and usability of a continuous temperature sensor for women. Data will compare the date of ovulation identified by the continuous temperature sensor to that of transvaginal ultrasound and serum progesterone levels. Subjects will also compare sensor results to once-daily oral temperatures and urine luteinizing hormone (LH) status.

Up to 25 healthy female volunteers or females currently trying to conceive will wear the continuous temperature sensor for 3 menstrual cycles. Subjects will record their daily oral temperature, and record their urine luteinizing hormone (LH) status via ovulation prediction kits. Subjects will return to the clinic after a positive urinary LH test to receive transvaginal ultrasound scans to confirm ovulation (ultrasounds will be repeated daily until evidence of ovulation is documented by follicular collapse). Ovulation will also be confirmed by serum progesterone. Subjects will complete an online questionnaire to assess the usability and comfort of the continuous temperature monitor.

Eligibility Criteria:
Inclusion Criteria:

1. Participant is willing and able to give informed consent for participation
2. Females aged 21 to 43 years
3. Have a body mass index (BMI) above 19 and below 29
4. Regular menstrual cycles, i.e. no greater than 7 days difference between the shortest and longest cycle in the last 6 months
5. Minimum menstrual cycle 24 days
6. Maximum menstrual cycle 35 days
7. Normal pap smear within the last year
8. Willing to use the fertility device for at least 3 cycles
9. Willing to fill in online questionnaires
10. Willing to attend clinic up to 6 times per cycle for transvaginal ultrasound and blood tests
11. Willing to perform LH urine tests at home twice a day from day 8 of cycle until it is positive
12. Willing to document the last day of the previous menses and first day of the following menses.
13. Willing to measure and record oral at the same time each morning.
14. Normal pelvic ultrasound and blood results obtained during screening tests

Exclusion Criteria:

1. Any diagnosed systemic illnesses including thyroid disease, diabetes, yeast infection, Chlamydia, gonorrhea, trichomonas, bacterial vaginosis, inflammatory diseases, or are in an immuncompromised state
2. Polycystic ovary disease
3. Endometriosis or other chronic pelvic pain or pelvic pathology
4. Taking steroid medication, including oral contraceptives or anti inflammatory drugs
5. Pregnant
A Comparison Study of the Perclose Proglide (TM) SMC System Versus Figure-of-8- Suture Technique for Closure of Large-bore Femoral Venous Access.

This study aims to compare the efficacy and safety of two strategies for closing large caliber venous access in patients undergoing percutaneous procedures: compression with figure-of-8 suture versus closure with the Perclose-Proglide system.

This is a retrospective observational study that aims to compare two strategies for closing large-caliber femoral venous access in patients who have undergone percutaneous procedures.

The study's goal is to determine if there are significant differences in terms of efficacy and safety between the two closure strategies. Figure-of-8 suture compression is a well-established technique that has been used for decades to close large-bore femoral venous access, while the Perclose-Proglide system is a relatively new medical device that could have great utility for the closure of large-bore femoral venous access. By comparing these two strategies, researchers hope to determine the safety and effectiveness of the Perclose-Proglide system for closing large-bore femoral venous access in patients undergoing percutaneous procedures.

Eligibility Criteria:
Inclusion Criteria:

Patients will meet all inclusion criteria:

* Adult patients aged \> 18 years
* Patients who have undergone percutaneous interventional procedures
* Patients in whom the procedures have been performed with femoral venous access
* Patients who have required large caliber pods ≥ 14 French.

Exclusion Criteria:

Patients must not meet any exclusion criteria:

* Patients who have required access with surgical exposure.
* Patients who have required ipsilateral arterial access with a large caliber ≥ 14 French
* Patients with previous vascular surgery.
Antibiotic Use in French Nursing Home

CONTEXT: France is still one of the biggest consumers of antibiotics in Europe. An explanation for this increase in consumption would be aging. Thus, part of this aging population lives in nursing home, where the urinary tract infection is the second most suspected pathology. However, it can most often be bacteriuria requiring no antibiotic therapy. In nursing home, nurses who alert prescribers when an infection is suspected by describing clinical signs.However, his propensity to perform too rapidly and systematically an examination with dipsticks leads the physician to prescribe antibiotic. This is how a program called ATOUM is set up to reduce the prescription of antibiotics in nursing home. The present ATOUM 4 study builds on this program.

OBJECTIVE: To measure the effect of a nurse-centered multimodal intervention involving training and sensitization on urinary tract infection, asymptomatic bacteriuria, antibiotic resistance and interprofessional communication on antibiotic therapy. METHODS: This will be a randomized double-arm interventional study in 40 nursing home. The intervention group of 20 nursing home will receive a blended-learning intervention.

CONTEXT: France is still one of the biggest consumers of antibiotics in Europe. An explanation for this increase in consumption would be aging. Thus, part of this aging population lives in nursing home, where the urinary tract infection is the second most suspected pathology. However, it can most often be bacteriuria requiring no antibiotic therapy. In nursing home, nurses alert prescribers when an infection is suspected by describing clinical signs. However, their propensity to perform too rapidly and systematically an examination with dipsticks leads physicians to prescribe antibiotic. This is how a program called ATOUM is set up to reduce the prescription of antibiotics in nursing home. The present ATOUM 4 study builds on this program.

OBJECTIVE: To measure the effect of a nurse-centered multimodal intervention involving training and sensitization on urinary tract infection, asymptomatic bacteriuria, antibiotic resistance and interprofessional communication on antibiotic therapy. METHODS: This will be a randomized double-arm interventional study in 40 nursing home. The intervention group of 20 nursing home will receive a blended-learning intervention.The primary outcome will be the percentage of reduction in antibiotic prescription at the end of the twelve months following the first visit to nursing home. This data, aggregated by nursing home, will be obtained from the structures concerned via their prescription registration system.

Eligibility Criteria:
Inclusion Criteria:

* nursing home with registred nursing
* Presence of prescription registration system
* Situated in Paris and surb of Paris

Exclusion Criteria:

* n/a