cyrilzakka/clinical-trials huggingface dataset:
Duplex US in Pelvic Congestion Syndrome in Females (PCS)

To investigate the feasibility of Duplex US in Diagnosis of Pelvic Congestion Syndrome

* In the past, a diagnosis of chronic pelvic pain left many women frustrated with few treatment options and a lack of available resources. Their physicians were likewise perplexed, despite the endless acquisition of negative laboratory and imaging data as well as inconclusive consultations obtained. In the last 10 years, improved scientiﬁc understanding and increased physician awareness have lessened the confusion surrounding this condition and its distinct association with pelvic congestion syndrome (PCS). Furthermore, reﬁnements of medical and minimally invasive surgical solutions give affected patients more therapeutic choices today.
* Since anatomical venous variations in the pelvis are common, it is important to know the anatomy of these vessels for treatment planning. Imaging is critical in the evaluation of pelvic varices, both to differentiate them from other condition and also because pelvic varices may be secondary to serious underlying pathology, such as inferior vena caval obstruction, portal hypertension, increased pelvic blood flow, and vascular malformations.

Sonographic findings of pelvic congestion syndrome were dilated left ovarian vein with reversed caudal flow, presence of varicocele, dilated arcuate veins crossing the uterine myometrium, polycystic changes of the ovary, and variable duplex waveform during the Valsalva's maneuver. Combined transabdominal and transvaginal sonography are potentially useful as a noninvasive screening \& grading tool for determining which patients with chronic pelvic pain may benefit from selective ovarian venography and transcatheter embolization

Eligibility Criteria:
Inclusion Criteria:

* All patients with signs and symptoms of PCS

Exclusion Criteria:

* No
Safety and Effectiveness of CPI-1189 in HIV-Infected Males on Combination Anti-HIV Drug Therapy

The purpose of this study is to see if it is safe to give multiple doses of CPI-1189 to HIV-infected, otherwise healthy, males. The study will also look at how CPI-1189 affects the levels of HIV, T cells (cells in the body that help fight infection), and three anti-HIV drugs (zidovudine, lamivudine, and indinavir) in the blood.

Advanced HIV infection can cause AIDS dementia (brain damage due to HIV leading to losses of memory and muscle control). CPI-1189 may be able to postpone AIDS dementia or slow it down.

Late-stage HIV infection can cause AIDS dementia (brain damage due to HIV leading to losses of memory and muscle control). CPI-1189 may be able to postpone AIDS dementia or slow it down.

In this randomized, double-blind study, 48 HIV-infected, otherwise healthy, male volunteers receive either multiple-dose CPI-1189 or placebo by mouth for 15 consecutive days. Each dosing group begins 6 weeks following the start of the preceding group. Volunteers enter the study site the night before dosing on Days 1 and 15 and remain at the study site for 72 hours following dosing. Throughout the study, volunteers have physical exams and donate samples of blood, urine, cerebrospinal fluid, and sperm.

Eligibility Criteria:
Inclusion Criteria

You may be eligible for this study if you:

* Are an HIV-positive man who is otherwise in good health.
* Are 18-50 years old.
* Have a CD4 count of 75-500 cells/mm3.
* Are currently taking zidovudine (ZDV), lamivudine (3TC), and indinavir (IDV).
A Phase III Study of AK104 as Adjuvant Therapy in HCC With High Risk of Recurrence After Curative Resection

The efficacy and safety of AK104 as adjuvant therapy in hepatocellular carcinoma of high recurrence risk after curative resection.


Eligibility Criteria:
Inclusion Criteria:

1. Pathological diagnosis of HCC without any metastasis;
2. Receiving radical resection as the only anti-tumor treatment;
3. No evidence of residual cancer found during or after the operation;
4. Presence of any high risk factor of postoperative recurrence;
5. Child-Pugh grade: A;
6. ECOG score: 0;
7. Controlled underlying causes of HCC.

Exclusion Criteria:

1. Fibrolamellar hepatocellular carcinoma, sarcoma-like hepatocellular carcinoma, cholangiocarcinoma, etc;
2. Any anti-tumor treatment other than radical surgery before randomization;
3. Precarious liver function indicated by severe complications;
4. Recent procedures or medications leading to high risk of bleeding;
5. Poorly controlled or symptomatic hypertension, congestive heart failure, arrhythmia, etc;
6. Failure of performing enhanced CT or MRI scans of the liver;
7. Recent severe infections or systemic antibiotics use;
8. Active autoimmune diseases;
9. History of other incurable malignant tumors;
10. History of transplantation;
11. Pregnancy.
Ultra-protective Ventilation Monitored by Electrical Impedance Tomography in Patients With Severe Acute Respiratory Distress Syndrome on Veno-venous ECMO

For ECMO supported patients with severe ARDS (acute respiratory distress syndrome), usual care include use of "ultraprotective" mechanical ventilation with tidal volume and pressure reductions that might ultimately enhance lung protection of patients with ARDS. Although very low tidal might also cause pulmonary derecruitment. The aim of this study is to monitor effects of very low tidal volume on regression of overdistension and derecruitment using electrical impedance tomography.

Secondary aim is to describe the evolution of the optimal PEEP (Positive End Expiratory Pressure) during the decrease of the tidal volume

Patients requiring venovenous ECMO support for severe ARDS will be monitored with electrical impedance tomography during introduction of "ultraprotective" mechanical ventilation.

Monitoring will start with pre-ECMO ventilator setting, then the tidal volume will be lowered step by step. Other parameters of the ventilator will be kept constant. Then, cumulated collapse and overdistention percentages will be estimated for each tidal volume. Optimal tidal volume will be defined by the lowest sum of alveolar overdistension and collapse.

Also, at the end of each step, PEEP titration will be performed to identify the optimal PEEP setting that combines the best alveolar recruitment with minimal overdistention. The aim is to determine whether the derecruitment induced by the decrease in tidal volume can be reduced by the application of PEP. Then, comparison of the different tidal volumes with application of ideal PEEP will be performed: measurement of the percentage of collapsed and overdistended areas by impedancemetry method between the different levels of tidal volume with application of ideal PEEP.

Eligibility Criteria:
Inclusion Criteria:

* aged ≥ 18 years
* patient with ARDS on venovenous (VV)-ECMO
* Written informed consent
* patient affiliated to a social security scheme

Exclusion Criteria:

* Pregnancy
* Adult patient subject to a legal protection measure (tutor, curator, etc.)
* Patients with a pacemaker, automatic implantable cardioverter defibrillator,
* contraindications to thoracic belt placement (e.g., thoracic or spinal cord trauma, recent thoracic surgery)
* undrained pneumothorax, bronchopleural fistula
* hemodynamic instability (i.e., use of intravenous fluids of more than 10 mL/kg or vasopressors 2 mg/h of norepinephrine or 0.5 mg/h of epinephrine)
The Effect of Breastfeeding Pillow on Breastfeeding Self-Efficacy and Postpartum Comfort in Women Who Had Cesarean

The research is a randomised controlled experimental study. It was conducted to examine the effect of breastfeeding pillow on breastfeeding self-efficacy and postnatal comfort in primiparous puerperas who gave birth by caesarean section. The answers to the questions "Is the breastfeeding pillow effective on breastfeeding self-efficacy in primiparous puerperium giving birth by caesarean section?" and "Is the breastfeeding pillow effective on comfort during breastfeeding in primiparous puerperium giving birth by caesarean section?" are investigated. The puerperas in the experimental group were allowed to use a breastfeeding pillow during breastfeeding and evaluated at 24th and 48th hours. Puerperas in the control group continued routine breastfeeding and did not use a breastfeeding pillow. They were evaluated at 24th and 48th hours.


Eligibility Criteria:
Inclusion Criteria:

* Graduated from primary school
* No communication problems
* The desire to breastfeed your baby,
* The mother and the baby do not have any health condition that may prevent breastfeeding,
* First pregnancy,
* Having given birth at 37\> 37 weeks of gestation,
* Having a baby weighing at least 2500 g,
* Over 18 years of age,
* Caesarean section with a single healthy baby

Exclusion Criteria:

* having given birth more than once
* Under 18 years of age
* communication problems
* unhealthy baby birth
Temozolomide in Treating Patients With Recurrent Oligodendroglial Tumors

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients with recurrent oligodendroglial tumors following combination chemotherapy.

OBJECTIVES: I. Determine the response rate and duration of response in oligodendroglial tumors to temozolomide treatment in patients with progressive disease during or after procarbazine/lomustine/vincristine (PCV) chemotherapy. II. Determine the feasibility and toxicity of temozolomide chemotherapy following PVC chemotherapy in these patients.

OUTLINE: This is an open label, multicenter trial. Temozolomide is administered orally on days 1-5 of each 4-week course; treatment continues for a maximum of 12 courses. Patients are followed every 2 months for the first 6 months and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 16-29 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven oligodendroglioma or oligoastrocytoma (with at least 25% oligodendroglial elements) Recurrent or progressive disease following both radiotherapy and procarbazine/lomustine/vincristine chemotherapy (or other nitrosoureas-based chemotherapy) Contrast enhancing, measurable disease (at least one lesion measuring at least 1 cm) by CT or MRI required Within 2 weeks prior to study treatment Within 3 days following concurrent surgery for the recurrence Steroid doses stable or decreasing for at least 2 weeks prior to scan No extracranial disease

PATIENT CHARACTERISTICS: Age: 18-69 Performance status: WHO 0-2 Life expectancy: At least 3 months Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.25 times upper limit of normal (ULN) Alkaline phosphatase no greater than 2 times ULN AST/ALT no greater than 2 times ULN Renal: Creatinine no greater than 1.25 times ULN Creatinine clearance at least 60 mL/min Other: Not pregnant or lactating Effective contraception required of fertile women No diseases interfering with follow-up

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics No more than one prior chemotherapy regimen At least 4 weeks since prior chemotherapy Prior nitrosourea required At least 6 weeks since nitrosourea Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics More than 3 months since radiotherapy Surgery: Not specified Other: No concurrent treatment with other investigational agents or other antitumor agents
Measurement of Perioperative Glomerular Filtration Rate

Our objective is to monitor glomerular filtration rate (GFR)during the perioperative phase of patients undergoing robotic surgery for rectum or large bowel cancers. We will use both a single injection and a continuous infusion of iohexol to measure kidney function for 72 hours after surgery.

The considerable morbidity and mortality associated with perioperative acute kidney injury (AKI) is well documented and known to complicate recovery from surgery.

Accurate, direct measurements of glomerular filtration rate (GFR) may provide a tool to monitor perioperative onset of rapidly changing renal function. This may subsequently lead to design of randomized controlled trials examining the effects of earlier intervention with the aim to reduce the incidence of perioperative AKI.

Recently a protocol for continuous infusion of low-dose iohexol (CILDI) as a measure of GFR in stable patients over a range of GFR (28-128 mL/min/1.73 m2) has been developed. Accuracy of this infusion protocol was confirmed with the single bolus injection (SBI) method. Data also showed that the continuous infusion protocol of low-dose iohexol is an accurate and precise method when measuring changing GFR even in critical ill patients with variable AKI risks. Accordingly, SBI and CILDI together now allow us to explore unanswered research questions related to perioperative change in renal function.

Eligibility Criteria:
Inclusion Criteria:

* Rectum or colon cancer

Exclusion Criteria:

* Acute kidney injury grade 3 or higher
This is a Study to Evaluate the Safety and Tolerability of ABL503, and to Determine the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of ABL503 in Subjects with Any Progressive Locally Advanced or Metastatic Solid Tumors

This is a first-in-human Phase 1, single-arm, open-label, multicenter, multiple-dose, dose-escalation and dose-expansion study of ABL503 to evaluate the safety, tolerability, MTD and/or RP2D, PK, immunogenicity, preliminary antitumor activity, and the PD effect of ABL503 in subjects with any progressive locally advanced (unresectable) or metastatic solid tumors who are relapsed or refractory following the last line of treatment and have no available standard of care option. This study includes 3 parts: a dose-escalation part, a dose-expansion part and tumor-expansion part


Eligibility Criteria:
Inclusion Criteria:

* Histologically and/or cytologically confirmed diagnosis of any progressive locally advanced (unresectable) or metastatic solid tumors that have relapsed or are refractory following the last line of treatment, for which prior standard therapy has been ineffective, standard therapy does not exist, or is not considered appropriate.
* With AE(s) excluding alopecia or Grade 2 toxicities that are deemed stable or irreversible (eg, peripheral neuropathy) from prior therapy that have improved to Grade 1 or the baseline grade more than 14 days prior to the first administration of the study drug
* Adequate hematologic, hepatic, and renal functions confirmed based on the screening laboratory tests and reconfirmed with additional safety laboratory tests performed within 72 hours prior to the first administration of ABL503

Exclusion Criteria:

* Prior anticancer monoclonal antibody treatment or investigational therapy within 28 days prior to the first administration of study drug or has not recovered (ie, ≤ Grade 1 or at baseline grade) from AEs due to previously administered agent more than 14 days prior to ABL503 administration
* Prior chemotherapy or radiation therapy within 2 weeks or targeted small molecule therapy within 5 half-lives prior to the first administration of study drug or has not recovered (ie, ≤ Grade 1 or at baseline grade) from AEs due to previously administered agent more than 14 days prior to ABL503 administration
* Requiring or received systemic steroid therapy or any other immunosuppressive therapy within 14 days prior to study drug administration.
* Risk factors for bowel obstruction or bowel perforation (including but not limited to a history of acute diverticulitis, intra-abdominal abscess, and abdominal carcinomatosis.
* Discontinued from prior immunomodulatory therapy due to any intolerable immune-related adverse events (IrAEs) requiring systemic steroid treatment
* History of drug-induced pneumonitis (interstitial lung disease) or currently has pneumonitis
* Received prior treatment with an anti-4-1BB antibody
Efficacy of Biweekly Ranibizumab (0.5 mg) for Exudative Macular Degeneration Retinal Edema Refractory to Anti-VEGF

This is a 24 week open label study to assess the efficacy of bi-weekly ranibizumab for patients with retinal fluid due to exudative macular degeneration refractory to monthly therapy.

This is a 24 week, open-label, non-randomized, phase II study evaluating intravitreal ranibizumab dosed every 14 days in subjects with exudative macular degeneration who have persistent intraretinal or subretinal fluid despite chronic monthly anti-VEGF therapy (\>6 months). Subjects must have had a minimum of 5 intravitreal anti-VEGF injections administered every 4-6 weeks in the 6 months preceding enrollment.

Consented, enrolled subjects will receive multiple open-label intravitreal injections of 0.5 mg ranibizumab administered every 14 days (± 3 days). Subjects who have resolution of fluid will convert to monthly ranibizumab for the remainder of the study. If fluid recurs, subjects will return to biweekly treatment.

Patients will be assigned to receive treatment with either ranibizumab vial or PFSs so that approximately 10 patients will be treated with each delivery method option, and syringe preparation time (SPT) will be measured by an assistant who will be observing the procedure and timing with an automated stopwatch.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 50 years
* Exudative age related macular degeneration in study eye involving the fovea
* Best Corrected Visual Acuity (by ETDRS) letter score in study eye of \< 85 and \> 24 (approximate Snellen equivalent 20/20 to 20/320)
* Persistent intraretinal or subretinal fluid on SD OCT despite a minimum of 5 intravitreal anti-VEGF injections administered every 4-6 weeks in the in the 6 months preceding enrollment in the study eye
* At least 30 days from last intravitreal anti-VEGF injection in the study eye

Exclusion Criteria:

* Patient who are receiving systemic anti-VEGF or proangiogenic therapy
* Patients on chronic high doses corticosteroid therapy (\> than 10 mg of oral prednisone or equivalent greater than 10 days)
* Patients on chronic immunosuppressant therapy
* Patients on drugs known to have toxic side effects on the retina e.g. hydroxychloroquine
* History of intravitreal corticosteroids in study eye within 4 months of baseline
* Uncontrolled hypertension (defined as systolic \>180 mm Hg and/or diastolic \> 100 mm Hg while patient is sitting)
* History of stroke or APTC event in the previous year
* Any intraocular surgery in study eye within 90 days of baseline
* Presence of vitreomacular traction in study eye
* Presence of significant epiretinal proliferation in study eye
* Evidence of active infection in either eye
* Uncontrolled glaucoma in the study eye defined as a pressure \> 25 mmHg on maximal medical therapy
Expanded Access for the Treatment of Cancers With Rearranged During Transfection (RET) Activation

Expanded access for participants with cancer with RET activation who are ineligible for an ongoing selpercatinib (also known as LOXO-292) clinical trial or have other considerations that prevent access to selpercatinib through an existing clinical trial.

The treating physician/investigator contacts Lilly when, based on their medical opinion, a patient meets the criteria for inclusion in the expanded access program.

N/A for expanded access

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of cancer with RET activation, who are not eligible for an ongoing selpercatinib clinical trial and are medically suitable for treatment with selpercatinib
* Have progressed or are intolerant to standard therapy, or no standard therapy option exists, or in the opinion of the investigator, are unlikely to derive significant clinical benefit from standard therapy
* Have adequate organ function

Exclusion Criteria:

* Currently enrolled in an ongoing clinical study of selpercatinib or another RET inhibitor
* Clinically significant active cardiovascular disease or history of myocardial infarction within 6 months prior to study treatment; ongoing cardiomyopathy; or current prolongation of the QT interval corrected for heart rate using Fridericia's formula (QTcF) interval greater than 470 milliseconds
Retrospective Trial on Low Prognosis Infertile Patients

The main objective of this study is to analyze management of Controlled Ovarian Stimulation (COS) protocols in low prognosis patients, secondly to observe the clinical outcomes (Fertilization Rate, Pregnancy Rate, the Ongoing Pregnancy Rate and the Live birth Rate) and the total units of gonadotrophins consume per M2 oocyte retrieved in this subgroup.

Humanitas Fertility Center maintains an external audit anonymized electronic research queries system, exported from a certified only access web database, which at time of this analysis (cycles at December 31th 2016) include 26,883 consecutive fresh non-donors IVF cycles. Patients who underwent these cycles had consented in writing that their medical records could be used for research purposes, as long as the patients' anonymity was protected and confidentiality of the medical record was assured. Since both of these conditions were met, this study has been approved on March 2th 2017 with an expedited review and approval protocol by the center's Institutional Review Board (IRB).

At least 2,000 expected low prognosis patients in the Humanitas Fertility Center Database out of 12,545 cycles performed in the period 2010-2015 with completed pregnancy follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Age ≤ 44
* Body Mass Index; 18 ≤ BMI ≥ 27
* Number of oocytes retrieved ≤ 9
* Cycles performed between January 2010 - December 2015

Exclusion Criteria:

* Age \> 44
* Number of oocytes retrieved ≥ 10
* Abnormal uterine cavity
* Endometriosis III-IV stage or adenomyosis
* Testicular spermatozoa PGS (Preimplantation Genetic Screening) cycles