cyrilzakka/clinical-trials huggingface dataset:
Standard Tubal Ligation Versus Salpingectomy for Sterilization at the Time of Cesarean Delivery

The objective of this study is to evaluate the feasibility and safety of salpingectomy versus standard tubal ligation in women undergoing surgical sterilization at the time of a planned cesarean delivery. Salpingectomy is currently being investigated as a potential strategy for ovarian cancer prevention. While this procedure is currently performed during hysterectomies, its feasibility at the time of cesarean delivery is not well established.

This randomized, prospective clinical trial will compare the two sterilization methods to demonstrate that salpingectomy compared with standard tubal ligation at the time of cesarean delivery will not result in increased operative time, blood loss or other complications. This study is necessary to promote salpingectomy as a standard sterilization method during cesarean deliveries.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must have planned cesarean delivery and desire sterilization
* Subjects must be able to read and provide written informed consent
* Subjects must be English or Spanish speaking

Exclusion Criteria:

* Subjects with known hereditary cancer syndromes
* Subjects with a history of prior tubal surgery
* Subjects with a placenta accreta
* Subjects undergoing trial of labor after cesarean delivery
PRESSURE CHECK: Find Your Path to Better Health

This study seeks to develop the evidence for a sustainable, community-partnered, multi-level health system strategy to improve blood pressure control. Two team-based approaches are being tested: 1) a medical model of remote BP management (RBPM) alone, and 2) RBPM plus a social model with a community health worker (CHW). These 2 strategies are being compared with a standard community screening program with referral to primary care.

In this comparative effectiveness trial, we aim to answer the research question of whether a remote blood pressure management program (RBPM, inclusive of home blood pressure monitoring and telehealth visits with a nurse or pharmacist) alone or an RBPM program with community health worker (CHW) support is more effective than standard screening with education and referral to primary care in controlling blood pressure and addressing social determinants that lead to poor health outcomes.

This is a multisite study using a stepped wedge design. Health systems in 4 different cities are each partnered with 10 community based organizations (CBOs). CBOs are randomized into one of 4 sequences. Each sequence moves through the 3 study arms at different time points: Community Standard, RBPM alone, and RBPM+CHW.

At the CBOs, research health advocates screen for hypertension. Qualifying individuals who provide informed consent can enroll in the study and are assigned to the intervention that the CBO is in at that particular time. All participants receive a blood pressure cuff and a device that syncs their data with the research database. If enrolled in the RBPM arm, participants are scheduled for telehealth visits with the Pressure Check medical team to improve blood pressure control through lifestyle support and medication initiation/titration. If enrolled in the RBPM+CHW arm, participants additionally receive support from a CHW to help with medical visits and address social determinants of health. The primary outcome is blood pressure control at 6 months. Additional outcomes include implementation science to understand factors associated with adoption and outcomes, and 12 and 18 month blood pressure control.

In partnering with the community, health systems can extend their reach. CBO leaders support health messaging around hypertension and increase trust between the health system and their clients (patients). The two models, RBPM alone and RBPM+CHW, are based on the concept that disparities in hypertension control among Black, Latinx, and low-income populations exist because of inequities related to health system access and trust, individual-level socioeconomic and lifestyle factors, the physical/built environment, sociocultural factors, and discriminatory policies. Addressing these barriers may improve blood pressure control.

Eligibility Criteria:
Inclusion Criteria:

* Elevated BP, defined as an average resting BP of \>=135/85 mmHg based on 3 consecutive blood pressure readings

Exclusion Criteria:

* People who are pregnant
* Those that have end stage renal disease on dialysis
* People receiving active chemotherapy
Genetics of Pulmonary Hypertension

Despite the developments in recent years, pulmonary arterial hypertension (PAH) is still a disease with high mortality and morbidity. Although studies on genetic background have increased, the pathogenesis of PAH remains complex and unresolved. The most comprehensive data are related to bone morphogenetic protein receptor type 2 (BMPR2), and in recent years, new responsible or candidate genes have been identified, especially by new generation DNA sequencing In this study, it was aimed to determine the genetic background of patients with PAH and to investigate the genetics of secondary PAH not only HPAH.

In our study, changes in BMPR2, SARS2, KRT8, KRT18, SMAD9, CAV1, KCKN3, CPS1, TBX4, ACVRL1, G6PC3, EIF2AK4 and ENG genes will be screened in patients with PAH. In addition to previously reported changes in the relevant genes, previously unreported changes that are likely to be significant according to insilico methods are presented.

Patients' age, gender, mean follow-up time, underlying congenital heart anomalies, 6-minute walk test (6 MWT), proBNP, catheter measurement values (mPAB, m RAB, Rp/Rs, PVR), vasoreactivity test positivity, World health organization functional classification (WHO-FS), cardiac function measurements by echocardiography, treatments they received will be collected retrospectively.

Eligibility Criteria:
Inclusion Criteria:

* mPAB ≥25 mmHg, pulmonary capillary wedge pressure (PCWP) ≤15 mmHg, PVR index (PVRI) ≥3 WU.m2 in right heart catheterization.

Exclusion Criteria:

* Neonatal pulmonary hypertension
Acupuncture Point Stimulation for Treatment of Chemotherapy Nausea and Vomiting

This randomized pilot clinical trial studies giving acupuncture in reducing nausea and vomiting in patients undergoing chemotherapy. Pressing and stimulating nerves at an acupuncture point on the inside of the wrist may help control nausea and vomiting during chemotherapy.

PRIMARY OBJECTIVE:

I. To determine whether transcutaneous acupuncture point stimulation (TAPS) at P6 as an adjuvant treatment to standard antiemetic therapy reduces acute chemotherapy induced nausea and vomiting as compared to sham acupuncture point stimulation in children undergoing their first round of highly or moderately emetogenic chemotherapy.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients undergo TAPS at the true acupuncture point (P6) 30 minutes prior to first chemotherapy infusion and then four times a day for 20 minutes every 2 hours at 8am, 10am, 12pm, and 2pm. Patients then crossover to Arm II for the second course of chemotherapy.

ARM II: Patients undergo TAPS at a sham non-acupuncture point 30 minutes prior to first chemotherapy infusion and then four times a day for 20 minutes every 2 hours at 8am, 10am, 12pm, and 2pm. Patients then crossover to Arm I for the second course of chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Patient with a planned admission for at least 24 hours for highly emetogenic or moderately emetogenic chemotherapy at Lucile Packard Children's Hospital or Packard El Camino.
* Planned to undergo at least 2 more cycles of chemotherapy.
* Can include but not limited to: children with high risk ALL, AML, Ewing's Sarcoma, Osteosarcoma
* History of vomiting with prior cycles of chemotherapy (2 episodes of emesis at minimum) despite use of conventional antiemetic medications.
* Age 8-21.
* Parent must be able to understand and willing to sign written informed consent document.

Exclusion Criteria:

* Prior knowledge of acupuncture or experience with acupuncture or acupressure.
* There will be no restrictions regarding use of other Investigational Agents.
* Comorbid Diseases:

  * Diagnosis of any cardiac condition (cardiomyopathy, arrhythmia, pacemaker placement).
  * Any diagnosis requiring pediatric intensive care unit admission.
  * Patients with brain tumor, brain metastasis (these patients often require radiation and surgery in addition to chemotherapy which may confound the results)
  * Concomitant radiation therapy during current chemotherapy cycle.
  * Developmental delay patients with allergy to tape or leads will be excluded from the study.
* Pregnant patients will be excluded from the study.
* Cancer survivors will not be excluded from the study as long as they are undergoing chemotherapy treatment for their current cancer therapy.
* HIV-positive patients will not be excluded.
Sperm DNA Fragmentation in Recurrent Pregnancy Loss

In human, 2% of couples experimented Recurrent pregnancy loss (RPL). Currently, while etiological investigations were performed, 40 to 50 % of RPL were unexplained. In animals' studies, several studies have underlined the importance of sperm quality for a normal embryo development. In human, epidemiological studies have demonstrated that several male risk factors have effects on development (male mediated development toxicology). However, few studies have explored sperm DNA fragmentation on embryo development but after in vitro fertilization. In natural pregnancy only rare studies have been performed but with different populations definitions and different methods of sperm exploration. In this context sperm DNA fragmentation exploration appears justified. The present study purpose to conduct a case - control study in order to research paternal role in RPL.


Eligibility Criteria:
Inclusion Criteria:

* Cases: Man from couples with RPL (more than 2 miscarriages) RPL classical etiological exploration negative (unexplained RPL) Healthy voluntaries
* Control: Man from couples who have a child after a natural pregnancy obtained in the year following child desire.

Healthy voluntaries

Exclusion Criteria:

* Cases: Etiological exploration of RPL positive Man with chromosomal anomaly
* Cases and controls:

Ongoing pathology Chemotherapy or radiotherapy history Hyperthermia (fever) in the last three months Pregnancy obtained by assisted reproduction (Inseminations, in vitro fertilization) Women \> 38 year old
Video Vitals and Biomarkers

The investigators are doing this research to study the ability of mobile devices to measure vital signs and biomarkers from video as compared to standard-of-care clinical office tools.


Eligibility Criteria:
Inclusion Criteria:

* Must be able to stay in a seated position for 30 minutes
* Must be able to participate in a venous blood draw

Exclusion Criteria:

* Condition that prevents prolonged seated position
* Condition that restricts ability to provide venous blood sample
AStudy To Evaluate Safety And Eficacy Of Apixaban In Japanese Acute Deep Vein Thrombosis (DVT) And Pulmonary Embolism (PE) Patients

The purpose of this study is to investigate safety of apixaban in Japanese acute DVT/PE subjects when symptomatic DVT/PE subjects are treated with 10 mg BID apixaban for 7 days as initial therapy followed by 5 mg BID apixaban for 23 weeks as long-term therapy (total treatment period is 24 weeks)


Eligibility Criteria:
Inclusion Criteria:

* Acute symptomatic proximal DVT with evidence of proximal thrombosis
* Acute symptomatic PE with evidence of thrombosis in segmental or more proximal branches

Exclusion Criteria:

* Active bleeding or high risk for bleeding contraindicating treatment with UFH and a VKA.
* Uncontrolled hypertension: systolic blood pressure \> 180 mm Hg or diastolic blood pressure \> 110 mm Hg
* Subjects requiring dual anti-platelet therapy
PAncreas Borderline and Locally Advanced Snapshot Study

The project's objective is to carry out prospectively, in France, for one year, a descriptive registry study in the management of patients with borderline or locally advanced pancreatic adenocarcinoma, and to collect both the patient's demographic characteristics, but also the therapeutic regimens applied, the types of surgeries performed and the outcome of the patients after surgery, and at three months of follow up (preoperative data, complications's post surgery, quality of the resection, etc.)

* Multicenter, observational prospective study over one year in France in patients with borderline or locally advanced pancreatic adenocarcinoma operated between September 2022 and August 2023.
* Patients will be screened by the pancreatic's surgeons practicing in a reference centers during preoperative surgical consultations (V1),
* The patient's non-objection will be sollected,
* The end of follow-up's patient will take place during the post-operative consultation approximately 3 months after surgery (V3)
* Between V1 and V3, preoperative data (demography, history, tumor characteristics, neoadjuvant treatments performed, tumor response), operative, intraoperative, pathological and postoperative data will be collected via a e-CRF " the REDCAP software".

Eligibility Criteria:
Inclusion Criteria:

* Any patient over the age of 18, operated on for pancreatic adenocarcinoma, borderline or locally advanced, between September 2022 and August 2023, in France
* Diagnosis of pancreatic adenocarcinoma:

  * either after cytopuncture with anatomopathological result confirming the diagnosis,
  * or with strong suspicion on the combined criterias : clinical, biological and morphological criterion (according to INCa 2019 and NCCN recommendations ) in the event of absence of anatomopathological documentation (failure of several fine needle punctures (maximum 3)/or non-contributory anatomopathological examinations),
* Borderline or locally advanced character depending on the presence of a contact of the tumor with nearby vessels and defined by morphological examination (scanner +/- MRI). These criteria are defined by the NCCN Guidelines for Pancreatic Adenocarcinoma V.1.2021, international reference

Exclusion Criteria:

* Patient under juridic protected or subject to any measure of legal protection,
* Patients not operated on for their pancreatic adenocarcinoma,
* Adenocarcinoma of the pancreas operable immediately on diagnosis,
* Metastatic pancreatic adenocarcinoma from the outset on diagnosis,
* Patient without pancreatic adenocarcinoma after histological examination (in the case where the pancreatic lesion was operated on for strong suspicion of pancreatic adenocarcinoma on the combined clinical, biological and morphological criterion (according to INCa 2019 and NCCN recommendations, but that the lesion on definitive pathological examination is not a pancreatic adenocarcinoma)
Investigating the Effectiveness of Tresiba® (Insulin Degludec) After Switching Basal Insulin in a Population With Type 1 or Type 2 Diabetes Mellitus

This trial is conducted in Europe. The aim of this trial is to investigate the effectiveness of Tresiba® (insulin degludec) after switching basal insulin in a population with type 1 or type 2 diabetes mellitus.

EU-TREAT (EUropean TREsiba AudiT)


Eligibility Criteria:
Inclusion Criteria:

* Informed consent will be obtained before any study-related activities. Study-related activities are any data collection from the medical records of the patient
* Age at least 18 years at the time of Tresiba® initiation
* T1DM or insulin-treated T2DM patients
* Switched to Tresiba® (with or without prandial insulin) after any basal insulin (with or without prandial insulin). Switch must have occurred at least 6 months prior to data collection and the patient may or may not be treated with Tresiba® at the time of patient selection
* Previously treated with any basal insulin (with or without prandial insulin) for at least 6 months prior to switching to Tresiba®
* At least one documented medical visit in the first 9 months after Tresiba® initiation
* Minimum available data at the time of Tresiba® initiation: age, type of diabetes, HbA1c (Glycated haemoglobin), duration of diabetes, duration and type of insulin treatment, medical follow-up at the study site of at least 1 year, and an eGFR (Estimated glomerular filtration rate )value in the last 12 months

Exclusion Criteria:

* Previous participation in this study. Participation is defined as having signed the Informed Consent
* Participation in a diabetes clinical trial or receipt of any investigational medicinal product up to 12 months before or any time after the initiation of Tresiba®
* Current participation in another non-interventional study on insulin degludec (Tresiba®)
* Patients treated by continuous subcutaneous insulin infusion or premix insulin in the 6 months prior to receiving Tresiba®
Role of Endothelin-1 in Flow-mediated Dilatation

Endothelial dysfunction of conduit arteries contributes to the increased morbidity and cardiovascular mortality in patients with essential hypertension and appears increasingly as an independent therapeutic target. We have shown previously that besides a decrease in the availability of NO and other endothelium-derived vasodilators factors, the epoxyeicosatrienoic acids, an increase in the vasoconstrictor endothelin-1 (ET-1) may play a role in the pathophysiology of this endothelial dysfunction. Indeed, the local concentrations of endothelin-1 during the endothelium-dependent dilation of the radial artery in response to a sustained increase in blood flow decreased significantly in healthy volunteers controls but not in hypertensive patients. This lack of adaptation of the endothelinergic system could be due to a decreased clearance of endothelin-1 by endothelial ETB receptors, potentiating the vasoconstrictor action of endothelin-1 mediated by ETA receptor activation at the muscular level. However, to validate this hypothesis , it is needed to demonstrate the physiological role of ETA receptor and ETB in sustained flow-mediated dilatation of conduit arteries.


Eligibility Criteria:
Inclusion Criteria:

* Male, Caucasian, aged 18 to 35 years
* Non-Smoking
* Resting heart rate\> 50 and \<90 bpm
* SBP \<140 mmHg and DBP \<90 mm Hg at rest in the supine position for 10 minutes
* Normal ECG

Exclusion Criteria:

* Known allergy
* Intolerance to glyceryl trinitrate
* Intolerance to lidocaine
* Family history of hypertension
* Excessive alcohol consumption ( more than 50 g / day)
* Addiction or presumption of illicit drug use
* Subject refusing blood samples for serology of hepatitis B , C and HIV
* History of illness or psychological or sensory abnormality that may prevent the subject to understand the requirements for participation in the protocol or prevents giving informed consent
* Metabolic or endocrine disease
* Immunological diseases
* Renal or hepatic impairment
* Ischemic or obstructive heart disease
* Neoplastic disease
* Gastrointestinal disease
* Neurological disease , intracranial hypertension , seizure disorders
* Compulsive overeating , bulimia, anorexia
* Severe psychiatric illness
* Presence of a clinically significant abnormality in laboratory tests carried out at the inclusion visit .
* HBs Ag , HCV Ab , Ac HIV 1 or HIV 2 positive .
* The use of any drug in the range of less than 5 half-life time, in particular betablockers, sildenafil, cimetidine, amiodarone .
Assessment of Distal Protection Device in Patients at High Risk for Distal Embolism in Acute Coronary Syndrome (ACS)

Attenuated plaque ≥ 5mm by intravascular ultrasound(IVUS) was reported to be high risk for distal embolism in Acute coronary syndrome(ACS). The purpose of this study is to assess the effect of thrombus aspiration catheter and distal protection device (filter wire; Filtrap™) in the aforementioned subgroup of patients at high risk for distal embolism.


Eligibility Criteria:
Inclusion Criteria:

Patients who were diagnosed as ACS and meet the following criteria.

* Patients with acute myocardial infarction or unstable angina within 2 months from onset.
* Patients who have severe coronary stenosis which require PCI and in whom attenuated plaque ≥ 5mm (longitudinally) by IVUS before PCI is observed prior to balloon dilatation and stent deployment.

Exclusion Criteria:

* Patients who need balloon expansion (including small diameter balloon) for IVUS catheter crossing.
* Patients who were resuscitated after dead on arrival
* Graft lesion or in-stent restenosis lesion
* Patients on dialysis or renal failure (Cr\>1.5mg/dl).
* Left main trunk lesion
* Target vessel size is \<2.5mm or \>5mm
* Ineligible for PCI
* Lactating and (possibly) pregnant woman or having possibility of pregnant
* Patients who are considered ineligible by the attending physician
Comparison of a Novel Wound Dressing Stratamed Versus Current Clinical Practice After Follicular Unit Extraction Hair Transplantation

Follicular donor sites on the scalp for hair transplantation will be treated with studied products post harvest.

A randomized side of the scalp will be treated with Stratamed, the other side with standard clinical practice.

Subjects will be assessed live immediately post treatment and in 2 sessions during the healing phase post harvest. Subjects will also complete subject reported outcome questionnaires at home between study visits.


Eligibility Criteria:
Inclusion Criteria:

* Over 18 years old
* Able to provide informed consent
* Planning to undergo follicular unit extraction hair restoration

Exclusion Criteria:

* Significant medical or surgical conditions
* Unable to give informed consent
* Patient unable to apply topical device
* Allergy or intolerance to ingredients or excipients of the formulation of studied products
* Pregnancy
Cabergoline Effect on Blood Sugar in Type 2 Diabetics

Diabetic patients with poorly control blood sugar are prescribed cabergoline for 1 months and their blood glucose is evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* HbA1C\>7

Exclusion Criteria:

* HbA1C\>10
* Psychiatric disorders