cyrilzakka/clinical-trials huggingface dataset:
Study of the Effectiveness of Dydrogesterone in the Treatment of Endometriosis-related Pain

The study is an observational, multicenter, prospective, single arm study to evaluate the efficacy of dydrogesterone in endometriosis-related pain (EAP).


Eligibility Criteria:
Inclusion Criteria:

* Female, ≥18 and ≤45 years of age.
* With normal menstrual cycles (according to the International Federation of Gynecology and Obstetrics \[FIGO\]-2018 classification system) in the preceding 6 months before Cycle 0, defined as menstrual frequency ≥24 to ≤38 days, menstrual duration ≤8 days, shortest to longest cycle variation ≤7-9 days, normal flow volume (patient determined) and no intermenstrual bleeding.
* Have clinically or surgically diagnosed endometriosis according to routine clinical practice.
* Complaints of ERP.
* Prescribed treatment with Duphaston® according to the local approved label for treatment of endometriosis 10 mg BID or TID from the 5th to the 25th day of the menstrual period.
* Signed informed consent form (ICF).

Exclusion Criteria:

* With definite diagnosis of adenomyosis confirmed by clinical diagnosis or histopathology.
* Routine consumption of analgesics other than for the pain of endometriosis.
* Patients receiving hormonal treatment (e.g., dienogest, levonorgestrel releasing intrauterine system, dydrogesterone, etc.) or hormonal contraceptives (including intrauterine devices, contraceptive patches, contraceptive rings, oral contraceptives, etc.) during the previous menstrual cycle prior to Cycle 0.
* Ongoing pregnancy.
* Menopause or premature ovarian failure.
* Had surgery within 3 months before enrollment or have planned surgery during the study.
* Any coexisting disease(s) with or without chronic concomitant medication that may affect the assessment of pain intensity at the investigator's judgment.
* With any metabolic and genetic diseases that may affect pregnancy and fetus at the investigator's judgment.
* With contraindications for dydrogesterone treatment listed in the locally approved label (instructions for the medical use of Duphaston®).
* Other conditions that made the patient's participation impossible (based on the investigator's decision).
* Fertility treatments requiring assisted reproductive technology.
* Patients simultaneous participating in any interventional clinical study during observation period.
Dopamine Versus Dobutamine for Treatment of Arterial Hypotension in Term and Preterm Neonates

The purpose of this study is to examine the effects of Dobutamine as compared to Dopamine in term and preterm neonates with arterial hypotension on cerebral and renal oxygenation, fractional tissue oxygen extraction, mean arterial blood pressure and cardiac output.

The investigators hypothesize that Dopamine has a stronger effect on blood pressure than Dobutamine but Dobutamine has a stronger effect on cerebral oxygenation and cardiac output than Dopamine.


Eligibility Criteria:
Inclusion Criteria:

* fluid refractory arterial hypotension
* newborn infant below 44 weeks postmenstrual age
* parental informed consent

Exclusion Criteria:

* preterm infant below 28 weeks postmenstrual age during the first week of life
* congenital life-threatening malformations
* decision for palliative care
* hemorrhagic shock
* other obvious cause for arterial hypotension that requires immediate specific treatment, e.g. tension pneumothorax
Study Comparing Two Administration Pathways for Adenosine During Microvascular Function Assessment

The aim of this study is to investigate the agreement and reproducibility between intravenous and intracoronary adenosine administration during invasive assessment of microvascular function.

Goals of this study are:

1. Agreement and reproducibility between intravenous and intracoronary adenosine administration in the IMR (Index of microvascular resistance) value.
2. Agreement and reproducibility of FFR(fractional flow reserve), CFR (coronary flow reserve), MRR (microvascular resistance reserve), RRR (resistive reserve ratio) and reproducibility of each of these as compared with CFRabs (absolute coronary flow).
3. Time required for IMR measurements

The study is a single-center randomized, cross-over controlled, open label trial to investigate the reproducibility and agreement between intravenous and intracoronary adenosine administration during invasive assessment of microvascular function.

The primary analysis will be on the per-protocol population (i.e. including all patients who are not protocol violators).

Primary endpoint:

1. Agreement and reproducibility between intravenous and intracoronary adenosine administration in the IMR value.

Secondary endpoints:

1. Agreement and reproducibility of FFR, CFR, MRR, RRR and reproducibility of each of these as compared with CFRabs.
2. Time required for IMR measurements
3. Presence and severity of angina, assessed by SAQ(Seattle Angina Questionnaire)-7
4. Assessment of safety: Presence and severity of AV( atrioventricular) block, dyspnea, flush

Eligibility Criteria:
Inclusion Criteria:

* Chronic coronary syndrome (including patients with anginal equivalents).
* Indication to cardiac catheterization;
* Indication to the assessment of microvascular function (note: patients will be asked for participation and consented prior to the first measurement of microvascular function, which will be conducted as per clinical indication)
* Willingness to participate and ability to understand, read and sign the informed consent
* Age\>18 years

Exclusion Criteria:

* Age \<18 years
* Bronchial asthma, COPD (chronic obstructive pulmonary disease)
* Secondary or tertiary atrioventricular block without prior pacemaker implantation
* Previous CABG (coronary artery bypass graft) with patent grafts to the left anterior descending coronary
* Epicardial coronary disease (FFR \<0.80 with evidence of a focal stenosis) in the left anterior descending territory
* Inability to provide informed consent
Systemic Treatments for Alopecia Areata Registry

A multicenter prospective registry (STA2R) is conducted to assess systemic treatments for alopecia areata, focusing on effectiveness, safety, and long-term outcomes.

Rationale:

Alopecia areata (AA) is a dermatological disorder characterized by non-scarring hair loss, significantly affecting the quality of life of patients. While some patients experience spontaneous hair regrowth or respond well to localized treatments, patients with moderate-to-severe AA represent a subgroup that requires more extensive systemic therapies for effective management. Currently, the clinical management of moderate-to-severe AA is primarily based on expert opinions. There is a lack of research on systemic treatments for moderate-to-severe AA, comprising only a small number of randomized controlled trials and observational studies. Furthermore, there is a clear absence of long-term, prospective, and comparative data on these therapies. Most conventional systemic treatments for AA are prescribed off-label, underlining the importance of gaining a more comprehensive understanding of their effectiveness and safety.

Therefore, a long-term prospective registry is conducted. This registry will evaluate the real-world utilization of systemic treatments in AA patients, aiming to provide valuable insights into the effectiveness, safety, and long-term outcomes of these therapies. By collecting and analyzing such data, this registry endeavors to contribute to evidence-based clinical management, ultimately improving care for AA patients.

Objective:

The aim is to establish a comprehensive cohort of AA patients receiving systemic treatments, with the primary objective of assessing the short- and long-term effectiveness and safety of various systemic treatments for AA.

Study type:

This is a long-term multicenter prospective, observational, non-interventional registry.

Study population:

All adult AA patients starting systemic treatment, who are willing to provide voluntary informed consent prior to inclusion in the registry and comply with the requirements of the registry.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with alopecia areata;
* Starting/using a systemic treatment for alopecia areata;
* Informed consent for registry participation obtained from patient and/or caretaker.

Exclusion Criteria:

* Not sufficiently capable of understanding the Dutch language;
* Not willing to participate.
Reducing HIV Risk Among Adolescents: Evaluating Project HEART

This study evaluates an educational web-based intervention designed to increase adolescent girls' motivation and skills to engage in safer sexual behavior (Project HEART: Health Education and Relationship Training). Half of participants will receive Project HEART and half of participants will receive Project Growing Minds, an attention-matched control website focused on growth mindsets of intelligence and self-regulation. The ultimate goal of this work is to help girls reduce their risk of HIV and other sexually transmitted diseases and to avoid unplanned pregnancies.

This study evaluates an educational web-based intervention designed to increase adolescent girls' motivation and skills to engage in safer sexual behavior (Project HEART: Health Education and Relationship Training). Half of participants will receive Project HEART and half of participants will receive Project Growing Minds, an attention-matched control website focused on growth mindsets of intelligence and self-regulation. The ultimate goal of this work is to help girls reduce their risk of HIV and other sexually transmitted diseases and to avoid unplanned pregnancies.

Primary outcomes for this study include 1) acceptability of the program, 2) communication self-efficacy, and 3) communication intentions.

Eligibility Criteria:
Inclusion Criteria:

* 10th grade girl
* Able to read English

Exclusion Criteria:

* None
Comparison of the Effects of Electric Current With Needles and Surface Electrodes on the Abdominal Contour of Women

The goal of this clinical trial is to compare the acute effects of percutaneous and transcutaneous eletroclipolysis on abdominal contour in women. The main question it aims to answer are:

• Is there superiority in percutaneous and transcutaneous electrolipolysis techniques?

Participants will undergo 12 sessions of 50 minutes each performed twice a week, totaling 6 weeks, after randomizing the hemibody for each technique.

Researchers will compare the hemibody with the percutaneous technique with the hemibody with the transcutaneous technique to see if there is a reduction of the adipose tissue.

Abdominal Adiposity consists of an increase in adipose tissue in the abdomen region, which may be associated as a risk factor for cardiovascular pathologies, metabolic disorders and dyslipidemias, in addition to affecting self-esteem and social life due to aesthetics body provided by the volume increase of the contour. Electrolipolysis proves to be one of the accessible and low-cost resources, capable of promoting good therapeutic results through the passage of electric current to the adipose tissue, either with its percutaneous or transcutaneous technique. The study aims to compare the acute effects of percutaneous and transcutaneous electrolipolysis, considering comfort during execution.

Eligibility Criteria:
Inclusion Criteria:

* Women between with localized abdominal fat
* Body Mass Index (BMI) between 18.5 and 29.9 kg/m2 (adequate weight and overweight)
* Who have not undergone any treatment for the condition experienced in the last 6 months
* Sedentary
* Not on a supervised diet

Exclusion Criteria:

* Smokers
* Alcoholics
* Pregnant women
* Metabolic and circulatory system disorders
* Pacemaker
* Metallic implants
* Tumors/metastasis
* Dermatitis
* In treatment with corticosteroids and/or prolonged progesterone
* Skin ulcers/lesions
* Needle phobia (aichmophobia)
* Sensitivity alteration in the region to be treated
* Unable to understand the form and/or procedure
* Not completing the suggested protocol
* Dietary changes during the research
Revolade Tablets Specified Drug-use Survey

This is a multicenter, single-arm, non-interventional study (NIS) to confirm the safety and efficacy of eltrombopag in Anti-Thymocyte Globulin (ATG) treatment naive pediatric patients with aplastic anemia (AA).

The objective of this survey is to confirm the safety and efficacy of eltrombopag in ATG treatment naive pediatric patients with AA. Eltrombopag should be administered according to the dosage and administration specified in the latest version of the package insert. The observation period is 1 year (364 days) from the start of treatment with this product, regardless of whether treatment with eltrombopag is continued or not. However, if hematopoietic stem cell transplantation is performed within 1 year after the start of treatment with eltrombopag, the observation period shall be until the date of hematopoietic stem cell transplantation.

Eligibility Criteria:
Inclusion Criteria:

* Patients whose legally acceptable representative has given written consent for cooperation in this survey prior to enrollment in this survey
* Patients aged ≥ 6 years and \< 18 years at the start of treatment with eltrombopag
* Pediatric patients with AA who receive eltrombopag for the first time in combination with ATG after the approval of additional dosage and administration for "ATG-naïve pediatric patients with AA"

Exclusion Criteria:

* Patients who have received ATG without concomitant use of eltrombopag
* Patients with congenital AA
* Patients with suspected or confirmed diagnosis of myelodysplastic syndrome (MDS) at the start of treatment with eltrombopag
* Patients who have received any drug products containing the same ingredient as eltrombopag (including investigational products)
Vitamin D Deficit in Women With Uterine Fibroids

Determinate the level of vitamin D in blood, and evaluate the prevalence of deficit and insufficiency among patients with diagnosis of uterine fibroids

A cross-sectional prevalence study will be carried out, taking patients with a diagnosis of uterine fibroid in two hospitals; blood level of vitamin D will be taken to determine the proportion of patients with deficit and insufficiency; In addition, the number, size and type (according to the PALM-COEN classification) of the uterine fibroids in each patient will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Diagnosis of uterine fibroid

Exclusion Criteria:

* Female with diagnosis of uterine fibroid under treatment with exogenous vitamine D
Dosage Schedule Study of Pemetrexed Monochemotherapy for Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

Patients affected by non-small cell lung cancer (NSCLC) will be treated in pemetrexed monochemotherapy regimen for a maximum of 8 cycles. Pemetrexed is an enhancer of some biomolecules involved in the gemcitabine mechanism of action. Purpose of the trial is to monitor the blood values of these biomolecules at different time intervals, to optimize the synergism between pemetrexed and gemcitabine.


Eligibility Criteria:
Inclusion Criteria

* Histologically or cytologically proven IIIB and IV NSCLC.
* No symptomatic uncontrolled brain metastasis
* Not suitable for platinum containing regimens if chemo-naive
* Performance status less than or equal to 2 on the Eastern Cooperative Oncology Group (ECOG) Scale.
* Creatinine Clearance (CrCl) greater than or equal to 45 milliliters per min (mL/min)

Exclusion Criteria

* Prior radiation to greater than 25% of bone marrow
* Inability to interrupt Aspirin at doses of greater than 1.3 grams/day or non-steroidal anti-inflammatory agents for a 5-day period.
* Presence of clinically relevant third-space fluid collections not controllable.
* Significant cardiac disease
Acceptance and Commitment Therapy With Vestibular Rehabilitation for Chronic Dizziness

The purpose of this study is to examine the effectiveness of group acceptance and commitment therapy with vestibular rehabilitation for chronic dizziness, in comparison with self-treatment vestibular rehabilitation in addition to clinical management.

The purpose of this study is to examine whether group acceptance and commitment therapy combined with vestibular rehabilitation in addition to clinical management for patients with persistent postural-perceptual dizziness is more effective than treatment-as-usual(TAU), which is self-treatment vestibular rehabilitation in addition to clinical management.

Eligibility Criteria:
Inclusion Criteria:

* Persistent postural-perceptual dizziness (diagnosed by the diagnostic guideline of ICD-11 beta version at Dec. 2016)
* Existing handicap due to dizziness (DHI equal to or more than 16)
* Written consent

Exclusion Criteria:

* Vertigo/dizziness/unsteadiness by organic brain diseases, diagnosed by neuro-otologist
* Vertigo/dizziness/unsteadiness explained by only organic cause or drug, diagnosed by neuro-otologist
* Physical status inappropriate for psychotherapy or vestibular rehabilitation
* Current psychiatric disorder other than anxiety disorders, somatic symptom disorder, or illness anxiety disorder (DSM-5), diagnosed by psychiatrist
* History of schizophrenia or bipolar disorder diagnosed by psychiatrist
* Increased risk of suicide or self-harm diagnosed by psychiatrist
* Started or increased SSRI/Venlafaxine within 1 month before treatment
* Any cognitive behavioral therapy or vestibular rehabilitation except this study
* Otological surgery or device therapy for dizziness
* Insufficient understanding of the Japanese language
Trial of Operative Fixation of Fractured Ribs in Patients With Flail Chest

Background: Fracture of several ribs in more than one place as the result of trauma, leads to paradoxical movement of the chest wall and ventilatory failure. The mainstay of management in these patients has traditionally been analgesia and positive pressure ventilation to splint the chest wall and allow healing of the ribs to begin. However, this management option leads to prolonged intensive care unit (ICU) stay with increasing complication rates as patients remain on a ventilator for prolonged periods. Patients often remain on a ventilator for two to three weeks while waiting for enough rib healing to provide sufficient chest wall stability to allow the patient to take over all their breathing themselves. Until that time, patients are at risk of pneumonia and sepsis and other complications. Long term disabilities which have been reported in these patients include ongoing pain syndromes, inability to return to work, particularly manual type labour and cosmetic chest wall deformities.

An alternative treatment strategy is to operatively fix the ribs. By fixing the ribs operatively, the patient no longer requires internal pneumatic stabilization (provided by mechanical ventilation) and can be weaned from the ventilator within days rather than weeks. This can potentially lead to earlier discharge from the intensive care unit, and an avoidance of the multiple complications which arise in the ventilated patient. Rib fixation may also lead to less pain and deformity, improved mobility in the post injury phase and earlier return to work.

Hypothesis: that early operative fixation of ribs in patients presenting with flail chest secondary to trauma will result in less mechanical ventilatory requirements, earlier discharge from the intensive care unit and lower rate of complications associated with prolonged mechanical ventilation. This will lead to cost savings in the treatment of these patients.


Eligibility Criteria:
Inclusion Criteria:

* patients with multiple (\>3) fractured ribs between the level of ribs 3 to 10 resulting in a paradoxical movement of the chest wall -

Exclusion Criteria:

* age \> 75 years
* Spinal injuries which would preclude placement of the patient in a lateral decubitus position
* Open rib fractures with soiling or infection
* Severe head injury
* Uncorrected coagulopathy
* Adult respiratory distress syndrome
* Sepsis
Clinical Outcomes in Hereditary Cancer

Compare the clinical characteristics and post-surgical outcomes (overall survival)of pancreatic cancer patients of Ashkenazi descent with or without germline founder mutations in BRCA1 or BRCA2 .

Compare the clinical characteristics and outcomes (time to progression) of breast cancer patients of Ashkenazi descent with or without germline founder mutations in BRCA1 or BRCA2 receiving paclitaxel chemotherapy for metastatic disease.

Compare the clinical characteristics and post-surgical outcomes (overall survival)of pancreatic cancer patients of Ashkenazi descent with or without germline founder mutations in BRCA1 or BRCA2 .

Compare the clinical characteristics and outcomes (time to progression) of breast cancer patients of Ashkenazi descent with or without germline founder mutations in BRCA1 or BRCA2 receiving paclitaxel chemotherapy for metastatic disease.

Eligibility Criteria:
Inclusion Criteria:

* Included in DB0363-03
* Jewish religious preference at registration
* Archival material available for testing
* Adequate post-surgical follow-up
* Jewish religious preference at registration
* Archival material available for testing
* Adequate follow-up to determine time to progression

Exclusion Criteria:

-Subjects will not be included in the analyses if a DNA sample cannot be obtained.
Pyrophosphate Homeostasis and Hepatic Expression of ABCC6.Pyro-TH

In animals, normal hepatic expression of ABCC6 (ATP-binding transporter cassette, subfamily C, member 6) determines plasma pyrophosphate (PPi) concentration. PPi prevents the formation of hydroxyapatite crystals on tissues by precipitation of calcium and inorganic phosphate (Pi). It is an endogenous compound whose deficiency causes diffuse vascular calcifications in certain rare monogenic diseases, including the elastic pseudoxanthoma caused by the mutation of ABCC6. PPi is produced by enzymatic transformation of extracellular ATP and, in animals, the liver is the main supplier of ATP and PPi (more than 90%). In humans, liver transplantation offers the possibility of correlating the plasma concentration of PPi (\[PPi\]pl) with hepatic expression of ABCC6. Liver transplantation is performed in the treatment of chronic liver failure (Child B or C) or, in the absence of liver failure, in the treatment of hepatocellular carcinoma. By measuring\[PPi\]pl before transplantation and after liver function restoration and by measuring ABCC6 in the diseased liver and healthy liver, it is possible to determine whether liver failure is associated with decreased\[PPi\]pl and decreased liver expression of ABCC6, which is the objective of our pilot study. Its interest is to establish a physiopathological link between the frequent vascular calcifications in obese patients with hepatic steatosis and the production of PPi.

prupose: Look for a deficit in\[PPi\]pl in patients before the transplant compared to the phase of restoration of liver function


Eligibility Criteria:
Inclusion Criteria:

Indication for liver transplantation Age greater than or equal to 18 years Patients affiliated to social security

Exclusion Criteria:

Patient not affiliated to social security Non-consenting patient or unable to understand the protocol and how it works Fulminant Hepatitis