cyrilzakka/clinical-trials huggingface dataset:
Influence of Laparoscopic Endometrioma Stripping Surgery on Serum Anti-mullerian Hormone Levels

To compare changes in follicular ovarian reserve in women before and six months after laparoscopic operation: endometrioma stripping surgery. Also, to compare follicular ovarian reserve in women with endometrioma(s) with follicular ovarian reserve of healthy infertile women of the same age group.

In order to investigate the impact of laparoscopic stripping surgery on follicular ovarian reserve, blood samples will be obtained before the operation, from 2nd to 5th day of the menstrual cycle, to determine levels of endocrine markers of ovarian reserve (FSH, E2, AMH and Inhibin B). Cancer antigen 125 (CA -125) and IL-6 will be measured also. US markers (antral follicular count- AFC) will be obtained at the same time as endocrine markers. All laparoscopic stripping surgery will be performed during the early or middle follicular phases of menstrual cycle, under general anesthesia, by the same team of gynecological endoscopist. The cyst wall will be completely stripped off from the normal ovarian tissue by traction and opposite traction with two grasping forceps. Hemostasis will be achieved using bipolar forceps electrocoagulation. All endometrioma specimens that will be obtained from operation will be submitted for pathology examination. One and six months after the laparoscopic cystectomy, from 2nd to 5th day of menstrual cycle, we will determine endocrine markers of ovarian reserve and levels of CA 125 and IL-6.

The control group will be consisted of healthy women with infertility problem. From the second to the fifth day of the menstrual cycle we will take blood samples to determinate endocrine markers of follicular ovarian reserve: AMH, FSH, E2, Inhibin B.

Eligibility Criteria:
Inclusion Criteria:Study group: Women with endometrioma(s)

* Age: 18- 42 years of age
* Regular menstrual cycles defined as cycle length between 25- 35 days
* Ultrasound made diagnosis of endometrioma unilateral or bilateral ≥4 cm in diameter.
* Laparoscopically and histologically confirmed diagnosis.
* Agreement to be enrolled in the study

Control group: Healthy reproductive aged women with tubal, unexplained or male infertility.

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Exclusion Criteria:

* Previous ovarian surgery
* Suspicious of malignancy
* Known endocrine disorder or other chronic diseases.
* Use of oral contraceptive drug, gonadotropin- releasing hormone (GnRH) agonist/ antagonist, or other drugs related with ovarian function in at least 3 months before surgery.
Computed Tomography (CT) and Lung Function Data Collection for Computational Fluid Dynamics (CFD) in Chronic Obstructive Pulmonary Disease (COPD) Patients

In this study, 20 COPD patients will undergo a high-resolution/multi slice CT scan and lung function tests to obtain patient specific geometries of the central and peripheral small airways and patient specific boundary conditions.

With Computational Fluid Dynamics (CFD), the investigators will be able to reconstruct the geometry and measure the resistance of the peripheral airways.

In a later stage, CFD will be used to simulate the reaction of the airways on various inhalation medications.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with documented COPD based on the following criteria:

   * Smoking history of at least 10 pack-years.
   * Decreased Tiffeneau index (FEV1/(F)VC \< 0.70).
2. Patients aged ≥ 40 years.
3. Patients should present moderate to very severe COPD with an FEV1 \< 80% of predicted (GOLD 2, 3 and 4).
4. Patients should be treated according to GOLD guidelines.
5. Maintained on stable respiratory medications for 4 weeks prior to visit 1
6. Able to perform lung function tests.

Exclusion Criteria:

1. Patients below the age of 40.
2. Patients who are pregnant or are breast-feeding.
3. A respiratory infection or exacerbation of COPD in the four weeks prior to screening.
4. BMI \> 35 kg/m².
5. Patients treated with BiPAP or CPAP.
6. Known active tuberculosis.
7. A history of asthma, cystic fibrosis, central bronchiectasis, interstitial lung disease or pulmonary thromboembolic disease.
8. A history of thoracotomy with pulmonary resection.
9. Active or untreated malignancy.
Retrieval-extinction Paradigm on Internet Gaming Disorder

The overall aim of this experimental study is to apply the new paradigm of substance addiction intervention to the study of Internet gaming disorder(IGD) subjects' intervention.

This study is based on the retrieval-extinction paradigm.As with the efficacy, the experiment aims to test the effect of the retrieval-extinction paradigm on game craving and behave of IGD subjects, so as to provide an empirical basis for the development of effective intervention means of Internet gaming disorder.

Eligibility Criteria:
Inclusion Criteria:

1. the 5th edition of Diagnostic and Statistical Manual of Mental Disorders (DSM-5 ) recommended diagnosis of Internet gaming disorder : the scores of the 9 items of DSM-5 recommended diagnosis for Internet gaming disorder ≥ 5.
2. the scores of the Young-Internet addiction Test ≥ 50
3. engagement in popular Internet games (e.g. Arena of Valor, League of Legends and Player Unknown's Battle Grounds) for over 20 hours per week for a minimum of 12 months.

Exclusion Criteria:

1. current or history of use of illegal substances and other addictions;
2. current or history of psychiatric or neurological illness;
3. current use of psychotropic medications.
EURECA (EUropeanRElapseCAlprotectin) Study

This study will investigate the correlation of fecal calprotectin (FC) values to quiescent ulcerative colitis and to disease activity (relapse) as assessed by clinical data and endoscopy.

The study is prospective with a longitudinal approach. About 200 patients will be followed every 3 to 12 months (at basal, 3, 6, 9 and 12 months alternating visits to telephone contacts) and subsequently for further 6 months in 3 different sites (competitive enrollment, 1site/country, Italy, France and Spain respectively). Fecal samples for immunoassays will be collected at follow up visits, stored frozen (-20°C) and sent to testing lab for their determination.

The following assessments are foreseen:

Clinical history and demography (screening), Proctosigmoidoscopy (basal), Hemochromo with WBC differential count, C-reactive protein (every 6 months from screening up to 12 months; relapse), Coagulation (screening) Specimen collection for fecal calprotectin determination (within 1-2 weeks from Informed Consent signature; for basal time point; every next 3 months from basal up to 12 months and at month 18; relapse), Coproculture for Salmonella, Shigella, E. Coli and Campylobacter (relapse), Pharmacological ongoing therapy, Mayo score (each time point; relapse)

Eligibility Criteria:
Inclusion Criteria:

* Adults,18 years and older, either genders
* Subject previously diagnosed with left-sided colitis or pancolitis based on endoscopy and, if available, confirmed by histological examination of biopsy taken during endoscopy
* Subject in clinical and endoscopic remission. Remission will be documented by proctosigmoidoscopy.
* Subject who may receive maintenance therapy as per current medical practice, e.g. mesalazine, corticosteroids, azathioprine, anti-TNF
* Availability of stool specimen for basal time point
* Subject willing and able to sign, the approved Informed Consent Form for this project in accordance with international and national regulations
* Subject able to understand and follow study procedures

Exclusion Criteria:

* Any subject that does not meet the inclusion criteria
* Subject with microscopic colitis
* Subject with Crohn's disease
* Subject with limited proctitis
* Subject with severe chronic disease affecting the possibility to comply with the study protocol (i.e. severe cardiovascular disease, renal or liver failure, neurologic disease, hematological disease and mental disorder)
* Subject who is regularly taking oral anticoagulants
* Subject who is currently pregnant or lactating
* Subject unable or unwilling to subscribe informed consent
* Subject unable or unwilling to perform required study procedures
Multiple Dose ASM8 in Mild Asthmatics

To determine the safety and efficacy of multiple doses of ASM8 antisense oligonucleotides in asthmatics.

This is a double-blind, placebo-controlled, crossover trial to evaluate the safety, tolerability and efficacy of inhaled ASM8 for the treatment of allergen-induced asthma. Individuals with stable, mild to moderate allergic asthma by American Thoracic Society (ATS) criteria (1), with a history of episodic wheeze and shortness of breath, will be eligible for enrolment. The study is divided into 2 parts.

Eligibility Criteria:
Inclusion Criteria:

* Part 1: Men and women 18 to 65 years of age; generally good health; mild to moderate, stable, allergic asthma as defined by ATS criteria (1); history of episodic wheeze and shortness of breath; forced expiratory volume in 1 second (FEV1) at baseline ≥70% of the predicted value; able to comprehend and follow all required study procedures; willing and able to sign an informed consent form.

Part 2: Methacholine challenge at baseline (PC20 ≤16 mg/mL); positive skin-prick test to common aeroallergens (cat, dust mite, grass, pollen) and positive allergen-induced early and late airway bronchoconstriction.

Exclusion Criteria:

* Part 1 and Part 2: Significant acute or chronic medical or psychiatric illness; known coagulopathy, worsening of asthma or respiratory infection in the preceding 6 weeks; use of inhaled or oral corticosteroids within the last 28 days, antihistamines, immunosuppressives, nonsteroidal anti-inflammatory drugs, or anticoagulants (intermittent doses of short-acting β2-agonist are allowed); use of medications that may interact with ASM8; investigational drug use within 30 days; any clinically significant abnormality on screening laboratory determinations; current tobacco use in previous 3 months or 10 pack-years; pregnant or lactating women; women actively seeking pregnancy or who are not using adequate contraception; history of serious adverse effect (SAE) or hypersensitivity to any drug; 20% decrease in FEV1 or FVC with baseline saline in methacholine challenge during screening.
A Study of Imlunestrant, Investigator's Choice of Endocrine Therapy, and Imlunestrant Plus Abemaciclib in Participants With ER+, HER2- Advanced Breast Cancer

The main purpose of this study is to measure how well imlunestrant works compared to standard hormone therapy, and how well imlunestrant with abemaciclib work compared to imlunestrant in participants with breast cancer that is estrogen receptor positive (ER+) and human epidermal receptor 2 negative (HER2-). Participants must have breast cancer that is advanced or has spread to another part of the body. Study participation could last up to 5 years.


Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of ER+, HER2- locally advanced or metastatic breast cancer
* Have disease that has demonstrated progression on or after an aromatase inhibitor alone or in combination with a cyclin-dependent kinase (CDK)4/6 inhibitor

  -- Participants are expected to have received prior treatment with a CDK4/6 inhibitor, if this treatment is approved and can be reimbursed
* Must be deemed appropriate for treatment with endocrine therapy
* If female, have a postmenopausal status by natural or surgical means or by ovarian function suppression
* Have RECIST evaluable disease (measurable disease and/or nonmeasurable bone-only disease)
* Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group scale (Oken et al. 1982)
* Have adequate renal, hematologic, and hepatic organ function
* Must be able to swallow capsules/tablets

Exclusion Criteria:

* Have received prior treatment with chemotherapy (except for neoadjuvant/ adjuvant chemotherapy), fulvestrant, or any investigational-ER-directed therapy (including SERDs and non-SERDs), any PI3K-, mTOR- or AKT- inhibitor
* Have visceral crisis, lymphangitic spread within the lung, or any evidence of leptomeningeal disease.
* Have symptomatic or untreated brain metastasis.
* Have serious preexisting medical conditions that, in the judgment of the investigator, would preclude participation in this study
* Known allergic reaction against any of the components of the study treatment
A Study of mRNA Vaccines AK154 Monotherapy or in Combination With AK104/AK112,and Sequential mFOLFIRINOX in Surgically Resected PDAC

To explore safety and efficacy of neoantigen personalized mRNA vaccines AK154 monotherapy or in combination with AK104/AK112 and sequential mFOLFIRINOX regime in Resected PDAC

This is a prospective, open-label, single-center, exploratory clinical study. To explore the safety, tolerability, efficacy, immunogenicity, and PK/PD profile of neoantigen personalized mRNA vaccine AK154 monotherapy or combined with AK104 or AK112, sequential mFOLFIRINOX chemotherapy regimen as postoperative adjuvant therapy in Surgically Resected Pancreatic Adenocarcino

Eligibility Criteria:
Inclusion Criteria:

* Voluntarily signed the informed consent form and complied with protocols requirements
* Patients with radiographically resectable primary pancreatic tumors
* Histopathology or cytology confirmed resected PDAC with macroscopic complete resection (R0 and R1)
* Pancreatic cancer surgical staging per AJCC 8th edition staging: T 1-3, N0-2, M0
* ECOG 0 or 1
* Life expectancy ≥ 6 months
* Surgical complications have recovered,
* Adequate organ function
* Patients with fertility are willing to use an adequate method of contraception.

Exclusion Criteria:

* The presence of other pathologic types
* Participating in another clinical study
* Have received treatment for pancreatic cancer, including chemotherapy, radiation therapy, targeted therapy, immunotherapy,etc
* Plan to receive a live-attenuated vaccine within 28 days prior to initiation of study treatment or during the study treatment or within 90 days after the end of study treatment
* Severe infection occurs within 4 weeks prior to the first dose
* Requiring systemic therapy with glucocorticoids or other immunosuppressive drugs within 14 days prior to initial administration.
* Acute pancreatitis or subclinical pancreatitis
* Active autoimmune disease
* Allergic to immunotherapies and related drugs
* History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
* Splenectomy history
* Active tuberculosis
* Known or highly suspected history of interstitial pneumonia.
* Clinically significant liver disease
* Uncontrolled or severe cardiovascular disease.
* Severe bleeding tendency or history of coagulopathy
* Active malignancy within the last 3 years
* Active syphilis infection
* Any other situations that are not suitable for inclusion in this study judged by investigator.
Evaluation of Cow Milk-Based Formulas - Functional Proteins

The purpose of this study is to look at the function of infant formula components to optimize the nutritional content and functionality of a marketed routine infant formula.


Eligibility Criteria:
Inclusion Criteria:

* 10-18 days of age
* 37-42 weeks gestation
* birth weight 2500 g or more
* consuming one source of nutrition

Exclusion Criteria:

* metabolic or chronic disease
* acute infection
* feeding difficulties
* consumed complementary foods or donor milk
* steroid use
Methyl-Donors and EpiGenetics in The Gambia

Accumulating evidence suggests that early-life nutrition can affect metabolism and thus increase the risk of disease in adulthood (e.g. type II diabetes and obesity). One possible mechanism to explain these effects is epigenetic variation at critical periods of development. Epigenetic variation describes non-inherited permanent alterations to an individuals DNA.

Recent work in mouse models has demonstrated that maternal nutritional status can affect such epigenetic processes such as DNA methylation and gene expression during embryonic development, with profound effects on outcomes. The investigators aim to study these processes in humans for the first time. The investigators will exploit the "experiment of nature" setting in The Gambia, i.e. fluctuation in diet according to season. During the 'hungry' season diets are known to be depleted in nutrients required for epigenetic gene regulation. Nutritional biomarkers in blood as well as the dietary intake will be measured in pregnant women according to season. A blood sample will also be taken from babies born to these women to determine whether there is a direct effect of diet on mothers' nutritional status and hence variation in DNA methylation patterns in their babies by season.


Eligibility Criteria:
Inclusion criteria women:

- women aged 18-45 years on 15th March 2009, resident in West Kiang

Exclusion criteria women:

* on contraception
* confirmed pregnancy at recruitment
* enrolment in any study other than the ENID (Early Nutrition and Immune Development) trial (ISRCTN49285450)
* suffering from severe anaemia (haemoglobin \<7 g/dl) or known sickle cell disease

Inclusion criteria infants:

- born to the above women

Exclusion criteria infants:

- those known to be severely malnourished (weight-for-height Z-score \< -3)
ElectrocardioGraphic Imaging During Left bUndle Branch Implant to valiDate Ecg Criteria

The goal is to validate the resynchronization criteria with a non-invasive technique, during the LBBP implant. Non-invasive real-time ventricular activation maps will be created and analyzed before, during, and after the implantation of the left bundle branch lead, including right septal pacing, mid and deep septal pacing and pacing when reaching the left bundle branch according to the published standard LBBP criteria. Using these maps, the investigators will quantify activation times and evaluate changes in the ventricular sequence during implantation.


Eligibility Criteria:
Inclusion Criteria:

* Left bundle branch pacing indication
* Capability of standing up to place the ECGI vest

Exclusion Criteria:

* Less than 18 years-old
* Patients with cognitive impairment
Texting for Diabetes Success in Pregnancy

Diabetes during pregnancy can be a challenging circumstance requiring extensive patient learning and self-care. The purpose of this study is to develop and pilot test a patient-centered diabetes education and self-care tool using text messaging to provide supportive messaging and education to underserved women with a pregnancy complicated by diabetes.

Low-income, pregnant women in the Chicago area are frequently affected by obesity or diabetes. The addition of a disease in pregnancy amplifies the requirements for optimal self-care during pregnancy. This load of information poses a significant burden, particularly for women with additional socioeconomic barriers to self-care. Preliminary work suggests patients must overcome a number of social, psychological, and knowledge-based barriers to achieve successful diabetic control in pregnancy.

This project involves development and preliminary evaluation of a patient-centered education and self-care tool for use with women whose pregnancies are complicated by diabetes. The study begins with development of a text messaging curriculum to provide motivational and educational support. We will use a one-way, non-interactive text-based educational platform to provide supportive and educational messages to a cohort of 40 women with diabetes. Women receive 3-5 text messages per week until delivery. The goal is to develop a program that can be expanded to a clinical trial in which perinatal outcomes are assessed.

The primary outcome is patient satisfaction and opinions about the texting program, as measured via a qualitative interview upon study completion. Participants underwent an enrollment survey to assess health literacy/numeracy, diabetes self-efficacy, diabetes knowledge, personality, and social hassles. They underwent a baseline in-depth one-on-one interview focusing on barriers to successful self-care with pregnancy and diabetes. Follow-up surveys and an exit interview elicited information about their opinions of the texting program. Additional goals included determining feasibility for future expansion as a trial.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant
* English-speaking
* Have gestational diabetes mellitus, type 2 diabetes mellitus, or type 1 diabetes mellitus
* Age 18 years or older
* Access to a phone that can receive text messages

Exclusion Criteria:

* Gestational age greater than 30 weeks
* Women not meeting the above inclusion criteria
Pain Perception and the Autonomic Nervous System

In this study, we want to investigate how pain processing and sensation are related to a certain part of the nervous system, the so-called autonomic nervous system.

For this purpose, we apply heat and pressure stimuli to the skin and test pain processing by means of ratings scales and sensory tests. Breathing, heart rate and sweat response are also measured. To assess the spinal cord level, we measure muscle response (measured by electromyography, EMG) to electrical stimulation. Additionally, sensory nerves will be stimulated at the ear and participants will also be given various questionnaires to complete.

This study investigates the effects of autonomic regulation on pain perception and experimentally induced pain sensitivity. Participants come for one or two study visits, that will last approximately 3 hours. The study is divided into two phases: the pilot phase and the main experimental phase.

During the pilot phase, the perception of pressure and heat stimuli, as well as spinal excitability, will be assessed before and during different types of electrical stimulation of sensory nerves at the outer ear.

During the main experimental phase, skin sensitivity and spinal excitability will be assessed before and after repetitive heat stimulation and stimulation of sensory nerves at the outer ear.

In both study phases, the activity of the autonomic nervous system will be assessed throughout the experiment, and questionnaires will be completed.

Eligibility Criteria:
Inclusion Criteria:

1. Over 18 and below 40 years of age
2. Good general health
3. Able to give informed consent

Exclusion Criteria:

1. Any major medical or psychiatric condition (e.g. heart disease, diabetes, autoimmune disorders, infectious diseases, major depressive disorder), any chronic pain condition, any respiratory problems, any acute pain at time of study
2. Inability to follow study instructions, e.g. due to language problems
3. Pregnancy (female participants will be asked if pregnancy could be possible)
4. Increased alcohol (\&gt;2 (for women)/4 (for men) standard glasses per day or \&gt;5 (for women)/4 (for men) glasses at least once a month within a few hours) or caffeine consumption (≥ 400mg per day)
5. Consumption of alcohol, drugs, analgesics within the last 24 h
6. Consumption of more than 100 mg of caffeine within the last 8 h
7. Scar tissue or generally reduced sensitivity in the designated testing site areas
8. Shoe size \&lt; 38 (if experiment is conducted at the feet)
9. History of cardiovascular disease or carotid artery disease
10. Medication or Substances inferring with the autonomic nervous system or with pain sensitivity (e.g. Benzodiazepines, Nicotine)