cyrilzakka/clinical-trials huggingface dataset:
Estrogen (Gel)Transdermal vs Oral Estrogen for Endometrial Preparation

The goal of this randomized study trial is to comparing transdermal estradiol gel and oral estradiol for endometrial preparation in the Frozen Embryo Transfer Cycle. The main question\[s\] it aims to answer is: • Can Transdermal estrogen (gel) can be equally efficacious as compared to oral estrogen in hormone replacement FET (HRT- FET) cycles ? The Transdermal gel would have the added benefit of a higher patient comfort with fewer side effects and a better safety profile. Participants planned for Frozen embryo transfer will undergo H-P-O axis suppression on previous cycle D21 of menses with gonadotropin-releasing hormone(GnRH) agonist depot preparation (Inj. Decapeptyl 3.75 mg) IM . The study will compare Transdermal E2 gel with Oral E2 tabs. The patients will be randomized into an oral and gel group, and all patients will participate only once in the study.

Estrogen priming is essential for the induction of progesterone receptors and to build endometrial thickness, both of which play an important role in regulating endometrial receptivity . Different routes of Estrogen administration are oral (tablets), transdermal (patch/gel), and vaginal (tablets).

Eligibility Criteria:
Inclusion Criteria:

* Infertile patients aged 23-35 years.
* BMI 18.5 to 29.9 kg/m2.
* A normal uterine cavity assessed by 3D ultrasound (USG)/hysteroscopy.
* Patients who underwent IVF/ICSI and who have cryopreserved their embryos.
* Those receiving donor oocytes or donor embryos.
* Patients undergoing hormonal replacement frozen embryo transfer (HRT-FET) cycles with GnRH agonist suppression.
* Embryo Transfers of good quality embryos -2/3/4/5 AA, AB, BA(As per Gardner Grading System).

Exclusion Criteria:

* Preimplantation Genetic Testing for Aneuploidies (PGT-A) cycles.
* Patients who had a FET performed in natural or stimulated cycles.
* Patients who had more than 2 failed transfers due to thin endometrium.
* Patients having uterine anomalies.
* Known cases of adenomyosis and endometriosis.
* Underlying cardiac/renal/hepatic/thromboembolic disorders, h/o anxiety or depression.
* E2 \>50 pg./ml, P4 \> 1 ng/ml and on D2 of menses.
* On D2 scan presence of a cyst or a dominant follicle.
* Patients with a history of recurrent 1st-trimester abortions.
Intravenous BIBH 1 in Patients With Metastatic Colorectal Cancer

Study to evaluate the anti-tumour activity, safety and pharmacokinetics of unlabelled sibrotuzumab administered weekly (seven days +/- one day) at a dose of 100 mg (a total of 12 administrations) in patients with metastatic colorectal cancer.


Eligibility Criteria:
Inclusion Criteria:

* Patients with metastatic colorectal cancer International Union Against Cancer (UICC) Stage IV who are progressive under at least two previous chemotherapy regimes or who refused conventional treatment or who are not eligible for conventional treatment
* Progressive disease documented by subsequent computed tomography (CT) or magnetic resonance imaging (MRI) scanning prior to study entry. The last CT or MRI scans must be performed within 1 month before study entry. The first CT or MRI scan should be conducted within 6 months before study entry
* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
* Expected survival of ≥ 6 months
* Greater than or equal to 18 years of age
* Platelet count ≥ 100 x 10\*\*9/L
* Total leukocytes ≥ 2500/mm\*\*3
* Alanine aminotransferase/Aspartate aminotransferase (ALT/AST) ≤ 4 x upper limit of normal
* Total bilirubin ≤ 2.0 mg/dl (or 34µmol/L, Systeme International (SI) unit equivalent)
* Serum creatinine ≤ 2.0 mg/dl (0.20 mmol/l)
* Written informed consent in accordance with Good Clinical Practice and local legislation

Exclusion Criteria:

* Active metastatic disease to the central nervous system, exhibited by new or enlarging lesions on CT or MRI scan or within 3 months of treatment (i.e., surgery or radiotherapy) for brain metastases
* Exposure to an investigation agent within 30 days prior to the first BIBH 1 infusion
* Patients who are not fully recovered from surgery (incomplete healing)
* Chemotherapy or immunotherapy within 30 days prior to the first BIBH 1 infusion
* Radiation therapy to the symptomatic sites included for tumour measurements within 30 days prior to study entry
* Previous administration of a murine, chimeric or humanised measurement and/or antibody fragment (e.g. BIBH 1, Panorex)
* Serious illness: e.g., active infections requiring antibiotics, bleeding disorders, patients with known untreated or unstable coronary heart disease (e.g. unstable angina or myocardial infarction within 6 months prior to study entry) or diseases considered by the investigator to have potential for interfering with obtaining accurate results from this study
* Women who are breast-feeding or pregnant
* Men and women of childbearing potential who are unwilling to utilise a medically acceptable method of contraception
* Patients who suffer from autoimmune diseases
Treatment of Anxiety Disorders With Trigeminal Nerve Stimulation

Primary objectives: The primary objective is to ascertain if trigeminal nerve stimulation is an effective treatment with high tolerability for patients with panic disorder, generalized anxiety disorder and social anxiety disorder.


Eligibility Criteria:
Inclusion Criteria:

* Meet DSM5 criteria for panic disorder, social anxiety disorder or generalized anxiety disorder.

Exclusion Criteria:

* Subjects undergoing cognitive behavioural therapy.
* Subjects undergoing pharmacological treatment for an anxiety disorder.
* Subjects undergoing pharmacological treatment with antidepressants or benzodiazepines.
* Subjects with moderate to severe major depressive disorder based on the PHQ-9 test (score of 15 or above) at baseline.
* Moderate to high current suicidality or "suicide likely in near future" or current suicidal behavior disorder.
* Concurrent diagnosis of OCD, PTSD, bipolar disorder, schizophrenia, schizoaffective disorder, personality disorders, substance use disorders, intellectual disabilities or dementia.
* Subjects diagnosed with neurological diseases including trigeminal neuralgia.
* Pregnant or breastfeeding women.
* Subjects who are experiencing seizures.
* Individuals with implanted VNS or other electrical devices.
* Subjects who are already undergoing transcutaneous electrical nerve stimulation.
* Consumption of cannabis, any cannabis by-products, illicit drugs, or alcohol above 3 drinks per week.
* Consumption of natural health products that may affect anxiety or depression symptoms.
Effectiveness of a Psychological Intervention on Mental Health and Sleep.

Background: The COVID-19 pandemic represented a global public health problem that brought considerable consequences to the physical and mental health of the entire population. Objective: To compare the effectiveness of the brief behavioral intervention for insomnia by teleconsultation (BBII-TC) with the brief behavioral intervention for face-to-face insomnia (BBII) on symptoms of insomnia, anxiety, depression, quality of sleep and life in a sample. of patients with long COVID. Methodology: Randomized controlled trial of equivalence with two groups in parallel (1:1) with repeated measures in pretreatment, posttreatment and follow-up at 3 months. The sample will be composed of male or female participants, in an age range of 18 to 40 years. The sample size was calculated, obtaining a total of 52 participants, the expected effect size is .40, with a significance of 0.05 and a probability error of 80%. Participants in the two groups will be assessed with the following instruments: Sleep Diary, Patient Health Questionnaire 9, Pittsburgh Sleep Quality Index , Insomnia Severity Index, SF-36 Health Survey and Generalized Anxiety Disorder 7; at the beginning and end of treatment; and in a follow-up at 3 months. TData analysis: The Kolmogrov-Smirnov test will be carried out to determine the normality of the data, in case the distribution is parametric, an ANOVA of repeated measures will be carried out for the comparison of data between the pre, post and monitoring for each of the groups; in the event that the data does not have a normal distribution, the Friedman test will be performed for the comparison of repeated measures. Finally, to avoid bias in the data analysis, an external investigator will be asked to perform the randomization and data processing.

Once the sample is composed, the participants will be randomized in a simple computerized way to one of the two groups. A structured clinical interview will be carried out, then they will be given the sleep diary and the instruments will be applied to measure the degree of symptoms of sleep disorders.

Eligibility Criteria:
Inclusion Criteria:

* Have a personal pathological history of diagnosis of COVID-19 (mild or severe) by PCR test or antigen test in the last 6 months.
* Present symptoms of insomnia.
* Present anxiety symptoms.
* Present symptoms of depression.
* Be between 18 and 40 years old.
* Have digital devices such as a computer, tablet or smartphone with internet access.

Exclusion Criteria:

* Being in psychological or pharmacological treatment to control insomnia, anxiety, depression, at the time of the study.
* Presenting symptoms of another sleep disorder such as obstructive sleep apnea, restless legs syndrome, or sleep disorder due to work hours (1).
* Suffering from cardiorespiratory or neurological sequelae of COVID-19 do not allow the participant to take the treatment.
* Consume psychoactive substances of abuse (Cannabis, cocaine, solvents, cannabidiol).
A Study of HG146 Capsule in Chinese Subjects with Relapsed and Refractory Multiple Myeloma

This study is designed to evaluate the tolerability and safety of HG146 capsule in patients with multiple myeloma.

This study is mainly designed to evaluate the tolerability and safety of HG146 capsule in patients with multiple myeloma. Secondly, to get pharmacokinetic data and preliminary efficacy of HG146 capsule in human.

This study adopts the traditional design of "3 + 3" dose escalation. The starting dose is 5 mg and subsequent dose group is respectively for 10, 15 and 20 mg. For each dosing group, subjects are administered orally HG146 every other day for two weeks, followed by one week of rest with 21-day as one treatment cycle. Patients will be treated for 4 cycles or disease progression or unacceptable toxicities, whichever comes first.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of multiple myeloma requiring systemic therapy (International Myeloma Working Group \[IMWG\]) and 2 cycles of treatment including proteasome inhibitors and/or immunomodulators.
* Serum M protein≥ 10.0g / L, or urine M protein ≥ 200mg / 24h.
* Not suitable for autologous bone marrow transplantation or refuse autologous bone marrow transplantation or relapse after autologous bone marrow transplantation.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 or 2.
* Expected survival of ≥3 months.
* Hemoglobin ≥ 80 g/L, Platelet≥75×10\^9/L, Absolute Neutrophil Count≧1.0×109/L (1000 cells/mm3), Prothrombin time(PT) and activated partial thromboplastin time ≤ 2 x Upper Limit of Normal (ULN).
* Bilirubin in serum\<1.5\*ULN (2.0mg/dL/20mg/L/34.2μmol/L); glutamic-pyruvic transaminase (ALT) and/or Aspartate Aminotransferase (AST)≤3\*ULN (upper limit of normal).
* Normal electrocardiogram, echocardiography and myocardial enzyme spectrumCalibration of blood calcium concentration≤ULN.
* Men and women, Non-pregnant women who did not consider giving birth during the trial or five years after the end of the trial.
* The patient is able to swallow the capsule.
* Patients must provide written consent.

Exclusion Criteria:

* Severe allergies to the study drug or any of its excipients.
* The possibility of gene toxicity, mutagenesis and teratogenicity.
* Men and women who did not have sperm or egg cells stored in vitro before the trial and who planned to have children again within five years.
* Pregnant or lactating women.
* Perform autologous bone marrow transplantation 3 months before admission.
* Receive allogeneic bone marrow transplantation.
* Use HDAC inhibitors before.
* Two weeks prior to admission, received radiotherapy or bone marrow suppressive chemotherapy or biological treatment.
* Patients with history of other malignant tumors, except the tumor is in remission and has not been treated for at least 5 years.
* Patients with dysphagia or oral absorption disorder.
* The investigators determine the conditions not suitable for the study.
Cross Cultural Validation of the Italian Version of the Bt-DUX

The purpose of the presented study is to translate the English Bt-DUX (Bt-DUX-Eng) questionnaire into the Italian language and then examine the validity of the Italian version of the Bt-DUX (Bt-DUX-It).

Validation of the Italian Bt-DUX:

Cross sectional study among patients of the Istituto Ortopedico Rizzoli, Bologna, Italy, will carry out. All patients who underwent a surgical intervention due to a malignant bone tumour in the leg will be identified through hospital records and a survey consisting of different QoL questionnaires will be executed:

Bt-DUX, EORTC QLQ C-30, The Toronto Extremity Salvage Score (TESS).

Eligibility Criteria:
Inclusion Criteria:

* Patients are eligible if they're aged between 15 and 25 years at the time of the selection, if the time since surgery is ranged between 12 and 60 months, if the malignant bone tumour (osteosarcoma or Ewing's sarcoma) was located around the hip or the knee and the surgical intervention consisted of limb sparing or ablative surgery.

Exclusion Criteria:

* Patients will be excluded if other medical conditions limit their physical activities.
Positive Pressure and Gravity Affect Volumetric Capnography

Volumetric capnography is an interesting and non-invasive tool for monitoring ventilation in mechanically ventilated patients. The aim of this study was to test the effect of positive pressure ventilation and different body positions on volumetric capnograms.

In this interventional study awake and healthy volunteers will be submitted to spontaneous, pressure support and control pressure ventilation using a tight nasal mask. Volumetric capnography and electrical impedance tomography (EIT) will be continuously recorded during the protocol. Different body positions were randomly tested. Analysis of global and regional distribution of ventilation using EIT will be matched with changes observed in volumetric capnography-derived parameters.

Eligibility Criteria:
Inclusion Criteria:

* American Society Anesthesia physical status I.
* Age between 25-39 years old,
* Body mass index between 23-28 kg/m2,
* Non-smokers.

Exclusion Criteria:

* Presence of pulmonary or cardiac diseases.
* Abnormal spirometry.
Influence of Co-existing Mutations on Sorafenib Maintenance Therapy After Allo-HSCT for Patients With FLT3-ITD AML

The purpose of this study is to reveal the influence of co-existing mutations on the efficacy of sorafenib maintenance after allogeneic hematopoietic stem cell transplantation for patients with FLT3-ITD AML.

Internal tandem duplication of FMS-like tyrosine kinase 3 (FLT3-ITD) mutations have been reported in 20%-30% of patients with acute myeloid leukemia (AML). FLT3-ITD-positive AML patients have an inferior survival, primarily due to lower complete remission (CR) rate and higher relapse rate. Our previous studies demonstrated that post-transplantation sorafenib maintenance could improve the outcomes of FLT3-ITD-positive AML patients. However, whether other co-existing mutations influence the efficacy of post-allo-HSCT sorafenib maintenance remains unknown.

Eligibility Criteria:
Inclusion Criteria:

* FLT3-ITD Positive AML
* Allo-HSCT Recipients

Exclusion Criteria:

* cardiac dysfunction (particularly congestive heart failure)
* hepatic abnormalities (bilirubin ≥ 3 mg/dL, aminotransferase\> 2 times the upper limit of normal)
* renal dysfunction (creatinine clearance rate \< 30 mL/min)
* Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)
* Patients with any conditions not suitable for the trial (according to the investigators' decision)
Semaglutide as an Adjunct to Dieting in the Treatment of Type 2 Diabetes

The pharmacological approaches in the treatment of type 2 diabetes (T2DM) have advanced radically during the last decades. However, focus on long-term management of body weight, which is an essential part of treatment success, is often lacking. Excluding surgery, there are only a few effective treatment methods for obesity. Management of obesity is also greatly challenged by weight regain, which is common after a successful lifestyle intervention. Weight regain typically results in the deterioration of glucose homeostasis in T2DM. However, understanding the pathomechanisms of weight regain and subsequent worsening of glucose homeostasis is still insufficient. Therefore, T2DM treatment programs that target long-term weight management have been scarce. This study aims to fill the gaps in the current knowledge by advancing the development of treatment programs for T2DM that simultaneously head for improved glucose metabolism and improved long-term body weight control.

In this randomized, double-blind, parallel, placebo-controlled trial we compare the effects of semaglutide 1.34 mg/ml vs. normal dieting by randomizing the patients with both T2DM and overweight/obesity (BMI ≥27) (n=50, aged ≥18 to \< 65 years) to two groups: both groups participate in a similar lifestyle treatment to induce weight loss, but one group gets an add-on of semaglutide 1.34mg/ml while the other is treated with placebo. Additionally, a reference group of healthy normal weight non-diabetic individuals (BMI ≤ 25 kg/m2, n=25, aged ≥18 to \< 65 years) are included as controls at the initiation of the study.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years and \<65 years
* BMI: ≥27 kg/m2
* T2DM (HbA1c ≥ 6.0% if on anti-diabetic medication or HbA1c≥6.5% if non- medicated)
* Participant is willing and able to give informed consent for participation in the study

Exclusion Criteria:

* Contraindication to trial drugs
* Use of insulin or GLP-1RAs (during the past 3 months)
* Use of anti-obesity drugs (during the past 3 months)
* Weight change of \>5% during the past 3 months
* Bariatric surgery or planned bariatric surgery during the trial
* History of pancreatitis
* Impaired renal function (GFR\<30 ml/min/1.73m2)
* Impaired hepatic function (ALAT\>2 x upper limit normal)
* Clinically significant active cardiovascular disease
* Clinically significant abnormality in the ECG
* Cancer (except basal or squamous cell skin cancers)
* Major psychiatric disease (such as severe depression, bipolar disorder, schizophrenia)
* Substance abuse
* Learning disability
* Females of childbearing potential not using adequate contraceptive methods
* Pregnancy
* Lactation
* Any other condition that in the opinion of the investigator could interfere with the conduction of the study or interpretation of the study results
Cardiopulmonary Exercise Testing to Evaluate Pulmonary AVMs

Pulmonary arteriovenous malformations (PAVMs) are a rare vascular condition affecting the lungs. PAVMs lead to low blood oxygen levels, yet are very well tolerated by patients. This study will examine the exercise capacity of PAVM patients using formal cardiopulmonary exercise tests performed on a stationary bicycle.

It is well known that the lung is the site at which oxygen enters the blood stream, diffusing from the alveolar air sacs into the pulmonary capillaries. This newly oxygenated blood is carried to the heart in the pulmonary veins, then passes into the systemic circulation to provide oxygen to the tissues.

Patients with pulmonary arteriovenous malformations (PAVMs) have abnormal vascular connections between pulmonary arteries and pulmonary veins in the lung. Blood flowing through PAVMs therefore bypasses the oxygenation sites in the pulmonary capillaries. Low blood oxygen levels (hypoxemia) is frequent in PAVM patients but breathlessness (dyspnea) is not. The investigators have shown that dyspnea was not a common presenting complaint in a large UK series, and that there is little correlation between severity of dyspnea in PAVM patients, and blood oxygen levels.

In this study the investigators will address the question "Why are hypoxemic PAVM patients not more dyspneic?"

The investigators will address this by first performing standardised cardiopulmonary exercise testing, as used in the clinic, on age and sex matched patients with PAVMs and healthy controls. Physiological parameters will be compared, to test the null hypothesis that the impact of exercise on PAVM patients' cardiopulmonary systems does not differ to normal controls.

If the expected differences are confirmed, the investigators will examine if there is any difference to normals by re-examining the exercise tolerance of the PAVM cohort after they have had their PAVMs treated by embolization.

Most patients with PAVMs have an underlying hereditary vascular disorder, hereditary haemorrhagic telangiectasia. Assuming the expected differences between PAVM patients and controls are confirmed, the investigators will therefore also examine which pattern HHT patients without PAVMs display. Finally, cellular and molecular methods will be used to dissect mechanistic pathways.

Eligibility Criteria:
Inclusion Criteria:

* Ability to provide informed consent
* Healthy volunteers: no concurrent health reason to avoid exercise
* Pulmonary AVMs: pulmonary AVMs confirmed by CT scan
* Hereditary hemorrhagic telangiectasia without pulmonary AVMs: HHT according to current international consensus criteria, with no evidence of PAVMs on dedicated thoracic CT scan.

Exclusion Criteria:

* Inability to provide informed consent.
* Any known cardiovascular abnormality including a history of syncope (faintness, dizziness, lightheadedness or loss of consciousness due to an abnormality of the cardiovascular system).
* Current respiratory tract infection (eg a cold).
* Pregnancy.
* Claustrophobia or needle phobia
Study of Treatment Used for Migraine Headaches (MK-0974-076)

This study will describe the reasons for triptan utilization patterns (continuation and discontinuation) in triptan-naïve participants and assess the stability of treatment utilization patterns over time according to standard medical guidelines or clinical practice standards of the investigating physician.

After study start, the Protocol was amended to clarifiy that the first triptan prescription must have been received by the participant within a time window of 3 months (± 2 weeks) prior to the participant being identified by the Investigator, and could be enrolled into the study within 6 months of taking the prescribed triptan medication for the first time and that use of a sample triptan would not disqualify a participant as long as the sample was of the same triptan that was eventually prescribed.

Eligibility Criteria:
Inclusion criteria:

* At least 18 years of age in the United States at the time of consent
* Physician-diagnosed migraine with or without aura
* At least two and up to a maximum of 8 moderate to severe migraine attacks during the 30 days prior to screening
* Initial triptan prescription 3 months (± 2 weeks) prior to being identified as eligible for this study, and triptan-naïve before that initial prescription
* Used triptan medication at least once within 6 months prior to the date of informed consent for screening
* Internet access and able to complete online surveys via electronic data entry

Exclusion criteria:

* Treated with triptans prior to this study
* In active litigation and compensation issues including disability dispute cases with a Government agency
* Participation in a clinical trial within the last 90 days