cyrilzakka/clinical-trials huggingface dataset:
A Study of OBIZUR in Adults With Acquired Hemophilia A (AHA) in South Korea

Acquired hemophilia A (AHA) is a rare bleeding condition which prevents blood clotting. Acquired means that people are not born with this condition or have a family history of blood clotting conditions. People living with AHA can have sudden and severe bleeding. They also have longer bleeding compared to people without AHA.

The main aim of the study is to learn how safe OBIZUR is in adults with AHA.

Other aims are to see how effective OBIZUR is to control bleeding and how treatment is used in a routine clinical practice setting.

The treatment of the participants will be determined by the treating physicians.

During the study, data already existing in the participants' medical record and new data will be collected.

This is a prospective, and retrospective, multicenter, single-arm non-interventional post-marketing surveillance study.

Eligibility Criteria:
Inclusion Criteria:

* Participants with AHA.
* Participants who are determined to have the clinical need to receive Obizur treatment.
* Participants aged 18 years or older at time of initiation of Obizur treatment.
* Participants agreed to participate in the study and voluntarily signed the informed consent.

Exclusion Criteria:

* Participants with hypersensitivity to any of the components of this drug.
* Participants with Congenital Hemophilia A with Inhibitors (CHAWI).
* Participants for whom Obizur treatment is contraindicated as per product label.
* Participants who has participated in another clinical study involving a medicinal product or device within 30 days prior to enrollment or is scheduled to participate in another clinical study involving a medicinal product or device during the course of the study.
Combining Genomics and Imageomics to Predict the Sensitivity of Neoadjuvant Pemetrexed and Cisplatin Chemotherapy in Patients With Lung Adenocarcinoma

Combining genomics and imageomics to predict the sensitivity of neoadjuvant pemetrexed and cisplatin chemotherapy in patients with lung adenocarcinoma


Eligibility Criteria:
Inclusion Criteria:

* 1. Aged between 18 and 75 years;
* 2. Lung adenocarcinoma;
* 3. The patient is able to receive neoadjuvant pemetrexed and cisplatin chemotherapy
* 4 .The patient is able to understand and comply with the study and has provided written informed consent.

Exclusion Criteria:

* 1. Patients with a history of lung surgery;
* 2. Postoperative pathology showed non-primary lung cancer;
* 3. Patients with a history of other tumors;
* 4. Patients with severe complications (coronary heart disease, valvular heart disease, end-stage renal disease, severe liver cirrhosis);
* 5. Unable to cooperate with the researchers because of dementia or cognitive decline
* 6. Other situations that are not in conformity with the standards and requirements of this trial.
Acceptability Study by Patients Admitted for Suicide and by Medical Staff for Clinical Data Collection Through an E-health Platform

The study goal is to determine the feasbility and interest of monitoring mental health and non mental health related simptoms in Outpatients in order to prevent suicide.

Taking into account the strengths and pitfalls of existing suicide risk assessment methods, we have designed a system capable to combine EMA and continuous monitoring of patients using the smartphone's and/or wearable's sensors and data entry in order to monitor and predict suicide risk. For example, both poor sleep quality and disturbed appetite are clinical markers of depression, with a bidirectional relationship. Their changes could precede the increase of suicidal behavior as sleep and appetite are both influenced by mood state and regulated by the serotonergic system. Our hypothesis is that tracking mental health simptoms regularly through self-report could serve as a consistent and non-biased shortcut to assess mood state, its biological underpinnings and could potentially predict suicidal behavior.

Eligibility Criteria:
To be eligible for the study, patients must be 18 years or older, attend an outpatient clinic or emergency departments of participating clinical services and owning an android or IOS smartphone
Radical Versus Conservative Surgery in Liver Cystic Echinococcosis: a Prospective Cohort Study in a High-volume Western Centre

The goal of this observational study is to compare the results in terms of morbidity and disease-free survival between groups of patients with liver cystic echinococcosis (LCE) managed with radical surgery (RS) or conservative surgery (CS), and to evaluate potential risk factors of clinically relevant biliary fistula and liver recurrence.

Main hypothesis:

1. Radical surgery (RS) in LCE has better postoperative results than conservative surgery (CS) in terms of global morbidity, specific morbidity and liver recurrence rate.

   Secondary hypotheses:
2. It is possible to identify preoperative and intraoperative prognostic factors of higher morbidity and recurrence rate.
3. The location of the residual pericystic layer in CS is related to a higher incidence of liver recurrence.
4. The percentage of residual pericystic layer in CS is related to a higher incidence of postoperative biliary fistula.

Main outcome:

1. To assess the incidence of liver recurrence between the RS and the CS groups, identifying potential risk factors.
2. To evaluate the incidence of postoperative biliary fistula between the RS and the CS groups, identifying possible risk factors.

Secondary outcomes:

1. To estimate the incidence of overall morbidity related to surgery.
2. To estimate the incidence of specific morbidity related to surgery (biliary fistula, intra-abdominal abscess, residual cavity abscess, hemoperitoneum, incisional infection, liver failure, respiratory infection, others).
3. To specifically analyze the incidence of postoperative biliary fistula and complex biliary fistula, and identify possible risk factors.
4. To estimate the incidence of mortality related to surgery.
5. To estimate the rate of hepatic and extrahepatic recurrence (number of disease-free months)
6. Prepare a recommendation for a standardized management algorithm for LCE patients based on the results obtained in the study and make it applicable to clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Adult population (18 years or older) of both sexes surgically intervened for a diagnosis of LCE at the Bellvitge University Hospital and during the period described using a conservative or radical technique.
* Patients with asymptomatic liver hydatid cysts of active type or transition CE1 to CE3 according to the WHO classification.
* Patients with symptomatic or complicated hepatic hydatid cysts of any type (CE1 to CE5) according to the WHO classification.

Exclusion Criteria:

* Patients under 18 years of age.
* Patient operated on for LCE diagnosis with inactive asymptomatic cysts (CE4 or CE5 according to the WHO classification).
* Patients with less than 1 year of follow-up.
A Study of the Interaction of Rifampin and Vinflunine in Subjects With Advanced Cancer

The purpose of this study is to test how vinflunine interacts with rifampin in the human body


Eligibility Criteria:
Inclusion Criteria:

* Cancer unresponsive to previous treatment
* Consent for genetic samples

Exclusion Criteria:

* Cancer of the blood
* Spread of cancer to the brain
* Moderate or severe nerve damage
* Low white blood cell counts and platelet counts
* Inadequate liver or kidney function
* Prior treatment with vinflunine
* Use of certain medications that might interfere with the metabolism of vinflunine
Lomecel-B Delivered During Stage II Surgery for Hypoplastic Left Heart Syndrome (ELPIS)

This study is designed to assess the safety, tolerability, and efficacy of Lomecel-B as an adjunct therapy to the standard stage II (BDCPA) surgical intervention for HLHS. Lomecel-B will be delivered via intramyocardial injections

This study is designed to assess the safety, tolerability, and efficacy of Lomecel-B (formerly LMSCs) as an adjunct therapy to the standard stage II (BDCPA) surgical intervention for HLHS, which is typically performed at 4 - 6 months after birth. Lomecel-B will be delivered via intramyocardial injections.

A total of 30 patients will be enrolled in 2 stages with 3 Cohorts.

In the first stage, 10 consecutive HLHS patients will be enrolled and treated with Lomecel-B (Cohort A). The first 3 patients will be treated no less than 5 days apart, and will be evaluated for any treatment-emergent adverse events (TE-AEs) (e.g., induced myocardial infarction or perforation). These patients will undergo full evaluation for 5 days to demonstrate safety prior to proceeding with the remainder of the cohort. After 6 months post-treatment of the last patient of Cohort A, a formal safety review will be conducted prior to proceeding to the next phase.

The second stage is double-blinded, in which 20 HLHS patients will be randomized to either receive treatment with Lomecel-B (Cohort B, 10 patients), or will receive no cells and no injection (Cohort C, 10 patients).

Eligibility Criteria:
Inclusion Criteria: all patients must have HLHS (all types) requiring BDCPA surgery.

Exclusion Criteria: all patients must not have any of the following.

1. Significant coronary artery sinusoids.
2. Requirement for mechanical circulatory support prior to BDCPA surgery.
3. Underlying evidence of arrhythmia requiring anti-arrhythmia therapy.
4. Need for concomitant surgery for aortic coarctation or tricuspid valve repair.
5. HLHS and restrictive or intact atrial septum.
6. Undergoing the Stage I (Norwood) procedure that does not have HLHS.
7. Serum positivity for: HIV; hepatitis B virus surface antigen (HBV BsAg); and/or viremic hepatitis C virus (HCV).
8. Parent/guardian that is unwilling or unable to comply with necessary follow-up.
9. Unsuitability for the study based on the Investigator's clinical opinion.
10. Documented chromosomal abnormalities
Evaluating the Safety, Tolerability, and Pharmacokinetics of BIIB095 in Healthy Participants

The primary objective of the study is to evaluate the safety and tolerability of single- and multiple-ascending oral doses of BIIB095 in healthy participants. The secondary objectives are to characterize the single- and multiple-oral-dose PK of BIIB095 in healthy participants and to investigate the effect of food on the single-oral-dose PK of BIIB095 in healthy participants.


Eligibility Criteria:
Key Inclusion Criteria:

* Ability of the subject to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use confidential health information in accordance with national and local subject privacy regulations.
* Must have a body mass index between 18 and 30 kg/m2, inclusive.
* All women of childbearing potential and all men must practice highly effective contraception during the study and for 5 times the half-life or 3 months, whichever is longer, after their last dose of study treatment. In addition, subjects should not donate sperm or eggs during the study and for at least 3 months after their last dose of study treatment.
* Must be in good health as determined by the Investigator, based on medical history and Screening evaluations.

Key Exclusion Criteria:

* History of any clinically significant cardiac, endocrine, gastrointestinal, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, or renal disease, or other major disease, as determined by the Investigator.
* Significant history of fainting or vaso-vagal attacks, as determined by the Investigator.
* Current condition known to affect cardiac conduction, or a personal or familial history of Brugada syndrome.
* Congenital nonhemolytic hyperbilirubinemia (Gilbert's syndrome).
* History or risk of seizures or a history of epilepsy, significant head injury or related neurological disorders (excluding childhood febrile convulsions), as determined by the Investigator.
* Current enrollment in any other drug, biologic, device, or clinical study, or treatment with an investigational drug or approved therapy for investigational use within 30 days (6 months for biologics) prior to Day -1, or 5 half-lives of the agent, whichever is longer.
* Exposure to more than 4 experimental chemical entities within 12 months prior to the first dosing day.
* Breastfeeding, pregnant, or planning to become pregnant during study participation

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
A Comparison of Manufacturing Processes for AIR OPTIX® COLORS Contact Lens

The purpose of this feasibility study was to compare AIR OPTIX® COLORS contact lenses manufactured using an automated process to AIR OPTIX® COLORS contact lenses manufactured using a semi-automatic process.


Eligibility Criteria:
Inclusion Criteria:

* Able and willing to sign a written Informed Consent form.
* Cylinder ≤ -0.75 diopter (D).
* Able to achieve visual acuity (VA) of at least 20/30 Snellen in each eye at distance with contact lenses (CLCVA) and best corrected visual acuity (BCVA) ≥ 20/25.
* Have spectacles that provide acceptable vision and be willing to wear them if unable to wear the study lenses.
* Successful daily wear of single-vision spherical soft contact lenses in both eyes during the past 3 months for a minimum of 8 hours/day, 5 days/week.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Eye injury or surgery within twelve weeks immediately prior to enrollment in this trial.
* Pre-existing ocular irritation that would preclude contact lens fitting.
* Currently enrolled in an ophthalmic clinical trial.
* Evidence of systemic or ocular abnormality, infection, or disease likely to affect successful wear of contact lenses or use of accessory solutions, as determined by the investigator.
* Pathologically dry eye.
* Other protocol-defined exclusion criteria may apply.
Role of Progesterone in Hypoactive Sexual Desire Disorder in Menopausal Women

The objective of this study is the role of vaginal progesterone gel in the treatment of menopausal hypoactive sexual desire disorder. Half of the study participants will receive a standard dose of self applied vaginal progesterone gel and the other half will receive oral vitamin tablets.

Steroid hormones play fundamental roles in sexual behaviour. Sexual activity is related to hormone concentrations and ovulation in women. Women's sexuality, unlike that of most mammals, is not solely defined by sexual receptivity during the short window of fertility. Women are also prone to initiate luteal-phase sex when serum levels of progesterone are highest in the menstrual cycle.As a result of ovarian hormonal cessation after menopause women may face alterations in sexual desire.

The role of progesterone supplementation in improving sexual desire in the menopausal period is investigated.

Eligibility Criteria:
Inclusion Criteria:

* Menopausal status
* Sexually active

Exclusion Criteria:

* Medical history of chronic psychiatric disease
* Medical conditions associated with female sexual dysfunction; cardiovascular disease, uncontrolled chronic HT (hypertension) ,DM (diabetes mellitus), History of gynecologic surgery, female gynecological cancer ( breast, ovarian, uterine, cervical)
* Medications associated with female sexual dysfunction; Antidepressants opiates, beta blockers, Antiepileptics ( gabapentin, topiramate,phenytoin) benzodiazepines
Development of Ivermectin for Alcohol Use Disorders

Current pharmacotherapies for alcohol use disorders (AUDs) have limited efficacy. Thus, the development of effective treatments for AUDs represents an important public health objective. Repositioning, i.e. using existing approved drugs for other indications, represents a fast and economically feasible approach for drug development. Ivermectin (IVM) is an FDA-approved antiparasitic medication that can significantly reduce alcohol intake in mice, suggesting that it may be useful in the treatment of AUDs in humans. The goal of this project is to provide key clinical evidence that IVM can be repositioned as a novel therapeutic agent to treat AUDs.

Current pharmacotherapies for alcohol use disorders (AUDs) have limited efficacy. Thus, the development of effective treatments for AUDs represents an important public health objective. Repositioning, i.e. using existing approved drugs for other indications, represents a fast and economically feasible approach for drug development. Ivermectin (IVM) is an FDA-approved antiparasitic medication that can significantly reduce alcohol intake in mice, suggesting that it may be useful in the treatment of AUDs in humans. The goal of this project is to provide key clinical evidence that IVM can be repositioned as a novel therapeutic agent to treat AUDs. We will enroll 10 alcohol dependent individuals in a placebo-controlled randomized pilot safety trial of IVM (30 mg orally once) over a 2-day (1-night) inpatient stay at the UCLA CTRC and employ a well-characterized battery of behavioral paradigms (i.e., alcohol administration and cue exposure). The goals of the study are to test: (a) the safety of combining IVM, at a dose currently shown to be safe in humans (30 mg), with moderate doses of alcohol (0.08 g/dl); and (b) whether IVM reduces the reinforcing effects of alcohol during alcohol administration and whether it reduces alcohol craving during cue exposure, as compared to placebo.

Eligibility Criteria:
Inclusion Criteria:

* age between 21 and 65;
* meet current DSM-V diagnostic criteria for an alcohol use disorder

Exclusion Criteria:

* current treatment for alcohol problems, a history of treatment in the 30 days before enrollment or current treatment seeking;
* a current (last 12 months) DSM-V diagnosis of dependence on any psychoactive substances other than alcohol and nicotine;
* a lifetime DSM-IV diagnosis of schizophrenia, bipolar disorder, or any psychotic disorder;
* positive urine screen for narcotics, amphetamines, or sedative hypnotics;
* serious alcohol withdrawal symptoms as indicated by a score ≥ 10 on the Clinical Institute Withdrawal Assessment for Alcohol-Revised (CIWA-R);
* pregnancy, nursing, or refusal to use reliable method of birth control (if female);
* a medical condition that may interfere with safe study participation (e.g., unstable cardiac, renal, or liver disease, uncontrolled hypertension or diabetes);
* AST, ALT, or GGT ≥ 3 times upper normal limit;
* currently on prescription medication that contraindicates use of IVN;
* any other circumstances that, in the opinion of the investigators, compromises participant safety.
Acalabrutinib (ACP-196) in Combination With ACP-319, for Treatment of B-Cell Malignancies

This study is evaluating the safety, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy acalabrutinib and ACP 319 in B-cell malignancies.

Part 1, Dose Escalation, is comprised of 3 dosing cohorts of 6 subjects each. Acalabrutinib dosing is fixed in all cohorts at 100 mg PO twice daily (BID). In addition to acalabrutinib, subjects in Cohort 1 will receive ACP-319, 25 mg BID; Cohort 2 will receive ACP-319, 50 mg BID: and Cohort 3 will receive ACP-319 100 mg BID. The maximum tolerated dose (MTD) of the study treatment combination will be determined by assessing dose-related toxicities (DLTs) for each cohort at the end of Cycle 1 prior to dose escalation. If there are greater than or equal to 2 DLTs in a cohort, dose escalation will not occur and the MTD will be the highest daily dose for which less than 33% of the subjects in that cohort experienced DLTs in Cycle 1.

Part 2, Dose Expansion, includes 12 subjects per histology, dosing at the MTD for the combination of acalabrutinib and ACP-319 established in Part 1. Subjects will continue dosing until disease progression or unacceptable drug-related toxicity.

Eligibility Criteria:
Main Inclusion Criteria:

* Diagnosis of a b-cell malignancy as documented by medical records and with histology based on criteria established by the World Health Organization (WHO).
* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
* Agreement to use contraception during the study and for 90 days after the last dose of study drugs if sexually active and able to bear or beget children.

Exclusion Criteria

* A life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of study drugs, or put the study outcomes at undue risk.
* Central nervous system (CNS) involvement by lymphoma/leukemia
* Any therapeutic antibody within 4 weeks of first dose of study drugs.
* The time from the last dose of the most recent chemotherapy or experimental therapy to the first dose of study drugs is \< 5 times the half-life of the previously administered agent(s).
* ANC \< 0.5 x 10\^9/L or platelet count \< 50 x 10\^9/L unless due to disease involvement in the bone marrow.
* Creatinine \> 1.5 x institutional upper limit of normal (ULN); total bilirubin \> 1.5 x ULN (unless due to Gilbert's disease); and aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 3.0 x ULN.
Learning Oriented Physiotherapy - a New Approach

Outpatients that suffer from different anxiety disorders may have physical ailments that negatively affect daily life functioning and quality of life. LOF is a physical therapy approach focusing on the link between bodily and mental balance and through defined, but simple movements, patients are expected to learn how to cope and reduce health complaints.

This study aims to investigate the short- and longterm effect of LOF compared to other standardized psychiatric treatments given in the clinic on levels of anxiety and depression, health related function and quality of life.


Eligibility Criteria:
The study population will be recruited among patients referred to three Norwegian psychiatric outpatient clinics for anxiety-like conditions. The same criteria for inclusion and exclusion will be applied for the experimental and active comparator group.

Inclusion Criteria:

Participants should be

* 18 years or older
* able to read, write and speak Norwegian
* understand the project information and consent

Exclusion Criteria:

Participants should not

* have ongoing substance abuse or addiction.
* be psychotic.