cyrilzakka/clinical-trials huggingface dataset:
Healing Through Affective Self-Awareness in Fibromyalgia: a Randomized Controlled Trial

The investigators are studying whether a brief three-session mind-body workshop helps people with fibromyalgia. The investigators hypothesize that this workshop will significantly improve pain and other symptoms, compared to usual care.

The affective self-awareness approach presumes that many chronic pain states, such as fibromyalgia (FM), can be effectively treated by encouraging self-awareness of emotional tension. While anecdotally effective in selected patients, this approach has thus far not been tested in a randomized controlled trial. Our purpose is to determine whether an affective self-awareness approach significantly improves pain, tenderness, and other FM symptoms in a random sample of FM patients; and to determine what psychosocial factors predict a favorable response.

Comparisons: changes in ratings of pain, tenderness, and other symptoms between two arms of the study:

* three weekly 2-hour small-group meetings supplemented with daily writing and meditative exercises to enhance affective self-awareness
* usual care

Eligibility Criteria:
Inclusion Criteria:

* fibromyalgia, as defined by American College of Rheumatology 1990 criteria.
* at least 18 years of age.
* have access to transportation to and from Providence Hospital, Southfield, MI.

Exclusion Criteria:

* co-morbid medical conditions capable of causing a worsening of physical functional status independent of FM, including morbid obesity, autoimmune diseases, cardiopulmonary disorders (e.g. angina, congestive heart failure, COPD, chronic asthma), uncontrolled endocrine or allergic disorders (e.g. thyroid dysfunction, Type I diabetes), pregnancy, and malignancy within the preceding 2 years.
* any present psychiatric disorder involving a history of psychosis (e.g. schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder etc.), post-traumatic stress disorder, current suicide risk or history of suicide attempt, or substance abuse within 2 years. Note: Subjects with mood or anxiety disorders otherwise will not be excluded.
* changes in medication regimen within one month prior to enrollment.
Clinical Study of Probiotic Treatment for Androgenetic Alopecia

The primary objective of the study is to assess the efficacy of DA-001 as an oral supplement for treatment of female pattern hair loss.

DA-001 is a botanical supplement demonstrated natural ingredients known to exert anti-androgen effects. The ingredients were tested in-vitro and have demonstrated the anti-androgen effect. This study aims to compare DA-001 to topical minoxidil in the treatment of female pattern hair loss (also known as androgenetic alopecia).

Eligibility Criteria:
Inclusion Criteria:

* Females Age 18 or older
* Diagnosed with female pattern hair loss
* Willing and able to apply the treatment as directed, comply with study
* Otherwise healthy
* Able to give informed consent

Exclusion Criteria:

* A medical history that may interfere with study objectives
* Women who are pregnant, lactating, or planning to become pregnant during the study period
* Subjects who have experienced a clinically important medical event within 90 days of the visit (e.g., stroke, myocardial infarction, etc)
* Subjects who have known allergies to any excipient in DA-001
* Subjects who are currently participating in another clinical study or have completed another clinical study with an investigational drug or device in the treatment area within 30 days prior to study treatment initiation
* Subjects who have used any topical prescription medications in the treatment area within 30 days prior to study treatment initiation
* Subjects who have had a dermatological procedure such as surgery in the treatment area within 30 days prior to study treatment initiation
* Subject is unable to provide consent or make the allotted clinical visits
Does Timing of VT Ablation Affect Prognosis in Patients With an Implantable Cardioverter-defibrillator?

The purpose of this study is to assess whether the burden of untreated non-sustained ventricular tachycardias (VTs), or episodes treated with anti-tachycardia pacing, correlates with appropriate implantable cardiac defibrillator (ICD) shock therapies and to evaluate if the timing of radiofrequency VT ablation affects the prognosis of ICD recipients.

Enrolled patients will remain in a first phase of the study until the first appropriate ICD shock will be delivered.

The objective of this first stage is to assess whether the burden of untreated non sustained VTs or episodes treated with anti-tachycardia pacing is predictive of appropriate ICD shocks.

The second phase of the study will start after the first appropriate ICD shock delivered for VT.

Patients will be then randomized to immediate VT ablation or to standard treatment, meaning waiting until next arrhythmic storm to perform a VT ablation procedure.

The objective of this phase is compare the rate of worsening heart failure hospitalizations and deaths from any cause between the two groups.

Eligibility Criteria:
Inclusion Criteria:

* Patients already implanted with ICD (single-/dual -chamber, with or without cardiac resynchronization therapy) for primary or secondary prevention of sudden cardiac death

Exclusion Criteria:

Phase A exclusion Criteria:

* General contraindication to transcatheter ablation
* Contraindication to antithrombotic therapy
* Patients chronically treated with class I and III antiarrhythmic drugs

Phase B exclusion criteria:

* Patients developing first occurrence of incessant VTs
* Patients receiving a shock for first occurrence of clinically verified ventricular fibrillation
* Patients with aetiology differing from ischemic heart disease for coronary artery disease and from non-ischemic dilatative cardiomyopathy
MAnagement of Systolic Blood Pressure During Thrombectomy by Endovascular Route for Acute Ischaemic STROKE

Stroke is the third most common cause of death in New Zealand and is one of the leading causes of long-term disability at all ages. A life-saving clot retrieval procedure can save lives and prevent disability of patients with ischaemic stroke who get to hospital in time. In New Zealand, 90% of clot retrieval procedures are performed under general anaesthesia. Many anaesthetic drugs can affect blood pressure (BP) and blood flow within the brain. Increasing BP during the procedure could provide additional benefits in this devastating disease. A large trial is needed to investigate BP management during clot retrieval.

Internationally stroke ranks second among all causes of disability and is adding to considerable worldwide healthcare burden. Over the last 5 years a new procedure to remove clots (Endovascular Thrombectomy - EVT) has been effective for the treatment of acute large strokes, with significant reductions in long term patient disability compared to standard treatment. However, there minimal guidance on blood pressure management during the procedure. The brain is especially vulnerable to low blood pressure during the acute stroke period due to low blood supply, impairment of how the brain regulates blood flow and further falls in blood flow to the brain. High blood pressure may be beneficial due to increased blood flow in areas at risk during this time. It could be harmful due to brain injury process, swelling, and bleeding into the brain. Conversely, relatively low blood pressure could be harmful. Current evidence is limited to large observational studies. This randomised controlled study will examine the safety and efficacy of two systolic blood pressures (SBP) management arms during general anaesthesia for EVT on outcomes in patients with acute ischaemic stroke.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with anterior circulation stroke (ICA or proximal M1 or M2 segment of MCA) treated with ECR within 6 hrs of stroke onset and ECR patients presenting within 6-24 hours and favourable penumbra on perfusion scanning (see criteria 1-3).

Additional criteria in the 6 to 24-hour window.

1. 'wake up' stroke; CT with no (or at most minimal) acute infarction or
2. patient 80 years or older (NIHSS of 10 and infarct volume less than 21 ml on DWI or CT perfusion-CBF)
3. patient less than 80 years (NIHSS of 10 and infarct volume less than 31 ml on DWI or CT perfusion-CBF NIHSS of 20 and infarct volume less than 51 ml on DWI or CT perfusion-CBF).

Exclusion Criteria:

* Rescue"' procedures eg acute ischaemic stroke associated with major medical procedures such as coronary artery stenting and coronary artery bypass

  * pre-stroke mRS\>=3
  * not having GA
  * terminal illness with expected survival \<1 year
  * pregnancy
  * cardiovascular conditions where BP targeting will be contra-indicated
  * unable to participate in 3-month follow up
Efficacy Study of FloSeal for Prevention of Lymphocele After Lymphadenectomy for Gynecologic Cancer

To compare the incidence of lymphocele and lymphatic ascites between patient who use versus who do not use FloSeal during lymph node dissection


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed primary cancer of the uterine cervix, uterine corpus, ovary, and fallopian tube
* FIGO stage Cervical cancer: FIOG stage IA2-IIA2 Uterine cancer: FIGO stage I-III Ovarian and fallopian tubal cancer: FIGO stage I-IIIB
* Patients who undergoing surgery including pelvic and/or para-aortic lymph node dissection
* Patients with adequate bone marrow, renal and hepatic function:

WBC \> 3,000 cells/mcl Platelets \>100,000/mcl Creatinine \<2.0 mg/dL Bilirubin \<1.5 x normal and SGOT or SGPT \<3 x normal

* American Society of Anesthesiology Physical Status 0-1
* Performance status of ECOG 0-2
* Patient must be suitable candidates for surgery
* Patients who have signed an approved Informed Consent

Exclusion Criteria:

* Patients with a history of pelvic or abdominal radiotherapy;
* Patients who are pregnant
* Patients with contraindications to surgery;
* Patients who are unfit for Surgery: serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator);
* Patient's compliance and geographic proximity that do not allow adequate follow-up.
* Patients who undergo only lymph node sampling
COMpassion for Psychiatric Disorders And Self-Stigma

People with mental disorders face frequent stigmatizing attitudes and behaviors from others . In response to this, they tend to isolate themselves, with the risk of impeding care and the process of recovery and integration into society . Stigmatization can also be assimilated by patients themselves - i.e. self-stigma. Self-stigma is involved in diminished coping skills that lead to social avoidance and difficulties in adhering to care . Reducing self-stigma and its emotional corollary, shame, is thus crucial to attenuate the disability associated with mental illness. Shame is inherent to self-stigma and leads to difficulties in adhering to care as well as greater severity of clinical presentations . Compassion Focused Therapy (CFT) is a third wave cognitive behavioral therapy that targets shame reduction and hostile self-to-self relationship and allows for symptom improvement while increasing self-compassion, a major resilience factor . Although shame is a prominent part of the concept of self-stigma, the efficacy of CFT has never been evaluated in individuals with high levels of self-stigma.

In this study, the investigators will evaluate the efficacy and acceptability of a group based CFT program on decreasing self-stigma, compared to treatment as usual (TAU) and a psychoeducation program whose efficacy has been assessed in a previous trial.


Eligibility Criteria:
Inclusion Criteria:

1. Patient ≥18 years of age
2. Patient informed of the results of the preliminary medical examination
3. Patient affiliated to a social health insurance plan (beneficiary or beneficiary's family)
4. Patient with one or several diagnoses of chronic psychiatric disorder (schizophrenia, schizoaffective disorder, bipolar disorder, recurrent major depression, borderline personality disorder) or a neurodevelopmental disorder (autism spectrum disorder) treated as an outpatient or in a day hospital
5. CGI-Severity score\<6 assessed by the psychiatrist (Berk et al., 2008) ISMI score indicating moderate to high self-stigma (\>2.5; Lysaker et al., 2007)

   Exclusion criteria:
6. Patient in an exclusion period determined by a previous or ongoing study
7. Patient participating in an interventional study involving psychotherapy or an experimental drug
8. Patient in acute episode of their disorder according to the CGI Severity score
9. Patient in a medical emergency or immediate life-threatening situation
10. Patients with an intellectual disability (IQ\<70) estimated via the fNART (Mackinnon \& Mulligan, 2005)

12. Legal issues: care under constraint or patient deprived of freedom because of a judicial measure 13. Patient who does not speak and read French sufficiently
PORTuguese Research on Telemonitoring With CareLink® (PORTLink)

Compare use of Carelink system - monitoring system - with traditional in-clinic follow up, in patients with implantable cardiac defibrillator (ICD)

The objective of the PORTLink (PORTuguese Research on Telemonitoring with CareLink), a multicenter randomized study, is to assess the safety, functioning and costs of remote ICD monitoring when compared to traditional in-clinic follow-up. It will evaluate aspects such as the clinician and patient acceptance and satisfaction with the reviewing device data via the website, the complexity for troubleshooting calls to the support center, the utilization of emergency resources by symptomatic patients, the percentage of the unscheduled appointments after a remote interrogation, the levels of anxiety, depression and quality of life, and the main consumed resources with CareLink System.

Eligibility Criteria:
Inclusion Criteria:

* Subject has implanted Medtronic Implantable Cardioverter Defibrillator: CRT-D (Cardiac Resynchronization Therapy - Defibrillator), ICD
* Subject or the subject's caregiver is willing and able to use the Medtronic CareLink Monitor and perform the required duties at home or have a family member or assistant to perform those studies
* Subject has signed a Patient Informed Consent Form from this study

Exclusion Criteria:

* Subject has medical condition(s) that would limit study participation (e.g. hearing or speech impaired with no family member or assistant available)
* Subject is less than 18 years of age
* Subject is enrolled or intends to participate in another clinical trial
A Study to Evaluate AB308 in Combination With AB122 in Participants With Advanced Malignancies

This is a Phase 1/1b, multicenter, open-label, dose-escalation, and dose-expansion study to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and clinical activity of AB308 in combination with zimberelimab (AB122) in participants with advanced malignancies.


Eligibility Criteria:
Inclusion Criteria:

* Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
* Male or female participants ≥ 18 years of age (or age ≥ regionally approved age of consent for participation in investigational clinical studies) at the time of signing the informed consent.
* Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
* Adequate organ and marrow function

Exclusion Criteria:

* History of trauma or major surgery within 28 days prior to the first dose of study treatment.
* Prior treatment with an anti-TIGIT antibody.
* Any active or prior autoimmune disease that required treatment within 3 years of the first dose of study treatment.
* Prior chemotherapy, targeted small-molecule therapy, immunotherapy, or biologic agents, or use of other investigational drugs within 28 days before first dose of study treatment.
* Discontinued prior immunotherapy for immune related adverse events with a high severity.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
A Research Study Looking at How Oral Semaglutide Works in People With Type 2 Diabetes in Denmark, as Part of Local Clinical Practice

The purpose of the study is to collect information on how Rybelsus® works in people with type 2 diabetes and to see if Rybelsus® can lower their blood sugar levels. Participants will get Rybelsus® as prescribed to them by the study doctor. The study will last for about 8-10 months. Participants will be asked to complete a questionnaire about how they take their Rybelsus® tablets. Participants will complete this questionnaire during their normally scheduled visit with the study doctor. Participants will be asked to complete some questionnaires about their diabetes treatment. Participants will complete these during their normally scheduled visits with the study doctor.


Eligibility Criteria:
Inclusion Criteria:

* Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol)
* Diagnosed with type 2 diabetes mellitus
* The decision to initiate treatment with commercially available oral semaglutide has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician based on local label before and independently from the decision to include the patient in this study
* Male or female, age above or equal to 18 years at the time of signing informed consent
* Available HbA1c value less than or equal to 90 days prior to the 'Informed Consent and Treatment Initiation visit' (V1) or HbA1c measurement taken in relation with the 'Informed Consent and Treatment Initiation visit'(V1) if in line with local clinical practice
* Treatment naïve to injectable glucose-lowering drug(s). An exception is short-term insulin treatment for acute illness for a total of less than or equal to 14 days

Exclusion Criteria:

* Previous participation in this study. Participation is defined as having given informed consent in this study
* Treatment with any investigational drug within 30 days prior to enrolment into the study
* Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
Efficacy and Safety of Perindopril 5 mg / Indapamide 1.25 mg / Amlodipine 5 mg Fixed Combination in Hypertension

The purpose of this study is to investigate the efficacy and safety of a fixed-dose combination of perindopril 5 mg /indapamide 1.25 mg / amlodipine 5 mg compared to the free combination of the same components (perindopril 4 mg / indapamide 1.25 mg in a single pill and amlodipine 5 mg pill given separately at the same time) in chinese patients with uncontrolled essential hypertension.


Eligibility Criteria:
Main Inclusion Criteria:

* Men or women of Asian origin
* ≥18 years old
* Treated for essential hypertension
* Having the day of the selection visit an uncontrolled hypertension treated with any anti-hypertensive monotherapy at maximal dose or any dual therapy at starting dose according to investigator's routine practice or at least 1 month prior to the visit
* Having at the selection visit a sitting SBP≥140 and \<180 mmHg and DBP≥90 and \<110 mmHg

Main Exclusion Criteria:

* Known or suspected symptomatic orthostatic hypotension or positive orthostatic test at the selection visit
* Treatment with more than 2 antihypertensive drugs or with 2 antihypertensive drugs at the highest doses at the selection visit
CAB-ROR2-ADC Safety and Efficacy Study in Patients With TNBC or Head & Neck Cancer (Ph1) and NSCLC or Melanoma (Ph2)

The objective of this study is to assess safety and efficacy of CAB-ROR2-ADC in solid tumors

This is a multi-center, open-label, Phase 1/2 study designed to evaluate the safety, tolerability, PK, immunogenicity, and antitumor activity of BA3021, a conditionally active biologic (CAB) ROR2-targeted antibody drug conjugate (CAB-ROR2-ADC) BA3021 in patients with advanced solid tumors.

This study will consist of a dose escalation phase and a dose expansion phase with BA3021 in Phase 1. Phase 2 will study BA3021 alone or in combination with a PD-1 inhibitor.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumor and have failed all available standard of care (SoC) therapy and for whom no curative therapy is available or who are not eligible, intolerant to or refuse standard therapy.
* Patients must have measurable disease.
* For the dose expansion phase: Patients with locally advanced unresectable or metastatic, non-small cell lung cancer (NSCLC), triple negative breast cancer (TNBC) and soft tissue sarcoma (STS)
* Age ≥ 18 years.
* Adequate renal function
* Adequate liver function
* Adequate hematological function
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Life expectancy of at least three months.

Exclusion Criteria:

* Patients must not have clinically significant cardiac disease.
* Patients must not have known non-controlled CNS metastasis.
* Patients must not have a history of ≥ Grade 3 allergic reactions to mAb therapy as wellas known or suspected allergy or intolerance to any agent given during this study.
* Patients must not have had major surgery within 4 weeks before first BA3021 administration.
* Patients must not have had prior therapy with a conjugated or unconjugated auristatin derivative/vinca-binding site targeting payload.
* Patients must not have known human immunodeficiency virus (HIV) infection, active hepatitis B and/or hepatitis C.
* Patients must not be women who are pregnant or breast feeding.
Perinatal Handwashing Intervention in Bangladesh

The purpose of this study is to determine if an intensive handwashing intervention administered to primiparous women during their pregnancy can increase maternal handwashing with soap at critical times.

In high neonatal mortality settings, about half of neonatal deaths are estimated to occur because of infectious syndromes such as sepsis, acute respiratory infection, neonatal tetanus, and diarrhea. Promoting handwashing to mothers in the post-neonatal period has been shown to reduce the risk of pneumonia and diarrhea among infants \> 28 days old but there is little information on the protective effect of handwashing for neonatal health outcomes. The proposed study will assess motivators and barriers to handwashing with soap among new mothers, and develop and test a hand cleansing promotion intervention in rural Bangladesh. The handwashing behavior change intervention will include approaches to enhance maternal expectations of being a good nurturer, as well as enhancing maternal self-efficacy to carry out handwashing behavior.

Eligibility Criteria:
Inclusion Criteria:

* Primiparous women who plan to remain in the study area up to 1 months after birth

Exclusion Criteria:

* Prior live birth