cyrilzakka/clinical-trials huggingface dataset:
A Controlled Trial of Mifepristone in Gulf War Veterans With Chronic Multisymptom Illness

We propose to conduct placebo-controlled trial of the glucocorticoid receptor antagonist mifepristone in Gulf War veterans (GWV) with chronic multisymptom illness (CMI) to examine its effects on physical and mental health and cognitive functioning. In addition, we propose to examine whether HPA axis biomarkers or their response to mifepristone are useful predictors of clinical response.


Eligibility Criteria:
Inclusion Criteria:

* Veteran of the 1991 Gulf War
* Veteran meets criteria for multisymptom illness

Exclusion Criteria:

* Veteran lacks the capacity to provide consent.
* Veteran has a major medical or neurological disorder or traumatic brain injury
* Veteran has morning plasma cortisol level less than 5 mcg/dl or a history of adrenal insufficiency
* Veteran is taking oral corticosteroids
* Veteran has a lifetime diagnosis of schizophrenia, schizoaffective disorder or bipolar disorder
* Veteran has been psychiatrically hospitalized or attempted suicide within the previous 2 years
* Veteran has current suicidal ideation
* Veteran is pregnant or breastfeeding or plans to become pregnant within the year (male or female) not willing to use appropriate forms of contraception during the study and for at least 90 days post treatment.
* Women veterans with diseases of the uterus by history or a family history of uterine cancer
* Known allergy to mifepristone
Sleeping for Two: RCT of CBT-Insomnia in Pregnancy

Cognitive-behavioural therapy for insomnia (CBT-I) has been shown to be an effective treatment for insomnia in multiple populations, including women during pregnancy and postpartum. Online CBT-I has also been shown to be effective and comparable to in-person CBT-I, and shows promise as an accessible treatment alternative to in-person CBT-I for pregnant women experiencing insomnia. As the harmful consequences of insomnia or sleep disturbances have been well documented during late pregnancy, this randomized-controlled trial will compare the efficacy of both in-person and online CBT-I on pregnant women with insomnia to a wait-list control group.

The primary aim of the current project is to evaluate the impact of a 6-week in-person CBT-I, versus online CBT-I, versus a wait-list in reducing symptoms of insomnia (assessed subjectively by self-report and objectively with actigraphy) experienced in pregnancy. The investigators hypothesize that participants who receive a 6-week program of either in-person CBT-I or online CBT-I (versus a wait-list) will report fewer insomnia symptoms and have improved objectively assessed sleep measured at one-week post-treatment. Based on previous research findings, the investigators do not expect that there will be a difference between in-person CBT-I and online CBT-I administration.

The secondary aim is to investigate if CBT-I versus a wait-list will reduce symptoms of depression at one-week post-treatment. The investigators hypothesize that participants who receive in-person CBT-I and online CBT-I (versus a wait-list) will report fewer depressive symptoms measured at one-week post-treatment.

Eligibility Criteria:
Inclusion Criteria:

* Age: 18 years or greater
* Gestation: 12 - 30 weeks
* Identifying as experiencing sleep disturbances
* Language: English-intermediate or above
* Have access to internet

Exclusion Criteria:

* Experiencing symptoms of sleep disorders other than insomnia
* Currently taking prescribed medications for sleep problems
* History of untreated, serious psychiatric illness
* Substance-use during pregnancy
Senaparib in mCRPC Patients With Homologous Recombination Repair Gene Alterations After Docetaxel Treatment

The purpose of this study is to evaluate the efficacy and safety of Senaparib in metastatic castration-resistant prostate cancer (mCRPC) patients with homologous recombination repair (HRR) gene alterations after docetaxel treatment

This is a randomized, double-blinded, placebo-controlled, multicenter, Phase II study in mCRPC patients with HRR gene alterations after docetaxel therapy to evaluate the anti-tumor activity and safety of Senaparib.

Eligibility Criteria:
Inclusion Criteria:

1. Patients must voluntarily participate in this clinical study. Be willing written informed consent form (ICF) prior to any study activity.
2. Male ≥18 years of age on the day of signing the ICF.
3. Patients must have histologically or cytologically confirmed prostate adenocarcinoma.
4. Surgically or medically castrated, with serum testosterone levels of ≤50 ng/dL (≤1.73 nmol/L). If the patient is being treated with LHRH agonists/antagonists (patient who have not undergone orchiectomy), this therapy must be continued throughout the study.
5. Patients have adequate organ functions, as indicated by the following laboratory values (had not received blood transfusion, apheresis infusion, erythropoietin, granulocyte colony-stimulating factor (G-CSF), and other relevant medical support within 14 days before the administration of study drug).
6. Patients have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
7. Male patients must use a condom during treatment and for 3 months after the last dose of study drug when having sexual intercourse with a woman of childbearing potential. Female partners of male patients should also use an acceptable method of contraception if they are of childbearing potential.

Exclusion Criteria:

1. Previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT).
2. Prior treatment with a polyadenosine 5'diphosphoribose polymerisation (PARP) inhibitor, including Senaparib.
3. Patients with a known hypersensitivity to Senaparib or any of the component of Senaparib.
4. Initiating bisphosphonate/denosumab therapy or adjusting bisphosphonate/denosumab dose/regimen within 28 days prior to the first dose of study drug. Patients on a stable bisphosphonate/denosumab regimen are eligible and may continue.
5. Patients who have received strong inhibitors/inducers of CYP3A4 which cannot be discontinued 21 days prior to the first dose of study drug and withheld throughout the study drug treatment. Patients received phenobarbital/enzalutamide will require a 5-week washout prior to the first dose of study drug.
6. Patients with MDS or AML, or with clinical features suggestive of MDS or AML.
7. Patients with serious acute or chronic infections.
8. Patients who have received a live virus or bacterial or RNA vaccination within 28 days prior to the first dose of study drug.
9. Patients are unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee.
Psychosocial Counseling in Afghanistan

The assessment intends to investigate the efficacy of psychosocial counseling for the treatment of help seeking individuals with psychosocial problems in Mazar-e-Sharif, Afghanistan. Treatment was administered by local counselors who had received specific education and training

Psychosocial stress due to conflict and war causes major mental health problems in many resource-poor countries, especially those coping with ongoing war-like conditions. There is a lack of intervention research in these population. The purpose of this assessment was to examine whether the type of psychosocial counseling developed by our group is effective in reducing symptoms of depression and anxiety and significantly increasing the quality of life of help-seeking Afghans.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of mental health problems by a local medical doctor

Exclusion Criteria:

* Schizophrenia
* Mental retardation
Cognitive-Based Compassion Training (CBCT) for People Living With HIV (PLHIV)

The purpose of the study is to examine the effects of cognitive-based compassion training (CBCT), a meditative practice based on Buddhist teachings, on long term emotional well-being and immune system improvement with people living with Human Immunodeficiency Virus (PLHIV).

The proposed study will investigate the efficacy of cognitive-based compassion training (CBCT), a contemplative technique based on the Tibetan Buddhist tradition of compassion meditation, for enhancing immune restoration and psychological resilience in people living with HIV-1 (PLHIV). Psychosocial stress has been associated with increased circulating concentrations of key inflammatory biomarkers. The patients with HIV must cope with the physical impact of HIV disease itself, the often complex treatment regimens and side effects of combination antiretroviral therapy (ART), illness-associated psychological and existential dilemmas, changes in social roles and lifestyle patterns relative to illness progression, social stigma, and financial and material resource concerns. This study aims to determine if engagement with CBCT is associated with reduced circulating concentrations of stress-related inflammatory biomarkers, improves HIV-related clinical outcomes and decreases stress in PLHIV.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects living with HIV-1 infection who have been on continuous ART for a minimum of 12 months and:

   * are followed longitudinally for their HIV healthcare at the Infectious Disease Program
   * meet criteria for immunological non-responsiveness as defined by adherence to ART and cluster of differentiation 4 (CD4) count \<350 cells/μL despite complete virologic suppression (\> 2 plasma HIV viral load (pVL) below the limit of detection including the most recent pVL prior to enrollment).
2. Ability to give informed consent.
3. Score at least 1 standard deviation above socioeconomic status (SES)-matched general population norms on Perceived Stress Scale (PSS)

Exclusion Criteria:

1. History of psychosis
2. HIV-related neurocognitive decline
3. Substance abuse within the last year
4. Documented history of cirrhosis or a total bilirubin ≥ 2.0 mg/dL
5. Known or possible pregnancy or attempting to become pregnant
6. BMI below 17 or above 30
7. Age \< 18
8. Bipolar disorder
9. Bleeding disorders such as thrombocytopenia or significant gastrointestinal bleeding within the past year
10. Continuous ART for \< 12 months
Treatment of Infertility by Collagen Scaffold Loaded With Autologous Bone Marrow Stem Cells

Study of the treatment of infertility caused by severe intrauterine adhesions or endometrial dysplasia by collagen scaffold loaded with autologous bone marrow stem cells, and to provide clinical evidence for the treatment of uterine infertility

Infertility is defined as a women fails to become pregnant after having a normal sex life for two years without contraception. There is no effective treatment to the infertility caused by severe intrauterine adhesions or endometrial dysplasia which affects embryos implantation. The existing drugs, physical or surgical treatments had no significant effects to severe intrauterine adhesions.Collagen is the main component of the extracellular matrix with good biocompatibility, and it has been approved for the reparation of skin and oral mucosa by State Food and Drug Administration. Bone marrow stem cells have been used in the clinical treatment of blood diseases, and achieved good results. In this study, collagen scaffold and autologous bone marrow stem cells are combined, and they showed good biological safety

Eligibility Criteria:
Inclusion Criteria:

* Infertility caused by serious intrauterine adhesions or endometrial dysplasia
* Hysteroscopy examination confirmed intrauterine adhesions or endometrial dysplasia
* Monitoring of endometrial cycle
* Sign a consent form
* Follow the test plan and follow-up process

Exclusion Criteria:

* Abnormal chromosome karyotype
* Congenital uterine malformations
* Severe endometriosis
* Severe adenomyosis
* Contraindications to pregnancy
* Contraindications to bone marrow collection
* Contraindications to hormone replacement therapy
* Medical history of pelvic tumors or receiving pelvic radiotherapy
* Unable to adhere to the hospital examination and follow-up, or carrying on other treatment during follow-up period
Immunity Against Severe Acute Respiratory Syndrome Coronavirus 2 Disease (COVID-19) in the Oncology Outpatient Setting

The COVIDOUT study will prospectively investigate the serological immunity of outpatient cancer patients to evaluate the prevalence of previous severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections and dependency of serological immunity on systemic (chemo)therapy after COVID19 disease as well as after vaccination.

In this prospective observational study all cancer patients who are regularly treated in the Oncology Outpatient Clinic of the University Medical Center Hamburg-Eppendorf (UKE) will be included in the study upon consent.

Data will be collected as follows:

(i) Serological antibody screening at study inclusion and every 3 months (ia) In case of vaccination monthly screening for 3 months (ii) Routine clinical data: demographic and biometric data, medical history, common laboratory parameters (iii) Patient questionnaire: assessment of past COVID-19 infection, past COVID-19 specific symptoms, social environment, vaccination

Recruitment is limited to a one-year period (December 2020 - December 2021)

Eligibility Criteria:
Inclusion Criteria:

* Known diagnosis of cancer
* Active disease or (in case of cure) last systemic therapy \<12 months
* Signed informed consent

Exclusion Criteria:

* Refusal of participation
Extension Study of Pimavanserin in Irritability Associated With Autism Spectrum Disorder

52-week, open-label extension study of double-blind study ACP-103-069 to determine the long-term safety and tolerability of pimavanserin for the treatment of irritability associated with ASD in children and adolescents (aged 5 to 17 years).

ACP-103-069 is a 6-week, randomized, double-blind, fixed-dose, placebo controlled, parallel group study of pimavanserin in children and adolescents with irritability associated with autism spectrum disorder (ASD).

This study will be conducted as a 52-week, open-label extension study of the antecedent double-blind study to determine the long-term safety and tolerability of pimavanserin for the treatment of irritability associated with ASD in children and adolescents (5 through 17 years old at the time of enrolling into the antecedent double-blind study).

Eligibility Criteria:
INCLUSION CRITERIA:

* Has completed the treatment period of study ACP-103-069
* Informed consent prior to the conduct of any study procedures
* Continues to be both clinically stable and not at imminent risk of suicide or injury to self, others, or property
* Continues to be medically stable at enrollment
* For female patients only: unable to become pregnant or agree to use a highly effective non-hormonal method of contraception. Females of childbearing potential must have a negative pregnancy test

EXCLUSION CRITERIA:

* Patient or parent/legally accepted representative is judged by the Investigator to be inappropriate for the study
* Requires treatment with a medication prohibited by the protocol, including concomitant psychotropic drugs targeting irritability, including those used off-label (clonidine, guanfacine, and propranolol; lithium, valproate), medications that prolong the QT interval; and strong cytochrome P450 (CYP) 3A4 enzyme (CYP3A4) inhibitors and inducers
* At a significant risk of suicide, or is a danger to self or others
* At risk of significant violent behavior to the extent that participation would pose an undue risk to other patients, caregivers, or others
* Positive urine drug test
* Serious and/or unstable psychiatric, neurologic, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical disorder, including cancer or malignancies
* Any change in medical or treatment status that may increase the risk associated with taking pimavanserin, would interfere with safety assessments, or would confound the interpretation of study results
* Clinically significant abnormal ECG of protocol-defined cardiac conduction abnormalities
* Weight \<15 kg
* Additional inclusion/exclusion criteria apply. Subjects will be evaluated at screening to ensure that all criteria for study participation are met.
Propionibacterium Acnes in Shoulder Arthroplasty

The investigator's plan to determine whether pre-operative skin preparation with hydrogen peroxide alters rates of P acnes culture positivity. They hypothesize that pre-operative skin preparation with hydrogen peroxide will reduce rates of P acnes culture positivity.

Over half of all post-operative infections after shoulder arthroplasty are due to Propionibacterium acnes. Even in apparently "aseptic" revisions, nearly all cultures taken at the time of revision surgery are positive for P acnes, and thus low-grade infection with this bacteria may be a more common cause of failure than previously suspected. Current antibiotic prophylaxis methods are ineffective against P acnes. Despite intravenous cefazolin, P acnes can be cultured from the glenohumeral joint in 42% of patients undergoing primary total shoulder arthroplasty. Despite skin preparation with chlorhexidine, P acnes can be cultured from 73% of portal sites in arthroscopy. P acnes is further insensitive to alcohol. Dermatologists have long been treating P acnes as it is a primary cause of acne vulgaris. One of the most popular and effective treatments for acne vulgaris is topical benzoyl peroxide. A prior prospective clinical trial demonstrated that adding topical 5% benzoyl peroxide 48 hours prior to surgery reduced P acnes culture positivity to 6%. The downside of this treatment is that it must be applied by the patient, at home, for 48 hours prior to surgery. An additional downside is that benzoyl peroxide is a skin irritant that not all patients tolerate.

In aqueous environments, benzoyl peroxide rapidly decomposes into benzoic acid and hydrogen peroxide. Benzoic acid is a skin irritant and hydrogen peroxide is the active ingredient. Benzoyl peroxide is used instead of hydrogen peroxide because hydrogen peroxide breaks down into water and oxygen when exposed to light. Recently, stabilized forms of hydrogen peroxide have been developed and have been demonstrated to be equally effective to benzoyl peroxide in the treatment of acne vulgaris. One potential reason for hydrogen peroxide's efficacy against P acnes is that it is absorbed into the skin, addressing P acnes residing in sebaceous glands. To date, no studies have examined whether the addition of hydrogen peroxide to pre-operative skin preparation can reduce intra-operative P acnes culture positivity.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing primary shoulder arthroplasty

Exclusion Criteria:

* Patients with prior shoulder surgery.
* Patients with a symptomatic infection or history of infection, recent antibiotic use (within six weeks), or with clinical signs of infection such as an elevated ESR, CRP, positive aspiration cultures, or positive biopsy.
* Patients with a known hypersensitivity to hydrogen peroxide.
Implementation of IVS3 for Upper Limb Motor Recovery

This study measures participant satisfaction and upper extremity function in outpatients with chronic stroke when exposed to the IVS3 device. Investigators hypothesize that treatment with the IVS3 device will be feasible and tolerable for use in the outpatient setting.

This study will investigate the implementation of the intensive visual stimulation three (IVS3) device in the outpatient rehabilitation setting. This is a phase I/II open label study that will assess participant satisfaction and upper extremity function in outpatients with chronic stroke (10 with hemi spatial neglect and 15 without), when exposed to IVS3 for 30 minutes and conventional treatment for 15 minutes, across 12 sessions in 4-6 weeks at Weill Cornell medicine outpatient rehabilitation (single site).

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years old
2. English speaking
3. History of ischemic or hemorrhagic stroke ≥ 6 months prior to study enrolment
4. FMA-UE: 20 \< x \< 50 (moderate impairments)
5. With or without hemi spatial neglect

Exclusion Criteria:

1. Spasticity or increased tone with MAS ≥3 in the upper extremity
2. Unable to communicate effectively or provide informed consent
3. Significant visual impairments
4. Concurrent occupational therapy being received outside of the study
5. Pregnant or incarcerated individuals
Genotyping Directed Salvage Therapy in Children Who Have Failed Dual NRTIs

In HIV-NAT 013 phase I study, genotyping was performed in 95 children on dual NRTI which showed that almost all children had resistance to NRTi. The HIV-NAT 013 phase II is a follow up study to evaluate treatment outcome after salvage therapy and the evolution of mutations.

The HIV-NAT 013 study (conducted in 2003) evaluated prevalence and pattern of RT mutation in 95 children treated with dual NRTI. The study showed almost all children to have some degree of NRTI resistance and 40% with multi NRTI resistance. The mutation reported was major mutation.

After the study, the patients were managed based on the physician's judgment using genotyping results. The 95 patients in HIV-NAT 013 are categorized into 3 groups.

1. No viral resistance
2. Low grade resistance with or without clinical/ immunological failure
3. High grade resistance with or without clinical/ immunological failure.

There are limited prospective studies evaluating outcome of decision regarding salvage therapy after genotyping results

There are also new mutations that are not considered major mutation that may affect treatment outcome

Knowledge learned from this study will benefit Thai children with NRTI resistance by helping pediatricians better choose salvage treatment options

Eligibility Criteria:
Inclusion Criteria:

* All children from HIV-NAT 013 phase I

Exclusion Criteria:

* No inform consent obtained
Mucus Removal Before Embryo Transfer

Despite these revolutionary changes in the laboratory, little has changed with the process of embryo transfer (ET). A study to prospectively evaluate the role of cervical mucus removal prior to embryo transfer on pregnancy rates in ART will be undertaken.

ET involves placing the embryo(s) obtained before assisted reproduction technology (ART) into the uterus via a catheter advanced through the cervical canal. Yet this is the final, and in some respects the most critical, process in the sequential events that encompass an ART cycle. If an embryo cannot be delivered to the uterine cavity atraumatically and in a location for optimal implantation, the steps of ovarian hyperstimulation, oocyte retrieval, embryo culture, and embryo selection will have no benefit. Contamination of the catheter with blood may be a marker for difficult ET and has also been linked to poor ET outcomes. When retrospectively assessing outcomes, Goudas et al. (1) demonstrated a clinical pregnancy rate of 50% with no blood, and this rate fell by half when a small amount of blood was noted on the catheter tip. Pregnancy rates fell even further, to 10%, when there was a significant amount of blood (1). Similarly, in a preliminary study, blood or mucus on the tip was associated with a significantly lower pregnancy outcome (2). Blood and mucus were associated with an increased risk for unsuccessful transfers with odds ratios of 1.9 and 1.8, respectively. Although all these data suggest a possible role of cervical mucus in embryo transfer, there is no clinical evidence on the effect of removal of cervical mucus on the outcome of IVF/ICSI. In view of this uncertainty, a study to prospectively evaluate the role of cervical mucus removal prior to embryo transfer on pregnancy rates in ART will be undertaken. It is hypothesized that removal of cervical mucus will achieve higher clinical pregnancy rates.

Eligibility Criteria:
Inclusion Criteria:

* IVF or OD patients with supernumerary embryos (oocyte's age will be considered as patient's age).
* Normal transvaginal ultrasound at screening, without evidence of clinically significant abnormality consistent with finding adequate for ART with respect to uterus and adnexa
* Single embryo transfer
* Embryo transfer at the blastocyst stage
* Embryo with a morphological classification of ≥3BB

Exclusion Criteria:

* Preimplantation genetic diagnosis and/or screening