cyrilzakka/clinical-trials huggingface dataset:
Housing and Health Study

The goal of the project is to examine the impact of providing housing for people living with HIV who are homeless or at imminent risk of homelessness on their HIV disease progression, risks of transmitting HIV, and medical care access and utilization.

Evidence is accumulating that homelessness and housing may be important factors that influence human immunodeficiency virus (HIV) sex and drug risk behaviors. Despite this apparent connection, few studies have investigated whether homelessness or unstable housing, compared with stable and adequate housing, is linked with HIV risk behaviors, and whether change in housing status is associated with change in risk behaviors.

The Housing and Health Study is a multi-site, multi-agency research collaboration. This project is a unique collaboration between federal agencies (the Department of Housing and Urban Development and the Centers for Disease Control and Prevention), local government agencies, universities, and private not-for-profit organizations.

The goal of the project is to examine the impact of providing housing for people living with HIV who are homeless or at imminent risk of homelessness on their disease progression, their risks of transmitting HIV, and medical care access and utilization. A total of 630 people living with HIV from three study sites complete the baseline study sessions. Half the participants (n=315) are randomly assigned to each of the two study groups. Treatment group participants receive Housing and Health Study housing rental assistance, and comparison group participants receive assistance finding housing according to local standard practice.

At baseline, 6, 12, and 18 months after baseline, participants complete study questionnaires and provide blood specimens to test for CD4 and viral load. In addition, the cost effectiveness of the study will be investigated by examining the HIV-related costs averted by providing housing to persons at high risk for transmitting HIV.

Eligibility Criteria:
Inclusion Criteria:

* HIV seropositive
* At least 18 years of age
* English or Spanish speaking
* Able to provide informed consent
* Able to participate in data collection protocol
* Categorized as low income (less than 80% of the Area Median Income)
* Homeless or at imminent risk of homelessness
* Able to provide information about identity

Exclusion Criteria:

-
Rapid Technique for the Detection of Intestinal Anti-transglutaminase Antibodies

Intestinal Celiac Disease (CD)-antibodies have been described as the best marker to reveal progression toward villous atrophy and could become the diagnostic marker to make prompt diagnosis in the wide clinical spectrum of CD reducing the delay in diagnosis and treatment. The introduction of either anti-endomysial antibodies (EMA) assay or rapid anti-Transglutaminase 2 (TG2) test on supernatant of mechanically lysed biopsy samples in the clinical practice would improve the diagnosis of CD, especially in clinically challenging scenarios. The availability of an accurate test for identifying intestinal CD-antibodies that do not need the culture of intestinal biopsy is less expensive, less time consuming and easier to perform would facilitate the implementation of such technology outside research laboratories, and enable the diagnosis of CD at the end of Gastrointestinal Endoscopy (GIE).


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing an elective esophagogastroduodenoscopy (EGD) for suspected CD, eosinophilic esophagitis, autoimmune enteropathy, inflammatory bowel disease, gastritis, gastric or duodenal ulcer, gastroesophageal reflux disease.

Exclusion Criteria:

* Bleeding disorders
* Patients fulfilling the new ESPGHAN Guidelines for diagnosing CD (version 2020), for a serology based CD diagnosis
* Subjects in whom intestinal biopsies are not indicated as part of the diagnostic process.
A Study of Tanespimycin (KOS-953) in Patients With Relapsed-refractory Multiple Myeloma

This is a phase 2/3, open label trial for patients with relapsed-refractory multiple myeloma. Study agent is tanespimycin (KOS-953), at three different dose levels in combination with a fixed dose of bortezomib.

Phase 2/3 combination study comparing bortezomib plus one of three doses of tanespimycin in patients with relapsed-refractory multiple myeloma after failure of at least three prior anti-cancer therapy regimens. Prior therapy must include bortezomib and lenalidomide. Primary objective is to assess the dose-response relationship of objective response rate (ORR) using EBMT/IBMTR criteria of any three dose levels of tanespimycin (KOS-953) in combination with bortezomib after four treatment cycles.

Eligibility Criteria:
Inclusion Criteria:

* Good performance status
* Histologic evidence of multiple myeloma
* Have had at least three prior treatment regimens for multiple myeloma that included both bortezomib and lenalidomide
* No prior treatment with a heat shock 90 inhibitor or an investigational proteasome inhibitor
* No known infections of HAV, HBV, HCV, or HIV
* No chemotherapy, radiation therapy, or immune therapy for three weeks prior to enrollment.
Arimoclomol in Sporadic Inclusion Body Myositis - Open Label Extension Trial

A multicenter, nonrandomized, open-label, uncontrolled clinical extension trial designed to compare the efficacy and safety of early versus delayed start of arimoclomol in the treatment of Inclusion Body Myositis (IBM)

This was planned to be a 40-month open-label extension trial of the 20-month randomized, double-blind, placebo-controlled IBM4809 trial. The open-label trial was terminated early by the sponsor as a consequence of the results of IBM4809 which did not meet any of its efficacy endpoints. Therefore, the actual average duration of open-label treatment was approximately 28 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Patient is able to comprehend and is willing to provide written informed consent and is capable and willing to comply with trial procedures.
2. Patient has completed the IBM4809 trial on treatment with Investigational Medicinal Product (IMP).

Exclusion Criteria:

1. Known or suspected allergy or intolerance to arimoclomol or its constituents.
2. Exposure to any other investigational treatment within 30 days or \<5 half-lives of the baseline visit or taking part or planning to take part in another interventional trial.
3. Significant protocol deviation in the blinded IBM4809 trial based on the investigator's judgement in discussion with the medical monitor.
4. Women who are lactating or pregnant, or men or women unwilling to use a highly effective method of birth control if not surgically sterile (defined as bilateral tubal ligation, bilateral oophorectomy, or hysterectomy for women; vasectomy for men) for female participants until 4 weeks after last dose and for male participants up to 3 months after last dose. Premenopausal women must have a negative pregnancy test prior to dosing with trial medication. Acceptable methods of birth control are:

   * Hormonal methods associated with inhibition of ovulation such as oral, implantable, injectable, or transdermal contraceptives for a minimum of 1 full cycle (based on the patient's usual menstrual cycle period) before arimoclomol administration.
   * Total abstinence from sexual intercourse since the last menses before arimoclomol administration. (The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence \[calendar, symptothermal, post-ovulation\] methods are not acceptable methods of contraception).
   * Intrauterine device (IUD) or intrauterine hormone-releasing system (IUS).
5. Any concurrent condition that in the investigator's opinion will significantly interfere with assessment of safety or efficacy.
6. Inability to comply with the protocol-specified procedures/evaluations and scheduled visits as per the investigator.
Efficacy and Safety of Eslicarbazepine Acetate as Therapy for Patients With Painful Diabetic Neuropathy

The primary objective of the study is to assess the efficacy of eslicarbazepine acetate (ESL) as therapy for patients with painful diabetic neuropathy.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent to participate in the study
* Men and women aged 18 years or older
* Diagnosis of diabetes mellitus Type 1 or 2
* Diagnosis of pain attributed to diabetic neuropathy for more than 1 year prior to enrolment
* Stable glycemic control: (total glycated haemoglobin \[HbA1c\] level ≤ 11% at screening)
* Cooperation and willingness to complete all aspects of the study
* Completion of at least 4 daily diaries during the week preceding randomisation
* A minimum average daily pain score of 4 on the Numeric rating pain scale (NRPS) in the last 4 diary entries before randomisation.

Exclusion Criteria:

* Pain of other origin that might confound the assessment of neuropathic pain of diabetic origin
* Significant or unstable medical or psychiatric disorders
* Drug or alcohol abuse in the preceding 2 years
* Peripheral vascular disease with a history of amputation, except amputation of toes
* Severe renal function impairment, as shown by calculated creatinine clearance values \< 30 mL/min at screening
* Relevant clinical laboratory abnormalities (e.g., Na+ \<130 mmol/L, alanine (ALT) or aspartate (AST) transaminases \>2.0 times the upper limit of normal, white blood cell count (WBC) \<2,500 cells/mm3)
* Previous participation in any study with eslicarbazepine acetate
* Pregnancy or breast feeding
* History of hypersensitivity to the investigational products or to drugs with a similar chemical structure
* History of non-compliance
* Likelihood of requiring treatment during the study period with drugs or other interventions not permitted by the clinical study protocol.
* Participation in a clinical study within 3 months prior to screening
* Any clinically significant concomitant condition, which might influence the assessments or conduct of the trial
Tracheal Tube Cuff Shape and Pressure

This is a randomized controlled trial focusing on the effect of different tracheal tube cuff shape; the tapered-shaped tracheal tube cuff versus the cylindrical-shaped tracheal cuff in anterior cervical spine surgery.

High endotracheal cuff pressure (ETCP) during surgical retractor splay associates with recurrent laryngeal nerve paresis/ palsy and results in post-anterior cervical spine surgery (post-ACSS) dysphonia. Control of intraoperative ETCP during ACSS may benefit voice outcome. The taper-shaped tracheal tube cuff was originally designed as a new strategy to reduce fluid leakage across the conventional cylindrical cuff and prevention of ventilator associated pneumonia. Literature has revealed the just seal pressure for the tapered-shaped tracheal tube (TT) cuff was lower than conventional cylindrical cuff. Therefore the investigators hypothesize that use of a tapered-shaped ET cuff during the surgery can lead to a lower ETCP during retractors splay and improve voice recovery after ACSS. In this study, 80 patients were randomized into 2 groups, to receive endotracheal intubation using TaperGuard tracheal tube (tapered- shaped cuff) or a conventional tracheal tube (a cylindrical cuff). The just seal pressure, intraoperative cuff pressure, and postoperative sore throat and voice outcome are recorded and compared.

Eligibility Criteria:
Inclusion Criteria:

* Receiving elective anterior cervical spine surgery
* Right side approach

Exclusion Criteria:

* Unstable cervical spine (acute trauma history, or dislocation/ subluxation in image studies)
* Anticipated difficult airway
* Facial anomaly that may hinder facemask ventilation
* Preoperative hoarseness or vocal cord palsy regardless of etiology
* Re-operation of cervical spine surgery or left side approach
* BMI \>35
* Operation field involved cervical spine C1 or C2
* Unwilling to sign the informed consent
* Unwilling to finish the study
Phase II Study of Therapy With PS 341 in Patients With Advanced Stage Non Small Cell Lung Cancer

The purpose of this study is to develop new treatments that will hopefully result in the relief of symptoms and prolongation of life. For this reason, your doctors have offered you treatment with a new experimental drug called PS 341.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have confirmed NSCLC (squamous, adeno- and large cell anaplastic carcinoma)stage III B or Stage IV.

No prior chemotherapy regimen Patients must have adequate organ and marrow function

Exclusion Criteria:

* Untreated symptomatic brain metastasis Patients with known HIV positivity
Influence of OATP1B1 and CYP2C9 Genotypes on the Pharmacokinetics of Bosentan Before and During Clarithromycin

The aim of the present study is to assess the impact of the OATP1B1 genotype (SLCO1B1\*15 vs. wild type; \~2% SLCO1B1\*15 haplotypes in Caucasian population) and the CYP2C9 genotype (\*2 and \*3 allele vs. wild type; \~5% poor metabolisers in Caucasian population) on the pharmacokinetics of bosentan and the impact of CYP3A4-inhibition by clarithromycin on steady state bosentan which is a CYP3A4 inducer itself.

This study will focus on differential effects of genotypes and co-medication on the pharmacokinetics of bosentan at the metabolic and transport level. Participants will be genotyped for CYP2C9 (inclusion criterion), OATP1B1 (inclusion criterion), and CYP3A5 (no inclusion criterion).


Eligibility Criteria:
Inclusion Criteria:

* Good state of health (physically and mentally)
* Able to communicate well with the investigator, to understand and comply with the requirements of the study
* Voluntarily signed informed consent after full explanation of the study to the participant.
* No clinically relevant findings in any of the investigations of the pre-study examination, especially aminotransferase elevations ≥ 3 × ULN. Minor deviations of other laboratory values from normal range may be acceptable, if judged by the investigator to be of no clinical relevance.
* Known genotype for CYP2C9 and OATP1B1 polymorphism.
* Agreement to abstain from alcoholic beverages during the time of the study.
* Females must agree to use a reliable contraception (Pearl Index \<1%), e.g. double barrier method.

Exclusion Criteria:

* Any regular drug treatment within the last two months, except for oral contraceptives in female volunteers and L-thyroxine.
* Any intake of a substance known to induce or inhibit drug metabolising enzymes or drug transporters within a period of less than 10 times the respective elimination half-life or 2 weeks, whatever is longer
* Any participation in a clinical trial within the last month before inclusion
* Any physical disorder which could interfere with the participant's safety during the clinical trial or with the study objectives
* Any acute or chronic illness, or clinically relevant findings in the pre-study examination, especially: a) any condition, which could modify absorption, distribution, metabolism, or excretion of the drug regimen under investigation b) Allergies (except for mild forms of hay fever) or history of hypersensitivity reactions
* Regular smoking
* Blood donation within 6 weeks before first study day
* Excessive alcohol drinking (more than approximately 20 g alcohol per day)
* Inability to communicate well with the investigator due to language problems or poor mental development
* Inability or unwillingness to give written informed consent
* Known or planned pregnancy or breast feeding
* Pre-existing moderate or severe liver impairment
Use of Bevacizumab to Modulate the Outcomes of Trabeculectomy Surgery

Vascular epithelial growth factor (VEGF) plays a critical role in vessel growth and wound healing. Bevacizumab, a non specific VEGF inhibitor, has been successfully used for the treatment of eye diseases associated with neovascularization. The purpose of this randomized study is 1) to investigate the effects of intraoperative subtenon injection of bevacizumab on the outcomes of trabeculectomy surgery. 2) to measure plasma and aqueous levels of VEGF and assess its association with the outcomes of trabeculectomy surgery. Trabeculectomy surgery, where a small drainage canal is created at the front of the eye, is the most common glaucoma surgery performed worldwide. The goal of the surgery is to control intraocular pressure. Failure of this procedure is most commonly caused by excessive scarring of the surgical site. If scarring occurs, the drainage canal can close. By adding Bevacizumab at the time of surgery, wound healing may be slowed and surgical failure prevented.

The results of this study will be helpful in the future development of new more effective and safe surgical techniques for treatment of glaucoma.

Patients who have given informed consent are randomized into two groups. One group receives standard of care for trabeculectomy surgery and the other group receives standard of care plus an injection of Bevacizumab at the surgery site. Both groups have a one time collection of ocular fluid and a blood sample taken from a vein in the arm. After surgery, patients are seen by their study doctor six times in the following year. At these visits measurements are taken of their visual acuity, eye pressure and blood pressure. The doctor does a clinical exam and at months six and twelve photographs of the patients' eye are taken.


Eligibility Criteria:
Inclusion Criteria:

* any type of glaucoma, except neovascular or inflammatory
* patients requiring trabeculectomy or combined cataract surgery with trabeculectomy surgery

Exclusion Criteria:

* younger than 30 years of age
* previous ocular surgeries excepting cataract surgeries
* patients who have had or present with intraocular inflammation
* neovascular glaucoma
* patients who are aphakic
* diabetic retinopathy
The Effect of Selective Serotonin Reuptake Inhibitor (SSRI) Treatment on Affective Symptoms and Fertility Treatment Outcome in Women Undergoing in Vitro Fertilization (IVF)

Women undergoing IVF show a high prevalence of depressive and anxiety symptoms. Furthermore, stress has harmful consequences on IVF and pregnancy outcomes. An immunological cascade was suggested to be involved in the process. Treatment in this setting is usually psychotherapy rather than pharmacotherapy, despite reasonable biological evidence suggesting beneficial influence of antidepressant therapy on pregnancy and well-being. Moreover, pharmacotherapy is more available and affordable than psychotherapy in the public health system. The investigators suggest to study the efficacy of antidepressant treatment in women undergoing IVF treatment, presenting with mild mood symptoms. The investigators hypothesize that treatment will result in a greater attenuation of affective symptoms, as well as in higher pregnancy success rates. Furthermore, certain immunological stress-reactive factors, may prove to be the biological mechanism underlying these effects.


Eligibility Criteria:
Inclusion Criteria:

1. Women 18 - 45 y.o.
2. A score higher then 45 on the Zung Self-Rating Anxiety Scale or a score higher then 16 on the Center for Epidemiologic Studies Depression Scale
3. Understanding of Hebrew
4. Willing to sign the informed consent

Exclusion Criteria:

1. An axis I DSM IVTR diagnosis other then a depressive, adjustment or anxiety disorder
2. Suicidal ideation
3. Current treatment with antidepressant medication
4. Physical illness explaining depressive symptoms (e.g. hypothyroidism, neurological disease, severe anemia, renal failure etc.)
5. Alcoholism or drug abuse and dependence
6. Past severe side effects to SSRIs
7. Failed IVF (4 trials of good quality embryo reinstatement without achieving pregnancy)
The Effect of a Mindfulness-Based Stress Reduction Program in Patients With Multiple Sclerosis

The aim of this study is to investigate the effect of an mindfulness-based stress reduction (MBSR) program designed in accordance with the literature and the basic principles of the program on fatigue, self-efficacy and stress for individuals with multiple sclerosis (MS).

Thirty members of the Multiple Sclerosis Society with multiple sclerosis were randomized as experimental and control groups. Participants in the experimental group received an 8-week MBSR program by an MBSR instructor. The patients in the control group continued to visit the society for their scheduled examinations and controls; no intervention was given to them. Outcome measurements consisted of Fatigue Impact Scale (FIS), Self-Efficacy Scale and Perceived Stress Scale.

The use of mindfulness-based interventions to reduce fatigue in individuals with MS is supported by meta-analytic evidence. A systematic review concluded that mindfulness-based interventions effectively improves the quality of life in MS patients. To characterize the best formatting, mechanisms of action, and outcomes in MS patients with a wider range of social, educational, and clinical backgrounds, more research is necessary.

Participants in the experimental group received an 8-week MBSR program by an MBSR instructor. Each meeting were planned as a 3-hour session that completes the mindfulness training procedures by doing an opening meditation of 30- 45 minutes about that week, after the information about the meeting topic of the week is discussed. Experiences after meditation were shared with the group. Each week, the meeting topic and meditation continued with different contents, and practice meditations on the subject were held every week and home exercises were given. Home practice meditations were performed by listening to the guide audio recording with headphones. All home exercises in the training content were followed up on a daily basis and recorded.

The patients in the control group continued to visit the society for their scheduled examinations and controls; no intervention was given to them. Furthermore, the control group received an invitation to participate in an identical MBSR program session following the study's conclusion.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of relapsing-remitting MS or progressive MS
* over 18 years of age,
* neurologist confirmed diagnosis of MS,
* a score of less than or equal to 7.0 on the Expanded Disability Status Scale (EDSS).

Exclusion Criteria:

* comorbidities with life-threatening physical or mental health (such as active psychosis, suicidal ideation, or terminal or life-threatening co-occurring medical diseases), or disorders that are predicted to severely restrict participation and adherence (e.g., dementia, pregnancy, ongoing substance abuse);
* individuals who are presently undergoing non-pharmacological psychological treatments or prior formal training in mindfulness