cyrilzakka/clinical-trials huggingface dataset:
Vorinostat (MK-0683, SAHA [Suberoylanilide Hydroxamic Acid]) + Lenalidomide + Dexamethasone in Multiple Myeloma (MM) (MK-0683-074)

The purpose of this Phase I study of vorinostat in combination with lenalidomide and dexamethasone in participants with relapsed or refractory multiple myeloma is to determine the maximum tolerated dose (MTD) as estimated by the incidence of dose-limiting toxicities (DLTs) and recommended Phase 2 dose (RP2D) as estimated by the incidence of drug-related adverse events (AEs).


Eligibility Criteria:
Inclusion Criteria:

* Is a male or female at least 18 years old
* Has relapsed or refractory MM and has had at least one prior therapy
* Female participants of childbearing potential must have 2 negative serum pregnancy tests prior to receiving the first dose of study drugs
* Female participants who can become pregnant must agree to use 2 separate forms of effective birth control at the same time, 4 weeks before, while taking, and for 4 weeks after stopping lenalidomide; post menopausal participants should be free from menses for \>2 years, or are surgically sterilized
* Male participant agrees to use an adequate method of contraception for the duration of the study, even if the participant has undergone a successful vasectomy
* Male participants must agree to use a latex condom during sexual contact with a pregnant female or a female who can become pregnant; this is required for the duration of the study, and for 4 weeks after stopping therapy
* Has at least 3 weeks washout prior to treatment
* Is able to swallow capsules and is able to take or tolerate oral medications on a continuous basis

Exclusion Criteria:

* Has prior treatment with a histone deacetylase (HDAC) inhibitor
* Has prior allogenetic bone marrow transplant
* Has received intravenous antibiotics, antiviral, or antifungal agents within 2 weeks prior to the start of the study drug
* Uses illicit drugs, substance abuse or had a recent history (within the last year) of drug or alcohol abuse
* Is pregnant or breast feeding or expecting to have a baby during the course of the study
* Has human immunodeficiency virus (HIV) infection
* Has Hepatitis B/C infection
* Is currently receiving treatment for another type of cancer other than skin or cervical cancer that has not been in remission for 5 years or longer
Effects of HIA and PCE in Primary Dysmenorrhea

The main purpose of study is to manage the unpleasant pain suffered by females during Mensturation. The aim of this study is to guide physiotherapist that how to apply these exercises to manage dysmenorrhea.

There are less research on effectiveness of pelvic clock exercises in dysmenorrhea they are very less evidence and less documented in literature.. Although there are many researches on high intensity aerobics.Previous researches only have lierature about aerobics.So to address this literature gap, conduct a prospective randomized controlled trial to investigate the effects of high intensity aerobics and pelvic clock exercises in primary dysmenorrhea.

Eligibility Criteria:
Inclusion Criteria:

* Girls aged 17-23 years with regular menstrual cycle
* Unmarried girls

Exclusion Criteria:

* Athletes, Married women,
* Girls who were regularly exercising
* Having any pelvic pathology, abnormal menstrual cycle.
Botox on Vulvar Vestibulitis

The study seeks to evaluate the effect of botulinum toxin on vulvar vestibulitis (VVS) after local injection with Botox, a potential treatment to relieve patients of vulvar pain, reducing the need for painkillers, and improving the sexual quality of life of the patients.

Vulvar vestibulitis (VVS) is characterized by pain confined to the vulvar vestibule that occurs upon touch and attempted introitus entry ( e.g. intercourse, tampon insertion), with minimal associated clinical findings.

The aetiology of VVS is not well established and many variables have been associated with the condition, e.g. neuropathy secondary to inflammation.

Injection of Botulinum Toxin is tested as a therapeutic option for this condition.

A temporary paralytic effect on the surrounding skeletal muscle hypertonicity is seen and earlier in cases described as a successful treatment of pelvic floor dysfunction, dyspareunia and interstitial cystitis.

Eligibility Criteria:
Inclusion Criteria:

* Vulvar vestibulitis
* Safe birth control

Exclusion Criteria:

* Treated earlier with Botulinum toxin
* Ongoing vulvar infection
* Age\<18
* Skin disease
* Pregnancy
* Myasthenia gravis
* Amyotrophic lateral sclerosis (ALS)
* Diabetes
* Using:

  * Calcium antagonists;
  * Aminoglycosides;
  * Magnesium sulfate;
  * Systemic steroid treatment
Psychological Predictors in Colorectal Cancer Surgery Recovery

This is an observation pilot trial aimed to study to the association between mindfulness and other psychological factors, including both protective and risk factors, with recovery of functional ability following colorectal cancer surgery.

Preliminary evidence suggests that there are multiple variables that may influence the functional recovery following colorectal cancer surgery, some of which deal with the psychological domain. Distress and depression can negatively affect the perceptions of functional ability, while resilience and effective coping styles promote a better psychological adaptation to challenging situations. Furthermore, psychosocial prehabilitation and interventions have been proposed as a feasible and cost-effective way to positively influence the recovery after surgery in association with the Enhanced Recovery After Surgery (ERAS) protocol.

In particular, mindfulness is proved to be associated with higher quality of life in different medical conditions, including oncological patients and has been also associated with improved clinical outcomes.

The aim of the study is to investigate the association of mindfulness and other psychological predictors with functional and quality of life outcomes in patients undergoing colorectal surgery for oncological condition.

Eligibility Criteria:
Inclusion Criteria:

* Patients \> 18 years old (both males and females).
* Patients diagnosed with colorectal cancer.
* Patients scheduled for elective open or laparoscopic surgery for curative intent.

Exclusion Criteria:

* Patients unable to give the written informed consent.
* Patients \< 18 years old.
* Patients undergoing surgery in emergency setting.
* Patients with pre-operative evidence of metastatic cancer or colorectal cancer recurrence.
* Pregnant or breastfeeding patients.
* Any condition that, in the opinion of the investigator, can interfere with the study protocol (e.g. neuropsychiatric disorders or dementia).
Study of NGM831 as Monotherapy and in Combination With Pembrolizumab or Pembrolizumab and NGM438 in Advanced or Metastatic Solid Tumors

Study of NGM831 as Monotherapy and in Combination with Pembrolizumab or Pembrolizumab and NGM438 in Advanced or Metastatic Solid Tumors


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically documented locally advanced or metastatic solid tumor malignancy.
* Adequate bone marrow, kidney and liver function
* Performance status of 0 or 1.
* Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade 1 except for AEs not constituting a safety risk by Investigator judgement.

Exclusion Criteria:

* Prior treatment targeting ILT3.
* Prior treatment targeting LAIR1.
The Effect of Electrotherapy on Young Individuals with Neck Pain

The aim of this clinical study was to investigate the effects of different electrotherapy interventions on pain and hand function in young individuals with neck pain.

The main question that the study aimed to answer is: are two different electrotherapy interventions superior to each other for pain and hand function? Participants will be assigned to either transcutaneous electrical nerve stimulation, high-voltage pulsed galvanic stimulation, or placebo. Participants will receive a total of 20 sessions of electrotherapy intervention, 20 minutes per day, 3 days a week. Participants will be evaluated before the intervention, after 1 session, and 1 week after the completion of the 20-session intervention.


Eligibility Criteria:
Inclusion Criteria:

* Being between 18-30 years old
* Complaining of neck pain
* Volunteering to participate in the study

Exclusion Criteria:

* Having received any anti-inflammatory treatment in the last 3 months
* Having received any physical therapy and rehabilitation treatment in the last 3 months
* Doing regular exercise
* Not attending work sessions
Long-Term Follow-Up Gene Therapy Study for Leber Congenital Amaurosis OPTIRPE65 (Retinal Dystrophy Associated With Defects in RPE65)

This study is a longer-term follow-up study for patients who have been administered AAV2/5-OPTIRPE65 in the Phase I/II, open label, non-randomised, two-centre, dose escalation trial in adults and children with retinal dystrophy associated with defects in RPE65.

The follow up study is designed to collect data on longer-term safety and efficacy of AAV2/5-OPTIRPE65 administration in the OPTIRPE65 trial.

Eligibility Criteria:
Inclusion Criteria:

* Were enrolled and treated in the prior open-label, Phase I/II, dose escalation study involving intraocular administration of AAV2/5-OPTIRPE65

Exclusion Criteria:

* Individuals will be excluded if they are unwilling or unable to meet with the requirements of the study.
A Safety Study of Intravenous Immunoglobulin in Patients With Chronic Immune Thrombocytopenic Purpura (ITP)

It is known that intravenous immunoglobulins can induce hemolysis, but the mechanism is not known in detail. The primary objective of this study was to investigate the specificity of antigens on red blood cells in patients with chronic immune thrombocytopenic purpura (ITP) who have shown signs of clinically relevant hemolysis following treatment with the intravenous immunoglobin Privigen®. The study was to explore potential mechanisms of hemolysis by analysis of the specificity of the antibodies possibly involved. To distinguish between clinically non-relevant hemolysis and a relevant intravascular hemolysis, an independent adjudication by a committee was performed for each patient with signs of hemolysis determined in the laboratory or in the clinic.

This study was requested as a post-marketing commitment study by the United States Food and Drug Administration (FDA). By September 2014, no case of clinically significant intravascular hemolysis was found, and the FDA agreed to halt the study and analyze all hemolysis-relevant endpoints using FDA criteria for hemolysis in addition to analyses planned in the protocol. The study was not restarted.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of chronic ITP
* Age of 18 to 65 years
* Platelet count of ≤ 30 x 10\^9/L at screening

Exclusion Criteria:

* Planned splenectomy throughout the study period
* Treatment with immunoglobulin G for intravenous administration (IVIG) or anti-D immunoglobulin within 3 weeks prior to screening
* Use of drugs that have any pharmacological effect on the blood clotting system within 3 weeks prior to screening
* Known allergy or other severe reactions to blood products including intolerability to previous IVIG
* Known hyperprolinemia
* Red blood cell transfusion or erythropoietin treatment within the last 14 days
Mesenchymal Stem Cells in the Treatment of Relapsed/Refractory Severe Acquired Aplastic Anemia

Mesenchymal stem cells have been tested in many autoimmune disorders with encouraging results and may be an alternative to the treatment of immune-mediated severe acquired aplastic anemia.

Acquired aplastic anemia is a bone marrow failure syndrome characterized by and empty bone marrow and low blood counts. Most of the cases are immune-mediated. Allogeneic bone marrow transplant is the preferable treatment modality for patients younger than 40 years with a matched sibling donor. Patients not eligible for transplant are treated with intensive immunosuppressive therapy often based on anti-thymocyte globulin and cyclosporine.

However, up to one third of patients treated with immunosuppression are refractory and one third of those who response eventually relapse. Refractory and relapsed cases may be the result of insufficient immunosuppression and these cases may benefit from additional immunosuppression. Mesenchymal stem cells infusion may be a potential treatment option, considering its properties to modulate the immune system.

Refractory or relapsed patients with aplastic anemia will be treated with conventional immunosuppressive regimen (anti-thymocyte globulin plus cyclosporine) combined with intravenous infusion of allogeneic unrelated bone marrow mesenchymal stem cells.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Acquired Aplastic Anemia
* Relapse/refractory to at least 1 immunosuppressive first line treatment
* Not eligible to allogeneic bone marrow transplantation

Exclusion Criteria:

* Previous or current malignancy
* Active or latent infectious disease
* Positive serologic tests for HIV, HCV, HBV, HTLV-1 and 2, Syphilis or Chagas disease
* Previous drug reaction for antithymocyte globulin, cyclosporin or corticosteroids
* Severe organic impairment (renal, hepatic, cardiac, pulmonary)
* Uncontrolled hypertension or diabetes
* Pregnancy
* Previous history of allergic reaction to penicillin or streptomycin
* Severe psychiatric disorder
A Retrospective, Observational Study to Collect Clinical Safety and Performance Data of POLYMAILLE® EXTRA THIN Vascular Prothesis

The purpose of this PMCF study is to evaluate a minimum of 125 subjects in 1 or 2 sites in France at least 1-year follow-up after surgery until a maximum of 5 years in the indication of abdominal and peripheral arterial surgery not crossing the knee flexion crease.

the objectives of the evaluation will describe safety and performance of POLYMAILLE® EXTRA THIN.


Eligibility Criteria:
Inclusion Criteria:

* Patients must meet all the following inclusion criteria in order to be eligible for inclusion in the study:

Patient has a minimum of 1-year post-operative follow-up data available, or complete data to death

Exclusion Criteria:

* Patients who refused the collection of their personal data.
Influence of an Innovative Telemetric Smartphone Application on Re-hospitalization

A randomized, open, mono-centric pilot study to investigate the influence of an innovative telemetric smartphone application on re-hospitalization and quality of life after cryoballoon pulmonary vein isolation in patients with paroxysmal atrial fibrillation.

The telemetric smartphone application includes a digitized medical record, a mobile ECG device and a 24-hour on call service by a cardiologist. The hypothesis is that the use of a telemetric smartphone application can reduce re-hospitalization in patients after cryoballoon pulmonary vein isolation. Secondary endpoints are quality of life measurements, health care cost calculations and recurrences of atrial fibrillation after ablation. All patients will undergo ablation and will be randomized into two groups: 1) conventional follow up with outpatient visits 6 and 12 months after ablation compared to 2) a structured follow up with the smartphone application, a mobile ECG device (patients will be able to send in as many ECGs as wanted), up to three phone calls with a cardiologist (24-hour on call service) as well as outpatient visits 6 and 12 months after cryo-ablation.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Written informed consent
* symptomatic paroxysmal atrial fibrillation (at least two episodes within 3 months prior to ablation)
* cryoballoon pulmonary vein isolation
* possession of a compatible smartphone

Exclusion Criteria:

* Age \< 18 years
* persistent or permanent atrial fibrillation (AF)
* prior catheter or surgical ablation of AF
* pregnant females
* contraindication for oral anticoagulation
* manifest hyper-/hypothyroidism
* no intention to cooperate
* alcoholism
Sonu Nasal Congestion Relief Study in Patients Suffering From Moderate to Severe Nasal Congestion

To demonstrate the safety and effectiveness of Sonu for the treatment of patients suffering from moderate to severe nasal congestion.

Sonu consists of and acoustic vibrational headband worn circumferentially at the level of the forehead. A smart phone App, paired to the headband, delivers acoustic resonant frequencies of the subject's nasal cavity through the headband and provides relief. Sonu is intended to be used for the treatment of moderate to severe nasal congestion due to rhinitis.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age and older
* Present with symptoms of nasal congestion for 1 month or more prior to treatment
* Have a 24 hour reflective nasal congestion subscore of the TNSS of 2 or more on a 0 to 3 scale at the time of screening

Exclusion Criteria:

* Head, nasal or sinus surgery within 3 months
* Sinus infection diagnosed within the last month, or rhinitis medicamentosa
* Documented history of nasal polyposis or mass
Core Temperature in Patients With OHCA

A prospective observational study aiming to monitor core temperature via an esophageal probe in out of hospital cardiac arrest during transport and until arrival in hospital. Insertion of an esophageal temperature probe will be done on scene during ongoing resuscitation manoeuvres based on European Resuscitation Council Guidelines 2015 (or newer). Environmental temperature influence and hypothermia prevention interventions will be monitored.

Prospective observational study to evaluate the body temperature difference in patients in out of hospital cardiac arrest on site and at arrival at the hospital.

If the patient fulfills the inclusion criteria and after establishment of CPR measures according the ERC resuscitation guidelines (2015 or newer) an esophageal probe will be inserted and bodytemperature is measured; on site ambiental temperature will also be measured. Weather conditions, altitude on site, activity of the patient and hypothermia protection (eg. clothes) will bei documented. On arrival in hospital the body temperature will be measured with the esophageal probe;

Eligibility Criteria:
Inclusion Criteria:

* Out of hospital cardiac arrest
* Patients transferred to hospital
* \> 18 years

Exclusion Criteria:

* Obvious signs of death
* Obvious lethal injury/injuries incompatible with life
* Confirmation of death on scene
* \< 18 years
Technology Enhanced Nurse Navigator Trial (TENN Trial)

The purpose of the Technology Enhanced Nurse Navigator Trial (TENN) Trial is to find the best way to provide breast cancer patients with information through a computer connected to the internet. The study will determine if giving information during treatment may help patients cope better with their treatment. The hypothesis is that participants assigned to receive Technology-Enhanced Nurse-directed Navigation will be more likely to adhere to treatment regimens and have improved symptom management than women who have access to the education portal only.

Treatment for breast cancer has been proven to decrease death from breast cancer. The key to the success of treatment is getting the right dose at the right time, but many women do not receive optimum treatment. Treatment delays, missed appointments, and failure to take medication on a regular basis lead to poorer survival from breast cancer. In a study among low income women only 60% of women adhered to the treatment, that is, taking their medication at least 80% of the time. Twenty percent of women, who were supposed to take 5 years of hormone treatment, had stopped their medication in the first year. Similar problems occur with chemotherapy and radiation therapy. Many barriers interfere with adherence to treatment, including poor symptom management, missed appointments, and cancelled appointments. Nurse navigation can help manage and minimize symptoms, assist with appointment reminders, and answer questions to obtain optimum breast cancer treatment. The goal of the proposed study is to rigorously test the delivery of nurse-navigation through a web-based knowledge and communication portal (Technology Enhanced Nurse-directed Navigation (TENN) for its impact on treatment adherence and symptom management. The success of this program will be measured by improved treatment adherence, health outcome measures such as fatigue and symptom management, patient-reported quality of life, reduced distress, and patient satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* Enrolled in the BCCDT program for the adjuvant treatment of breast cancer,currently on medical assistance,or with an income that does not exceed 300% of the Federal Poverty Level, based on family size.
* English-speaking
* Able to give informed consent
* Not enrolled in another case-management program
* Residing within the Verizon 3G Coverage area

Exclusion Criteria:

* Non-English speaking
* Enrolled in a case management program.
* Unable to sign an informed consent
Study of DCR-A1AT in Healthy Adult Volunteers

This is a research study to test an experimental study drug (belcesiran, also known as DCR-A1AT). This drug is being tested to see if it helps people with a rare condition known as Alpha-1 Antitrypsin Deficiency, or A1ATD. Prior to initiation of this study belcesiran had not yet been tested in humans. All study participants will be randomly assigned to either receive the study drug or a placebo. This will allow for the sponsor to compare the effects of the study drug with that of the placebo. A placebo looks like the study drug but does not contain any of the study drug.

The main purpose of the first part of the study is to evaluate the safety profile of the study drug in people who do not have A1ATD. This part of the study will also help find the dose of the study drug that has an acceptable safety profile for testing.

A1ATD- associated liver disease is a progressive Alpha-1 Antitrypsin-Deficiency Associated Liver Disease condition resulting in liver fibrosis, cirrhosis, and hepatocellular carcinoma. The lack of functional A1AT in individuals with PiZZ genotype, in conjunction with other precipitating factors, can lead to unchecked activity in neutrophil elastases in the alveoli; causing emphysema and chronic obstructive pulmonary disease (COPD). This loss-of-function mechanism can be addressed with intravenous augmentation therapy, which aims to substitute the missing A1AT by infusing alpha1 proteinase inhibitor (A1PI), purified from pooled human plasma.

While augmentation therapy can address the loss of A1AT in the lungs, no treatment exists for the associated liver disease.

Given the severity of the disease, with approximately 10% of affected patients developing liver cirrhosis and a subgroup of those patients in need of liver transplantation, and lack of an effective treatment that addresses the toxic hepatic "gain-of-function" mechanism, there is an urgent unmet medical need to develop a therapy that can help in this particular patient population.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female aged 18 to 55 years, inclusive. Female participants must be either surgically sterile or postmenopausal. No women of childbearing potential are eligible for enrollment.
* Overtly Healthy, as determined by the investigator.
* Serum A1AT protein concentration \>100 mg/dL
* Adequate forced expiratory volume in one second (FEV1) and adequate FEV1/forced vital capacity (FVC) ratio
* Non-smokers with a \<2 pack-year history and smoking cessation for at least 6 months with a negative urinary cotinine test a screening

Exclusion Criteria:

* Presence of any condition or comorbidities that would interfere with study compliance or data interpretation or potentially affect participant safety
* Clinically significant abnormal laboratory tests
* Received an experimental drug within past 4 months
* Prior to use of RNAi drug or oligonucleotide-based therapy
* Known human immunodeficiency virus (HIV), hepatitis C virus (HCV), or Hepatitis B (HBV)
* Serum creatinine or estimated glomerular filtration rate (eGFR) outside normal reference ranges.