cyrilzakka/clinical-trials huggingface dataset:
Transplant and Addiction Project (TAP) - 1

The purpose of this study is to test a novel distance-based (telephone) intervention to help transplant candidates with current or recent substance abuse to stay "clean and sober" both prior and following transplant surgery.

Participants who need a liver or renal transplant and who are ineligible due to current or recent (past 6 months) alcohol and/or other drug abuse are being recruited from the transplant programs at St. Luke's-Roosevelt Hospital Center (renal), Columbia Presbyterian Hospital (renal/liver) and Virginia Commonwealth University Medical Center (liver). Baseline and follow-up computer-assisted assessments and structured clinical interviews along with collection of biological samples (urine, hair) will occur in the transplant clinics; however, phone counseling sessions originate at St. Luke's. Participants are randomly assigned to one of two treatments: (1) usual care (no phone counseling) or (2) usual care + counseling. The telephone counseling sessions are designed to help participants become motivated to remain abstinent and improve other health behaviors such as sleep or stress management.

Eligibility Criteria:
Inclusion Criteria:

* End stage liver or renal disease
* Having used drugs or alcohol during the past 6 months
* Turned down for transplant due to current or recent substance use
* Access to telephone

Exclusion Criteria:

* Psychotic or other unstable serious psychiatric disorders that preclude full, active participation
* Moderate to severe hepatic encephalopathy
* Non-English speaking
Efficacy Study of Dietary Intervention and Weight Loss in Improving Psoriasis

This is a multicenter randomized controlled clinical trial evaluating the impact of a structured non pharmacological intervention consisting in intensive weight reduction (qualitative and quantitative changes in diet associated with physical exercise) compared to an intervention based on a simple informative counseling about the utility of weight loss for clinical control of psoriatic disease.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of chronic plaque psoriasis
* BMI \> 25 Kg/m²
* Patients under systemic treatments for psoriasis or candidates for such treatments

Exclusion Criteria:

* Diagnosis of other type of psoriasis or psoriatic arthritis
* Patients under local treatments or candidates for such treatments
* Patients expected to have poor compliance at follow-up evaluation
Endoscopic eTEP Versus Open Rives-Stoppa

Observational cohort study (partially retrospective, partially prospective) comparing the endoscopic extended totally extraperitoneal prosthesis (eTEP) repair for midline abdominal hernias to open Rives-Stoppa repair (control).

See included study protocol. Included patients will be registered to the European Hernia Society (EHS) registry.

Eligibility Criteria:
Inclusion Criteria:

Group 1 (eTEP):

* Participants who underwent an eTEP procedure in the investigators' center
* Preoperative existence of one or more midline abdominal wall hernias
* Preoperative existence of rectus abdominis diastasis

Group 2 (Rives-Stoppa, control group):

- Participants who underwent an open Rives-Stoppa (midline repair with sublay mesh) in the investigators' center

Exclusion Criteria:

Group 1 (eTEP):

* Preoperative absence of midline abdominal wall hernias
* Preoperative absence of rectus abdominis diastasis
* Intraoperative performance of transverse abdominis release (TAR)
* Intraoperative inguinal hernia repair

Group 2 (Rives-Stoppa, control group):

* Intraoperative performance of transverse abdominis release (TAR)
* Intraoperative performance of anterior component separation
* Intraoperative inguinal hernia repair
Pelvic Floor Muscle Training in the Treatment of Erectile Dysfunction

Erectile dysfunction affects about 40% of all men above the age of 40 and the prevalence increases with increasing age. It is not possible to cure the condition as current forms of treatment are aimed solely at improving symptoms. Treatment options today include medications, injection therapy, and vacuum pumps, among others. However, pelvic floor muscle training is a natural, inexpensive, and non-invasive form of treatment that is used to a limited extent.

Theoretically, a strengthening of the pelvic floor muscles can help increase the intracavernous pressure and thereby the hardness of the erection. Furthermore, tense pelvic floor muscles can help compress pelvic veins and reduce blood flow away from the penis which prolongs the erection. Finally, it is possible that pelvic floor muscle training can contribute to an increased blood supply to the pelvic floor and the penis which will have positive effects in relation to both the integrity of the penile tissue and the physiological erection mechanism itself.

This study aims to investigate the effect of pelvic floor muscle training in men with erectile dysfunction.

The study hypothesis is that pelvic floor training can provide a clinically significant improvement in the erection function at individual patient level


Eligibility Criteria:
Inclusion Criteria:

* Erectile Dysfunction for more than 6 months
* IIEF-EF score \< 25
* In a stable heterosexual relationship in minimum of 3 months (since all questionnaires are only validated for heterosexuals)

Exclusion Criteria:

* Known psychiatric, neurological, and/or endocrine disorders (including hypogonadism with total testosterone \<12 nmol / l)
* Traumatic nerve damage
* Diabetes
* Previous surgery or radiotherapy in the pelvic region
* Nerve disorders that prevent nerve connection to the pelvic floor muscles
* Severe heart disease in the form of unstable angina, NYHA class \> II heart failure, uncontrolled arrhythmia or severe symptomatic and/or severe valvular disease
* Use of anti-androgen drugs Peyronie's disease and/or previous cases of priapism
* Alcohol overconsumption (more than 21 items per week)
Effects of Whole Grain Rye on Metabolic Risk Markers and Mood

The purpose of the study is to investigate, in healthy middle age subjects, effects of whole grain rye on cognitive functions, mood, and cardiovasculair risk markers


Eligibility Criteria:
Inclusion Criteria:

* healthy
* BMI 19-28
* plasma glucose \< 6.1 mmol/L
* non smooker

Exclusion Criteria:

* known metabolic diseases
* known gastrointestinal disorders
* known cognitive decline.
The Laparoscopic Right Colectomy With Intracoroporeal Anastomosis

This is a randomized, controlled, "non-inferiority" trial to determine the non-difference in post-operative complications rate in laparoscopic right colectomy with intracorporeal or extracorporeal anastomosis formation.

The design involves random allocation of eligible patients to laparosopic colectomy with intracorporeal or extracorporeal anastomosis.

Postoperative complications in both groups will be recorded in accordance with the Clavien-Dindo classification. The level of postoperative pain will be registred according to the visual analogue pain scale (VAS). Also the investigators will study the time of activation of patients, patient self-care scope according to the Bartell scale, postoperative hospital stay will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Patients age is 18 years and older
* Patients with right colon cancer
* Informed agreement

Exclusion Criteria:

* Carcinomatosis
* Primary tumor stage T4b
* Refusal of anastomosis
* Refusal of the patient to participate in the study
Eicosapentaenoic Acid (EPA) for Treatment of Colorectal Cancer Liver Metastases

Eicosapentaenoic acid (EPA) is a naturally occuring omega-3 polyunsaturated fatty acid found in oily fish. EPA has anti-colorectal (bowel) cancer activity in experimental models. This trial will test whether EPA reduces markers of tumour growth, and is safe and well tolerated,in patients with colorectal cancer liver metastases awaiting surgery.

A double-blind, randomised, placebo-controlled trial of eicosapentaenoic acid (EPA), in the free fatty acid form, 2g daily in patients who will undergo liver resection surgery for colorectal cancer liver metastases.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 18 years
* Either sex
* Liver resection deemed clinically appropriate for management of metastatic colorectal cancer
* Duration between decision to perform liver resection and surgery greater than 2 weeks
* Ability to give written informed consent and follow study protocol
* Telephone contact possible

Exclusion Criteria:

* Neo-adjuvant chemotherapy for colorectal cancer (CRC) liver metastasis
* Chemotherapy for any cancer in the previous 3 months
* Known bleeding diathesis or anticoagulation therapy
* Fish or seafood allergy
* Use of fish oil supplements (eg. cod liver oil) and unwilling to stop for the duration of the study
* Pregnancy
* Non-aspirin non-steroidal anti-inflammatory (NSAID) or corticosteroid use
* Renal impairment (serum creatinine \>150)
* Active inflammatory disease (e.g. Inflammatory Bowel Disease, Rheumatoid Arthritis).
Acute Tear Production Following Single Use of the Oculeve Intranasal Neurostimulator

The primary objective of this study is to evaluate acute tear production as measured by tear meniscus height (TMH) captured by optical coherence tomography (OCT) after single use of the Oculeve Intranasal Neurostimulator (OIN) in participants with dry eye.

This is a prospective, single-arm, multicenter, open-label clinical trial in which participants will use the OIN once following study enrollment.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with dry eye disease
* Literate, able to speak English or Spanish, and able to complete questionnaires independently
* Willing to sign the informed consent and deemed capable of complying with the requirements of the study protocol

Exclusion Criteria:

* Chronic or recurrent epistaxis, coagulation disorders or other conditions that, in the opinion of the investigator, may lead to clinically significant increased bleeding
* Nasal or sinus surgery (including history of application of nasal cautery) or significant trauma
* Cardiac demand pacemaker, implanted defibrillator or other implanted electronic device
* Corneal transplant in either or both eyes
* Participation in any clinical trial with a new active substance or a new device within 30 days of the Screening Visit
* Women who are pregnant, planning a pregnancy, or nursing at the Screening Visit
Apolipoprotein (APO)E Genotype, Meal Fatty Acids, Postprandial Lipaemia

Cardiovascular disease (CVD) is the greatest cause of morbidity and mortality in the UK. Abnormalities in the concentration and/or composition of lipoproteins (the lipid carrying particles), in particular low density lipoproteins (LDL) in circulation, is one of the most important physiological defects contributing to the development of CVD.

The LDL cholesterol (LDLC) response to fatty acid change is in part mediated by the APOE genotype, with E4 individuals (25% of the UK population) being most responsive to changes in dietary fats, showing greater reductions when low levels of saturated fats or fish oils are consumed and greater increases when high levels of these fats are consumed. Therefore the aims of the present study is to understand the mechanism that regulates the higher LDLC response associated with saturated fatty acids and fish oil consumption in healthy men prospectively recruited based on their APOE genotype.


Eligibility Criteria:
Inclusion Criteria:

* Gender Male
* Age 18-70 years
* Body Mass Index (BMI) \< 32 kg/m2
* Plasma triglycerides 1-4 mmol/l
* Plasma cholesterol \< 8 mmol/l
* Glucose \< 7 mmol/l
* Haemoglobin \> 11 g/dl
* ApoE E3/E3, E3/E4

Exclusion Criteria:

* Blood pressure \> 200/95 mmHg
* Had suffered a myocardial infraction or stroke in previous 2 years.
* Diabetes mellitus
* Liver disease
* Other endocrine disorders
* Unstable angina
* Familial hyperlipidaemia
* Any dietary restrictions or an a weight reducing diet
* On fatty acid supplements e.g. evening primrose oil or fish oils
* Vigorous exercise e.g. competitive athletes
* ApoE2/E2, apoE2/E3 and apoE2/E4
* Any other parameter on which the investigators felt an individual was unsuitable
A Study of Participants with Β-Thalassemia Treated with Betibeglogene Autotemcel

The main aim of this study is to collect real-world longitudinal data on participants with β-thalassemia treated with betibeglogene autotemcel (beti-cel) in the post marketing setting. To assess the long-term safety, including the risk of newly diagnosed malignancies, after treatment with beti-cel and evaluate the long-term effectiveness of treatment with beti-cel.


Eligibility Criteria:
Inclusion Criteria:

* Participant must be treated with beti-cel in the post marketing setting at a center in the US that participates in the Registry.
* Participant must sign an informed consent and/or assent prior to enrollment as required under applicable laws and regulations.
* Participant must have signed an informed consent and/or assent permitting data to be shared with Center for International Blood and Marrow Transplant Research (CIBMTR).
* Participant must be followed by a hematologist based in the US.

Exclusion Criteria:

- There are no exclusion criteria for Registry participation.
Study of AEE788 in Patients With Recurrent/Relapse Glioblastoma Multiforme (GBM)

AEE788 is an orally active, reversible, small-molecule, multi-targeted kinase inhibitor with potent inhibitory activity against the ErbB and VEGF receptor family of tyrosine kinases. It has an IC50 of less than 100 nM against p-EGFR, p-ErbB2, and p-KDR (VEGFR2). This study will assess the safety, pharmacokinetic/pharmacodynamic (PK/PD) profiles and clinical activity of AEE788 in a recurrent GBM population.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed GBM in first or second recurrence or relapse
* Adequate hematologic, hepatic and renal function
* Age ≥ 18 years
* Karnofsky performance status score ≥ 70%
* Life expectancy ≥ 12 weeks

Exclusion Criteria:

* Peripheral neuropathy \> grade 1
* Diarrhea \> grade 1
* Gastrointestinal dysfunction
* Compromised cardiac function
* Concurrent severe and/or uncontrolled medical conditions
The Efficacy of S-adenosyl Methionine (SAMe) Versus Pentoxiphylline in Patients With Non-alcoholic Steatohepatitis With Fibrosis

Nonalcoholic fatty liver disease is one the most commonly encountered conditions in a daily outpatient Hepatology clinic. Secondly our country is the diabetic capital of the world and so the incidence of NAFLD (Non Alcoholic Fatty Liver Disease) is expected to rise in the future. It is a spectrum of hepatic pathology, ranging from simple steatosis, steatohepatitis, to cirrhosis. Nonalcoholic steatohepatitis (NASH) is a more advanced form of disease where steatosis is accompanied by hepatocyte injury as well as infiltration of inflammatory cells. Approximately 10-20% of patients with NASH may progress to cirrhosis. NASH is felt to be a major etiology of cryptogenic cirrhosis. Around 6230 human studies out of which 49 RCTs have been done till date to define the appropriate treatment of nonalcoholic steatohepatitis. However, still a controversy and no recommended treatment available till date. Recently published PIVENS trial has shown that Vitamin E has proven benefit in NASH. Other trials have also shown that pentoxiphylline has shown benefit in the form of histological improvement and biochemical improvement in the form of liver enzymes. Role of SAMe has been studied in alcoholic liver disease and showed to improve in both biochemical and histological features. However the usefulness of SAMe in NAFLD is not known till now. Hence this study has been designed.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 70 years
* Persistently abnormal ALT \>1.2 times upper limit of normal
* Histological evidence of NASH (Non alcoholic Steatohepatitis) on liver biopsy. The minimal criteria for diagnosis of NASH included the presence of lobular inflammation and fibrosis up to stage 3 as per Burnt stating.

Exclusion Criteria:

* Alcohol intake of more than 40gm / week with features suggestive chronic liver disease .
* Other known cause of chronic liver disease like Hepatitis B,C, autoimmune liver disease, Wilson's disease, alpha 1 antitrypsin deficiency and hemochromatosis, primary biliary cirrhosis, PSC (Primary Sclerosis Cholangitis).
* Patient on Medication like estrogens, amiodarone, MTx, tamoxifen, ATT (Antitubercular Treatment)
* Pregnancy or lactation
* Hypersensitivity to methylxanthines (e.g., caffeine, theophylline,)
* Recent retinal/cerebral hemorrhage
* Acute myocardial infarction or severe cardiac arrhythmias.
* Impaired renal function.
Randomized Study of Albuterol in Patients With Facioscapulohumeral Muscular Dystrophy

OBJECTIVES: I. Determine whether albuterol increases strength in patients with facioscapulohumeral dystrophy as measured by quantitative voluntary isometric contraction testing.

II. Determine whether albuterol increases muscle mass in this patient population as determined by 24 hour urinary creatinine excretion and dual energy x-ray absorptiometry (DEXA).

III. Examine the long term safety of albuterol in this patient population.

PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled study. Patients are randomized into one of three treatment groups. The first group receives placebo. The second group receives low dose albuterol orally every 12 hours. The third group receives high dose albuterol orally every 12 hours. Treatment continues for 52 weeks unless unacceptable side effects occur.

All patients return for follow up assessments at weeks 4, 12, 24, and 52.

Completion date provided represents the completion date of the grant per OOPD records

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Facioscapulohumeral dystrophy Weakness of the facial muscles, including frontalis, orbicularis oculi, or orbicularis oris Weakness of scapular stabilizers or foot dorsiflexors Weakness of grade 2 or worse in the arm using the upper extremity grading scale No other neuromuscular diseases that may mimic the clinical presentation of facioscapulohumeral dystrophy: Ptosis or ophthalmoparesis (other than congenital strabismus) Elbow contractures Strictly unilateral weakness Dermatomyositis-like skin rash Symmetric distal sensory loss Muscle biopsy findings of mitochondrial myopathy, chronic denervation, dermatomyositis, inclusion body myositis, or congenital myopathy Electromyographic (EMG) findings of myotonia, fasciculations, or neurogenic motor unit potentials --Prior/Concurrent Therapy-- Endocrine therapy: No prior long term use of oral corticosteroids for more than 1 year At least 3 months since prior use of corticosteroids No concurrent use of immunosuppressive agents Surgery: No concurrent surgeries Other: No concurrent use of sympathomimetic agents, antidepressants, or beta receptor blockers --Patient Characteristics-- Age: 18 to 80 Performance status: Ambulatory Cardiovascular: No cardiovascular disease, including hypertension and coronary artery disease Other: Not pregnant or nursing No concurrent uncontrolled medical or psychological condition
Efficacy and Safety of ME3183 in Subjects With Moderate to Severe Plaque Psoriasis

The purpose of this study is to assess the efficacy and safety of ME3183 administered orally for moderate to severe plaque psoriasis in adults.


Eligibility Criteria:
Inclusion Criteria:

* Male and female, ages 18 to 75 years
* Participant with stable moderate to severe chronic plaque psoriasis of at least 24 weeks duration.

Exclusion Criteria:

* Other than psoriasis, history of any clinically significant (as determined by the Investigator) or other major uncontrolled disease.
* Active or chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at Screening.
* Hepatitis B surface antigen positive at Screening.
* History of HIV or Positive for the HIV antibodies at Screening.
* History of allergy to any component of the study treatment.
* Active tuberculosis (TB) or a history of incompletely treated TB.
* Active infection (bacteria, viral, fungal, etc.) requiring treatment with systemic antibiotics within 4 weeks of Screening.
* Malignancy or history of malignancy except for treated \[ie, cured\] basal cell or squamous cell in situ skin carcinomas and treated \[ie, cured\] cervical intraepithelial neoplasia or carcinoma in situ of the cervix with no evidence of recurrence.
* Pregnant or breast feeding
* Received ustekinumab, secukinumab, brodalumab, ixekizumab, guselkumab, risankizumab, tildrakizumab, or briakinumab within 24 weeks of first administration of study treatment.
* Received TNF-α inhibitor(s)/blocker(s) within 8 weeks of first administration of study treatment.
* Received rituximab within 24 weeks of first administration of study treatment.
* Received phototherapy or any systemic medications/treatments within 4 weeks of the first administration of study treatment.

Other protocol defined inclusion/exclusion criteria could apply
Randomized Comparison of Mindfulness Versus Group Support for Treatment of Low Sexual Desire in Women

The purpose of this study is to determine whether an 8-session mindfulness-based intervention (MBCT group) is effective for women with low sexual interest/desire in reducing sexual distress, improving their sexual response, and increasing their mindful skills, compared to a support group.

HYPOTHESES:

1. Compared to baseline, the MBCT group will have significant post-treatment improvements in self-report measures of: (a) sexual distress; (b) sexual desire, subjective sexual arousal, perception of genital arousal, and sexual pleasure; (c) relationship satisfaction; (d) depressive symptoms and rumination; (e) perceived stress, general anxiety, anxiety sensitivity, and sexuality-related situational anxiety (as self-reported at the sexual arousal assessment); and (f) mindfulness, self-compassion, non-attachment, and interoceptive awareness.
2. Compared to baseline, the MBCT group will have significant post-treatment improvements in laboratory physiological measures of: (a) genital sexual response as measured by a vaginal photoplethysmograph, (b) interoceptive awareness, as measured by a heart rate perception task, and (c) cortisol:DHEA ratio as measured by hormonal assays of saliva samples.
3. We hypothesize that the changes in the endpoints listed in #1 or #2 will be significantly greater in the MBCT group than in the support group.
4. We hypothesize that participation in the MBCT group will significantly increase concordance between genital and subjective sexual arousal.
5. Mindfulness, self-compassion, and interoceptive awareness will significantly mediate improvements in sexual distress and desire in the MBCT group at all post-treatment assessment points.
6. Expectations of change with treatment will not significantly moderate improvements in sexual distress and desire in the MBCT group.
7. Participants' impressions of change will be significantly greater in the MBCT group compared to the support group at all post-treatment assessment points.
8. We hypothesize that participants will experience fewer breaks in the sexual response cycle throughout the course of the eight-week treatment.

Eligibility Criteria:
Inclusion Criteria:

* must be experiencing distressing sexual interest/desire and/or sexual arousal concerns
* must between the ages of 19 - 65
* must be fluent in English

Exclusion Criteria:

* not experiencing distressing sexual interest/desire and/or sexual arousal concerns
* not between the ages of 19-65
* unable to read, write, speak and understand English