cyrilzakka/clinical-trials huggingface dataset:
Lymphodepletion and Anti-PD-1 Blockade to Reduce Relapse in AML Patient Not Eligible for Transplant

AML is the most common acute leukemia in adults. Most patients can undergo allogeneic stem cell transplantation as a possible cure; however, many patients are not candidates for allogeneic transplant due to age, overall health, psychosocial factors, and/or lack of available donors. Therefore, these patients are unable to receive the therapeutic benefits of the "graft-versus-leukemia" effect of donor immune cells. The aim of this study is to hopefully break immune tolerance to AML cells to provide better outcomes in patients with non-favorable risk AML.

Non-favorable risk AML patients will undergo a preparative regimen of lymphodepletion of Flu/Mel followed by autologous transplantation. Anti-PD-1 therapy of pembrolizumab will begin on Day +1 following stem cell transplantation and will be administered every 3 weeks for a total of 8 doses. According to the literature, the risk of 2-year relapse is estimated to be 60-80% in patients with non-favorable risk AML in CR-1. With this protocol, investigators hypothesize that following lymphodepleting chemotherapy and pembrolizumab, the 2-year relapse risk will decrease to less than or equal to 35%. The one-sided Wald test at 5% significance level will be used to test the hypothesis. The size of 20 patients yields the power of 90.5% assuming that the actual 2-year leukemia-free survival is 60%.

Eligibility Criteria:
Inclusion Criteria:

* Non-favorable risk AML
* In CR-1 or subsequent CR
* Completed at least one cycle of consolidation chemotherapy
* Collection of at least 2x106/kg CD34+ cells
* KPS of 70% or greater

Exclusion Criteria:

* Received investigational agent within 4 weeks of first dose
* Prior chemotherapy, radiation therapy within 2 weeks of first dose
* Hypersensitivity to pembrolizumab or any of its excipients
* Received prior therapy with anti-PD-1, anti-PD-L1, or anti-PD-L2 agent
Effectiveness of Advisor-Teller Money Manager

VA investigators have described greater substance use at the beginning of the month when disability and other monthly checks are received. The proposed research addresses an important VA priority�seeing that veterans� funds are spent to improve veterans� quality of life and are not misspent on substances of abuse.

Background:

VA investigators have described greater substance use at the beginning of the month when disability and other monthly checks are received. The proposed research addresses an important VA priority�seeing that veterans� funds are spent to improve veterans� quality of life and are not misspent on substances of abuse.

Objectives:

The objective was to determine the effectiveness of a money management-based therapy called ATM for veterans who abuse cocaine or alcohol compared to a financial advice control condition.

Methods:

Veterans were randomly assigned to 36-weeks of ATM or to the control condition, financial advice. ATM (Adviser-Teller Money Manager) involves meeting with a money manager at least weekly. The money manager performs three functions�limiting patients� access to funds by storing checkbooks and ATM cards, training patients to budget their funds, and linking spending to treatment goals. The control condition involved listing income and expenses in a workbook. Veterans were enrolled from each of two sites if they had spent at least $100 in the preceding 90 days on alcohol or cocaine, and had at least $300 per month income. Measures of treatment fidelity and participation included number of visits attended, whether funds were stored, monthly income and expenses and Likert-scaled ratings from 1-4 of money management-related outcomes. Outcome measures collected included urine toxicology tests and breathalyzers, self-reported substance use as assessed by the ASI follow-up, and secondary measures including quality of life and psychiatric symptomatology.

Status:

Data analysis is ongoing. Attempts are being made to (a) disseminate ATM and assess its effect among homeless women veterans (b) determine the reliability and validity of money management-based assessments used to determine which veterans are capable of managing their funds (c) optimize funds management by disabled veterans.

Eligibility Criteria:
Inclusion Criteria:

Age _\>18. Meets DSM-II criteria for cocaine abuse or alcohol abuse. Self-reported use of at least $100 worth of alcohol or cocaine during 30 days within last 90 days. Income of at least $300 per month.

Exclusion Criteria:

Currently receives money management, physiological dependence on alcohol or opiates, has a conservator or other payee
Prostate Nutrition and Exercise STudy (ProNEST)

The purpose of this study is to test the feasibility of nutrition and exercise counseling program for reducing the incidence of metabolic syndrome in prostate cancer patients on Androgen Deprivation Therapy.

This is a pilot study to evaluate the role of dietary modifications and exercise in patients started on ADT for preventing and or delaying metabolic syndrome in this aging population. The study will employ a randomized, 2-arm wait-control design. Subjects will be randomized in a 1:1 ratio into two arms: dietary modifications and exercise counseling (Arm A) or standard of care (Arm B). The duration of intervention in Arm A will be 24 months. At 12 months, participants in Arm B will be offered the same intervention that Arm A received during months 1-12. Medical records will be accessed up to 5 years for standard of care visits. The goal of this project is to generate preliminary data on the feasibility of applying such an intervention on a much bigger population with approximately 100 subjects on each arm. For this pilot, we aim to randomize 20 patients to each arm. The principal investigator or co-investigators who are evaluating the patient will perform the randomization since this is an open-label, non-therapeutic study. The ADT received by patients on both arms is considered standard of care therapy for their prostate cancer.

Eligibility Criteria:
Inclusion Criteria:

1. Patient has provided written, informed consent
2. 18 years of age or greater
3. Histologically or biochemically confirmed hormone-naïve prostate adenocarcinoma
4. Recently started or re-started ADT within 4 months of starting the study
5. Eastern Oncology Co-operative Group (ECOG) performance 0-1
6. Patient who is on an antihypertensive medications with a blood pressure less than 130 systolic and 85 mm Hg diastolic
7. Patient who is on an antihyperlipidemic agents with TG ≤ 150 mg/dl, serum HDL ≥40 mg/dL

Exclusion Criteria:

1. Current use of taxane based chemotherapy for metastatic disease
2. Clinically significant or active cardiovascular disease:

   1. No previous MI within the past 12 months
   2. No uncontrolled angina within 12 months
   3. History of Mobitz II second degree or third degree heart block without a permanent pacemaker in place
   4. Uncontrolled hypertension (systolic BP \> 170 mmHg or diastolic BP \> 100 mmHg at screening)
   5. CHF with NYHA class 3 or 4
3. Structurally unstable bone lesions suggesting impending fracture
4. Estimated life expectancy of \< 6 months
5. Patients who meet criteria for metabolic syndrome that are uncontrolled based on the Internal Diabetes Federation.
Physiotherapy of At-Risk Infants, Physiotherapist or Family?

Early physiotherapy reduces neuromotor problems in at-risk infants. This study was planned to compare the effects of an early goal-directed neuromotor physiotherapy (GDNT) application between preterm and term at-risk infants.

Early physiotherapy reduces neuromotor problems in at-risk infants. This study was planned to compare the effects of an early goal-directed neuromotor physiotherapy (GDNT) application between preterm and term at-risk infants. Eighteen at-risk infants between the ages of 0 and 12 months were assigned to the preterm and term groups according to their gestational and corrected age. Each group received GDNT for 45 min, three days per week for 12 weeks. The effectiveness of the therapy was measured using Alberta Infant Motor Scale (AIMS), Hammersmith Infant Neurological Examination (HINE), and Goal Attainment Scale (GAS).

Eligibility Criteria:
Inclusion Criteria:

* being diagnosed as "at-risk" by a pediatric neurologist, having intraventricular hemorrhage, periventricular leucomalacia, hypoxic ischemic encephalopathy, and prematurity, Apgar score of 5 or less at 5 min, chronic lung disease, seizures, meningitis, hyperbilirubinemia, being twins or triplets, and having intrauterine growth restriction;
* being outside of the neonatal intensive care unit;
* being between 0 and 12 months old (corrected age for premature infants);
* having a family acceptance for the participation in 12 weeks of therapy program.

Exclusion Criteria:

* having congenital anomalies, musculoskeletal disorders, cyanotic congenital heart disease and mechanical dependency, and
* lack of informed content by the parents.
Ejaculatory Sparing Transurethral Incision Of The Prostate (ES-TUIP) Versus Conventional TUIP

In this study, Investigators planned to compare ejaculatory sparing and non-ejaculatory sparing (conventional) TUIP using both subjective and objective assessment tools for the degree of deobstruction.

Furthermore, the impact of both techniques on ejaculation and its secondary effect on orgasm perception and different domains of sexual function will be thoroughly assessed.


Eligibility Criteria:
Inclusion Criteria:

* American society of anesthesiologists (ASA) score ≤3.
* TRUS estimated prostate weight ≤ 35 grams.
* Sexually interested and having continuous relationship with the same partner (interested).
* Bladder outlet obstruction index (BOOI ) ≥ 20 as per pressure flow study

Exclusion Criteria:

* Preoperative sexual or ejaculatory disturbances or pelvic pain syndrome
* Neurological disorders that can affect potency and ejaculation e.g. long standing uncontrolled diabetes mellitus (DM) type 2 (\> 10 years), DM type 1, cerebral stroke, Parkinsonism
* Urodynamic changes consistent with urethropathy or detrusor hypocontractility
* Previous pelvic surgeries or radiotherapy
Efficacy of Desensitizers in Reducing Post-operative Sensitivity Following Composite Restorations

Composite is one of the common aesthetic restorations used in the dentistry. With the advancements in the biomaterials the application of the composites has broadened. However due to various factors the composites are associated with dental sensitivity. Hence in our study we evaluate and compare the effectiveness of three desensitizing agents in reducing the post-treatment sensitivity for class I composite restoration.

A double-blind, randomized, controlled clinical trial was conducted in which 80 subjects requiring class I cavity were randomly assigned to 4 groups of 20 patients each: Group C (Control group), Group GL (Gluma group), Group SF (Shield Force Plus group), and Group TC (Telio CS group). The class 1 cavity was prepared and after etching, the desensitizers were applied (except in the control group) and later composite restoration was done. The postoperative pain/sensitivity level was recorded according to the Visual Analogue Scale (VAS) on intake of cold drinks; intake of hot drinks; and intake of sugar for different periods of time.

Eligibility Criteria:
Inclusion Criteria:

The selection criteria:

* Age was 20-45 years.
* Vital teeth, (electric pulp test)
* Apical periodontal ligament space radiographically identified
* The remaining dentin thickness at least 1mm.

Exclusion Criteria:

* Restored, periodontally weak nonvital teeth are excluded.
The Effect of a Very Low-residual Diet on the Preparation Before Capsule Endoscopy

The aim of the proposed study is to compare prospectively two methods of small bowel preparation prior capsule endoscopy study, the effect on the cleanliness and the quality of visualization after two protocols of preparation: a 12 hour fast only versus 24 hour of a very low residual diet (ENSURE, Abbott Laboratories, Israel) + 12 hour fast.


Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients who will submitted to capsule endoscopy due to following medical indications:

  * suspected Crohn's disease
  * obscure GI bleeding
  * iron deficiency anemia
  * suspected malabsorption disease
  * unexplained abdominal pain
  * unexplained chronic diarrhea

Exclusion Criteria:

* pregnancy
* patients who had previous surgery on Gastrointestinal tract
* patients with previous intestinal obstruction
* patients who will refuse to participate in the study
* diabetes mellitus
* known celiac disease
Intra-arterial Stem Cell Therapy for Patients With Chronic Limb Ischemia (CLI)

The purposes of this study are to determine whether intra-arterial injection of autologous stem cells is effective in the treatment of chronic limb ischemia (CLI), to characterize stem cell dysfunction in patients with CLI, and to relate the stem cell function with clinical outcome.

Despite advances in surgical and radiological vascular techniques, a significant number of patients with chronic critical limb ischaemia (CLI) are not eligible for revascularization procedures, often leaving amputation as the only option. Consequently, exploring new strategies for revascularization of ischemic limbs is of major importance. Preclinical studies and pioneering clinical trials suggest that administration of bone marrow (BM) mononuclear cells (MNC) into ischemic limbs enhances neovascularization, improves tissue perfusion and prevents amputation. However, no definite proof is available as the clinical studies thus far have been small and lacked double-blinded controls.

JUVENTAS is a randomized, double-blinded placebo-controlled trial in 109 - 160 patients with CLI to investigate the potential clinical effects of repeated intra-arterial infusion of BM-MNC in these patients (the exact number of patients to be included cannot be specified in advance because of the planned group sequential interim analyses). In addition, it will study the functional characteristics of the BM-MNC obtained from CLI patients and relate BM-MNC dysfunction to clinical outcome.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Severe infra-popliteal peripheral arterial occlusive disease \[PAOD\] (Fontaine class IIb, III or IV)
* Invalidating intermittent claudication, persistent, recurring rest pain requiring analgesia and/or non-healing ulcers present for \> 4 weeks without evidence of improvement in response to conventional therapies
* Ankle brachial index \< 0.6 or "unreliable"
* Not eligible for surgical or radiological revascularization
* Written informed consent

Exclusion Criteria:

* History of neoplasm or malignancy in the past 10 years
* Serious known concomitant disease with life expectancy of less than one year
* Anticipated inability to obtain 100 ml of bone marrow aspirate
* Known infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C virus
* Follow-up impossible
Orthostatic Dysregulation and Associated Gastrointestinal Dysfunction in Parkinson's Disease - Evolution

Symptoms of blood pressure dysregulation, impaired swallowing and digestion are common amongst parkinson patients. The overall aim of this study is to examine blood pressure regulation and esophageal motility and gastric emptying in Parkinson's disease (PD) patients.

The investigators hypothesize that - compared to age-matched controls - PD patients display an altered regulation of blood pressure, altered gastroesophageal motility, and delayed gastric emptying. These symptoms occur already early in the disease process, but aggravate with progression of the disease.

The investigators will perform a 7-day blood pressure measurement, measurement of central blood pressure and pulse wave velocity, assessment of pulse variability, Schellong tests to assess orthostatic function, high resolution manometry assessments during swallowing acts, and a 13C-sodium octanoate breath test to assess gastric emptying, in 18 PD patients (9 each Hoehn\&Yahr stages 1,2) and 12 age- and gender-matched healthy controls. Results will be interpreted in relation to the severity of PD motor symptoms.

The investigators anticipate that blood pressure dysregulation and gastroesophageal motility disturbances will be present only in PD subjects, but not in matched controls without neurological disorders and without any extrapyramidal motor signs. Furthermore, the investigators expect to find an association between motor impairment and the severity of these autonomic symptoms, however, that according to the Braak staging, subtle disturbances must already be present in the early stages of PD.


Eligibility Criteria:
Inclusion criteria: - informed, written \& formal consent for participation

* male/female subjects, aged 50-70 years
* PD patients (9 subjects each in Hoehn \& Yahr stage 1 \& 2)

Exclusion criteria: - Antihypertensive treatment

* medication influencing gastrointestinal motility for at least the elimination half life of the drug
* medication interfering with blood-pressure regulation for at least the elimination half life of the drug
* significant systemic illness
* BMI \< 18 or \> 30kg/m2
* symptoms or a history of GI disease or surgery
* with any evidence of infectious disease
* evidence or history of drug or alcohol abuse
* diabetes mellitus
WhatsApp-based Psycho-socio-educational Intervention (WeLove) for Prevention of Psychological and Sleep Problems in Pregnant Women and Their Partners: A Three-arm Double-blinded Pilot Randomised Controlled Trial

Objectives: (1) evaluate the feasibility and acceptability of the WhatsApp-based psycho-socio-educational intervention (WeLove); (2) preliminarily examine the effects of the intervention on psychological symptoms (depression, anxiety, stress symptoms), sleep quality, and life satisfaction; and (3) preliminarily examine the interdependence between psychological symptoms and sleep quality in pregnant women and their partners.

Methods: The investigators will use WhatsApp to provide the six sessions of the intervention, which include psychological, social, and educational components. A three-arm double-blinded pilot randomised controlled trial (RCT) is used in 60 couples, followed by individual face-to-face interviews for process evaluation in 10 to 20 couples based on data saturation. Participants will be assigned to one of three groups and 20 couples per group: intervention 1 (couples for WeLove), intervention 2 (pregnant women for WeLove), or the control group (use WhatsApp as normal). Participants will be assessed pre- and post-intervention. Generalised estimating equation analysis and thematic analysis will be performed to examine the research objectives.

Study design A prospective randomised double-blind, three-arm, parallel-group design will be adopted. The report of the trial will follow the Consolidated Standards of Reporting Trials guidelines for an Internet-based intervention (CONSORT-EHEALTH).

Eligibility Criteria:
Inclusion Criteria:

* pregnant with a gestation of \>12 to 28 weeks and their partners over 18 years
* able to read and understand Chinese
* have electronic devices with WhatsApp that can contact the Internet
* can provide written consent and voluntary participation in this study

Exclusion Criteria:

* current severe medical illnesses
* psychological and sleep disorders
A Study to Evaluate Rozanolixizumab in Study Participants With Generalized Myasthenia Gravis

The purpose of this study is to assess the safety, tolerability and efficacy of additional 6-week treatment cycles with rozanolixizumab in study participants with generalized myasthenia gravis (gMG).


Eligibility Criteria:
Inclusion Criteria:

* Study participant must meet one of the following:

  1. completed MG0003 \[NCT03971422\]
  2. required rescue therapy during the Observation Period in MG0003 or
  3. completed at least 6 visits in MG0004 \[NCT04124965\]
* Body weight ≥35 kg at Baseline (Day 1)
* Study participants may be male or female

Exclusion Criteria:

* Study participant has a known hypersensitivity to any components of the study medication or other anti-neonatal Fc receptor (FcRn) medications
* Study participant with a known tuberculosis (TB) infection, at high risk of acquiring TB infection, or latent tuberculosis infection (LTBI), or current/history of nontuberculous mycobacterial infection (NTMBI)
* Study participant met any mandatory withdrawal or mandatory study drug discontinuation criteria in MG0003, or MG0004, or permanently discontinued study drug in either study
* Study participant intends to have a live vaccination during the course of the study or within 8 weeks following the final dose of rozanolixizumab
* Study participant with severe (defined as Grade 3 on the Myasthenia Gravis-Activities of Daily Living (MG-ADL) scale) weakness affecting oropharyngeal or respiratory muscles, or who has myasthenic crisis or impending crisis
Study Evaluating Oral MOA-728 in Subjects on Methadone Therapy

To evaluate the effects of single oral doses of MOA-728 compared to a positive control in subjects on methadone therapy.


Eligibility Criteria:
Inclusion:

1. Healthy men or women, aged 18 to 65 years.
2. History of methadone treatment for at least 1 month, at a dose \>=30 and \<=140 mg/day.

Exclusion:

1. History or active presence of clinically important medical disease.
2. Allergy to opioids.
Efficacy of Ciclesonide and Fluticasone Propionate in Adult Patients With Moderate and Severe Persistent Asthma (18 to 75 y) (BY9010/IT-101)

The aim of the study is to compare the safety and efficacy of ciclesonide versus fluticasone propionate on the lung function, symptoms, use of rescue medication, and occurrence of side effects (such as candidiasis, hoarseness) in adults with persistent asthma. Ciclesonide will be inhaled twice daily at one dose level; fluticasone propionate will be inhaled twice daily at one dose level. The study duration consists of a baseline period (2 weeks) and a treatment period (24 weeks). The study will provide further data on safety and tolerability of ciclesonide.


Eligibility Criteria:
Main Inclusion Criteria:

* Written informed consent
* History of bronchial asthma for at least 6 months
* Pre-treatment with CFC-beclomethasone dipropionate (CFC-BDP) ≥ 1000 mcg/day or equivalent and a long-acting beta agonist (LABA) either in free or fixed combination
* FEV1 ≥ 80% of predicted

Main Exclusion Criteria:

* Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids or contraindications for the use of LABAs
* COPD
* Smoking with ≥10 pack-years
* Pregnancy
* Intention to become pregnant during the course of the study
* Breast feeding
* Lack of safe contraception