cyrilzakka/clinical-trials huggingface dataset:
Sitagliptin in Renal Transplant Recipients

The major cause of premature death in renal transplant recipients is cardiovascular disease. Sitagliptin stimulates insulin secretion and inhibits glucagon release, two central mechanisms in PTDM by interaction with a hormone system (incretins) that just recently it has become possible to modulate by drugs. Sitagliptin therefore is an interesting additional drug for the treatment of posttransplant diabetes mellitus in transplanted patients.

The primary objective of the present study is to investigate the effect of sitagliptin on insulin secretion in renal transplant recipients.

Secondary objectives are to study the effect on insulin sensitivity, fasting blood glucose, endothelial function, CsA/Tac blood concentrations.


Eligibility Criteria:
Inclusion Criteria:

* Renal transplant recipient more than 1 year posttransplant with stable renal function (less than 20% deviation in serum creatinine the last 2 months) and stable prednisolone dose for the last 3 months before inclusion.
* Patients in need of (additional) oral anti-diabetic treatment:

  * New onset diabetes patients with fasting plasma glucose 7-8 mmol/ l, and/or 2-hr plasma glucose 12-18 mmol/l after an oral glucose tolerance test (OGTT)
  * Patients already on oral hypoglycemic therapy, but with HbA1c 8-11%
* 18 years of age.
* Male patient, or female patient without childbearing potential (surgically sterilized or postmenopausal) or, if female of childbearing potential, is not lactating, has a negative pregnancy test at screening and is willing to utilize an effective method of contraception throughout the study period and for 90 Days following discontinuation of the Study Drugs.
* Signed informed consent.

Exclusion Criteria:

* Treatment with insulin
* Severe liver disease.
* Estimated GFR \< 25 ml/min/1.73 m2.
* Skin disorders that may influence laser Doppler flowmetry investigations.
* Pregnant or nursing mothers.
The Effect of D-cycloserine on Emotional Processing

To investigate the effects of N-methyl-D-aspartate (NMDA) partial agonist DCS on emotional processing, memory and stress tasks

The aim of the present study is to assess the effect of DCS on emotional processing relevant to antidepressant drug activity. For this, 40 healthy volunteers will be recruited to the study and randomized to receive a single session of 250mg DCS or placebo. 3 hours and 24 hours after active drug/placebo administration, the effects of emotional processing via the use of cognitive tasks will be assessed. Also, given the important role of DCS in memory and stress, we also include tasks to explore changes in autobiographical memory and in psychological and physiological measures of stress and arousal.

Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Willing and able to give informed consent for participation in the study
* Body mass index (BMI) within the range of 19-30kg/m2
* Sufficiently fluent English to understand and complete the task

Exclusion Criteria:

* Currently take any psychoactive medication.
* Have taken any CNS-active medication during the last 6 weeks.
* Currently take any medication with cycloserine, ethionamide or isoniazid
* Have suffered from any past or current psychiatric disorder (e.g. depression, anxiety)
* Have lifetime history of epilepsy or other significant disease or disorder which, in the opinion of the investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
* Have history of heart disease, significant hypertension
* Have history of Megaloblastic Anaemia, Sideroblastic Anaemia
* Have history of kidney disease with reduction in kidney function
* Have severe renal impairment
* Have suffered from lactose intolerance
* Are currently pregnant, breastfeeding or trying to get pregnant
* Have a current or past history of drug or alcohol dependency
* Have participated in a psychological or medical study involving the use of medication within the last 3 months
* Have previously participated in a study using the same, or similar, emotional processing tasks
* Smoke more than 5 cigarettes per day
* Have dyslexia (given the nature of the computer tasks)
Study of SGR-2921 in Relapsed/Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome

The purpose of this study is to evaluate safety and tolerability and to determine the maximum tolerated dose (MTD) and/or recommended dose (RD) of SGR-2921.

This is a study of SGR-2921, an oral, small molecule inhibitor of cell division cycle 7-related protein kinase (CDC7), in subjects with Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD), maximum tolerated dose (MTD) and/or recommended dose (RD) of SGR-2921.

Exploratory cohorts may evaluate additional PK, PD, preliminary anti-tumor activity, and safety to establish the SGR-2921 RD. A planned amendment will evaluate SGR-2921 in combination with other approved AML/MDS treatments such as hypomethylating agents (HMA), BCL2 inhibitors, IDH inhibitors or FLT3 inhibitors, in patients with AML and/or MDS.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years of age.
* Life expectancy ≥ 8 weeks.
* Confirmed diagnosis of R/R AML or High Risk (HR) and Very High Risk (VHR) MDS.
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.

Exclusion Criteria:

* Active malignancies within two years prior to the first dose, or requiring ongoing treatment, not related to AML or MDS.
* Clinical evidence of central nervous system (CNS) or pulmonary leukostasis, ≥ Grade 3 disseminated intravascular coagulation, or active CNS leukemia.
* Use of experimental drug, or therapy, or anti-cancer therapy within 14 days or 5 half-lives of the first dose of study drug.
* QT interval corrected for heart rate per Fridericia's formula ≥470 msec during screening ECG.
Evaluate and Understand Preferences and Representations in Families of Patients With Regard to High-throughput Sequencing Technology for Diagnostic Purposes

After the use of DNA chips for diagnostic purposes, high-throughput sequencing (HTS) is transforming the field of developmental diseases, from fundamental research to care. Nonetheless, before HTS can be transferred to everyday clinical practice, in particular for expert diagnosis using exome HTS, it is necessary to anticipate the nature of the information to be given to patients and to parents in order to obtain consent for exome HTS.

The objective in terms of public health is to allow patients with rare diseases to benefit from innovative technologies in optimal conditions of information and accompaniment.

the objectives of this project are to

1. evaluate the preferences of families of patients with development disorders as regard to suspicious and incidental findings from HTS before its introduction for diagnostic purpose,
2. and then, following the exome analyses carried out for diagnostic purposes, describe, analyse and understand the experience, expectations and reactions of families and geneticists concerning the diagnostic trajectory in general and at the time the results of the HTS were announced in particular A methodology that associated quantitative and qualitative approaches was chosen so as to combine the advantages and overcome the shortcomings of each: a quantitative study to investigate a large number of patients, which would ensure a certain representativeness of the population and allow sub-groups analyses to study the upstream phase concerning indications for high-throughput sequencing; and a qualitative study, which though it allows only a small number of patients to be investigated, makes it possible to describe, analyze and understand in depth the complex downstream phenomena of high-throughput sequencing results


Eligibility Criteria:
Quantitative study

* INCLUSION CRITERIA

  * parents of patients with development anomaly and/or intellectual deficiency with no etiological diagnosis
  * parents of patients consulting at the centres of reference in Dijon or Lyon
  * parents of patients who have not already benefited from HTS
  * parents of patients who are fluent in French
* NON-INCLUSION CRITERIA

  * persons without national health insurance cover
  * inability to answer the questionnaires

Qualitative study

* INCLUSION CRITERIA

  * persons who have provided written informed consent
  * parents of patients with a development anomaly
  * parents of patients consulting at the centres of reference in Dijon or Lyon
  * parents of patients who have already benefited from HTS for diagnostic purposes
  * persons fluent in French
* NON-INCLUSION CRITERIA

  * persons without national health insurance cover
  * cognitive impairment making it impossible for the person to understand the aims of the study
Safety and Tolerability of Oral LCL161 in Japanese Adult Patients With Advanced Solid Tumors

This study will evaluate safety and tolerability to estimate the maximum tolerated dose and/or recommended dose of oral LCL161 in Japanese patients with advanced solid tumors.


Eligibility Criteria:
Inclusion criteria:

1. Patients with a histologically or cytologically confirmed diagnosis of a solid tumor for which no further effective standard treatment is available.
2. ECOG performance status 0-1.
3. Patients must have recovered from all toxicities related to their previous treatment.

Exclusion criteria:

1. Unresolved nausea, vomiting, diarrhea or peripheral neuropathy CTCAE grade \>1.
2. History of or current interstitial lung disease or autoimmune disease.
3. History of or current impaired cardiac function or clinically significant cardiac diseases.
4. Women of child-bearing potential, unless they are using highly effective methods of contraception.

Other protocol-defined inclusion/exclusion criteria may apply.
Using Cueing Interventions to Promote Breastfeeding

Background: Interventions focusing on promoting good behavioural intentions were found to only have small-to-moderate effect sizes on changing the actual behaviours. Self-regulation plays an important role to maintain individual attentions to the distant benefits of healthy behaviours and resist to proximal tempting cues from unhealthy behaviours, and thereby facilitate the translation of good intention into actual behaviours. However, self-regulation resources are limited and can be depleted in certain contexts. Providing environmental cues relevant to the desirable behaviours can activate the nonconscious process and lead to behavioural change without conscious awareness, the underlying mechanism of cueing interventions.

Aims: To test the effectiveness of using two types of cues, social normative and goal-related cues, to activate the nonconscious process for facilitating the translation of intentions into actual behaviours. We hypothesize that (1) cueing interventions will be more effective than will conventional education-based interventions (providing factual information about health benefits) be for changing behaviours; (2) cueing interventions are more effective for participants who have a tendency to use an intuitive mode in information processing; and (3) goal priming is more effective for participants with stronger motivation to pursue the goal of sustaining breastfeeding.

Subject and study design: The hypotheses will be tested in the behavioural context of breastfeeding among first-time mothers because: first, primiparous women may have less self-regulation resources due to high cognitive demand for postpartum adjustment during motherhood transition; and second, while breastfeeding intention and initiation were high, maintaining breastfeeding for the first six months postpartum was generally low in Hong Kong, indicating a substantial intention-behaviour gap. We propose to recruit 600 primiparous women. Baseline assessments will be conducted face-to-face using a standardized questionnaire. Participants will be randomly allocated to the control group (receive education-based messages about the health benefit of breastfeeding) or one of the two intervention groups (receive either social normative cues or goal-related cues related to breastfeeding). All messages will be delivered through smartphone on a daily basis over 16 weeks postpartum.


Eligibility Criteria:
Inclusion Criteria:

* being ≥18 years
* being Chinese ethnicity and Hong Kong residents
* without any serious medical or obstetric complications
* having a full-term (i.e. gestational age ≥37 weeks) healthy infant with normal birthweight (≥2,500 grams)

Exclusion Criteria:

* with linguistic and cognitive barriers impeding completion of face-to-face and telephone interviews or comprehension of the intervention materials
* physical anomalies that contraindicate breastfeeding
Carotid Web and Stroke Registry.

Introduction:

Carotid Web (CW) is a common cause of stroke in young patients with a high recurrence rate. The factors associated with recurrences and the appropriate treatment to prevent them are currently unknown.

Main objective:

To compare recurrences of ischemic stroke (cerebral infarction or transient ischemic attack) in patients with CW according to the preventive treatment.

Secondary objectives:

* To describe the frequency of recurrences in patients with stroke and CW.
* To compare the risk of complications, especially hemorrhagic complications, in patients with stroke and CW according to the type of preventive treatment given.
* To describe the clinical and radiological characteristics of CW and identify which are associated with recurrences.
* To detect genetic polymorphisms associated with the presence of CW in stroke patients.

Study design:

Multicenter, prospective registry of consecutive cases with ischemic stroke in which a Carotid Web is detected between 2022 and 2024.

All patients with ischemic stroke or transient ischemic attack and age \> or = 18 years, in whom a Carotid Web is diagnosed, will be included. Demographic and clinical variables, genetic study (not mandatory), diagnostic methods of CW, reperfusion treatment and secondary prevention will be collected. During a minimum follow-up of six months, vascular events (stroke, transient ischemic accidents, cerebral hemorrhages) and treatments (antiplatelet therapy, anticoagulation, endarterectomy, endovascular therapy) will be collected.

Once the registry has been completed, the frequency of recurrences and the factors associated with them will be analyzed.

Study population:

Patients with ischemic stroke or transient ischemic attack in whom a Carotid Web is detected. It is estimated to obtain data from approximately 100 patients.

Variables:

Demographic, clinical (past medical history, stroke characteristics), radiological (diagnostic method of CW, morphological characteristics of CW), therapeutic (preventive treatment initiated) and prognostic variables will be collected. Recurrences in the form of stroke or transient ischemic attack (main variable) will be collected during a minimum follow-up of six months. Cerebral hemorrhages, mortality and therapeutic changes during follow-up will also be collected.

Ethical considerations:

This is an observational registry, with no changes in the management or treatment of the patients included, and with an anonymized data registry. Written informed consent will be requested from the patient or his/her representative for participation in the registry and for obtaining a blood sample for the genetic study.


Eligibility Criteria:
Inclusion Criteria:

* Patients with ischemic stroke or TIA and
* Age \> or = 18 years.
* Carotid Web diagnosed by angioCT, angioMRI or arteriography.
* Consent to participate from patient or representative

Exclusion Criteria:

* No informed consent obtained
The Effects of a Probiotic Fermented Milk on Functional Constipation in Adults

The purpose of this study is to determine the effects of daily consumption for 4 weeks of a fermented milk drink containing a live probiotic microorganism, Lactobacillus casei strain Shirota (LcS) compared to a placebo without LcS, among adults with functional constipation.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with functional constipation based on ROME II criteria
* Has a constipation severity score (Chinese Constipation Questionnaire or CCQ score) of at least 5, which is the cut-off point for constipated subjects (Chan et al, 2005)
* Free of any cardiovascular related diseases, diabetes, cancer, neurological diseases or any other serious illness, not physically or mentally handicapped
* Living in Klang Valley, with no pre-determined plans to be out of town for one week or longer during scheduled intervention period

Exclusion Criteria:

* Body Mass Index of less than 16, or 30 and above
* Pregnant
* Regular ingestion of probiotic products within the preceding four weeks
* Regular use of laxatives (average once a week or more)
* Intake of anticholinergics medications or medications against diarrhea or antibiotics in the preceding 1 month
* Persons with milk protein allergy
* Persons with constipation of organic or neurological origin based on health screening
* Persons with alarm features as assessed by physician during health screening
Autologous Slings With Vesico-Vaginal Fistula Repair

It is clear from multiple accounts in the literature that patients with a vesico-vaginal fistula (VVF) involving the bladder neck and/or proximal urethra have a high likelihood of residual incontinence. Performing subsequent surgeries after the initial VVF repair risks additional complications. Therefore, placement of an autologous sling at the time of initial VVF repair would not only assist in covering the fistula, but would also imitate the physiologic support that would theoretically improve urethral function. A rectus fascia sling would most naturally provide this support and warrants testing against the success of the PC sling.

Using the Goh scoring criteria, Goh class 3 and 4 VVF's are the type most involving the urethra. Therefore, this group of patients is the target population for this study. As there is currently no standard of care for repairing large urethral defects, this procedural technique combined with otherwise standardized fistula repair would not introduce any foreseeable harm to patients.


Eligibility Criteria:
Inclusion Criteria:

* Women with vesico-vaginal fistulas classified as Goh 3 or 4 at the time of surgery
* Patients who have consented for an autologous sling
* Patients who have not previously undergone repair attempt

Exclusion Criteria:

* Patients who require an abdominal approach to the VVF repair
* Patients found at surgery not to have a Goh 3 or 4 class VVF
* Patients requiring a complete urethral reconstruction
* Patients who have undergone previous attempt at repair
* Patients who require an alternative tissue grafting other than the rectus fascia or pubbococcygeus decided by the surgeon at the time of surgery
The Potential of Kava in Enabling Tobacco Cessation - Its Holistic Effects in Managing Stress and Insomnia Associated With Abstinence

This study will evaluate the compliance with a daily kava regimen among active smokers who have an intention to quit smoking. This study will also investigate whether kava use can facilitate tobacco cessation, reduce stress, and improve sleep.


Eligibility Criteria:
Inclusion Criteria:

* adults aged 21 years or above (legal age for smoking in the U.S.) up to 99 years old;
* self-reported smoking at least 10 cigarette/day for the past year with INTENTION to quit;
* expired carbon monoxide level of more than 8 ppm at recruitment;
* willingness to participate in the proposed study;
* access to a functional telephone;
* expected presence in the study's geographical area for the next 4 months;
* not currently enrolled in any smoking cessation programs; and
* female subjects of childbearing potential will be required to practice acceptable methods of birth control (the acceptable methods of birth control include birth control pills, Birth Control Shot, Birth Control Implant, IUD, Diaphragm, and cervical cap).
* if a participant takes kava dietary supplement, a 2-week washout period is needed for the participant to initiate this study or if a participant participated in a kava trial before, such as the kava JEK trial, the participant could be enrolled if the inclusion criteria above are met, including the 2-week washout period.

Exclusion Criteria:

* diagnosed with cancer (other than non-melanoma skin cancer);
* diagnosed with liver dysfunction or with previous liver diseases;
* levels of alanine transaminase, aspartate transaminase, alkaline phosphatase or total bilirubin over limit of normal (ULN) range at prescreen;
* inability to refrain from acetaminophen, alcohol (no more than one drink daily via self-report), or other potentially hepatotoxic substances;
* use any other non-cigarette nicotine containing products such as smokeless tobacco, cigar or e-cigarettes; or
* are pregnant or nursing (lactating) or of childbearing age planning to become pregnant or unwilling to use adequate contraception during the study;
* participant answered "Yes" to any of the Modified Ask Suicide Screening Questions questions 1 through 4, or refuses to answer. If subject answers 'Yes' to question 4 but the most recent suicide attempt took place \>12 months from screening visit then subject is still eligible.
Isokinetic Testing Protocol in Elderly and Young Men

An age-related decrease in muscular strength may have a detrimental effect on muscle fatigue and recovery. To date, only one study has determined the effect of varied rest intervals (RI) between exercise sets in active younger and older women. They reported that active younger and older women require similar RI between sets to recovery full isokinetic knee extension peak torque (PT). However, we are unaware of any published studies comparing RI PT recovery between younger and older men. Thus, the purpose of this study was to compare the effect of two different RI's between sets of isokinetic knee extension exercise on PT, and Total Work (TW) between untrained younger and older men.

18 young men (24.22 ± 2.58 yrs) and 20 older men (66.85 ± 4.02 yrs) performed 3 sets of 10 unilateral isokinetic knee extension repetitions at 60°/s. The rest intervals between sets were 1 and 2 minutes and were counterbalanced across 2 testing days, separated by a minimum of 48 hours. The work-to-rest ratio was 1:3 and 1:6. All subjects were not involved in exercise programs that included resistance exercises within the last 6 months. Statistical evaluation of the data was performed using a 2x 2 x 3 mixed factor repeated measures ANOVA \[age (younger and older) x rest interval (1 and 2 min) x set (1st, 2nd, and 3rd)\]. Statistical significance was set at p \< 0.05 for all comparisons.

Eligibility Criteria:
Inclusion Criteria:

* Less than 75 years
* Independent

Exclusion Criteria:

* History of cardiovascular disease
* Hypertension
* Orthopedic disease