cyrilzakka/clinical-trials huggingface dataset:
Evaluating Pyrroloquinoline Quinone (PQQ) for Improving Obese Pregnancy Outcomes

Maternal obesity (MO) affects 1 in 5 women and is strongly linked to increased birth weight, childhood/adolescent obesity, life-long metabolic and inflammatory disorders, and childhood neuropsychiatric disorders. There remains a critical unmet need for developing a safe and effective non-pharmacological approach for attenuating metabolic inflammation and ameliorating the adverse effects of MO on offspring health that originate in utero and extend into the lactational period. Pyrroloquinoline quinone (PQQ) is a diet-derived natural food supplement with anti-inflammatory properties that, in humans and mice, improves metabolism and exerts potent immunoregulatory effects. Researchers' central hypothesis is that PQQ administration during MO pregnancy 1) improves maternal metabolic and inflammatory indices, 2) improves utero-placental blood flow and ameliorates placental maladaptation (oxidative stress, hypoxia, inflammation and fatty acid transporter expression) and 3) reduces neonatal adiposity.

Women with a body mass index (BMI) greater than 30 will be recruited during their first trimester clinic visit up to 16 weeks of gestation. In addition to the blood draw and anthropometric measurements normally carried out at the first pre-natal visit, researchers will provide consented study subjects with pyrroloquinoline quinone (PQQ) or placebo in capsules at a dose of 20 milligrams per day. There will be 15 women per group. At \~30 days after initiating the study (4-week routine follow-up visit) blood samples will be obtained. At \~24-28 weeks gestation, during the 2nd trimester visit, study subjects will undergo the standard 1-hour oral glucose screen, routine prenatal complete blood count (CBC) evaluation, study maternal blood sampling, and anthropometric measurements. During the delivery inpatient admission, researchers will again collect maternal blood as well as placental tissue, and umbilical cord blood (plasma, aperipheral blood mononuclear cells) after delivery. Placental tissue (samples from four separate cotyledons) will be collected for protein (homogenate and plasma membrane isolation), ribonucleic acid (RNA), quantitative polymerase chain reaction (qPCR), and histology (fixed in 4% paraformaldehyde). The neonate will undergo PeaPod evaluation prior to discharge, and within 72 hours after birth. PQQ supplementation will continue for 30 days post-partum at which time maternal blood and breastmilk samples will be collected, as well as a follow up infant Peapod evaluation and maternal dual x-ray absorptiometry (DEXA) scan.

Eligibility Criteria:
Inclusion Criteria:

* Adult women
* Body mass index \>30 kg/m2
* Currently pregnant with gestational age up to 16 wks

Exclusion Criteria:

* Women with pregestational diabetes (type 1 or type 2)
* Smokers
* Women with other risk factors for placental insufficiency or preterm delivery
* Advanced maternal age (age ≥40 yrs)
* Pre-existing chronic hypertension
* Renal disease
* Thrombophilias
* Substance use
* Human immunodeficiency virus (HIV)
* Hepatitis C
* Autoimmune disorders
Alcohol Intake, Alcohol Metabolizing Enzymes Gene Polymorphisms and the Risk of Colorectal Cancer

According to the statistic reports from World Health Organization (WHO) International Agency for Research on Cancer (IARC), the incidence and mortality rate of colorectal cancer ranked third and fourth respectively among ten most commonly diagnosed cancer worldwide; moreover, based on the statistics from Health Promotion Administration, Ministry of Health and Welfare in Taiwan, the incidence and mortality rate of colorectal cancer ranked second and third respectively among call cancer in Taiwanese population. However, if colorectal cancer is diagnosed and treated in early phase, the 5-year survival rate for stage I colorectal cancer can be up to 90%; on the other hand, the 5-year survival rate for end stage colorectal cancer is only approximately 10%. Therefore, the screening, early diagnosis od colorectal cancer is crucial. To date, there are some known risk factors for colorectal cancer, including familial adenomatous polyposis, obesity, physical inactivity, etc. Alcohol had also been identified as an important risk factor for colorectal cancer, and the risk could be higher among Asian population because of the reduced enzymatic activity of some of the alcohol metabolizing enzymes. Thus, through this study, the investigators hope to find out the risk factors of colorectal cancer among Taiwanese population, including alcohol metabolizing enzyme gene polymorphisms and their interaction with environmental factors, to attain the purpose of early prevention of colorectal cancer.

The purpose of this study is to find out relationship between alcohol metabolizing enzyme gene polymorphism and colorectal cancer, and discuss the impact of the interaction between gene polymorphism and environmental factors on the risk of colorectal cancer.

Eligibility Criteria:
Inclusion criteria:

Case:

* Histologically confirmed colorectal adenocarcinoma at National Taiwan University Hospital (NTUH) from 2000 to 2016
* Age \>20 at the time of inclusion

Control:

* No diagnosis of colorectal cancer
* Age \>20 at the time of inclusion
* Family members of case, including parents, siblings, offspring, spouse mother-in-law or daughter-in-law

Exclusion criteria (Both for case and control):

* History of familial adenomatous polyposis
* History of partial or total removal of the colorectum
* History of inflammatory bowl disease
* History of malignant neoplasms
Study Evaluating Intepirdine (RVT-101) on Gait and Balance in Subjects With Dementia

This study seeks to evaluate the effect of intepirdine (RVT-101) on gait and balance in patients with Alzheimer's Disease, Dementia with Lewy Bodies or Parkinson's Disease Dementia.

To assess the effect of intepirdine (RVT-101) versus placebo on quantitative and qualitative gait and balance parameters.

Each subject will be randomized 1:1 to one of the following sequences:

Sequence 1: AB = RVT-101 35 mg during the early treatment period and Placebo during the late treatment period

Sequence 2: BA = Placebo during the early treatment period and RVT-101 35 mg during the late treatment period

Treatment A = RVT-101 35 mg once daily.

Treatment B = Placebo once daily.

Eligibility Criteria:
Key Inclusion Criteria:

Male or female subject with a clinical diagnosis of Alzheimer's disease (AD), dementia with Lewy bodies (DLB), or Parkinson's disease dementia (PDD).

Mini Mental State Examination score 14 to 26 Gait impairment, as assessed by history gathered by the clinical investigator and quantitative measurements Subjects must be on stable background acetylcholinesterase inhibitor therapy

Key Exclusion Criteria:

History and/or evidence of any other CNS disorder that could be interpreted as a cause of dementia (in the opinion of the investigator) Any clinically relevant concomitant disease which, in the opinion of the investigator, makes the subject unsuitable for inclusion in the study.
INCA - Intervention and Neuropsychology in Cannabis Abuse

INCA (Intervention and Neuropsychology of Cannabis Abuse) is a study combining two research goals. One is to study efficacy of a short intervention the 'Problem Profile Intervention', which utilizes individual feedback from a 'substance problem check-up'. Subjects will randomly receive the 'Problem Profile Intervention' or the WHO Brief Intervention, a brief intervention, which has been shown to be efficacious. Currently efficiency studies are under way. The WHO Brief Intervention has been translated into German by our group. In contrast to most other cannabis intervention studies the current study is focussed on cannabis abusers not so much cannabis-dependent subjects. A total of 160 subjects are to be recruited. Half of them will randomly receive either the Problem Profile Intervention or the WHO Brief Intervention (active control). A total of 25% of subjects from each group will be placed on a 3 months waiting list before receiving the intervention (inactive control). Intervention outcome will be assessed three months, six month and 12 months after the intervention. We hypothesize cannabis use to be reduced by 25% by the 'Problem Profile Intervention'. The second aim of the study is to study mechanism of substance abuse. Initial results from own studies and data from other groups point to executive cognitive functions as a subtle but important factor that can be compromised in cannabis users (Verdejo-Garcia et al., 2004; Garavan and Stout, 2005). Using an fMRI-study, we intend to examine a subgroup of our subjects on a specific aspect of executive functioning that has recently received major interest in drug research: Decision-making capability, or risk-taking behaviour, respectively (e.g. Ernst and Paulus, 2005).


Eligibility Criteria:
Inclusion Criteria:

* ASSIST-Score for cannabis consume ≥ 4 ≤ 26
* german mother tongue (or comparable level)

Exclusion Criteria:

* major current psychiatric disorder (e.g. psychosis)
* addiction to other illegal drugs or alcohol
* recent or current intravenous drug use
* CNS-affecting medication
* current psychotherapy, other treatment for substance use disorder

exclusion criteria for fMRI-part:

* left-handedness
* medication (birth control pill, thyroid gland hormones possible)
* internistic illnesses (hypertension, diabetes, diseases of lungs)
* metallic implants (cardiac pacemaker, ferromagnetic object implanted through surgical intervention or accident, large-area tattoos)
* history of serious trauma
* claustrophobia
* gestation
EPAD Monitoring of Patients Undergoing Robotic Assisted Laparoscopic Genitourinary Surgery

Participants to be enrolled in this study will have been scheduled to have laparoscopic genitourinary surgery and EPAD monitoring as part of their clinical care intraoperatively. Patients scheduled for genitourinary surgery are often at risk for developing nerve injuries due to intraoperative positioning.

Somatosensory evoked potential devices (SSEP) are commonly used to detect pending injury to peripheral nerves. The purpose of the present study is to use SSEP monitoring to determine the incidence and potential causes of significant changes in SSEP waveforms and correlate these changes with neurologic status of the brachial plexus after robotic surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled to undergo robotic assisted laparoscopic genitourinary surgery
* Patients who are scheduled to have EPAD monitoring as part of their clinical care intraoperatively

Exclusion Criteria:

• Patients with previous history of polyneuropathy, carpal tunnel, ulnar neuropathy, or similar neurological deficiencies
Effects of Endotracheal Tube Fixation Methods on Hemodynamic Parameters During Endotracheal Suction

Background: Endotracheal suction (ES), may cause changes like increase in blood pressure, heart rate (HR) and decrease in peripheral oxygen saturation (SpO2), which may cause changes in hemodynamic parameters (HPs) that increase the workload of the heart after surgery.

Aim: The aim of this study is to determine the effect of the methods used in endotracheal tube (ET) fixation on HPs \[systolic blood pressure (SBP), diastolic blood pressure (DBP), HR and SpO2\] during ES.

Study Design: The sample of this prospective, single-blind non-randomized clinical trial study included 86 intubated patients who were treated in the cardiovascular surgery intensive care unit (CVSICU) of a university hospital between September 2016 and December 2017.

Methods: The ET fixations of the experimental group (n=43) were performed with tube holders while the ET fixations of the control group (n=43) were performed using plasters. The HPs of the patients were measured before, during, at the end of suction and 5 and 15 minutes after suction.

Information collected from the relatives of the patient, patient file and the health care workers was used to fill out the "Patient Information Form".

When the study started, the first 43 patients were assigned to the control group and the following 43 patients were assigned to the study group in the CVS ICU. ET fixation in the control group was performed with plasters, which are routinely used in the ICU where the study was conducted. ET fixation of the patients in the study group was performed with an ET holder (AnchorFast Oral Endotracheal Tube Fastener, Hollister, Liberlyville, USA) when they arrived at the CVS ICU.

When the findings of patients' suction needs were observed (increase in respiratory rate, HR increase, arterial BP increase, high pressure alarm in ventilator, mucus in ET, cyanosis, dyspnea, restlessness, sweating, disturbance of blood gas parameters, wheezing, etc.), endotracheal suction was performed according to the application standards. The patients' SBP, DBP, HR and SpO2 values, which were displayed on the bedside monitor (Nihon Kohden, Tokyo), were recorded on the "Hemodynamic Parameters Form" just before, during, and at the end of endotracheal suction, and in the following 5th and 15th minutes.

During the suction process, it was ensured that the patients were in the supine position in which the head of the bed was lifted by 30 degree Before the intra-arterial BP was measured, the transducer was reset at the level of the right atrial (plebostatic axis) and the position was not changed during all the measurements.

Eligibility Criteria:
Inclusion Criteria:

* postcardiac surgery
* having endotracheal tube

Exclusion Criteria:

- pulmonary problems
Brief Group Intervention Using EFT (Emotional Freedom Techniques) for Depression in College Students

Depression is an important mental health concern in college students. This study will recruit students who test positive for moderate to severe depression on the Beck Depression Inventory (BDI). Subjects will be randomly assigned to either a treatment or a control condition. Those in the treatment group will receive four 90 minute group classes using EFT (Emotional Freedom Techniques) to address traumatic memories and other self-identified causes of depression. It will compare them to a no treatment control group.


Eligibility Criteria:
Inclusion Criteria:

* A score of 19 or more on the Beck Depression Inventory
* Currently enrolled at the University of Santo Tomas
* Able to read, understand, and complete forms

Exclusion Criteria:

* None
The Effects of Eccentric Compared to Standard Strength Training in Primary Spinal Cord Injury Rehabilitation

The goal of this clinical trial is to assess the effects of eccentric arm-crank (KREHA) training compared to standard clinical routine strength (STAN) training in individuals undergoing primary spinal cord injury (SCI) rehabilitation.

The main questions this trail aims to answer are:

* what are the effects of the training on upper body strength, aerobic performance, muscle volume, functional independence, and health-related quality of life?
* is the KREHA training feasible to implement into the rehabilitation routine?

Participants will:

* perform either 20 KREHA sessions or 20 STAN sessions within 12 weeks
* perform a test battery to collect data on training effects before (pretest) and after (posttest) the study intervention


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older.
* informed consent as confirmed per signature.
* traumatic or disease-related SCI.
* participating in the routine strength training program during primary SCI rehabilitation at the study center (generally this is initiated around one month after SCI onset).
* wheelchair dependency during activities of daily living, defined by a score of 0-2 in the SCIM subsection regarding "Mobility in the house".
* passed sports medical assessment and having sufficient biceps/triceps function to perform arm-crank training, as determined by an experienced sports medicine physician

Exclusion Criteria:

* inflammatory or neurodegenerative diseases (including multiple sclerosis or Guillain-Barré syndrome).
* comorbidities or other health issues that may interfere with study participation, inability or contraindications to undergo the investigated intervention.
* MRI contraindications (magnetic metal parts or electronic implants such as pacemakers in the body).
* pregnancy (anamnestic).
Survival After Blood Transfusion in the French Administrative Regions of Burgundy and Franche-Comté

Red blood cell transfusion (RBC) is the main symptomatic treatment for severe anemia. RBC transfusion has proven its efficacy regarding mortality and morbidity, but it is not without side effects. The infectious side effects of transfusion are largely considered under control, non-infectious side effects are taking center stage. Seeking explanations for the beneficial and deleterious effects of RBC transfusions is necessary to ensure the safe and optimal use of this precious resource.

The investigators aim to study the impact of donor and RBC characteristics on patient survival.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 and over
* Erythrocyte Transfusion between 2007 and 2011
* Performed at the University Hospital of Besançon or Dijon

Exclusion Criteria:

* Transfusion of any blood product prior to January 1st, 2007
Long Term Safety Protocol for the AcrySof CACHET Phakic Lens

The purpose of this long term safety study is to estimate the annualized endothelial cell loss (ECL) rate (for up to 10 years following date of implantation) of subjects previously implanted with the ACRYSOF CACHET Phakic Intraocular Lens (L-series) from precursor clinical studies C-02-23, C-02-40, C-03-21 and C-05-57.

Subjects previously enrolled in protocols C-02-23 (NCT00726024), C-02-40 (NCT00727805), C-03-21 (NCT00726297), and C-05-57 (NCT00727688) who received an L-series lens either in the first eye or second eye (including those who were explanted) were enrolled in this open-label, non-randomized, non-controlled, extension study in which they attended postoperative visits for up to 10 years following the date of implantation. Subjects could enroll in the study at any time, thus the Entrance Visit may have coincided with any visit (Year 4 to Year 10).

Eligibility Criteria:
Inclusion Criteria:

* Previously implanted with an ACRYSOF CACHET Phakic Lens (L-Series) from clinical studies C-02-23, C-02-40, C-03-21 and C-05-57 and eligible for continued follow-up (i.e., exited from the previous study).
* Able to understand and sign a statement of informed consent.
* Willing and able to complete the yearly postoperative study visits.

Exclusion Criteria:

* None
Talocrural Mobilization With Movement in Spastic Cerebral Palsy

The aim of this randomized controlled trial is to find the effect of Mulligan's Mobilization with Movement of Talocrural joint in Cerebral Palsy Patients having spasticity on improving Ankle Range of Motion, improving balance and its effect on Gait speed.

Cerebral palsy is a neurodevelopmental disorder involving abnormalities in muscle tone and motor function due to damaged cerebral tissue in development. It is a nonprogressive upper motor neuron lesion characterized by abnormal tone, posture, balance and movement and clinically classified based on the predominant motor syndrome. In spastic CP, there is significant weakness that contributes to abnormal posture and movement. This is also accompanied by decreased muscle endurance and loss of selective motor control (SMC). Spastic diplegia is a very common form of CP, with a wide range of ambulatory outcomes, and is most frequently accompanied by ankle spasticity. Abnormalities, such as excessive plantar flexion of the ankle, leads to individuals with CP have in both static and dynamic balance.

Joint mobilization has not only the mechanical effect of disrupting the contracture by direct movement of the joint area, but also stimulates mechanoreceptor activation when stretching occurs in the capsule and ankle ligaments.

The Mulligan Mobilization with movement (MWM) is a physical therapy technique that combines joint mobilization techniques with active movement. It aims to improve joint range of motion, reduce stiffness, and enhance functional mobility, is expected to produce an instantaneous improvement in the patient's abilities by simultaneous applying of pain-free accessory glides.

This study will contribute in describing long lasting effects of Mobilization With Movement, with multiple assessments, on ankle range of motion, balance, and gait speed, and to check whether the amount of regaining is similar between patients undergoing MWM with conventional therapy and those with conventional therapy alone

Eligibility Criteria:
Inclusion Criteria:

* Both genders
* Age group 8-18 years
* Diagnosis of spastic Cerebral Palsy
* CP to follow verbal directions
* Modified Ashworth Scale score of '1' or '1+'
* Function classification system (GMFCS) level I or II ability to walk
* 10 m or more independently

Exclusion Criteria:

* visual, hearing disorders
* verbal and cognitive disorders (unable to comprehend commands)
* recent lower extremity surgery
* botulinum toxin injection
Clinical Outcomes After Acute Pulmonary Embolism

To investigate safety and effectiveness of PE treatment according to the decision of the multi-disciplinary pulmonary embolism response team (PERT) and to define and optimize treatment indications, institutional algorithms and interventional techniques for PE.

This single-center cohort study is designed to retrospectively and prospectively collect treatment and outcome data related to patients with PE and after activation of the PERT. Treatment information and outcomes after advanced treatment modalities, including systemic thrombolysis, catheter directed thrombolysis and surgical embolectomy, will be collected.

Retrospective patient data will consist of treatment and health related outcomes of consecutive patients treated for acute and chronic PE between October 2017 and April 2020 (to assess the learning curve of the PERT) and of patients receiving surgical embolectomy between January 2001 and April 2020. The retrospective data will be derived from the local institutional dataset and will be transferred to the study database. Prospective patients will be included after May 2020.

Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients with pulmonary embolism matching the criteria for treatment according to the decision of the PERT.
* Written informed consent

Exclusion Criteria:

* High probability of non-adherence to the follow up requirements
Southeast Asian Brugada Syndrome Cohort

Brugada syndrome (BrS) is the leading cause of sudden death in young Asian adults including Thailand. This syndrome may be hereditary and involve mutations in certain genes. Aim of the study is to identify the relationship between genetic variants and the diagnosis/clinical severity of patients with BrS.

This cohort study recruits BrS patients with confirmed Brugada type 1 ECG and healthy volunteers in Thailand. Data collection consists of demographic, clinical data, ECG and blood sample for genetic studies. Genotyping was done by whole genome sequencing and SNP array then compared between cases and controls. Each BrS patient will be followed up prospectively for symptoms and AICD shock. Subsequently, the study will analyze relationship between genetic variants and clinical data against clinical severity of BrS patients.

Eligibility Criteria:
Inclusion Criteria:

* Thai nationality
* The patient has at least one of confirmed Brugada type 1 ECG in at least one of right precordial leads (v1 or v2) with or without pharmacologic provocative testing. The confirmed ECG is standard 12 lead ECG or Brugada lead

Exclusion Criteria:

* The patient has other cardiac diseases such as ischemic heart disease, valvular heart disease, congenital heart disease, myocarditis and pericarditis
* The patient has type 2 or type 3 Brugada ECG without type 1 ECG during pharmacologic provocative testing and/or Brugada lead
* The patient had one time of Brugada type 1 ECG during drug use without reproducibility