cyrilzakka/clinical-trials huggingface dataset:
Cognitive Rehabilitation During Transcranial Direct Current Stimulation

The purpose of this study is to explore whether active transcranial direct current stimulation during cognitive rehabilitation tasks can boost cognitive enhancement without severe side effects in mild cognitive impairment or mild dementia patients.

This study explores the additive effect of transcranial direct stimulation compared to sham stimulation during cognitive rehabilitation tasks in mild cognitive impairment or mild dementia patients. Potential participants are recruited by physicians' referral or self-entry. Informed consent by a clinical research coordinator and research physician is performed followed by screening. Participants who passed screening go through 10 sessions of active or sham transcranial direct current stimulation and are evaluated their cognitive function at screening, at the end, and two weeks after the intervention. For quality assurance, independent researcher regularly monitor and audit as participants are enrolled in the trial.

Eligibility Criteria:
Inclusion Criteria:

* participants with a diagnosis of either major neurocognitive disorder or mild neurocognitive disorder, defined in Diagnostic and Statistical Manual of Mental disorder (DSM-5)
* taking the stable dose of psychotropic medication, such as cholinesterase inhibitors or NMDA(N-methyl-D-aspartate) receptor antagonist, for the past two weeks
* ambulant by oneself with or without aiding devices.

Exclusion Criteria:

* with severe psychotic symptoms requiring antipsychotic treatment
* with risks of hospitalization within 6 weeks because of severe depression and/or suicide ideation
* clinically contraindicated to electroconvulsive therapy (ECT) or transcranial direct current stimulation (tDCS)
* with the Mini-Mental State Examination (MMSE) score of less than 18 or the Clinical Dementia Rating Scale (CDR) score of more than 2,
* unable to participate for more than 2 days during the trial
* unable to write a sentence or copy a figure on MMSE at screening.
Pigtail Catheter Versus Chest Tube in the Management of Traumatic Pneumothorax

A small 14-French(F) pigtail catheter (PC) has been shown to work equally well with traditional 32-40F chest tube (CT), especially in traumatic pneumothorax.

There are no clinical data on tube-site pain. The investigators hypothesize that PC tube site pain is less than CT.

Primary outcome: - Tube site pain

* Pain medication requirement

Secondary outcome: failure rate insertion-related complication

Eligibility Criteria:
Inclusion Criteria:

* 18 years old and above
* Suffer traumatic pneumothorax that requires chest tube insertion

Exclusion Criteria:

* Emergency chest tube insertion
* patient refuses
* patient is unable to provide or rate pain assessment
* prisoner
* pregnancy
* patient with GCS less than 13
MK0429 Study in Prostate Cancer Patients With Metastatic Bone Disease (0429-011)

This two part study will evaluate the safety and tolerability of MK0429 in addition to assessing it's pharmacokinetic profile and pharmacodynamic response.


Eligibility Criteria:
Inclusion Criteria:

* Eligible patients must have:

  * Prostate cancer
  * Bone metastases without symptoms
  * Lack of response to hormone therapy as evidenced by a rising PSA or clinical progression

Exclusion Criteria:

* Prostate cancer-related bone pain
* Previously received bisphosphonate therapy (e.g. zoledronate)
* Received any investigational treatment within the last 30 days
Azithromycin for Uncomplicated Severe Acute Malnutrition in Burkina Faso (Pilot)

This pilot study is a randomized controlled trial designed to test the effect of the administration of adjunctive azithromycin in conjunction with standard outpatient treatment for uncomplicated severe acute malnutrition (SAM) in children aged 6-59 months. Children presenting to nutritional programs in Burkina Faso who meet eligibility criteria will be randomized to a single dose of oral azithromycin or a 7-day course of amoxicillin (standard of care) upon admission into the program. All enrolled children will receive ready-to-use therapeutic foods (RUTF). Enrolled children will be followed at each weekly clinic follow-up visit up to 8 weeks following admission. Data on anthropometric indicators, vital status, and adverse events will be collected during follow-up. Nutritional recovery over the 8-week study period will be compared by arm.


Eligibility Criteria:
Inclusion Criteria:

* Age 6-59 months
* WHZ \<-3 SD or MUAC \<115 mm
* No nutritional edema
* Able and willing to participate in full 8-week study
* Has not been admitted to a nutritional program for the treatment of SAM in the 3 preceeding months
* No antibiotic use in past 7 days
* No clinical complications requiring inpatient treatment (except for routine admission for children \<6 months)
* No congenital abnormality or chronic debilitating illness that would lead to predictable growth faltering or reduce likelihood of SAM treatment benefit (such as cerebral palsy, Down syndrome, congenital heart disease, cleft lip/palate, etc)
* No allergy to macrolides/azalides
* Sufficient appetite according to a feeding test with ready-to-use therapeutic food (RUTF)
* Appropriate consent from at least one parent or guardian

Exclusion Criteria:

* Age \<6 months or \>59 months
* WHZ ≥-3 SD or MUAC ≥115 mm
* Nutritional edema
* Not able or willing to participate in full 8-week study
* Admission to a nutritional program for the treatment of SAM in the 3 preceeding months
* Antibiotic use in past 7 days
* Clinical complications requiring inpatient treatment
* Congenital abnormality or chronic debilitating illness that would lead to predictable growth faltering or reduce likelihood of SAM treatment benefit (such as cerebral palsy, Down syndrome, congenital heart disease, cleft lip/palate, etc)
* Allergy to macrolides/azalides
* Insufficient appetite according to a feeding test with ready-to-use therapeutic food (RUTF)
* Parent or guardian refuses to provide consent
the Change in Carotid Intima-media Thickness After Laparoscopic Sleeve Gastrectomy

The aim of this study was to compare carotid intima-media thicknesses in laparoscopic sleeve gastrectomy patients preoperatively and at the end of the first postoperative year.

Obesity is not only a disease in itself, but also predisposes to many other diseases. Cardiac diseases are one of the systems that obesity predisposes to. Obesity has been found to increase the risk of cardiac disease by increasing carotid intima-media thickness in patients with obesity. Surgery is known to be the most effective treatment for obesity and laparoscopic sleeve gastrectomy is the most common bariatric surgery procedure. Laparoscopic sleeve gastrectomy may reduce the risk of cardiac disease by reducing carotid intima-media thickness in patients with obesity through effective weight loss.

Eligibility Criteria:
Inclusion Criteria:

* 18-65 years old,
* BMI \> 35 kg/m2
* Laparoscopic sleeve gastrectomy will be performed
* patients with cardiac disease

Exclusion Criteria:

* patients without cardiac disease
* patients who performed other bariatric surgery procedures
Evaluation of Sestrin Levels in Patients With Endometriosis

Serum sestrin levels of endometriosis patients are compared with a group of healthy volunteers of the same age.

Serum sestrin levels are compared with 45 endometriosis patients and 45 healthy volunteers of the same age. The energy metabolism of the endometriosis group and its possible relationship with the endometriosis stage will be compared since sestrin gives information about the energy metabolism of the people.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed with endometriosis (Surgery or ultrasound)
* Women without endometriosis

Exclusion Criteria:

* Women without endometriosis
* women who are only suspected endometriosis
Treatment of Crohn's Fistula Using a Porcine Intestine Submucosa Graft

Healing anal fistulas in Crohn's patients with an anal fistula plug.

The purpose of this study is to determine whether the Surgisis anal fistula plug is effective in healing anal fistulas in patients diagnosed with Crohn's Disease.

Eligibility Criteria:
Inclusion Criteria:

* Patient is diagnosed with Crohn's Disease
* Patient has a chronically draining anal fistula of Crohn's origin
* Patient is 18 years old or older
* Patient has signed an informed consent

Exclusion Criteria:

* Patient is pregnant or lactating
* Patient has peri-anal drainage with originates from outside the anorectal tract
Pharmacodynamics of Injection of Cisatracurium Base on Lean Body Mass Pattern to Maintain Deep Neuromuscular Blockade in Obese Patients

To observe the pharmacodynamics of intravenous injection of cisatracurium to maintain deep neuromuscular blockade in obese patients with lean body mass in laparoscopic colorectal surgery

According to the random number table method, one hundred and twenty patients who underwent elective laparoscopic colorectal surgery were divided into four groups (n=30): Normal weight patients according to lean body weight group(NL group), normal weight patients according to real weight group (NR group), obese patients according to lean body weight group(OL group), and obese patients according to real weight group(OR group).Intraoperative deep neuromuscular blockade (PTC≤2)was maintained in all four groups.The dosage of cisatracurium, the number of injections,time to effect,time to recovery from TOFr,time to recover TOFr（train-of-four rate） to 0.7 and 0.9,and time to stay in PCAU were recorded.The surgeon's satisfaction with the operative field and the average intraoperative pneumoperitoneum pressure were recorded at the time of pneumoperitoneum establishment,1 hour and 2 hours after pneumoperitoneum establishment.

Eligibility Criteria:
Inclusion Criteria:

* Laparoscopic Colorectal Surgery
* American Society of Anesthesiologists (ASA) grades I-III

Exclusion Criteria:

* Patients with heart, lung and other vital organ disorders
* Preoperative fluid and electrolyte disturbance
* Preoperative water and electrolyte disorders have a history of neuromuscular disease or take medications that have an impact on neuromuscular function
* There is a significant airway difficulty
* Refuse to sign informed consent
Metastatic Breast Carcinoma and Women Sexual Quality of Life

Sexual health is one of the relevant parameters for assesing the quality of life.

Improvement sexual and emotional function improves quality of life scores and depression or anxiety in curative phase.

The purpose of the study is to assess the quality of sexual life of postmenopausal women with metastatic breast cancer in couples and to establish links with overall quality of life and the quality of the relationship.

We use a quantitative methodology to assess quality of female sexual life, quality of life and quality o relationship with validated scientific questionnaires.

The sexual and emotional intimacy will be explored by semi structured interview, not mandatory for patients.

Eligibility Criteria:
Inclusion Criteria:

* Women with metastatic breast cancer
* Age ≥ 50 and \< 70 years old
* Diagnosis of metastatic breast cancer at least 6 months prior to study participation
* Patient living with a partner
* Menopausal women (absence of menstruation for 1 year minimum)
* ECOG performance status ≤ 2
* Affiliated to public health system
* Informed and having expressed her non-opposition

Exclusion Criteria:

* Patient in exclusive palliative care
* Single or not living in a couple
* Non-menopausal patient
Probiotics On Resistant Bacteria Colonization In Preterm Receiving Antibiotics

In this study, the investigators investigated the effect of probiotic use on colonization of resistant microorganisms in newborn preterm infants receiving antibiotics. This study of the use of probiotics in preterm neonates in neonatal intensive care units expect to prevent colonization by resistant microorganisms.

The gut which is sterile in newborn preterm infants begins to colonize with birth. Factors such as developmental immaturity of the immune system, encountering with the flora of neonatal intensive care unit, exposure to diagnostic and therapeutic interventional procedures, use of antibiotics, delay of enteral feeding may poorly affect the development of natural and mucosal immunity of intestine in newborns preterm during postnatal period. Exposure to these factors, newborn preterm infants' life threatens especially to change the development of the normal intestinal flora and intestinal immunity. Many randomized controlled studies reported that probiotics reduce intestinal inflammatory process and prevent colonization with pathogenic microorganisms of the intestines . In this study, the investigators investigated the effect of probiotic use on colonization of resistant microorganisms in newborn preterm infants receiving antibiotics.

Eligibility Criteria:
Inclusion Criteria:

* The study were included ≤36 weeks gestational age newborn preterm infants requiring antibiotic treatment and/or prophylaxis.

Exclusion Criteria:

* Newborn preterm infants who are congenital anomalies and not require antibiotic therapy and undergoing intestinal operation were excluded from the study.
Elastic Band Exercise on the Pain, Kinesiophobia, Functional, and Psychological Status

Aiming to determine the effects of elastic band exercise on kinesiophobia, functional capacity, and depression after the total knee arthroplasty, the present study was designed and carried out as a randomized controlled trial study. The study was carried out between October 2019 and April 2020 in the Physical Therapy and Rehabilitation Department of a training and research hospital.This study, the effects of elastic band exercise program on the pain, kinesiophobia, quality of life, depression, and functional capacity of TKA patients were examined. Elastic band exercise program significantly decreased the pain level, exercise fear, and depression level of patients and positively contributed to the quality of life and functional capacity.

All the participants were subjected to walking training and a standard postoperative care and exercise protocol until discharged from the hospital. During discharging, all the participants in both groups were provided with explanation and illustration about how to perform the exercises. In order to prevent any problem, the participants in both groups were recommended to start the at-home rehabilitation programs, which incorporate knee movement exercises, to be ready 2 weeks (14 days) after the surgery and they were asked to continue their current exercise programs thus far. The patients in control group were recommended to maintain only an at-home exercise program incorporating knee flexion and extension exercises.

The patients in intervention group were recommended to do, in addition to the at-home exercise program given to the patients in control group, elastic band exercises and researchers showed them how to use the elastic bands by making use of instructions.The participants were asked to do exercise 4 times a day with a minimum of 2 hours interval between the sessions. The participants were instructed to avoid elastic band exercise 1 hour before or after the meals in order to prevent a physical impairment and to adopt a moderately progressive approach in order to prevent lower extremity pain after exercise and to increase the sense of success and confidence.

Eligibility Criteria:
Inclusion Criteria:

Unilateral Total Knee Arthroplasty

Exclusion Criteria:

Bilateral Total Knee Arthroplasty
Romanian National Registry of Outcomes After Transcatheter Aortic Valve Implantation in Patients With Severe Aortic Stenosis - RO-TAVI

RO-TAVI is a national prospective, observational, multi-center registry registry of patients with aortic valve stenosis undergoing transcatheter aortic valve implantation (TAVI) to assess patient care and outcomes.

Background: Since the establishment of transcatheter aortic valve implantation (TAVI) in Romania in 2015 there has been a growing number of interventions being performed by an increasing number of hospitals throughout the country. In 2018, there were more than 250 implants, which are expected to grow in the following years by about 30% on an annual basis.

Objective: This is a national quality assurance initiative to improve patient care and outcomes. It further serves as a database for the assessment of the safety and efficacy of TAVI and its financial implications (e.g. reimbursement).

Design: National, prospective, observational, multi-center registry. All centers performing TAVI in Romania; minimum cases per center for inclusion: 20 cases/year-to-date Population: All patients undergoing TAVI in Romania at any of the participating centers with a CE-marked valve of any manufacturer given that they provide written informed consent.

Eligibility Criteria:
Inclusion Criteria:

* severe symptomatic aortic valve stenosis
* high risk or patients deemed amenable for TAVI by a multidisciplinary team
* signed informed consent to participate in the study

Exclusion Criteria:

* inadequate annulus size (\<18 mm, \>29 mm)
* left ventricle thrombus
* active endocarditis
* high risk of coronary ostium obstruction
* plaques with mobile thrombi in the ascending aorta, or arch
* hemodynamic instability
* estimated life expectancy \<1 year
* comorbidity suggesting lack of improvement of quality of life
* other situations adjudicated by the local HeartTeam
PHACE - Prospective Genetic Investigation

Investigation for potential PHACE syndrome gene.

Subjects with PHACE syndrome diagnosis will undergo a brief physical examination with possible external photographs. Cheek swabs will be sent for genetic analysis. Subjects will be notified of the results.

Eligibility Criteria:
Inclusion Criteria:

* PHACE syndrome diagnosis
* Must be willing to have an eye examination
* Must be willing to undergo genetic testing

Exclusion Criteria:

* No PHACE syndrome diagnosis
ProspectIve Cohort psoriASiS fOllow-up (PICASSO)

The main purpose of the PICASSO-project is to facilitate future psoriasis-research in dermatology. This register biobank will enable us to perform research in the field of metabolomics, mRNA-expression, cardiovascular impact and the microbiome. The final aims are patient stratification, better insight in disease-evolution and improved understanding of markers that predispose to severe disease.

The PICASSO-project is a prospective register with extensive biobanking in which patients with a recent onset of psoriasis (\<3 years) can be enrolled. Participants are followed for a period of 10 years, with scheduled visits every 2.5 years. The same protocol is followed for every visit. The registry captures patient demographics, medical history (personal and family), details of psoriasis treatment (previous and current), physical examination, disease activity scores and PROMs. Some patients (substudy) will undergo ultra-sound to determine carotid intima media thickness. Biobanking in this project encompasses extensive biosampling of multiple tissues. It is not within the scope of this project to administer study medication: patients receive standard of care treatment as prescribed by their physician.

Eligibility Criteria:
Inclusion Criteria:

* Clinical signs of Psoriasis since \>3 years
* adults (70 years old or less) and children (\>12 years old)
* willing and able to understand and sign the informed consent (plus legal representative in case of a minor)

Exclusion Criteria:

* unwilling or unable to understand and sign the informed consent
* disease duration longer than 3 years
Study Evaluating The Safety, Tolerability And Brain Function Of 2 Doses Of PF-0254920 In Subjects With Early Huntington's Disease

This study will evaluate the Safety, Tolerability and Brain Function of 2 doses of PF-0254920 in Subjects with Early Huntington's Disease.


Eligibility Criteria:
Inclusion Criteria:

* Must have a diagnosis of Huntington's Disease
* a CAG repeat expansion equal or great than 39
* a Unified Huntington Disease Rating Scale (UHDRS) Total Motor Score equal or greater than 5 and less than 60
* a UHDRS Total Functional Capacity equal or greater than 9

Exclusion Criteria:

* Subjects with evidence or history of severe acute or chronic medical condition or laboratory abnormality, or significant neurological disorder other than HD.
* Treatment with any antipsychotic medication within 5 weeks of enrollment
Use of Antibiotic Irrigation to Decrease Wound Infections in Pediatric Perforated Appendicitis

The proposed study will investigate whether antibiotic irrigation using a gentamicin/clindamycin solution during laparoscopic appendectomy is superior in preventing postoperative wound infections and IAA in perforated appendicitis compared to suction without irrigation. This will be the first prospective study to compare these two options in pediatric PA.

This study is for pediatric patients who are having an appendectomy and have a perforated appendix. The purpose of this study is to see whether antibiotic irrigation using gentamicin, clindamycin and suction during the surgery works better when compared to suction alone when cleaning the stomach cavity.

Arm A patients will have their abdomen irrigated with the antibiotics, gentamycin and clindamycin, and then the wound will be suctioned out. Arm B patients will not have the antibiotic irrigation but will have their wound suctioned.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female, age 18 years or younger
2. Scheduled to undergo laparoscopic appendectomy
3. Preoperative or intra-operative diagnosis of perforated appendicitis (PA).
4. Willingness to undergo treatments, provide written informed consent, and participate in follow-up.

Exclusion Criteria:

1. Male or female older than 18 years of age
2. Declined to undergo laparoscopic appendectomy
3. Not willing to provide written informed consent or undergo randomization of treatment
4. Pregnancy
Physical Activiy Intervention Programm

The purpose of this study is to evaluate the effectiveness of a recreational physical activity intervention for reducing the prevalence of overweight/obesity and other cardiovascular risk factors

A greater intensity of the intervention, and a longer weekly duration that extends until the weekend, could improve the efficiency in obesity.

Eligibility Criteria:
Inclusion Criteria:

* The parents of the children will be informed about the objectives and methods of the study, and will give their written consent to the participation of the children. Similarly, the study will introduce children from classroom to class and their oral consent will be obtained

Exclusion Criteria:

* Participating children will be free from serious learning difficulties, or physical or mental disorders, that could prevent participation in scheduled physical activities.
Comparison Between Oxomemazine, Guaifenesin and Potassium Iodate Versus Guaifenesin Monotherapy in Acute Cough Treatment

The purpose of this study is evaluate if efficacy of a combination dose of oxomemazine, guaifenesin and potassium iodate is superior than guaifenesin monotherapy in acute cough treatment.

STUDY DESIGN

* Open-label, superiority, prospective, parallel group, intent to treat trial
* Experiment duration: 7 days
* 3 visits (days 1, 2 and 7)
* Reduction cough symptoms
* Adverse events evaluation

Eligibility Criteria:
Inclusion Criteria:

1. Patients must be able to understand the study procedures agree to participate and give written consent.
2. Patients with productive cough as result an acute URTI (i.e., cold or flu) or allergic cough in the last 10 day.
3. Cough score superior to 3.

Exclusion Criteria:

1. Pregnancy or risk of pregnancy.
2. Lactation.
3. Fever above 38º C.
4. Patients with bacterial infections of the upper respiratory tract.
5. Any pathology or past medical condition that can interfere with this protocol.