cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Pramipexole Extended Release in the Treatment of Essential Tremor

Aim of the study is to perform a double-blind, crossover, placebo-controlled multicenter study evaluating the efficacy of pramipexole on essential tremor.

Essential tremor is one of the most common movement disorders with the prevalence of 3-5% among the elderly population. Although its main clinical feature is the bilateral, predominantly postural-kinetic tremor, newer studies suggest that ET is a spectrum of clinical features with both motor and nonmotor elements not homogeneously distributed.

Despite its high occurrence, the pharmacological treatment of ET is limited. Although the mainline drugs, propranolol and primidone, can provide good clinical benefit in a portion of cases, \>50% of the patients stop the medication due to inefficacy or side-effects. Hypotension, dizziness, bradycardia, cognitive impairment, fatigue and erectile dysfunction are the most common side-effects contributing to medication discontinuation.

In an open-label pilot study, the investigators previously demonstrated that 2.1 mg/day pramipexole extended-release improved both the severity of tremor (by 52%) and health-related quality of life.

The present study aims to confirm this hypothesis in a double-blind, crossover, placebo-controlled multicenter study.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of ET has to be unambiguous based on the clinical diagnostic criteria.
* Tremor has to be severe enough to produce disability.
* Patients must sign a written informed consent according with the approval of the Regional Ethical Board of University of Pécs

Exclusion Criteria:

* Exclusion criteria are established in accordance to the guidelines of Elble et al3.
* Presence of any medical conditions capable of producing tremor (e.g. hyperthyroidism, drug withdrawal, neuropathy, etc.).
* Except for cogwheel phenomenon, the presence of any abnormal neurological signs (e.g. dystonia, myoclonus, ataxia, parkinsonism, cerebellar or pyramidal signs, etc.)
* Atypical tremor appearance for ET (e.g. isolated vocal-cord tremor, orthostatic tremor, task-specific tremor, etc.)
* Presence or suspicion of psychogenic tremor
* Usage of medication capable of producing tremor (e.g. sympathomimetics, valproate, etc.)
* Concomitant administration of any drugs potentially capable of improving ET (e.g. antiepileptics, beta-receptor blockers).
* Previous neurosurgical treatment (e.g. deep brain stimulation or thalamotomy).
* Presence of serious concomitant disorders capable of interfering with the study (e.g. heart failure, tumorous disorders, etc.)
* Presence of any contraindication for pramipexole treatment (e.g. impulsive control disorder, known hypersensitivity to any components of the tablets, etc.)
Evaluate the Link Between the Characteristics of Oral Physiology and the Formation of the Food Bolus During the Consumption of Dairy Products in Elderly People

The aim of this study is to understand how dairy products enriched in minerals and proteins are broken down in the mouth. More specifically, investigators wish to evaluate the link between oral physiology (salivation and mastication) and formation of the food bolus during the consumption of enriched cheese, that is to say the way in which the food is broken down to be swallowed.

The study will take place at the INRA in Dijon during 2 one-hour sessions spread over 4 months. These two sessions will allow investigators to characterise the chewing behaviour of the subjects and their salivation, and the structure of the food bolus formed when eating the four products of the project.

For each of the four foods in each session:

* Two samples of saliva will be taken
* A video will be made of subjects eating one of the study products
* Subjects will chew the study foods and spit them out.


Eligibility Criteria:
Inclusion Criteria:

* Persons who have provided written consent
* Age ≥ 65 years old
* Persons living at home
* Persons who can travel independently

Exclusion Criteria:

* Adults under guardianship
* Persons without health insurance cover
* Persons in hospital
* Persons in institutions
* Persons whose Mini-Mental State Examination (MMSE) is \< 24
* Persons requiring enteral or parenteral nutrition
* Persons who in the previous 12 months received € 4500 for taking part in clinical trials, including the present study
* Persons in a period of exclusion of a previous study
* Food allergies (dairy products in particular)
The U.S. Embryologist Fatigue Study

The purpose of the study is to determine physical and mental health issues of U.S. embryologists related to their occupational characteristics, and how workplace fatigue and burnout may affect their quality of life, cynicism, interactions with patients, attention to detail, and lead to human error, the cause of the most severe IVF incidents that often make headlines and result in costly litigation. It will also correlate how the current manual workflows contribute to these health issues, and what measures can be taken to improve both working conditions and embryologists' health, and, therefore, improve patient care.

Embryologist fatigue surveys conducted in Spain and the United Kingdom reported that embryologists experience work-related mental health issues similar to surgeons in the United States (36.3% in Spanish and 27.8% in U.K. embryologists v. 34% in U.S. surgeons), as well as high rates of self-reported, work-related MSDs despite taking better care of themselves than the average population. Among prevalent mental issues, they highlighted fatigue, stress, and burnout as contributing factors to decreased efficiency, cynicism, and emotional exhaustion, which, together with having to handle the increasing cycle volume using conventional, manual protocols of cryomanagement, can lead to human error and IVF incidents. The known IVF incidents resulted in lost, damaged, or misplaced embryos and gametes, lawsuits, and reputational damage to patients and providers. In the absence of a "better than" cryopreservation storage solution, many programs just turned to buying more tanks and alarms and/or added expensive staff. The more effective solutions should focus on optimizing workflows by adopting innovation like automation and a digital chain of custody, organizational changes that will lead to a more productive, collaborative, and rewarding work environment, allowing embryologists to focus on patient care, scientific research, innovation, and career planning, and fewer incidents and lawsuits.

The purpose of this cross-sectional study using a web-based survey is to determine physical and mental health issues of U.S. embryologists related to their occupational characteristics, and how workplace fatigue and burnout may affect their quality of life, cynicism, interactions with patients, attention to detail, and lead to human error, the cause of the most severe IVF incidents that often make headlines and result in costly litigation. It will also correlate how the current manual workflows contribute to these health issues, and what measures can be taken to improve both working conditions and embryologists' health, and, therefore, improve patient care.

Eligibility Criteria:
Inclusion Criteria:

* complete surveys from embryologists;

Exclusion Criteria:

* incomplete surveys from embryologists; complete and incomplete surveys from non-embryologists.
Effects of tDCS Combined With CBI on Postsurgical Pain

The purpose of this study is to determine whether a new medical technology can help reduce post-operative total knee or hip pain when combined with a Cognitive-Behavioral intervention (CBI).

This new medical technology, is called transcranial direct current stimulation (tDCS), it uses a very small amount of electricity to temporarily stimulate specific areas of the brain thought to be involved in pain reduction. The electrical current passes through the skin, scalp, hair, and skull and requires no additional medication, sedation, or needles.

This study will investigate the effects of tDCS, the Cognitive-Behavioral (CB) intervention and their combination on pain among veterans following total knee arthroplasty (TKA) or total hip arthroplasty (THA). The Veteran may benefit in the form of decreased pain and opioid requirements following knee or hip replacement surgery. However, benefit is only likely if Veterans are randomized to one of the 3 (out of 4) groups.

This study hopes to determine the effects of these interventions and combined effect on post-operative pain, opioid use and functioning during the 48-hour post-operative period following a total knee or hip replacement.

The proposed study employs a randomized, double-blind, sham-controlled design to evaluate the effects of tDCS, brief Cognitive-Behavioral (CB) intervention and their combination on pain among veterans undergoing unilateral TKA or THA. 132 patients undergoing TKA/THA will be randomly assigned to one of four groups:

1. Group1- real tDCS + real CB intervention
2. Group2- real tDCS + education-only-control intervention
3. Group3- sham tDCS + real CB intervention
4. Group4- sham tDCS +education-only-control intervention

Participants will receive 2 tDCS/CBI treatments on the day of their surgery, and 2 tDCS/CBI treatments the day after their surgery. Participants' perioperative medication usage and pain ratings will be tracked during postoperative hospital stay. Follow-up data regarding pain and opioid use will be collected at 1, 3 and 6-months.

Eligibility Criteria:
Inclusion Criteria:

Participants will be 120 patients (132 recruited to account for 10% drop-out rate) undergoing TKA or THA surgery at the Ralph H. Johnson VAMC in Charleston SC.

* Mentally capable of reading, writing, giving consent, and following instructions
* Cleared for, and scheduled for unilateral TKA or THA surgery
* Able to hear CB intervention and understand educational materials through headphones in English

Exclusion Criteria:

* implanted medical devices above the waist
* pregnant
* history of seizures
* allergic to latex rubber
* psychiatric conditions except for depression and/or anxiety disorders (commonly seen in this population).
The Effect of External Pressure Applı̇ed to the Palm on Labor Paı̇n and Childbirth Experı̇ence

The study was carried out to evaluate the effect of external pressure applied to the palm on labor pain and childbirth experience.The sample of the randomized controlled study consisted of 60 nulliparous (30 in the experimental group and 30 in the control group) pregnant women who presented to Zeynep Kamil Gynecology and Pediatrics Training and Research Hospital between April and June 2020 to give birth and met the research conditions. The Descriptive Information Form, Follow-Up Form Related to Labor Action, Childbirth Experience Questionnaire (CEQ), and Visual Analogue Scale (VAS) were used in data collection. During the 5-6 cm, 7-8 cm, and 9-10 cm cervical dilatation stages of the labor process, palm external pressure was applied to the pregnant women in the experimental group, while standard midwifery care was provided to the pregnant women in the control group. The VAS was applied to both groups at admission to the hospital, before and after the 5-6 cm, 7-8 cm, and 9-10 cm cervical dilatation stages, and also at the 30th minute postpartum. Data were analyzed Statistical Package for Social Sciences 24.0 program using number, percentage, mean, standard deviation, the Kolmogorov-Smirnov test, Levene's test and independent samples t-test, one-way ANOVA test, analysis of variance, and chi-square test. In all analyses, p\<0.05 values will be considered statistically significant.

Labor pain adversely affects pregnant women's perception of the labor process and childbirth. When not taken under control, it causes pregnant women to have negative experiences about the labor process and consequently leads to a decrease in their satisfaction with childbirth. For this reason the study was carried out to evaluate the effect of external pressure applied to the palm on labor pain and childbirth experience. Hypotheses of the research; H 1 : External pressure applied to the palm during labor reduces the level of labor pain. H 1 : External pressure applied to the palm during labor increases the positive birth experience.

Eligibility Criteria:
Inclusion Criteria:

* Being aged between 18-35 years
* Being a nulliparous pregnant woman
* Being pregnant at term (between the 37th and 42nd weeks of gestation)
* Expecting the vaginal delivery
* Being in singleton and vertex presentation
* The weight of the fetus between 2500-4000 g
* Having had an uncomplicated pregnancy process for the pregnant woman and the fetus
* Being in the latent phase (cervical dilatation below 4 cm)

Exclusion Criteria:

* Having high-risk pregnancy
* Having any disease and disability related to the hand and palm
* Having any health problem preventing communication
* Being a pregnant woman in need of analgesics
* Pregnant women to whom non-pharmacological methods were applied to relieve pain
* Undergoing cesarean section due to possible indication
Diagnostic Role of Serum Testican and Ubiquitin Levels in Patients With Head Trauma

We aimed to determine if testican-1 and ubiquitin can serve as early indicators for diagnosing worsening clinical course (presence of intraparenchymal pathology) and mortality in patients with moderate traumatic brain injury.

The study specifically included patients over 18 years of age with moderate TBI (GCS: 9-13) who provided informed consent. The control group consisted of healthy individuals without any disease who voluntarily participated in the study. Patients with moderate TBI were divided into two groups: those with intracranial pathology (Subdural hemorrhage, epidural hemorrhage, subarachnoid hemorrhage, intraparenchymal hemorrhage, and contusion) and those without. Treatment was initiated according to ATLS in patients with moderate TBI, and blood samples taken at the time of admission to the emergency department were placed in Ethylenediaminetetraacetic acid (EDTA) tubes. The relationship between the patient's clinical scoring (GCS, ISS and AIS), brain CT results, and mortality status with testican-1 and ubiquitin levels was compared.

Eligibility Criteria:
Inclusion Criteria:

* being over 18 years old
* having a GCS score between 9 and 13

Exclusion Criteria:

* under 18 years of age
* had missing data
* were pregnant
* had neurodegenerative disease
* had Central Nervous System (CNS) infection
* had cerebral palsy
* had penetrating head injury (by a cutting or piercing tool such as a firearm, knife, axe)
* patients with severe (GCS: 3-8) or mild (GCS: 14-15) TBI
Gastrointestinal Tolerance of D-allulose in Children

D-allulose, a low-calorie sugar, provides an attractive alternative to sucrose and added sugars in products. This study aimed to verify the tolerance of d-allulose in children, in doses that are Generally Recognised As Safe (GRAS) and below maximum tolerable levels on g/kg basis.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy children of 6 to 8 years of age
2. Weight-for-age between the 5th and the 90th percentile as per the Centre for Disease Control and Prevention Growth Charts
3. Accustomed to having lunch between 12.00 pm and 2.30 pm
4. Routinely had up to 3 bowel movements per day or as few as 3 bowel movements per week
5. Were able to drink 120 ml within 30 minutes
6. With parents willing to continue their child's normal food and beverage intake and physical activity throughout the duration of the study
7. With parents willing and able to attend for all 7 visits

Exclusion Criteria:

1. Any major trauma or surgical event within the 3 months prior to screening
2. History or presence of clinically significant endocrine or GI disorder
3. Functional GI Disorders in accordance with Rome III Diagnostic Questionnaire for Paediatric Functional GI Disorders
4. More than 1 loose stool in the 48 hours preceding dosing, that met a Type 6 or Type 7 description on the Bristol Stool Chart
5. Use of any prescription medication, including antibiotics, laxatives and steroids
6. Regular GI complaints, such as stomach upsets, diarrhoea, constipation, flatulence, abdominal colic
7. Known intolerance or sensitivity to any of the study products, abdominal or anorectal surgery
8. Psychiatric disorders, anxiety, and depression
9. Lactose intolerance
10. Use of supplements that may have affected GI system including laxatives, fibre, and iron supplements
11. Exposure to any non-registered drug product within 30 days prior to screening visit.
Phase II Investigation of 99mTc-rBitistatin for Imaging Venous Thrombosis

99mTc-rBitistatin is a radiolabeled polypeptide which is designed to stick to blood clots so that the blood clots can be detected by imaging. The purpose of this trial is to evaluate in patients the safety of 99mTc-rBitistatin and its ability to locate blood clots in the arms and legs.


Eligibility Criteria:
Inclusion Criteria:

* peripheral acute venous thrombosis diagnosed by vascular ultrasound
* is able to give informed consent
* is likely to complete the study

Exclusion Criteria:

* is pregnant
* is lactating
* has a history of prior severe allergic reactions (anaphylactic response)
* prior use of GP IIb/IIIa antagonist (e.g., abciximab, eptifibatide)
* has a platelet count \<100,000 or history of thrombocytopenia
* has a history of stroke
* has a history of recent bleeding documented by decreasing hemoglobin (\>1 gm) in last 7 days
The Effect of Dimenhydrinate on Postoperative Nausea and Vomiting After Abdominal Hysterectomy: Randomized-controlled Trial

The aim of this clinical trial is to learn if Dimenhydrinate works to prevent postoperative nausea-vomiting in adult women who undergoing abdominal hysterectomy. The primary question is: Does Dimenhydrinate lower the proportion of postoperative nauseavomiting during the day 1 after surgery. Researcher will compare Dimenhydrinate to a placebo (a-look-alike substance that contains no drug) which will give intravenously when the patient come back to the ward, to see if Dimenhydrinate work to prevent nauseavomiting during the postoperative day1. All participants will receive standard treatment during pre-operative, intra-operative and the immediate post-operative periods. Participants will receive Dimenhydrinate or placebo only one dose after discharge from the recovery room. During the day 1 postoperative, participants will report their symptoms and keep a diary of the number of tmes they use additional anti-emetic drugs.


Eligibility Criteria:
Inclusion Criteria:

* 18-65 years female
* undergoing trans abdominal hysterectomy

Exclusion Criteria:

* undergoing emergency surgery
* pregnancy or breastfed women
* post delivery less than 6 weeks
* history of allergic reaction or precaution to use the protocol drug
* BMI less than 18 or more than 30 kg/m2
* Need ICU care after surgery
Analgesia for Total Hip Arthroplasty With PENG Block (ATHAPENG)

Analgesia for Total Hip Arthroplasty with PENG block (ATHAPENG)

Total hip arthroplasty (THA) for osteoarthritis is a commonly performed surgery worldwide. It is associated with significant pain, with median pain scores in the first 24 hours postoperatively exceeding 3 on the standardized numeric rating scale (NRS). Multimodal analgesia, including infusion of systemic analgesics and regional anesthesia through the Pericapsular Nerve Group Block (PENG block), has demonstrated efficacy in literature, when compared to other commonly used techniques such as the iliofascial block or surgical infiltration. However, analgesia provided by the PENG block appears to be incomplete, with a significant consumption of opioids in the postoperative period. The investigators hypothesis is that PENG block does not cover every hip sensitive territory involved during the surgical procedure.

The investigators conducted a single-center, observational, prospective study evaluating the antinociceptive effect of a PENG block performed preoperatively, at various surgical time points (incision, dislocation, femoral osteotomy, acetabular reaming, femoral reaming, femoral stem impaction, reduction, closure) by monitoring the Nociception Level Index (NOL index) during general anesthesia.

NOL index values (0 to 100) between 10 and 25 reflect nociception control, NOL index values exceeding 25 reflect excess of nociception, NOL index \< 10 reflects a potential excess of opioids infusion.

After surgery, pain scores (NRS), opioid consumption, and the presence of motor blockade within the first 48 hours postoperatively were also assessed.

The aim of the study is to determine the efficacy of PENG block combined to multimodal analgesia on intraoperative nociception and postoperative pain in patients undergoing total hip arthroplasty under general anaesthesia.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (\> 18 years old)
* Undergoing primary hip arthroplasty for osteoarthritis
* Under general aneasthesia
* With PENG block

Exclusion Criteria:

* Patient under 18 years old
* Severe cognitive impairment or patient under guardianship
* Pregnancy
* Allergy to local anaesthetics
* Chronic pain with daily opioid consumption
* Non sinusal cardiac rhythm
Genetic Examination of Patients With Primary Multiple Hernia

The investigators are performing a genetic study of patients with multiple hernias (at least 3 primary hernias) versus a healthy control group. This genetic information is compared with circulating and subcutaneously biomarkers such as matrix-metalloproteinases (MMP's).

The hypothesis is that patients with multiple hernias have different expression of specific genes compared to the healthy control group.

Other examinations performed on the patients enrolled in this study:

* Ultrasound (US) examination of the abdominal aorta to discover possible abdominal aortic aneurysms.
* Beightons score to evaluate the degree of joint hypermobility.

Eligibility Criteria:
Inclusion Criteria:

* Patients with minimum 3 primary hernias

Exclusion Criteria:

* Patients under 18 years
Prevalence, Risk Factors and Complications of Oropharyngeal Dysphagia in Stroke Patients

Oropharyngeal dysphagia (OD) is a common morbidity after stroke that disrupts swallowing physiology. The investigators aimed at evaluating the prevalence of oropharyngeal dysphagia (OD) after stroke and analysing the risk factors and associated complications.


Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to hospital with confirmed stroke diagnosis; signed informed consent

Exclusion Criteria:

* previous diagnosis of OD; transient ischemic attack; and being transferred from another hospital.