cyrilzakka/clinical-trials huggingface dataset:
Physiotherapy in the Treatment of Breastfeeding Difficulties

The objective of this randomized, single-blind clinical trial is to compare the efficacy of two treatments (Myofunctional Therapy and breastfeeding sessions) in infants who have difficulty breastfeeding during the first week of life.

The main questions to be answered are:

* Is breastfeeding improved with this type of intervention?
* What type of intervention is better?
* After carrying out these interventions, does the baby need to undergo surgery if it presents a sublingual frenulum? Participants must be infants who are one week old and who have been diagnosed with ankyloglossia through the Hazelbaker Scale. They will be randomly distributed into the two intervention groups and after one month of treatment, they will be assessed again using the same scale.

The researchers will compare the results between these two groups in order to verify the best intervention.

Infants who met the inclusion and exclusion criteria, respectively, were accepted to participate in the study. The randomization of the sample was performed by a statistician, who had no prior contact with either the infants or the parents. The online Randomizer (www.randomizer.org) program was used to randomly generate 200 sets of numbers, each containing two numbers ranging from 1 to 2 in random order. After signing the consent, a code was randomly chosen for each patient, thus ensuring that the 200 patients were equally distributed into two groups according to the group number of each code: group 1 (Myofunctional Therapy group) and group 2 (group sessions lactation).

Infants who met the inclusion criteria were referred to the rehabilitation and physiotherapy service. A physical therapist outside the study was in charge of evaluating the measurements of all infants during the first week of life through all the scales detailed below (pre-test). After randomly assigning the infants, another physiotherapist was responsible for applying the intervention once a week for 30 minutes for a period of 30 days. Once the intervention was finished, all the infants (both intervention groups) were reassessed by the physiotherapist outside the study using the same baseline scales (post-test).

Eligibility Criteria:
Inclusion Criteria:

* Full-term infants exclusively breastfed
* Born both by normal delivery and by cesarean section
* Who presented difficulty in breastfeeding

Exclusion Criteria:

* Preterm newborns
* With low birth weight (less than 2,500 kg)
* Mothers with flat or inverted nipples
* Patients who did not wish and did not authorize to participate in the study.
Pressure Therapy in the Treatment of Upper Arm of Cerebral Palsy Children

The purpose of this study is to assess the efficacy of a 6 months upper arm proprioceptive pressure therapy on Assisting Hand Assessment ("AHA") performance in Cerebral Palsy (CP). To perform this study, 80 CP patients aged of 5 to 10 years old will be included in a multicentric, double blind, prospective parallel-group randomized study. Treatment will be a pressure therapy using a LYCRA® compressive sleeve initially used in burn therapy. Primary outcome is to increase of 60% of AHA performance. The secondary outcome are to increase Quality of Upper Extremity Skill Test (QUEST), quality of life and improve Somatosensory Evoked Potentials (SEP).

The purpose of this study is to assess the efficacy of a 6 months upper arm proprioceptive pressure therapy on Assisting Hand Assessment ("AHA") performance in Cerebral Palsy (CP). To perform this study, 80 CP patients aged of 5 to 10 years old will be included in a multicentric, double blind, prospective parallel-group randomized study. Treatment will be a pressure therapy using a LYCRA® compressive sleeve initially used in burn therapy. Primary outcome is to increase of 60% of AHA performance. The secondary outcome are to increase Quality of Upper Extremity Skill Test (QUEST), quality of life and improve Somatosensory Evoked Potentials (SEP)

Eligibility Criteria:
Inclusion Criteria:

* Children with upper limb with pre/peri birth etiologic CP.
* Children aged 5 to 10 years

Exclusion Criteria:

* Children with language dysfunction
* LYCRA® allergia
* Botulic Toxin injection on upper limb 4 month before inclusion
First-in-Human Single Ascending and Multiple Dose of GLPG0555

The purpose of the study is to evaluate the safety and tolerability of single ascending (SAD) and multiple (MD) oral dose of GLPG0555 compared to placebo.

Also, pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG555 after single and multiple oral administration will be evaluated, and, if applicable, the maximum tolerated dose determined.


Eligibility Criteria:
Inclusion Criteria:

* healthy male, age 18-50 years
* BMI between 18-30 kg/m², inclusive.

Exclusion Criteria:

* significantly abnormal platelet function or coagulopathy
* smoking
* drug or alcohol abuse
Effect of Occupational Therapy at Home E-Rehabilitation (OTHER) for Persons Post-stroke

The goal of this (cost)effectiveness study is to compare care as usual with OTHER-intervention in Cerebro Vascular Accident (CVA) older adults in Geriatric Rehabilitation (GR). The main question\[s\] it aims to answer are:

1. What is the effectiveness of OTHER, as compared to occupational therapy as usual (CAU), on improving the self-perceived performance in daily activities of community-dwelling older persons post-stroke over a 24-week period after initiation of OTHER or CAU, as measured longitudinally (at week 4, 13 and 26)?

   Secondary:
2. What is the effectiveness of OTHER on improving satisfaction with the perceived daily performance of community-dwelling persons post-stroke, 26 weeks after start compared to usual OT? (quantitative approach)
3. What is the effectiveness of OTHER on improving physical activity of community-dwelling persons post-stroke, 26 weeks after start compared to usual OT? (quantitative approach)
4. What is the effectiveness of OTHER on improving self-management of community-dwelling persons post-stroke, 26 weeks after start compared to usual OT? (quantitative approach)
5. How do persons post-stroke and OT's experience and how do they reflect on OTHER in supporting a sense of self-management, safety and improving daily functioning? (qualitative approach).
6. What factors influenced the intervention delivery and the perceived benefits in the OTHER study (process evaluation)? 1) monitoring treatment fidelity, barriers and facilitators for implementation; 2) gain insight into the impact of OTHER on the GR transition to home; 3) to gain insight into what stroke survivors and OT's think of OTHER. 4) how participants, and professionals experience and thoughts they have on the OTHER-intervention in supporting daily functioning and self-management

   Cost-effectiveness
7. What is the cost-effectiveness of OTHER on improving self-perceived performance in daily activities and Quality Adjusted Life Years (QALYs) of community-dwelling persons post-stroke, 26 weeks after start compared to usual OT? (quantitative approach)

Participants will get the OTHER-intervention treatment given by de occupational therapist which consists of activity monitoring, coaching and videoconferencing to optimalise the transition from clinical care to home.

Researchers will compare care as usual to see if there is a effect on improving the self-perceived performance in daily activities, self-management and improving physical activity .


Eligibility Criteria:
Inclusion Criteria:

* be able to walk a few steps with or without a walking device.
* 60 years or older
* an assessment score of at least 16 on the Montreal Cognitive Assessment (MoCA)
* an indication for follow up GR at home

Exclusion Criteria:

* Who are terminally ill
* Who have severe aphasia; problems with understanding.
* Who has been assessed legally incapable by a geriatric doctor
SUPRAFLEX CRUZ PMCF Study ( rEpic05 )

Multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study to confirm and support the clinical safety and performance of Medical Device Regulations (MDR) with multivessel coronary disease requirements in all the CONSECUTIVE patients treated with (SUPRAFLEX CRUZ).

The objective of this multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study is to confirm and support the clinical safety and performance of the SUPRAFLEX CRUZ in a NON-SELECTED, Real World population under daily clinical practice when used as intended by the manufacturer to meet EU Medical Device regulation requirements for post-market clinical follow-up.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years old and;
* Patients treated with SUPRAFLEX CRUZ according to routine hospital practice and following instructions for use
* Patients with multivessel coronary artery disease (understood as that which affects more than one territory of the major epicardial coronary arteries - anterior descending, circumflex, right coronary artery) who is treated with more than 1 stent under study in lesions located in more than 1 of the aforementioned arteries.
* Substudy: Patients with Ejection Fraction \<45% by Echocardiography
* Informed consent signed

Exclusion Criteria:

* Not meet inclusion criteria
* Contraindication for antiplatelet treatment
* Patient life expectancy less than 12 months
Implant Healing Abutment and Chlorhexidine

The work hyposesis is based on the application of a chlorhexidine gel against the non-application on the healing abutments in patients who have received a submerged titanium implant to check its effect on healing and prevention of bacterial plaque accumulation during a period of 1 month.

Once the implants are integrated, and given the consent, the patients will be operated to connect the healing abutments as they come from the manufacturer (Mozo Grau, Ticare®). Patients will follow the study protocol in 2 arms.

The random distribution is made prior to assignment following the internet program https://www.random.org

Eligibility Criteria:
Inclusion Criteria:

* Good systemic health status (ASA I or II).
* No current pain.
* No use of painkillers or Anti-inflammatory drugs in the prior weeks.
* Older than 18 years.
* Oral hygiene index of ≤ 2 (Löe and Silness).
* A minimum of 2 mm of adhered gum.
* A minimum of 8 mm of vertical bone.
* A minimum of 7 mm of vestibule-lingual bone.
* Scheduled to receive a unitary implant.
* Willing to participate in this controlled study.

Exclusion Criteria:

* Pregnant or nursing women.
* Use of any type of medication that might affect the perception of pain.
* An history of alcohol or drug abuse.
* A requirement for guided regeneration or sinus lifting procedures.
* Failure to comply with the study protocol.
Marital Functioning Among Combat Veterans

The purpose of this research study is to examine marital dynamics related to husband-wife reunification following the veteran's return

We are interested in patterns of husband/wife communication and interaction regarding conflict resolution, trauma experiences, marital satisfaction, occupational functioning, social functioning, family functioning, and substance use.

We hope to discover ways to assist couples in reducing marital stress.

Eligibility Criteria:
Inclusion Criteria:

* 18 and older
* Married or in a married like relationship
* One partner has served in Afghanistan or Iraq

Exclusion Criteria:

* Separated
A Novel Electronic Method of Collecting Pain Scores in the Emergency Department

Can a novel electronic display of pain be successfully used in the emergency department and does it (1) change analgesic prescription and (2) change amount of pain experienced? Pain is a common symptom in emergency care. As patients are seldom reassessed, staff may not be aware of pain. Currently, members of nursing or medical staff need to ask patients about their pain and record it manually using a visual analogue scale from 0-10.

The new electronic display uses buttons to represent a pain scale from 0 (no pain) to 10 (worst pain). Patients will select the number that best corresponds to their pain every 15 minutes. In the experimental group, the score will be displayed on a screen. In the control group, the score will not be displayed. The investigators will compare the overall amount of pain in both groups, and will look at their pain management (painkillers prescribed). The investigators will also ask patients and staff for their opinions on the display.

The study will include adult patients in the emergency department at Leicester Royal Infirmary with an initial pain score of 5 or more who are able to make a decision about whether to participate. Participants will also need to be likely to stay in the hospital for more than 2 hours to allow the investigators to gather enough useful data. The study will recruit 200 participants. If the study can demonstrate that the monitor is acceptable to patients and staff and results in improved pain management, it is a low cost intervention which could be widely implemented within the NHS. It also has the potential for being used in other areas such as surgical wards. The investigators have previously found that 300-400 patients per week in the department have moderate to severe pain and might therefore benefit from this monitor.


Eligibility Criteria:
Inclusion Criteria:

* adult (18 years and over)
* underlying condition giving rise to significant pain (initial VAS pain score of 5 or more)
* likely to be staying in the hospital for at least 2 hours
* willing and able to give informed consent
* able to understand and speak a good level of English

Exclusion Criteria:

* children (under 18 years)
* patients not willing to undergo routine care (analgesic treatment)
* patients who do not have capacity to consent
* patients who are unwilling or unable to give informed consent
* prisoners
* patients who cannot understand the study information in English
* currently participating in another clinical trial as far as can be determined from information available at the time of assessment
* patients who have a physical or visual disability which will prevent them from holding or using the pain display
Single Versus Double Kirschner Wires for Intramedullary Fixation of Metacarpal V Fractures

Metacarpal V fractures are injuries of the upper extremities. They occur frequently, primarily in young adults.These fractures are caused by falling on the fist, sports accidents and direct or indirect forces.

Surgical intervention is necessary for fractures with a strong palmar angulation of the metacarpal bone or rotational deformity of the small finger. Due to the absence of guideline recommendations decisions about therapy are made taking into account logistical aspects, available hardware, individual expertise and preferences. The objective of the study is to compare the advantages and disadvantages of single versus double Kirschner wires for intramedullary fixation of metacarpal V fractures in order to standardize national therapy procedures.

Primary hypothesis:

In the surgical therapy of the dislocated and/or rotational deformed metacarpal V neck fracture, osteosynthesis with a single Kirschner wire is not inferior to osteosynthesis with a double Kirschner wire with regard to the functional outcome after 6 month, as measured with the Disabilities of the Arm, Shoulder and Hands Score (DASH).


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥18 years with a metacarpal V neck fracture with a palmar angulation and/or shortening and /or rotational deformity as determined on radiological diagnosis
* Trauma within 10 days before appearing in the study centre
* No specific medical treatment before
* Ability to fully understand the character and implications of the clinical trial
* Written or oral (in case of an injury of the dominant hand, if so attested by witnesses)consent

Exclusion Criteria:

* Indications for conservative therapy
* Patient is not suitable for anaesthesia
* Other physical conditions or characteristics which made surgical interventions inappropriate or to risky (e.g. open fractures, polytrauma, pregnancy, acute infections, pathological fractures)
* Prior participation in this study (e.g. injury of the contralateral hand) or participation in other interventional studies with the same objective
* Physical or mental diseases which makes the consequent participation in diagnostic, therapy and the follow-up-examinations unlikely
* Lacking language skills
Presurgery Anxiolysis in Children Treated With Hydroxyzine Versus Non-pharmacological Intervention (Distractoria Technique Clown)

This study evaluate the change in preoperative anxiety, baseline (M1) and pre-induction anxiety levels (M3), as shown by children undergoing MAS determined by the m-YPAS scale in the different APO management groups.Patients will be allocated in one of this four groups: hydroxyzine+clown; hydroxyzine alone, clowns alone or nothing


Eligibility Criteria:
Inclusion Criteria:

* Children between 2 and 16 years old
* Patients with programmed major ambulatory surgery.
* Assessment of anesthetic risk ASA I-II.
* Informed consent signed by their legal authorized representatives.
* No antihistaminic allergies.
* Assent signed by children between 12 and 16 years old.

Exclusion Criteria:

* Patients with previous surgeries.
* Anesthetic risk ASA more than II.
* Patients with hypersensitivity to the active substance, to any of the excipients, to cetirizine, to other piperazine derivatives, to aminophylline or etilenamida
* Patients with porphyria
* Patients with known QT prolongation, either congenital or acquired
* Patients with known risk factors for QT prolongation including a pre-existing cardiovascular disease, previous electrolyte imbalances, family history of sudden cardiac death, significant bradycardia and concomitant use of drugs with potential known to produce QT prolongation and / or induce Torsades de Pointes.
Stool Transplantation to Reduce Antibiotic Resistance Transmission

During this prospective observational study, the investigators collect the information about the outcomes of fecal microbiota transplantation in patients with blood disorders, performed to eradicate gut colonization with multidrug-resistant (MDR) bacteria.

Patients with blood disorders are characterized by poor diversity of gut microbiome, affected by repeated chemotherapy and antimicrobial treatments. This makes them vulnerable to colonization by pathogenic bacteria carrying genes responsible for antibiotic resistance. In case of gut mucosa injury and severe immune suppression, these colonizing bacteria may cause severe systemic infections. As the bacteria are secreted with the stool, the colonized patients become an epidemiologic threat to the others.

Fecal microbiota transplantation (FMT) was shown to be very efficient in treatment of relapsed and refractory Clostridium difficile infection and became a standard treatment. In home institution, the investigators use FMT not only in case of Clostridium difficile colitis, but also in case of gut colonization with multidrug-resistant (MDR) bacteria. This is based on assumption that physiological gut flora may outcompete the pathogenic bacteria similarly as in case of Clostridium difficile and lead to loss of colonization. The procedure is performed in all patients colonized, who qualify according to listed inclusion and exclusion criteria .


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 y
* Carrier status of MDR bacteria in stool: Klebsiella pneumoniae resistant to carbapenems, Pseudomonas aeruginosa resistant to carbapenems, Enterococcus faecalis VRE, Enterococcus faecium VRE, Enterobacter cloacae KPC+ or other MDR species documented by at least two stool cultures
* Blood neutrophil count \> 500/uL on the day of fecal microbiota transplantation

Exclusion Criteria:

* Inability to obtain informed consent and lack of consent
* Blood neutrophil count \<500/uL on the day of fecal microbiota transplantation or expected decrease to the mentioned number within 2 consecutive days
* Intensive, myelosuppressive chemotherapy (e.g. DHAP, ICE, ESHAP, HD-Cy, HD-Ara-C, DA, conditioning before allogeneic stem cell transplantation, BEACOPP) planned within 2 consecutive days
* Patients up to 1 month after hematopoietic stem cell transplantation
* Clinical signs of mucositis
* Severe liver failure
* Patients undergoing intensive antimicrobial treatment
Oral Health Educational Program on Oral Hygiene Knowledge and Practices in a Group of Orphan Children

An orphan is defined as "a child under the age of 18 whose mother, father, both parents, and a primary caregiver has died, and who is in need of care or protection". Orphans, therefore, are considered disadvantaged and socially marginalized population whom diseases burden is high. Egypt has 1.7 million orphaned children. The number of children between the age of 0 and 17 who are currently registered in orphanages is 12,015. Dental diseases especially plaque, gingival and dental caries are highly preventable, with the highest prevalence in the developing countries. Profound disparities exist in oral health status across different social and economic divisions. The pattern of orphanage living is quite different from family living as the latter provides physical security, food, and shelter but is devoid of psychological security. High prevalence of dental caries, gingivitis and dental trauma has been observed in children of orphanages. This has been attributed to many factors such as: lack of adequate staff, poor oral hygiene, improper nutrition and eating patterns, high consumption of sugary food, negligence of tooth brushing, moreover the children and caregivers knowledge, level of education and oral health illiteracy. Untreated oral diseases could lead to psychological and general health problems, pain and loss in school time. Recognition of these problems is essential to provide optimum oral health for these deprived children. Health education is an important tool of public health and an effective primary preventive method especially for school aged children in controlling plaque, gingival and dental diseases.

The aim of this study is to raise more awareness about the causes of dental diseases (plaque, gingival and dental caries and their prevention through implementing an educational program to the orphan children focusing on tooth brushing, proper use of fluoride products and proper nutrition. The objectives of this study are to evaluate the impact of the oral health education program on the Knowledge and practices of the orphans and also its effect on the gingival health and dental caries among the children in different branches of orphanages in Egypt.

Eligibility Criteria:
Inclusion Criteria:

* Orphan Children aged 7 years old and above.
* Educated children.
* No learning difficulty.
* No medical conditions.

Exclusion Criteria:

* Any child that refuses to participate