cyrilzakka/clinical-trials huggingface dataset:
Technological Balance and Gait Rehabilitation in Patients With Stroke Sequelae: Functional, Motor and Cognitive Outcomes

Stroke represents the leading cause of disability worldwide, with a significant impact on an individual, family, and economic impact. The recovery of smoother, safer, and more correct walking is an essential requirement to allow the patient to regain autonomy in the activities of daily living. Some preliminary studies have shown that robotic training of the gait training has influenced the functional and motor outcome in patients with stroke outcomes an improvement in endurance and walking strategies was observed. In addition, frequently, a stroke involves an alteration of the cognitive system that contributes to the deterioration of balance and gait during dual-task activities; the study of these processes can be of interest for rehabilitation purposes. Considering these preliminary data and that the patient must continuously find balance in overground walking, it is believed that a robotic balance treatment associated with conventional therapy may be more effective than conventional therapy alone. Therefore, this study aims to evaluate the effects of technological rehabilitation utilizing a robotic platform (Hunova® Movendo Technology srl, Genova, IT):

* (i) in terms of improvement in static, dynamic balance, and ambulation (assessed with clinical scales and instrumental measures);
* (ii) on fatigue, on cognitive performance in terms of sustained attention, dual-task cost and cognitive-motor interference and on quality of life.

Twenty-four patients of both sexes will be recruited, evaluated, and treated at the Rehabilitation and Physical Medicine Clinic, Fondazione Policlinico Universitario A. Gemelli IRCCS of Rome from Febraury 2022 to January 2023. Patients will be divided into two groups by randomization (described below): one group (experimental group, GH) will perform specific rehabilitation for the balance disorder using the robotic platform Hunova® Movendo Technology srl, Genova, IT) 3 times a week, for 4 weeks (12 total sessions), for 45 minutes of treatment, in addition to the conventional treatment conventional treatment and one group will perform only the conventional treatment (conventional group, GC), as per daily routine, as described later.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 55;
* Patients with outcomes of ischemic or hemorrhagic stroke documented through techniques of neuroimaging (magnetic resonance imaging or computed tomography);
* Latency from the acute event between 1 and 6 months;
* Cognitive abilities to execute simple orders and understand directions of the physical therapist \[assessed by Token Test (score ≥ 26.5)\];
* Ability to walk independently or with little assistance;
* Ability to understand and sign informed consent.

Exclusion Criteria:

* Presence of systemic, neurological, or cardiac pathologies that make ambulation risky or cause motor deficits;
* Orthopedic or postural problems;
* Presence of plantar ulcers;
* Partial or total amputation of foot segments.
Pentraxin-3 in Hysterectomy Patients

Comparison of the Tissue Trauma Markers Following Total Laparoscopic Hysterectomy vs Total Abdominal Hysterectomy

Acute trauma and major surgeries activate a series of cascades to evoke systemic inflammatory response. The magnitude of the resulting inflammatory response is proportional to the severity of the tissue trauma. Abdominal or laparoscopic technique is widely used for the purpose of hysterectomy surgery. It is crucial for many aspects to compare these two techniques of hysterectomy in terms of the surgery-induced trauma.

In this study, the severity of the inflammatory response resulting from the tissue trauma due to the techniques of TLH+BSO and TAH+BSO applied in our department were compared based on the PTX-3 molecule.

Eligibility Criteria:
Inclusion Criteria:

·TLH+BSO patients and TAH+BSO patients

Exclusion Criteria:

* History of a chronic disease (coronary artery disease, diabetes mellitus, hypertension, coronary liver failures, chronic kidney disease, chronic respiratory diseases, connective tissue disorders) which may affect levels of PTX-3 and other inflammatory markers.
* Prior surgery due to malignancy.
* History of an intra-abdominal surgery, except for cesarean section.
* History of any disease which may lead to intra-abdominal adhesions (endometriosis, past pelvic infection).
Beta 3 Agonists in Treatment of Non-neurogenic Voiding Dysfunction in Children

A randomized clinical study to evaluate the safety and efficacy of using the Beta 3 agonist drug (Mirabegron) combined with standard behavioral therapy in comparison to using the anticholinergic drug (Solifenacin) combined with behavioral therapy, for children with non-neurogenic voiding dysfunction refractory to behavioral therapy alone, using improvement of dysfunctional voiding symptom score as a primary measurement of efficacy.

The study aims to evaluate the beta 3 agonist drug (Mirabegron) as regard its safety and efficacy when used in children with non neurogenic voiding dysfunction, including children suffering from frequency, urgency, urgency incontinence and hesitancy who do not have neurological disease explaining these symptoms and who failed behavioral urotherapy.

The patients will be randomly allocated into two groups, one will receive standard behavioral therapy plus Mirabegron, the other will receive standard behavioral therapy plus the anticholinergic drug Solifenacin for three months. Patients will be assessed initially and after three months using:

* Medical and voiding history (bladder voiding diary, Dysfunctional voiding symptom score (DVSS) , Bristol Stool Scale)
* Dysfunctional voiding symptom score (DVSS) , Bristol Stool Scale
* Urine analysis and mid-stream urine culture.
* Uroflowmetry.
* Pelvic US and post-void residual urine (PVR).

Eligibility Criteria:
Inclusion Criteria:

* Children with non-neurogenic voiding dysfunction predominantly filling phase dysfunctions or OAB, refractory to behavioral therapy as a primary monotherapy, with dysfunctional voiding symptom score of ≥6 for females and ≥9 for males, between the age of 5 \& 18 years old.

Exclusion Criteria:

* Neurogenic or anatomical bladder problems.
* Patients with contraindications to Beta 3 agonists or anticholinergic drugs.
The Use of Botulinum Toxin in the Treatment of Itching From Hypertrophic Scar -- A Randomised Controlled Trial

Hypertrophic scar, a disfiguring tissue reaction to trauma, occurred in around 20 % of the population. The patients with hypertrophic scar usually seek medical assistance not just for the annoying appearance but mostly due to the intractable itchiness. There have been a variety of effective methods to alter the appearance of the scar. However, the treatments for itching from hypertrophic scar are scarce. In 2009, P.Gazerani used Botox to treat histamine-induced itch with favorable results. In the clinical setting, however, the efficacy of Botox to treat itch from hypertrophic scar was yet to be proven. Therefore, the goal of this study is to conduct a randomized controlled trials about using Botox to treat itch from hypertrophic scar.


Eligibility Criteria:
Inclusion Criteria:

1. The patients undergoing laparotomy and thoracotomy in Veterans General Hospital in Kaohsiung (VGHKS) during 2003/1/1\~2012/12/31
2. Hypertrophic scars containing more than two itchy sites with itchiness scale \>3
3. Good wound healing condition, no infection sign
4. Age older than 20 year-old

Exclusion Criteria:

1. Allergy to Botulinum toxin
2. Inability to express self-willingness
3. Pregnancy
Metformin in Pregnancy in Women With Polycystic Ovary Syndrome

The study provide a detailed longitudinal evaluation of the gluco-insulinemic assessment of pregnant PCOS women under metformin treatment. 47 non diabetic Polycystic Ovary Syndrome (PCOS) women became pregnant during metformin treatment and continued taking the drug during gestation. An oral glucose tolerance test and euglycaemic hyperinsulinaemic clamp were performed at each trimester of gestation.


Eligibility Criteria:
Inclusion Criteria:

* age 18-40 yr,
* metformin treatment for at least 3 months before entering the pregnancy,
* gestational age between 5 and 12 wk

Exclusion Criteria:

* diabetes mellitus
* significant liver or renal impairment
* neoplasms and other endocrine diseases
* the use of drugs other than metformin able to interfere with glucose and insulin metabolism.
Reducing Arm Morbidity in Pre- and Post-breast Cancer Surgery

The overall aim of this pilot study is to explore the feasibility of a randomized trial to test the effectiveness of physical therapy, provided both pre- and post-surgery, on reducing arm morbidity and increasing health-related quality of life (HRQL) post-surgery.

Breast cancer surgery is one of the most frightening health events a woman can experience. Not only is there fear of cancer and mortality, but also fear of disfigurement and disability arising from the surgery and from the subsequent chemotherapy and radiotherapy. The pre-operative period is a time of great anxiety and in the post-operative period this anxiety is compounded by pain and discomfort associated with the breast and axillary wounds. Lack of knowledge about follow-up treatment leads to fear and anxiety post-surgery. All women experience loss of mobility and function of the arm on the operative side for a period of time ranging from days to months to years. This arm morbidity interferes with participation in usual activities, is an additional source of stress compounding the psychological distress associated with the cancer itself, and has a negative impact on the quality of life.

The post-operative period may not be the most opportune time to introduce interventions to accelerate recovery. Many women will be concerned about perturbing the healing process and may be depressed and anxious as they await extra treatment for the tumor. The pre-operative period may be a more emotionally salient time to intervene in the factors that contribute to recovery.

The process of enhancing functional capacity of the individual to enable him or her to withstand stressors is termed "prehabilitation". This project deals with the effectiveness of prehabilitation with or without post-operative exercise to reduce arm morbidity and increase quality of life following breast cancer surgery.

The overall aim is to explore the feasibility of a randomized trial to test the effectiveness of physical therapy, provided both pre- and post-surgery, on reducing arm morbidity and increasing health-related quality of life (HRQL) post-surgery. The specific objectives of this pilot project are to:

1. estimate recruitment rates for such a trial;
2. estimate compliance to the protocols;
3. pilot the randomization procedures;
4. identify sub-groups of the population with different needs for pre-and post-surgical physical therapy;
5. estimate effect sizes to be used for sample size calculations for the main project and for budget justification.

Eligibility Criteria:
Inclusion Criteria:

* Women
* Diagnosed with breast cancer
* Able to complete questionnaires

Exclusion Criteria:

* none
Comparison of Intraoperative Intravenous Lidocaine Infusion and Transversus Abdominis Plane (TAP) Block for Post-operative Analgesia Following Laproscopic Cholecystectomy

This study is aimed to determine the post operative pain after laparoscopic cholecystectomy by dividing patients into three different group. Group A will receive lidocaine 2mg/kg bolus at induction followed by 1.5mg/kg/hr infusion. Group B will receive bilateral subcostal TAP block with 0.375% 20ml Ropivicaine on each side. Group C will not receive any additional pain regime apart from the routine intraoperative analgesics. Pain score will be assessed post operatively for 24 hours at regular intervals using visual analog score.


Eligibility Criteria:
Inclusion Criteria:

* Age group (18-65)
* Undergoing elective Laproscopic Cholecystectomy
* ASA status I or II

Exclusion Criteria:

* Participation in any other trial
* Known hypersensitivity to study medications
* Chronic Opioid used
* Seizure disorder
Multi-center, Randomized, Double-blind Efficacy and Safety of CD0271 0.3%/CD1579 2.5 % Topical Gel in Acne Vulgaris

The study hypothesis are based on the assumption that :

* CD0271 0.3%/CD1579 2.5% Gel provides superior clinical efficacy compared with Topical Gel Vehicle in the overall population and in the subgroup of severe Subjects
* CD0271 0.3%/CD1579 2.5% Gel applied once daily for up to 12 weeks has an acceptable safety and tolerability profile


Eligibility Criteria:
Inclusion Criteria:

1. Male or female, who is 12 years of age or older at Screening visit.
2. Clinical diagnosis of acne vulgaris with facial involvement.
3. An IGA of Moderate (3) or Severe (4) at Baseline visit.
4. A minimum of 20 but not more than 100 inflammatory lesions (papules and pustules) on the face (including the nose) at Baseline visit.
5. A minimum of 30 but not more than 150 non-inflammatory lesions (open comedones and closed comedones) on the face (including the nose) at Baseline visit.

Exclusion Criteria:

1. More than 2 acne nodules on the face at Baseline visit.
2. Acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), nodulo cystic acne, or acne requiring systemic treatment.
3. Underlying diseases or other dermatologic conditions that require the use of interfering topical or systemic therapy or that might interfere with study assessments such as, but not limited to, atopic dermatitis, perioral dermatitis or rosacea. This includes clinically significant abnormal findings, uncontrolled or serious disease, or any medical or surgical condition, that may either interfere with the interpretation of the clinical trial results, and/or put the subject at significant risk (according to Investigator's judgment) if he/she participates in the clinical trial.
4. The subject has received, applied or taken some specified treatments within the specified timeframe prior to the Baseline visit
5. The subject is unwilling to refrain from use of prohibited medication during the clinical trial.
6. Use of hormonal contraceptives solely for control of acne.
Visual Performance Investigation of Two Toric Soft Contact Lenses

The purpose of this study is to compare the amount of coma as measured by aberrometry induced by two silicone hydrogel toric lenses in astigmatic participants.


Eligibility Criteria:
Inclusion Criteria:

* Sign informed consent;
* Wears toric soft contact lenses;
* Can be successfully fit with study lenses within the power ranges available;
* Has cylinder of ≥ -0.75 diopter in both eyes;
* Has correctable vision of at least 0.1 (logMAR) or better in each eye at distance with both study lenses;
* Willing and able to wear study lenses on a daily wear basis for at least 5 days a week, minimum 8 hours per day, and attend all study visits;
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Any ocular condition that would contraindicate contact lens wear;
* Use of medications for which contact lens wear could be contraindicated;
* Monocular (only 1 eye with functional vision) or fit with 1 lens;
* History of herpetic keratitis, ocular surgery, or irregular cornea;
* Known sensitivity to the diagnostic pharmaceuticals to be used in the study;
* Requires presbyopic correction;
* Use of rewetting/lubricating eye-drops more than twice a day;
* Other protocol-defined exclusion criteria may apply.
Laparoscopic Versus Open Appendectomy Prospective Randomized Control Study

laparoscopic versus open appendectomy prospective randomized control study.Both surgical methods are safe and well established in clinical practice but there has been a controversy about which surgical procedure is the most appropriate in this research we are going to demonstrate which operative procedure is more beneficial with less disadvantages.

A double-blind study is one in which neither the participants nor the experimenters know who is receiving a particular treatment. This procedure is utilized to prevent bias in research results. Using envelopes as an allocation concealment method. Each patient will receive two envelopes one contain paper which determine that patient will have open surgery and the other determine that patient will have lap surgery and neither patient nor experimenters know about them and patient shall choose one of them which will determine what surgery will patient undergo .

Eligibility Criteria:
Inclusion Criteria:

1. patient age between 5-50 year old
2. patient diagnosed as acute appendicitis

Exclusion Criteria:

1. pregnacy
2. perforated appendix
3. severe obese patient
4. previous abdominal exploration
Pilot Study to Assess Feasibility, Reliability and Validity of the e-SSRS-IVR

The proposed study is designed to evaluate the clinical contents of the e-SSRS-IVR with respect to 1.the intent of the instrument (assess face and content validity), 2. system validation with respect to programming integrity, 3. implementation feasibility in clinical ill and healthy patient populations, and 4. criterion/predictive validity to discriminate patient population with known clinical status differences.


Eligibility Criteria:
Inclusion Criteria:

* English speaking adults, able/willing to read and provide written consent

Exclusion Criteria:

* Dementia, delirium, psychosis or deafness.
* Control subjects will be excluded for any MINI lifetime MDD or dysthymia diagnosis of a DSM-IV disorder except for specific phobia or dependence on nicotine and caffeine.
* Inpatients not admitted with suicidal ideations
Collagenase is a Common Treatment of MCP and PIP Joint Contractures in Dupuytrens Disease

To evaluate the effect of collagenase clostridium histolyticum treatment at the Department of Orthopaedic surgery at Horsens Regional Hospital after minimum one-year follow-up (FU).


Eligibility Criteria:
Inclusion Criteria:

* dupuytrens disease
* xiapex treatment

Exclusion Criteria:

- demens/other psychiatric diseases
Screening and Treating Asymptomatic Bacteriuria Every Trimester and Preterm Birth

This study is evaluating whether screening of a pregnant woman for asymptomatic bacteriuria in each trimester for early detection and treatment of bacteriuria will reduce the incidence of preterm birth in Harare.

Asymptomatic bacteriuria is common in pregnancy. If the disease is not detected early in pregnancy and treated it often progresses to an acute symptomatic disease, pyelonephritis which is associated with adverse pregnancy outcomes including preterm birth.

It is recommended that every woman be screened for asymptomatic bacteriuria by urine culture test at initial antenatal care visit so that the disease is if identified is treated early to prevent preventable complications of the disease in pregnancy. Culture test is expensive and therefore unavailable at several primary care settings especially in low resource settings where majority of pregnant women register and visit for antenatal care. In Zimbabwe antenatal care at primary care clinics is not including screening for asymptomatic bacteriuria. Majority who present with symptoms are empirically treated.

In this study the Griess nitrite test, an effective inexpensive screening test for asymptomatic bacteriuria is used. the test detects nitrite in urine which is associated with presence of nitrate reducing uropathogens, commonly the gram negative bacteria. All the positive samples will then be further tested by culture for bacteria identification, quantification and antibiotic sensitivity. A Randomized controlled trial research design is being used. participants are randomly allocated to intervention group or control group. Urine samples will be collected and tested 3 times for each recruited participant in the intervention arm. treatment will be initiated for positive result according to sensitivity test. Control group will only be subjected to routine existing antenatal care.

Participants will be recruited before 22 weeks gestation and followed on for second contact by 28 weeks and third contact by 36 weeks. Follow up will be stopped on delivery for noting gestation at delivery, whether preterm or term.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women registering at study site.
* Woman is able to identify her date of last menstrual period.
* Gestation of pregnancy is between 6 and 22 weeks.
* Woman is asymptomatic for bacteriuria
* Woman voluntarily signs the consent form

Exclusion Criteria:

* Pregnant woman ill and unwell
* Pregnant woman unwilling to sign consent form
* Woman who had antibiotic treatment 2 weeks before recruitment
* Woman on long term antibiotic treatment
* Woman who fails to identify date of last menstrual period
* Woman symptomatic for urinary tract infection
Efficacy of Ciclesonide Inhaled Once Daily Versus Fluticasone Propionate Inhaled Twice Daily in Children With Asthma (6 to 11 y) (BY9010/M1-206)

The aim of the study is to compare the efficacy of ciclesonide versus fluticasone propionate on lung function, symptoms, and use of rescue medication in children with persistent asthma. Ciclesonide will be inhaled once daily, using one of the two dose levels; fluticasone propionate will be inhaled at one dose level twice daily. The study duration consists of a baseline period (2 to 4 weeks) and a treatment period (12 weeks). The study will provide further data on safety and tolerability of ciclesonide.


Eligibility Criteria:
Main Inclusion Criteria:

* History of persistent bronchial asthma for at least 6 months
* FEV1 50-90% of predicted

Main Exclusion Criteria:

* Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids
* COPD (chronic bronchitis or emphysema) and/or other relevant lung diseases causing alternating impairment in lung function
* Respiratory tract infection or asthma exacerbation within the last 30 days prior to entry into the study
* History of life-threatening asthma
* Premature birth
* Current smoking
* Smoking history with either equal or more than 10 pack-years
* Pregnancy
* Intention to become pregnant during the course of the study
* Breast feeding
* Lack of safe contraception