cyrilzakka/clinical-trials huggingface dataset:
Comparison Of Clinical Efficacy Of A Herbal And A Non-Herbal Mouthwash On Dentinal Hypersensitivity

Aim of this study was to assess and compare the efficacy of a commercially available novel herbal mouthwash containing potassium nitrate on Dentinal Hypersensitivity (DH) compared to a placebo and non herbal potassium nitrate over a period of 12 weeks.

A total of 120 subjects were divided into 3 groups randomly. Group 1 was given the placebo mouthwash, Group 2 was given the herbal mouthwash ( Hiora K, which contains potassium nitrate derived from Suryakshara plant) and Group 3 was given the non herbal mouthwash (Containing non herbal potassium nitrate). Sensitivity scores (VAS score) were recorded at baseline, 3 weeks, 6 weeks and 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with a history of DH caused by gingival recession or cervical erosion were selected at baseline. Subjects with a minimum 20 natural permanent teeth and at least two teeth with a VAS score of ≥4 were included in the study.

Exclusion Criteria:

* of teeth with caries, defective restorations, chipped teeth and deep periodontal pockets (probing depth \>4 mm). Also, the subjects who had undergone periodontal surgery within the previous six months, and those with orthodontic appliances or bridge work that would interfere with evaluation were excluded. Subjects with the presence of occlusal overload or occlusal adjustment recently made in the tooth to be studied were also excluded. Subjects who had undertaken treatment with any product that could influence the DH of the patient in the 30 days prior to baseline were excluded. Also, the subjects with allergy to the ingredients used in the study or exhibiting any gross oral pathology, eating disorders, chronic disease, pregnancy and lactation, acute myocardial infarction within the past six months, uncontrolled metabolic disease, major psychiatric disorder, heavy smoking or alcohol abuse, any systemic disease or any disease requiring repeated or regular analgesia, anti-inflammatory drugs, or antihistamines were excluded from the study.
The Efficacy of Continuous Femoral Nerve Catheter Orifice Configuration for Postoperative Analgesia in Knee Arthroplasty

Femoral nerve catheter for postoperative analgesia will be included in the adult patients undergoing total knee arthroplasty included in the study. These patients will be randomized to the catheter tip configuration as CEMP (closed-ended multiport catheter) group and OESP (open-ended single port catheter) group. Patient controlled analgesia device will be attached to the peripheral nerve catheter of these patients. Demographic data of the patients , the number of pushing the button the amount of bolus dose given, and the total dose given in the patient controlled anesthesia device, the need for additional analgesia and the amount, pain scores, complications will be recorded for three days postoperatively. Records will be compared statistically.

Ethics committee approval was received on 10 December 2019, numbered 19/397. The study was planned to include 90 adult patients undergoing total knee arthroplasty at Gülhane Training and Research Hospital between 10 December 2019 and April 2020. Continue femoral nerve catheter for postoperative analgesia will be included in the patients included in the study. These patients will be randomized to the catheter tip configuration as CEMP (closed-ended multiport catheter) group and OESP (open-ended single port catheter) group. Patient controlled analgesia device will be attached to the peripheral nerve catheter of these patients. Demographic data of the patients who have placed an femoral nerve catheter and used the catheter successfully for three days postoperatively, the number of pushing the button, the amount of bolus dose given and the total dose given in the patient controlled anesthesia device,the amounts of need for additional analgesia and pain scores(Numeric rating Scale), complications will be recorded for three days postoperatively. Records will be compared statistically.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) Score I-III
* upper extremity surgery

Exclusion Criteria:

* emergency surgery,
* secondary surgery,
* chronic pain treatment
* pregnancy,
* any contraindication to peripheral nerve blockade,
* pre-existing peripheral nerve neuropathy,
* allergy to LA (study medications),
* ASA score ≥ 4,
* neurologic or neuromuscular disease,
* psychiatric disease,
* renal failure,
* hepatic failure,
* NSAID contraindication,
* inability to use a patient controlled analgesia (PCA) device,
* infection at the injection site
* withdrawal of consent.
Triclosan Coated Suture Wound Closure for Peripheral Vascular Surgery: a Prospective Multicenter Study

This is a prospective randomized multicenter study which purpose is to determine whether triclosan-coated sutures for wound closure after lower limb vascular surgery would reduce the incidence of surgical wound infections.


Eligibility Criteria:
Inclusion Criteria:

* patient undergoing peripheral vascular surgery procedure

Exclusion Criteria:

* patients refusal
Immersive Healing: The Therapeutic Potential of Virtual Reality

Phantom limb pain (PLP) is a significant and pervasive issue among upper limb amputees, severely impacting their quality of life. The literature delineating prevalence of upper versus lower limb amputations is limited, but the prevalence of total amputations in the United States is estimated to reach 3 million individuals by 2050, with approximately 185,000 new cases annually. PLP affects 60-68% of these patients, leading to heightened levels of anxiety, depression, and reduced overall well-being.

Although studies exploring the efficacy of VR therapy for PLP have reported positive outcomes, several limitations, such as small sample sizes, lack of randomization, and inconsistent treatment protocols, have impeded widespread adoption of these innovative approaches. Additionally, the literature does not sufficiently delineate which aspects of the phantom limb experience may be addressed with VR therapy. To overcome these limitations and optimize treatment efficacy, it is crucial to gain a comprehensive understanding of the phantom limb experience, including both somatosensory and kinesthesia-related symptoms. Additionally, this study will address these limitations by employing a larger sample size, rigorous methodology, and a standardized treatment protocol.

Eligibility Criteria:
Inclusion Criteria:

* History of major limb amputation
* Age \> 18 years old
* Presence of phantom limb pain or negative phantom sensation(s)

Exclusion Criteria:

* Active mental illness, neurological disease, or cognitive impairment that would interfere with survey completion
* Those without phantom limb pain or negative phantom limb sensations
* Non-English speaking
Comparative Head Lice Therapy With Dimet 5® vs. Hedrin® Once

Randomized, investigator-blinded, controlled, multicenter comparative study on the treatment of acute head lice infestation in children with 2 dimeticone preparations with different application times and compositions: Dimet 5® (100% dimeticone) versus Hedrin® Once Liquid Gel (4% dimeticone + nerolidol) with treatment success assessment via freedom from infestation of live head lice at final examination at V2, i.e. day 19 after first treatment.


Eligibility Criteria:
Inclusion Criteria:

* Acute head lice infestation
* Age ≥ 6 months
* Adequate informed consent for study participation:

  * Age-appropriate informed consent and verbal informed consent from the patient (if capable of both).
  * Written informed consent from the legal guardian(s) (written and verbal).

Exclusion Criteria:

* Adults (≥ 18 years of age)
* Known hypersensitivity to any component of the test or comparator product.
* Scalp lice therapy in the previous 2 weeks (with an appropriate drug or medical device).
* Severe disease of the scalp or injuries/open wounds on the hairy head
* Secondary infection in the area of the hairy head
* Treatment with cotrimoxazole or trimethoprim in the last 4 weeks or new treatment to be initiated now
* Other relevant reasons, e.g. diseases or dysfunctions, which, in the opinion of the investigator, militate against the inclusion of the patient in the study (including risk factors for severe COVID-19 disease in the case of SARS-CoV-2 infection)
* Simultaneous participation of another household member in the trial.
* Previous participation in this trial
* Participation in another trial within the last 30 days
* Inability of the legal guardian(s) to understand the study content and instructions.
* Limited legal capacity of the legal guardian(s)
* Apparent unreliability or unwillingness to cooperate on the part of the legal guardian(s)
* Known alcohol, medication or drug dependency of the legal guardian(s)
* Dependence of the patient or guardian on the sponsor or investigator.
Temporomandibular Joint in Patients With Rheumatoid Arthritis

the investigators study aimed to evaluate temporomandibular joint involvement in rheumatoid arthritis patients and healthy individuals 142 participants were recruited in two groups: 72 patients with Rheumatoid Arthritis (RA), and 70 healthy controls. All participants were tested for seropositivity of rheumatoid factor and anticitrullinated protein antibodies. TMD diagnosis was determined according to the standardized and validated diagnostic criteria for TMD (DC/TMD): myalgia, arthralgia, articular disc, displacement, degenerative joint disease, and headache attributed to TMD. Bruxism, a probable sleep and/or awake bruxism diagnosis was determined based on self-report and several clinical findings.


Eligibility Criteria:
* Inclusion criteria included:

  * age \> 18 years old
  * individuals who had a minimum of 12 natural teeth.
* Exclusion criteria

  * included: trauma or surgery on the jaw
  * facial nerve paralysis
  * tooth implant
  * scleroderma
  * cerebrovascular accident
  * schizophrenia
  * steroid injection within the last six months.
Mindfetalness to Improve Pregnancy Outcome

To improve pregnancy outcome, 39 000 pregnant women will be randomized to receive information about Mindfetalness or to routine care. The level of randomization will be the antenatal clinics in the Stockholm area.

The investigators have randomized 33 antenatal clinics in Stockholm to the intervention (receiving information about Mindfetalness) and 30 to routine care. The randomization was performed in blocks according to varying yearly volumes of pregnant women and socio-economic residential area. Three small clinics, with a total of 85 women listed in 2015, were not randomized. Another four clinics, receiving referrals of women with need for specialized care, were not randomized either. The recruitment is restricted to the 63 randomized clinics. In a pilot study in one antenatal clinic, the intervention has been tested among 102 women. A run-in period will start at high-volume antenatal clinics 1 September 2016, one month before the investigators start to register the women that will be observed for pregnancy outcome. All information, including that of possible effect-modifying and possible confounding factors, will be fetched from population-based registers and linked by the personal identify number unique for each resident in Sweden. The Swedish Medical Birth Register, Obstetrix, the Swedish Educational Register, the Prescribed Drug Register and the National Patient Register provide the information. By this design, and the analyses according to the intention-to treat principle, attrition and differential misclassification of outcome becomes negligible. Non-differential misclassification of the predictor (Mindfetalness or no Mindfetalness) will be substantial, diluting the effect estimates. This dilution may be compensated by the large size of the trial. Since the unit of randomization is the antenatal clinics residual confounding is an issue. The investigators will have, however, information on important possible confounding factors, including educational level, age, parity, body mass index, country of birth, diabetes mellitus before the pregnancy, certain other pre-pregnancy diseases, previous stillbirth, gestational diabetes mellitus and preeclampsia.

An article describing the study protocol has been published. A pilot study testing complicance of mindfetalness has been published. Data concerning outcome (all recruited women are followed from gestational week 32+0 until delivery) will be exported from the pregnancy register during October 2018.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant woman with a fetus being at least 25 weeks old (gestational age)
* Having a Swedish personal identity number

Exclusion Criteria:

* None
Efficacy and Safety of a Food Supplement With Standardized Menthol, Limonene, and Gingerol Content in Patients With Irritable Bowel Syndrome

The purpose of this study is to assess the efficacy and safety of a food supplement with standardized menthol, limonene, and gingerol content in patients with irritable bowel syndrome (IBS) or IBS/functional dyspepsia (FD).

Using a random number generator, 56 patients meeting inclusion criteria with IBS or IBS/FD were randomly assigned to either the intervention group (28 individuals) or the control group (28 individuals) (Table 2). Non-functional causes for the symptoms were excluded by a detailed evaluation of the medical history, physical examination, extensive panel of blood tests, stool analysis, and colonoscopy with biopsies.

Diarrhoea-predominant IBS patients (IBS-D) and mixed bowel habits IBS patients (IBS-M) were treated with smooth muscle antispasmodics. The constipation-predominant IBS patients (IBS-C) were treated with smooth muscle antispasmodics and laxatives. IBS/FD patients were treated with smooth muscle antispasmodics and proton pump inhibitors.

At Visit 1, all patients were randomly assigned into two groups. In the intervention group (Group 1), the supplement "Standart Zdorovya GASTRO" (1 capsule, 730 mg, once a day) was added to the standard treatment regimen for 30 days. In the control group (Group 2), placebo (1 capsule, 730 mg, once a day) was added to the standard treatment regimen for 30 days (Table 1). Researchers and patients were not informed who received a supplement or placebo. During the 30 days of the study, three outpatient visits were conducted (Visit 1 - Day 1, Visit 2 - Day 15 + 2 days, and Visit 3 - Day 30 + 2 days).

Symptom severity was assessed on each visit using "7x7" questionnaire \[Ivashkin, V., Sheptulin, A., Shifrin, O., Poluektova, E., Pavlov, C., Ivashkin, K., Drozdova, A., Lyashenko, O., Korolev, A., 2019. Clinical validation of the "7 × 7" questionnaire for patients with functional gastrointestinal disorders. J. Gastroenterol. Hepatol. 34, 1042-1048. https://doi.org/10.1111/jgh.14546\], on 1 and 3 visits stool samples were collected for the qualitative and quantitative composition of the intestinal microbiota based on 16S rRNA gene sequencing.

The study protocol was approved by the Ethics Committee of the Mental Health Research Center, Moscow, Russian Federation (No. 418 dated 01/31/2018) and written informed consent was obtained from all participants.

Eligibility Criteria:
Inclusion Criteria:

* irritable bowel syndrome (IBS)
* diarrhea-predominant IBS
* constipation-predominant IBS
* mixed-type IBS
* IBS/functional dyspepsia symptoms
* Must be able to swallow tablets

Exclusion Criteria:

* organic bowel disease
* renal disease
* hepatic insufficiency,
* schizophrenia
* bipolar disorder
* epilepsy
Robot-Assisted Stair Climbing Training

Stair climbing up and down is an essential part of everyday's mobility. Physiotherapy is focused on muscle strengthening, real floor walking and stairs climbing tasks, but these methods do not stress in terms of intensity stair-climbing practice. The aims of this study is to compare whether an intensive robot-assisted stair climbing training (RASCT) is more effective than conventional physiotherapy (CP) for improving stair climbing ability, gait and postural control in stroke patients.

Trial design: A pilot randomized (allocation ratio 1:1), single blind clinical trial (RCT) comparing the effects between the experimental \[Robot-Assisted Stair Climbing Training group (RASCT)\] and control group (Conventional Physiotherapy, CP) in improving stair climbing ability and postural control in stroke patients. The examiner will be blind to group assignment.

Eligibility Criteria:
Inclusion Criteria:

* First-ever ischemic or hemorrhagic stroke;
* More than or equal to 3 months post stroke;
* Age\>18 years;
* Mini- Mental State Examination (MMSE) score more than 23;
* Ability to stand for at least 1 min without arm support; ability to walk independently for at least 10 m with or without walking aids;
* Functional Ambulation Category score equal or more than 1.
* Signed informed consent form

Exclusion Criteria:

* Severe cognitive or communicative disorders that hamper collaboration;
* Unstable cardiovascular system conditions (i.e. labile compensated cardiac insufficiency, angina pectoris), deep vein thrombosis, severe neurological or orthopedic diseases which massively affect lower limb mobility; severe joint misalignment;
* Treatment of lower limb spasticity (i.e. botulinum toxin) in the 3 months prior to the start of the study and/or during its execution.
Cisplatin Plus Raltitrexed or 5-fluorouracil Concurrent With Radiotherapy for Head and Neck Squamous Cell Cancer

This study is a multicenter phase Ⅲ trial. The objective is to compare the efficacy and toxicity of cisplatin plus raltitrexed or 5-fluorouracil in concurrence with IMRT for patients with locoregionally advanced head and neck squamous cell cancer.

The objective is to compare the efficacy and toxicity of cisplatin plus raltitrexed or 5-fluorouracil in concurrence with IMRT for patients with locoregionally advanced head and neck squamous cell cancer.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed untreated head and neck squamous cell cancer patients
* 18-70 years
* Clinical stage: T3-4N0-3M0 or T1-4N1-3M0
* Hematologic function: WBC ≥ 4.0×109/L, PLT ≥ 80×109/L, Hb ≥ 10mg/dL
* Renal function: Cr ≤ 1.25×UNL
* Hepatic function: BIL ≤ 1.5×UNL, ALT/AST ≤ 2.5×UNL
* ECOG ≤ 1
* Woman and man of childbearing age must adopt contraception
* With written consent

Exclusion Criteria:

* Malignant history
* Pregnant or lactating women
* With other severe diseases (blood, liver ,kidney or heart diseases)
* Subjects not suitable for chemo-radiotherapy
* Without written consent
Correlation of Airflow Limitation and Other Respiratory Characteristics With Radiologic Changes of Lung Structure

The aim of the study is to assess the correlation between airflow limitation, perception of dyspnea and functional capacity with anatomic changes in pulmonary structure as seen on High Resolution CT in COPD patients.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of COPD
* Able to perform pulmonary function testing

Exclusion Criteria:

* Pregnant women
Intraoperative Dexmedetomidine Infusion in Endovascular Intervention for Aneurysmal Subarachnoid Hemorrhage

The aim of this study is to evaluate the role of intraoperative dexmedetomidine infusion in endovascular intervention for aneurysmal subarachnoid hemorrhage.

Aneurysmal subarachnoid hemorrhage is a sudden, life-threatening emergency caused by bleeding in the subarachnoid space between the brain and skull. Cerebral vasospasm (VSP) is the leading risk factor of neurological deterioration (i.e., delayed cerebral ischemia \[DCI\] and cerebral infarction) after aneurysmal subarachnoid hemorrhage (SAH) and a cause of morbidity and mortality.

Dexmedetomidine (DEX) is a highly selective α-2 adrenergic receptor agonist. The α -2 receptor agonists have a long track record of use for sedation and analgesia. It has been shown that α -2 agonists are neuroprotective in craniocerebral and subarachnoid injuries. Dexmedetomidine has a significant effect on the central nervous system and decreases the blood flow in the brain and the requirement or needs for cerebral oxygen. It also modifies memory and enhances cognitive ability effects like sedation, analgesic, and anxiolytics. Dexmedetomidine is shown to decrease catecholamine in the brain and improves the perfusion ability in the penumbra. The glutamate level is significantly reduced by Dexmedetomidine (DEX), and so injuries at the cellular level is reduced.

Eligibility Criteria:
Inclusion Criteria:

* Aged \>18 years.
* Both sexes.
* American Society of Anesthesiologists (ASA) I-III
* Unruptured subarachnoid hemorrhage (SAH) confirmed by digital subtraction catheter angiography (DSA) undergoing endovascular intervention with general anesthesia.

Exclusion Criteria:

* Subarachnoid hemorrhage (SAH) from a lesion other than a ruptured saccular aneurysm.
* Intraventricular or intracerebral blood in the absence of localized thick or diffuse Subarachnoid hemorrhage (SAH).
* No or localized thin subarachnoid hemorrhage (SAH) on computed tomography (CT).
* Cerebral vasospasm on admission digital subtraction catheter angiography (DSA).
* Hypotension (systolic blood pressure 90 mm Hg) refractory to fluid therapy.
* Neurogenic pulmonary edema.
* Cardiac failure requiring inotropic support.
* Severe or unstable concomitant condition or disease or chronic condition.
* Kidney and/or liver disease.
* Prior cerebral damage on computed tomography (CT) scan such as stroke (\>2 cm maximum diameter).
* Pregnancy.
* Traumatic brain injury.
* Previously treated cerebral aneurysm.
* Arterial venous malformation.
* Pre-existing cerebrovascular disorder that will affect diagnosis and evaluation of Subarachnoid hemorrhage (SAH).
* Ischemic heart disease or second or third-degree atrioventricular block.
* Long-term abuse of alcohol, opioids, or sedative-hypnotic drugs.
* Obesity (body mass index \[BMI\] \>30 kg/m2).
External Focus of Attention Posttraumatic Osteoarthritis

Knee injuries, especially those to the ACL, are common among physically active people. These injuries are frequently treated with surgical reconstruction (ACL reconstruction; ACLR). While ACLR restores stability it does not protect against future injury, long-term pain, disability, and arthritis associated with these injuries. Our study is going to examine new ways to provide feedback about the way people move to determine if these are better at modifying movement patterns that are known risk factors of posttraumatic osteoarthritis development than current standard treatments. If you participate, you will be asked to undergo a movement analysis in a research laboratory while you perform tasks such as walking and hopping. After this initial assessment, you will be randomly allocated to one of 2 treatment groups. Each treatment group will perform 4 weeks (3x/week) of exercises to change the way people walk. Participants will then report for follow-up movement analysis testing 1- and 4-weeks after completing the intervention.


Eligibility Criteria:
Inclusion Criteria:

* history of primary, unilateral ACL reconstruction 6-24 months prior to enrollment
* cleared to return to full activity by treating orthopedic surgeon

Exclusion Criteria:

* Body mass index \>35 kg/m2
* History of musculoskeletal injury sustained 3 months prior to enrollment
* Current participation in formal post-operative rehabilitation