cyrilzakka/clinical-trials huggingface dataset:
Theta Burst Transcranial Magnetic Stimulation as Treatment for Auditory Verbal Hallucinations

Auditory verbal hallucinations (AVH) are a characterising symptom of schizophrenia. In the majority of patients, these AVH respond well to antipsychotic medication. Yet, a significant minority continues to experience frequent AVH despite optimal pharmacotherapy. The number of alternative treatment options for this medication resistant group is currently low and most of them focus on coping with the hallucinations. Transcranial magnetic stimulation (TMS), in contrast, is a non-invasive technique of influencing cortical excitability. This technique has the potential to actually decrease the frequency and severity of medication resistant hallucinations.

Several previous studies have assessed efficacy of low frequency rTMS, with contradicting results. A previous large study by the investigators group could not demonstrate efficacy of low frequency rTMS. A new stimulation protocol using theta burst rTMS (TBS) could provide a more effective therapeutic option.

Objective: The present study aims to examine the efficacy of TBS on the severity of AVH. Study design: The objectives are tested in a randomized double blind placebo-controlled trail.

Study population: 60 patients with the diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder or psychosis not otherwise specified with frequent auditory verbal hallucinations will be included.

Intervention: The participant will receive either 10 TBS treatments or 10 placebo treatments consisting of 900 pulses each with a 30 minute interval on the left temporoparietal area, distributed over 5 treatment days. Stimulation will be at 80% of the motor threshold.

Main study parameters/endpoints: the main study parameter is the change in the severity of the AVH. The secondary study parameter is the number and severity of adverse events.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of schizophrenia, schizophreniform disorder, schizoaffective disorder or psychosis not otherwise specified.
* Age 18+ years.
* Frequent auditory verbal hallucinations (cut-off at \>once an hour).
* Written informed consent.

Exclusion Criteria:

* Metal objects in or around the head that cannot be removed (i.e. cochlear implant, surgical clips, piercing, cardiac pacemaker, medicinal pumps)
* History of seizures
* Increased intracranial pressure due to infarcts or trauma.
* History of eye trauma with a metal object or professional metal workers
* Patients who are coercively treated at a psychiatric ward (based on a judicial ruling)
* Patients who are represented by a legal ward or under legal custody
* In female patients, there should be no possibility for pregnancy as determined with a pregnancy test
* Changes in the prescribed medication in a period of 2 weeks prior to participation
Metric Charcteristics of Sit-to-stand Tests in Patients After Lower-limb Amputation

The aim of the study is to assess various aspects of reliability and validity of two sit-to-stand tests, the Five Times Sit to Stand Test (5TSTS) and the 30-Second Sit to Stand Test (30SSTS). The tests will be performed by patients after lower-limb amputation who have been newly fitted with a prosthesis. Each test will be performed with and without the prosthesis on two occasions: on the first day when the patients will be able to walk independently with their prosthesis and two weeks later. On the same two occasions, the patients will also perform three walking tests (in randomised order): the L-test, the 10-Metre Walk Test and the 6-Minute Walk Test. In addition, the patients will repeat the 5TSTS and the 30SSTS one day after the first assessment. The results will be used to detect the presence of a floor effect, assess repeatability and concurrent validity, as well as estimate minimal detectable change and effects size for the effect of rehabilitation.

All the tests will be performed using standardised protocols and technical aids. The assessments will be performed in the afternoon (after the daily rehabilitation program). The patients who will be able to perform the 5TSTS will perform that test first. If those patients will bill able to stand up within 30 seconds on each of the five trials, the 30SSTS will be performed next; otherwise, the number of times that the patient was able to complete the transition to the standing position will be recorded and taken as the 30SSTS result. Repetition of the outcome measurements will not serve to simply use the differences as the actual outcomes, but will serve to assess floor effect (the percentage of patients attaining the minimum possible score) on each occasion, to assess repeatability (intra-class correlation between the measurements on two consecutive days), minimal detectable change (calculated from the standard error of measurement, which will be estimated from the correlation between the measurements at the start and after two weeks) and effect size (difference between the mean measurements at the start and after two weeks, divided by the standard deviation at the start). In addition, the repeated measurements will be used to assess concurrent validity in terms of the correlation between the sit-to-stand tests and the walking tests on two occasions (at the start and after two weeks).

Eligibility Criteria:
Inclusion Criteria:

* unilateral trans-femoral or trans-tibial amputation
* fitted with a prosthesis for the first time
* being able to walk with the prosthesis independently (without walking aids or using a cane, crutch or walker)

Exclusion Criteria:

* balance disorder beacuse of neurological disease
* other muskuloskeletal impairments affecting the outcome measurements
* cardio-vascular disease that could be worsened by prforming the outcome measurements
* general ill health
Effect of Body Mass on Filgrastim Pharmacokinetics

Studies have shown that different percentages of body fat can alter the way drugs are distributed in the body. This study will use blood samples taken at different time points for patients taking Neupogen to determine if higher body weights affect drug exposure. The information gathered from this study will help understand if patients with higher body weights need a different dosing plan.

Patients in this study will have blood draws once before they take Neupogen and 6 times after they take the Neuopen (for a total of 24 hours). These patients will be in the hospital already and will not need to make additional trips back to have blood drawn. A total of about 5-6 tablespoons of blood will be drawn for this study. 15 obese patients and 15 matched, non-obese patients will be enrolled into this study.


Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 18 years
* Receiving filgrastim at 5mcg/kg ± 10%
* Admitted as an inpatient with an expected stay of at least 24 hours
* Weight is \> 190% of their ideal body weight (IBW) for "obese" patients or within 80 - 124% of IBW for matched control patients.
* Patient or their legally authorized representative understands and voluntarily signs the written informed consent prior to any study-specific procedures. A copy of the signed informed consent form will be retained by the treating institution.

Exclusion Criteria:

* Patients who have received filgrastim within 24 hours prior to enrollment
* Patients who have received pegfilgrastim within 14 days prior to enrollment
* Hypersensitivity reaction to filgrastim or any related product
* Patients who have taken lithium within 7 days of enrollment
* Serum Creatinine \> 1.5 mg/dL
* Patients who are pregnant or breastfeeding
* Patients who are unable to understand and/or render informed consent
The Effect of an Experimental Gel Based on Copaiba Oil Resin in Reducing Post-bleaching Tooth Sensitivity

This randomized, double-blind clinical trial aimed to evaluate the effect of an experimental gel containing copaiba oil resin in reducing postoperative tooth sensitivity caused by bleaching with 35% hydrogen peroxide. The volunteers of this study were randomized into 3 different groups - GC (placebo); GN (potassium nitrate and sodium fluoride); GCO (copaiba oil resin). The dental elements of the GCO received application of the experimental desensitizing gel on the buccal surfaces of the central incisors, lateral incisors, canines and upper and lower premolars, with a rubber cup in an active way, for 10 minutes. The GC and GN groups also received the application of a placebo gel and a nitrate potassium and sodiun fluoride gel, respectively, under the same conditions described for the experimental gel. Subsequently, all groups underwent in-office bleaching treatment with 35% hydrogen peroxide. Post-bleaching sensitivity was collected through a form composed of the visual analogue scale (VAS). Color measurement was performed at two times: baseline (Ti) and one week after the 3rd bleaching session (Tf).


Eligibility Criteria:
Inclusion Criteria:

* good oral hygiene
* absence of active caries lesions
* never undergone bleaching therapy
* not present dental hypersensitivity
* don't be a smoker
* don´t be pregnant
* present at least 28 teeth in the oral cavity

Exclusion Criteria:

* volunteers undergoing orthodontic treatment,
* presence of periodontal disease
* dental cracks or fractures
* restorations and prostheses on anterior teeth
* extensive molar restorations
* gastroesophageal disorders
* severe internal dental darkening
* presence of dentinal exposure in anterior and / or posterior teeth.
Preservation of Swallowing in Respected Oral Cavity Squamous Cell Carcinoma: Examining Radiation Volume Effects (PRESERVE): A Randomized Trial

The goal of this randomized treatment study is to formally compare quality of life in patients with at least one pN0 hemi-neck after resection of a squamous cell carcinoma of the oral cavity treated with a primary radiation therapy versus a secondary targeted radiation therapy approach, to provide a high level of evidence to guide the selection of treatment options.

The goal of this randomized treatment study is to formally compare quality of life in patients with at least one pN0 hemi-neck after resection of a squamous cell carcinoma of the oral cavity treated with a primary radiation therapy versus a secondary targeted radiation therapy approach, to provide a high level of evidence to guide the selection of treatment options.

The study will require a sample size of 90 patients randomized in a 2:3 between the two arms. Arm 1 (standard radiation therapy to tumor location and surrounding area) and Arm 2 (targeted radiation therapy to tumor location).

Patients will be followed for a total of 5 years.

Eligibility Criteria:
Inclusion Criteria:

* Willing to provide informed consent
* ECOG performance status 0-2
* Histologically confirmed, resected oral cavity squamous cell carcinoma with at least ipsilateral selective neck disection
* Patient has pathological features that are indications for PORT: positive or close (≤ 3 mm) margin, presence of LVI or PNU, pT3 or pT4 disease, positive lymph nodes, and PORT is recommended by treating physician
* Pathologically lympth node negative in at least one dissected hemi-neck with at least 10 nodes recovered in each pN0 hemi-neck

Exclusion Criteria:

* Serious medical comorbidities or other contraindications to radiotherapy
* Prior history of head and neck cancer within 5 years
* Any other active invasive malignancy, except non-melanotic skin cancers
* Prior head and neck radiation at any time
* Prior oncologic head and neck surgery in the oral cavity or neck
* Metastatic disease
* Locoregional disease recurrence identified following surgical resection but prior to the start of radiotherapy
* Inability to attend full course of radio therapy or follow-up visits
* Unable or unwilling to complete QoL questionnaires
* Pregnant or lactating women
An Analysis of Adverse Events and Satisfaction Outcomes of Women Who Underwent Primary and Secondary Breast Augmentation Using Silimed® Breast Implants with Smooth Surface

The study investigates the safety and performance of Silimed® brand smooth surface breast implants in women born with indication for primary and secondary (revision) augmentation to be followed up for 10 years. The safety of the smooth-surfaced Silimed® implant will be evaluated by estimating known and unexpected short-term and long-term risk/adverse event rates through patient reports of adverse events after implantation. The performance of using Silimed® brand smooth surface breast implants will be evaluated by evaluating satisfaction and quality of life after implantation.


Eligibility Criteria:
Inclusion Criteria:

* Provide written informed consent
* Female at birth
* Be 18 years of age or older
* Have a complaint of hypomastia
* Have an indication for breast augmentation with silicone implants
* Ability to comply with the protocol throughout the follow-up period.

Exclusion Criteria:

* Replacement of breast implants due to a complication
* Breast reconstruction in at least one breast
* Informed pregnancy or breastfeeding at the time of inclusion
* Sequelae of mastopexy
* Ptosis requiring mastopexy
* Breast changes or lumps rated BI-RADS 3 or higher on preoperative ultrasound or mammograms
* Advanced fibrocystic disease at the time of implantation
* Neoplasia of any type not yet treated or undergoing treatment at the time of implantation, - Active infection not yet treated or undergoing treatment at any site at the time of implantation
* Report or record of adverse reactions or intolerance to silicone prior to implantation
* Report or record of immune diseases affecting the active or undergoing treatment (e.g. lupus erythematosus, discoid lupus, scleroderma, etc.) at the time of implantation
* Signs of inflammation of the breast or implant site at the time of implantation
* Increased risk of post-implantation complications -immediate surgical complications caused by illicit drug use or medication use
* Having participated in another clinical trial within 6 months prior to implant placement
* Any other condition which, based on the opinion of the investigator or designee, may prevent the provision of informed consent, make study participation unsafe, compromise protocol adherence, complicate the interpretation of study outcome data, or otherwise interfere with the achievement of study objectives
The Effect of Menu Labels on Calories Ordered in Hispanics

Most studies on menu labels have been conducted in mostly non-Hispanic white individuals, and how menu labels affect calories and macronutrients ordered in Hispanics is not clearly understood. This study evaluated the impact of menu labels on calories and macronutrients ordered in Hispanics.

According to review studies, calorie labels on menus is not effective in reducing the number of calories ordered or consumed. Adding contextual information such as the energy needs per meal or interpretive information such as minutes of walking needed to burn the food calories or rank-ordering the food items from the lowest to the highest calorie content may be more effective in making food selections with fewer calories. Most studies on menu labels have, however, been conducted in mostly non-Hispanic white individuals, and how menu labels affect food choices in Hispanics in not well understood. This study evaluated the impact of menu labels on calories and macronutrients ordered in Hispanics by randomly assigning the participants to a menu with no labels (no labels), a menu with rank ordered calorie labels and a statement on the energy needs per meal (calorie labels), and a menu with rank ordered exercise labels (exercise labels). Calories and macronutrients ordered by the participants was assessed.

Eligibility Criteria:
Inclusion Criteria:

* Hispanics ages 18 through 65 years.

Exclusion Criteria:

* Not being able to read and write in either English or Spanish; pregnant or lactating women.
The HypoVoice Study

The HypoVoice study aims at identifying potential vocal biomarkers associated with hypoglycemia to pave the way towards a voice-based hypoglycemia detection approach.

While hypoglycemia has been widely studied in medical research, studies assessing vocal changes associated with this state are limited. This study aims at collecting a data set labelled with the gold standard (blood glucose) to provide a solid basis for the identification of vocal biomarkers using machine learning. Additionally, physiological data are collected using wearable sensors to assess whether additional integration of vital signs (e.g. heart rate) enhances the performance of hypoglycemia detection.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Type 1 Diabetes mellitus as defined by WHO for at least 6 months
* Aged 18 - 60 years
* HbA1c ≤9.0 %
* Functional insulin treatment with good knowledge of insulin self-management
* Native language German or Swiss German
* Use of continuous glucose monitoring (CGM) or flash glucose monitoring (FGM)

Exclusion Criteria:

* Incapacity to give informed consent
* Contraindications to insulin aspart (NovoRapid®)
* Total daily insulin dose \>2 IU/kg/day
* Pregnancy, breast-feeding or lack of safe contraception
* Active heart, lung, liver, gastrointestinal, renal or psychiatric disease
* Pacemaker or implantable cardioverter defibrillator (ICD)
* Epilepsy or history of seizure
* Chronic neurological or ear-nose-and-throat (ENT) disease influencing voice or history of voice disorder
* Illiteracy or dyslexia
* Active smoking
* Active drug or alcohol abuse
* Medication known to interfere with voice or to induce listlessness (e.g. opioids, benzodiazepines, etc.)
Pain and Safety of Microneedles in Oral Cavity

A randomized, crossover, double-blind, placebo-controlled, one-session clinical trial with 30 male volunteers was performed to access pain and safety of microneedle topical application in different regions of the oral cavity.

A randomized, crossover, double-blind, placebo-controlled, one-session clinical trial with 30 male volunteers was performed by applying a microneedle patch in the following regions of the oral cavity: lip (inner lower), buccal (cheek: 1 cm behind the month angle), tongue (dorsal surface), hard palate (anterior region), and attached gingiva (between central and lateral upper incisors). A 30 gauge hypodermic needle and an identical patch but without microneedles sticking out, were used as positive and negative controls, respectively. The application force was standardized to 10N by an applicator composed of a 5 mL syringe and a spring. Insertions were performed with a gap of 30 seconds. Pain and discomfort associated to the procedure was evaluated with a Visual Analogue Scale (VAS), by a blinded-dentist. The safety associated to microneedle application was verified immediately after the application (0h) and after the next day (24h). The different application sites were inspected visually for bleeding, ulceration, bruising, redness or swelling.

Eligibility Criteria:
Inclusion Criteria:

- Healthy male

Exclusion Criteria:

- Volunteers were free from cardiac, hepatic, renal, pulmonary, neurological, gastrointestinal and haematological diseases, psychiatric disorders, smokers or alcoholic.
Early Pregnancy Ultrasound Measurements and Prediction of First Trimester Pregnancy Loss.

Ultrasound measurements of fetus during first trimester may be an indicator of first trimester pregnancy loss. Investigators took 4 measurements of the fetus on 2 intervals during first trimester to confirm this hypothesis.

Ultrasound examination of gestational sac (GS) diameter, yolk sac (YS) diameter, crown rump length (CRL) diameter, embryonal heart rate (HR) using Samsung Medison SonoAce R3 through transvaginal probes (6.5 MHz) was conducted on 126 pregnant women. At least 2 scans were done for each participant one between 6-8 weeks and another one by the end of first trimester. Results then were compared to get the cut off values that can predict pregnancy loss.

Eligibility Criteria:
Inclusion Criteria:

* • Healthy pregnant female patient in the reproductive age group; 18 - 40 years old.

  * Gestational age: 6 - 13 weeks of gestations.
  * Singlton or multifetal pregnancy.
  * Any mode of conception included spontaneous, after superovulation with clomiphene citrate or letrozole with, or without, intrauterine insemination (IUI), and in vitro fertilization (IVF) after superovulation with gonadotropins.

Exclusion Criteria:

* • Patient with unsure date for the last menstrual period.

  * Pregnant women above 13 weeks gestation.
  * Patient with symptoms of threatened abortion or ectopic pregnancy at the initial antenatal visit.
  * Patient unable to come for follow up.
  * Any medical disorders as DM, HTN, ...
Sucrose Analgesia for the Reduction of Pain During Retinopathy of Prematurity Screening

Retinopathy of Prematurity (ROP) screening is one of many potentially painful diagnostic and therapeutic procedures performed routinely on preterm infants in the Neonatal Intensive Care Unit. Therefore strategies for stress reduction and pain management are essential to promote growth and development and minimize long-term sequelae. Procedural analgesia should include concepts of developmental care, non nutritive suck (NNS), pharmacological and non-pharmacological agents. Sucrose is thought to stimulate the body's activation of lingual sweet taste receptors and release of endogenous opioids, when combined with NNS, non-opioid mechanisms are also activated. The administration of sucrose or the combination of sucrose and non-nutritive sucking is one of the most frequently studied non-pharmacological interventions for relief of pain in neonates and oral sucrose has been shown to be an effective and safe therapy for common neonatal procedures such as heal lance, blood-letting and venepuncture. There is conflicting evidence on the benefit of sucrose in ROP screening. Therefore the purpose of this study is to determine the efficacy of sucrose combined with NNS as a potential regime for reduction of pain associated with retinopathy of prematurity screening.


Eligibility Criteria:
Inclusion Criteria:

* \< 1500 grams
* \< 32 weeks

Exclusion Criteria:

* Requiring mechanical ventilation excluding Continuous Positive Pressure Ventilation (CPAP), sedation
* Infants where consent to participate was not obtained
Comparing FARES Method With SPASO Method for Reduction of Anterior Shoulder Dislocation: a Prospective Randomized Trial

Shoulder anterior dislocation is a major disease entity in emergency department. There are more than 10 reduction methods that have been reported. Traditional reduction methods require sedatives, which could cause adverse effects on the patients such as respiratory suppression and allergy. There are some reduction maneuvers reported recently which do not need sedatives prior to performing reduction, including FARES method and SPASO method. So far, there are no well-designed study to compare these two methods. Besides, in clinical experience, we found that combining these two methods could even get higher successful reduction rate. This study is aimed to compare these two methods as a prospective randomized design, and furthermore, to show that combining these two methods could get higher successful reduction rate.


Eligibility Criteria:
Inclusion Criteria:

* shoulder anterior dislocation
* conscious clear
* communicable

Exclusion Criteria:

* unconscious
* non-communicable
* humeral neck fracture
* dislocation time \> 24 hours
* neurovascular compromise