cyrilzakka/clinical-trials huggingface dataset:
sTMS for Substance Use-disordered Veterans

The purpose of this study is to determine if synchronized transcranial magnetic stimulation is safe and tolerable in individuals with cocaine, opioid, or alcohol use disorders.

All non-life-saving human research studies suspended by sponsor in response to COVID19 social distancing policies

The goal of this proposal is to evaluate preliminary participant response to a pilot, controlled, feasibility study to evaluate changes in craving, substance use, and quality of life after 6 weeks of a low-risk non-invasive brain stimulation technique, called Synchronized Transcranial Magnetic Stimulation (sTMS), compared to sham, in Veterans with a substance use disorder (SUD). An important focus of this application will be evaluating the acceptability, tolerability, and safety of sTMS in this population. To the investigators knowledge, sTMS has never been used for SUDs, and holds considerable promise as a future treatment option for these prevalent disorders. However initial work in the acceptability, tolerability, and safety of this approach must be conducted first. This project is the first step towards the investigators long-term goal, which is to combine non-invasive brain stimulation with individualized psychotherapy or pharmacotherapy to reduce SUD problems and improve quality of life for Veterans.

Eligibility Criteria:
Inclusion Criteria:

* Eligible male and female Veterans
* between ages 18-70,
* Veterans who currently meet criteria for SUD, and, if applicable, have stable treatment regimen (i.e., medications and/or therapy) for at least 6 weeks prior to study procedures
* ongoing medications and psychotherapy will be allowed to continue unchanged during the study
* for safety, participants must also meet established criteria for MRI exposure, which is implemented as a conservative measure given the novel application of sTMS in this population

Exclusion Criteria:

* pregnancy/lactation,
* history of moderate or severe traumatic brain injury,
* current or prior neurologic disorder or lifetime history of

  * seizure disorder
  * CNS tumors
  * stroke
  * cerebral aneurysm,
* unstable medical condition,

  * active suicidality as assessed with the Columbia-Suicide Severity Rating Scale
  * primary psychotic disorder.
Group Balance Training for People With Multiple Sclerosis

People with multiple sclerosis (MS) often have affected balance capacity and an increased risk for falls. A risk factor for falls are activities requiring dual attention. Another factor leading to reduced balance capacity is trunk stability, and decreased trunk stability has been seen in people with MS compared to healthy controls. Earlier studies using core stability exercises have shown positive effects on balance, compared to no training. In Sweden, physical therapy for people with MS has often included group training. However, evidence for this intervention is scarce. The aim of this study is therefore to investigate balance training in group. The balance training includes core stability exercises and dual attention activities. A multi-centre study is planned with a waiting-list design. Participants are randomised to either exercise group with early start or with late start. The group balance training includes training 60 minutes 2 times per week for 7 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed multiple sclerosis by a neurologist, being able to walk 100 m with or without walking device, being able to get down on the floor with minor assistance

Exclusion Criteria:

* No balance deficit here defined as being able to stand still heel-toe for 30 seconds with arms crossed.
* Ongoing relapse, cognitive- or language difficulties that prohibits performing the outcome measures.
Factors Affecting the Difficulty of Laparoscopic D2 Lymph Node Dissection for Gastric Cancer

Laparoscopic D2 lymph node dissection (LND) for gastric cancer has a wide range of operations and a high degree of difficulty.The purpose of this study was to evaluate the relationship between clinicopathological factors and the difficulty of laparoscopic D2 LND.


Eligibility Criteria:
Inclusion Criteria:

1. all patients undergoing laparoscopic surgery
2. Laparoscopic system is 2D and has complete D2 lymph node dissection.

Exclusion Criteria:

1. patients undergoing laparotomy
2. incomplete video or clinicopathological information
Gut Microbiota in Adults With Chronic Widespread Pain

We aim to identify the gut microbiome composition in adults with CWP. We will collect the stool sample of 120 healthy individuals and 120 Chronic Widespread Pain patients. We hypothesize that the intestinal microbiota is altered in CWP compared to healthy subjects without CWP.

We aim to identify the variations in gut microbiota composition in Hong Kong adults with CWP. We hypothesize that the intestinal microbiota is altered in CWP compared to healthy control. The design of the study is a pilot case-control study with adults with CWP (n=120) and healthy adults without any chronic pain (n=120). Participants will be recruited in 8 general-outpatient clinics in the New Territories East region of Hong Kong.

Eligibility Criteria:
Inclusion Criteria:

1. Participants with Chronic Widespread pain

   Participants will be asked, "In the past 3 months, have you had pain in your muscles, bones and joints lasting at least 1 week?", as a screening question for CWP. To meet the criteria for CWP, subjects have to report musculoskeletal pain in at least 4 of 5 body regions and in at least 3 or more body quadrants (as defined by upper-lower/left-right side of the body) and axial skeleton (neck, back, chest, and abdomen), with pain duration of more than 3 months. A Widespread Pain Index (WPI) will be generated based on the number of pain sites. Subgroup of patients with fibromyalgia will be identified according to The American College of Rheumatology 2016 when subjects WPI of ≥ 7 and a symptom severity scale (SSS) score of ≥ 5 or a WPI between 4 and 6 and an SSS score of ≥ 9.
2. Healthy Participants

Healthy participants will be those without chronic pain and depression. A screening question 'In the past 3 months, have you had pain in your muscles, bones and joints lasting at least 1 week?' will be asked to determine whether participant has chronic pain. Depression status will be determined by the questionnaire "Patient Health Questionnaire-9"

Exclusion Criteria:

* Participants with major chronic illnesses, such as malignancy, active inflammatory diseases, autoimmune diseases and metabolic diseases such as diabetes mellitus and thyroid diseases etc.; use of antibiotics, probiotics or prebiotics in the preceding 2 months, any acute illness in the preceding month, change in regularly taken medication in the preceding month, and substantial dietary alterations in the preceding month.
ERIGO® Life- Control of Cardiovascular Parameters Via Verticalization and Simultaneous Mobilization

Early verticalization and stepping with the equipment of Hocoma ERIGO during monitoring of vital parameters. The device is already CE marked and, for the purposes of the study, will be used in accordance with the intended use (after-market clinical investigation).

In early rehabilitation of neurological patients, safe mobilization and intensive sensorimotor stimulation are key factors for therapeutic success. Early activation and stimulation of the patient intend enhancement of neuroplasticity and recovery. Furthermore, it improves the patient's communication and cooperation skills and counteracts secondary damages due to immobilization.

The study combines gradual verticalization during monitoring of vital parameters, with cyclic leg movement and foot loading. The table to ensures the necessary safety for the stabilization of the patient in the upright position. The patient stimulation is additionally enhanced by synchronized functional electrical stimulation (FES). By providing a safe solution for early mobilization, the Erigo counteracts the negative effects of immobility and accelerates the recovery process through intensive sensorimotor stimulation. It is the first choice therapy device for the early and safe mobilization of severely impaired, bed-ridden patients even in acute care.

Eligibility Criteria:
Inclusion criteria:

* minimum 18 years old
* normal response to verbal instructions
* oxygen saturation of the blood at least 92%
* healthy german speaking men and women
* non-smoker
* heartbeat 40-100
* systolic blood pressure 120 to 220 mmHg
* in patients: post acute phase: stroke or other neurological functional disorder

Exclusion criteria:

* severe contraction in the legs (Ashworth \>3)
* pregnancy
* acute pain syndrome
* severe cardio-pulmonary disease
* history of orthostatic dysregulation
* thrombophlebitis
* diabetes
* renal disease
* contraindication for electric stimulation (instable epilepsy, cancer, pacemaker, palliative care)
* weight \> 120kg
* height \> 210 cm
* skin lesions on legs
Evaluation of the AO Pediatric Classification for Long Bones Fractures Like a Guide for Treatment and Prognosis

1. Is the AO Pediatric classification for long bones fractures reproductible?
2. Is the AO Pediatric Classification for long bones fractures a treatment guide?
3. The AO pediatric Classification for long bones fractures could be a prognosis factor?

PROPOUSE:

1. To determinate the efectivity of the AO pediatric classification for long bones fractures.
2. To evaluate the functionality of the AO pediatric classification for long bones fractures.
3. To analyze if the AO pediatric classification for long bones fractures is a prognosis factor

Eligibility Criteria:
Inclusion Criteria:

Patients:

* Less than 16 years old.
* Open physis.
* Long bone fractures.
* X ray AP \& lateral comparatives.
* Informed consent for parents or tutor.
* Don´t let the treatment during the time of study.

Exclusion Criteria:

* Pathologic fractures.
* Fractures not included en the AO pediatric classification for long bones.
* Diseases that modifying the bone healing: Diabetes mellitus, osteogenesis imperfect, etc.
Dexamethasone and Postoperative Bleeding Following Tonsillectomy in Children

Tonsillectomy is one of the most frequently performed surgical interventions in children. However, it is associated with a high incidence of PostOperative Nausea and Vomiting (PONV), severe pain and haemorrhage.

There is strong evidence on the efficacy of Dexamethasone in reducing the incidence of PONV and pain after tonsillectomy, which led to consider this drug as a first line treatment in routine anaesthesia practice in such surgical setting. However, in the last decade, there have been arguments about the potential role of Dexamethasone in increasing the risk of postoperative bleeding in children and studies addressing the haemorrhage risk following administration of Dexamethasone for tonsillectomy are inconclusive.Thus, this study is aimed at providing evidence for the safety profile of Dexamethasone with regard to the risk of post-tonsillectomy bleeding in children when administered as a single intraoperative dose.

This double-blind (investigator-surgeon-patient blinded), randomized, placebo control, multicentre, international, pragmatic, non-inferiority trial is designed to to provide evidence of the Dexamethasone safety profile with regard to the risk of post-tonsillectomy bleeding in children when administered as a single intraoperative dose of 0.15mg/kg. The study is also aimed at characterizing whether the co-administration of non steroidal anti-inflammatory drugs for analgesia potentiates the risk of postoperative haemorrhage.

Sample size estimation is based on the definition of a minimal clinically important difference between the 2 groups of treatment (dexamethasone or normal saline) to be equal to 2% (non-inferiority margin). Thus, 3'794 children in total will be included with 1'897 children in each treatment group.

The follow-up will be performed by the parents via an "Application" for Android and Apple that has been developed specifically for this study.

Eligibility Criteria:
Inclusion Criteria:

* Children aged from 2 to 13 years admitted for tonsillectomy/ tonsillotomy with or without adenoidectomy
* Parents or legal responsible person willing and capable to follow data collection by the application (Android and iPhone) developed for this study

Exclusion Criteria:

* Children under Aspirin or any other anticoagulants with or without Congenital Heart Disease
* Children with any bleeding disorders (ex. Haemophilia, Von Willebrand Disease)
Study to Evaluate the Use of RHT-3201 in SCORAD Reduction in Young Patients With Atopic Dermatitis

The study's objective is to confirm that RHT-3201 reduces the signs and symptoms of moderate atopic dermatitis determined by SCORAD, in patients aged 1 to 12 years, as compared to placebo. It will also be examined if the RHT-3201 treatment, as compared to placebo, reduces the quantity of topical steroids used to treat disease flares


Eligibility Criteria:
Inclusion Criteria:

1. Patients and patients's parents or legal guardian have signed the informed consent.
2. Aged 1 to 12 years, diagnosed with atopic dermatitis according to Hanifin and Rajka criteria
3. Patients experienced AD symptoms for at least 6 months
4. SCORAD index of 20-40, both inclusive

Exclusion Criteria:

1. Patient has other active non-AD skin diseases that could difficult the atopic dermatitis evaluation
2. Active cutaneous or extracutaneous infection (bacterial, viral, fungal) requiring systemic treatment within 2 weeks of baseline (Localized molluscum contagiosum with \<20 lesions and viral warts are generally not reasons for exclusion.)
3. Medical history of immunodeficiency syndrome, autoimmune disease or malignancy for systemic therapies that modulate the immune system
4. Use of medications or treatments before baseline

   * Treated with corticosteroids, immunosuppressive treatment within 4 weeks of baseline
   * Treated with herbal medicines and health functional foods related to atopic dermatitis within 4 weeks of baseline
   * Treated with phototherapy treatments to atopic dermatitis within 4 weeks of baseline
   * Treated with probiotics within 4 weeks of baseline
   * Treated with systemic antibiotics within 2 weeks of baseline
   * Treated with topical steroids, topical immunomodulators, oral antihistamines, and topical antibiotic within 1 week of baseline (inhaled corticosteroids for asthma, no washout required if doses is stable)
5. Medical history of infectious intestinal disease within 2 weeks before screening
6. History of hypersensitivity to components contained in study product (Lactobacillus rhamnosus)
7. Participation in any other investigational drug study in which receipt of an investigational study drug or health functional food within the past 4 weeks before screening (or, if known, administered within 5 times the half-life)
8. Patients who are considered to be unacceptable in this study under the opinion of the investigator
An Observational Study on The Correlation Between Time of Initiation of Avastin (Bevacizumab) Treatment And Progression-Free Survival in Patients With Colorectal Cancer (CRONOS 1)

This single arm, prospective, observational study will assess the correlation between the time from start of chemotherapy to the start of Avastin (bevacizumab) treatment with progression-free survival in patients with previously untreated metastatic colorectal cancer. Patients will be followed for up to 12 months after progressive disease occurs.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/= the 18 years of age
* Previously untreated metastatic colorectal cancer
* Scheduled to start 1st line chemotherapeutic treatment
* ECOG performance status 0-1

Exclusion Criteria:

* Any conditions included in contraindication list for Avastin
* Prior chemotherapy for metastatic colorectal cancer
* Adjuvant/neoadjuvant chemotherapy or radio-chemotherapy of non-metastatic colorectal cancer completed \<6 months prior to treatment start
Study of Red Bull™ Sugar-Free Drink for Reduction of Fatigue in Prostate Cancer Patients Receiving LHRH Agonist Therapy

The purpose of this research study is to find out if Red Bull™ Sugar-Free Drink can reduce fatigue in prostate cancer patients receiving LHRH agonist therapy.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed prostate cancer
* Currently receiving LHRH-agonist therapy for greater than 6 months
* Measurable fatigue, defined as a score of ≥ 2 on the Bruera global fatigue severity scale
* Able to swallow Red Bull™ Sugar-Free Drink
* Life expectancy of at least 1 year
* Able to read and write in English
* Willing to limit consumption of alcohol to one drink per day

Exclusion Criteria:

* Current malignancy or received treatment for a previous malignancy within the last 3 years other than prostate cancer (exceptions are superficial bladder cancer or non-melanoma skin cancer)
* Myocardial infarction within past 6 months
* Any unstable serious co-existing medical condition(s) including but not limited to unstable or poorly controlled coronary artery disease, chronic atrial fibrillation, uncontrolled hypertension, uncontrolled diabetes, severe bleeding diseases or immune disorders
* Evidence of drug or alcohol abuse
* Known hypersensitivity to caffeine
* Known history of liver and kidney insufficiencies
* Known contraindications to Red Bull™ use
The Effectiveness of Commercial Weight Loss Programmes

The objective is to compare the effectiveness of 4 different commercial weight-loss diets available to adults in the UK.

This is achieved with a 6 month multi-centre randomised unblinded controlled trial of

* Dr Atkins' New Diet Revolution,
* The slimFast Plan,
* The weight Watchers Pure Points Programme,
* Rosemary Conley's "Eat Yourself Slim" Diet \& Fitness Plan.
* No diet (control)

Subjects are a community based sample of 300 (60 per group) otherwise healthy overweight and obese adults.

Main outcome measures are weight and body fat change over 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) \> 27 and \< 40 kg/m2.

Exclusion Criteria:

* History of coronary heart disease
* Type 1 or Type 2 diabetes
* Renal, liver or respiratory failure
* Gout
* Taking lipid lowering or anti-hypertensive drugs
* History of obesity with known cause (i.e. Cushings disease, hypothyroidism)
* Previous gastric or weight loss surgery
* Taking any weight loss drug (including Orlistat or Sibutramine)
* Clinical depression
* Eating disorders
* Drug or alcohol abuse
* Any malabsorptive state (including lactose intolerance)
* Being treated for a malignancy
* Being pregnant
* Breastfeeding
Denosumab and Teriparatide Study (DATA-HD and DATA-EX)

The aim of the study is to assess the effect of an antiresorptive medication in combination with standard dose or alternate dose teriparatide. The study extension will evaluate the effect of one-dose of zoledronic acid after the teriparatide/denosumab combination.


Eligibility Criteria:
Inclusion Criteria:

* women aged 45+
* postmenopausal
* osteoporotic with high risk of fracture

Exclusion Criteria:

* no significant previous use of bone health modifying treatments
A Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of Topical ESR-114 in Subjects With Plaque Psoriasis

This is a multicenter, double-blind, randomized, vehicle-controlled, parallel-group proof-of-concept study designed to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of topically applied ESR-114 following twice daily (BID) application for 42 days (6 weeks).


Eligibility Criteria:
Inclusion Criteria:

* Subject has a history of plaque psoriasis for at least 6 months.
* Subject has PGA of mild (2) or moderate (3) at Day 1.
* Subject has total LSS of ≥6 at Day 1.
* Subjects with plaque psoriasis-affected BSA to be treated of 1% to 15% at Screening and Day 1.

Exclusion Criteria:

* Subject has non-plaque psoriasis at Screening and Day 1.
* Subject has a history of skin disease or presence of skin condition that, in the opinion of the Investigator, would interfere with the study assessments at Screening and Day 1.
* Subject has used any topical therapy to treat psoriasis within 2 weeks prior to Day 1.
The Influence of Dual Task and Gait Speed on Gait Variability in Patients With Chronic Ankle Instability

Case-control study to evaluate gait parameters during different conditions between patients who suffer from chronic ankle instability and healthy individuals.

This case-control study will compare the different gait parameters such as stride time and stride length variability in different gait conditions (e.g., normal speed, normal speed with dual task, fast speed and fast speed with dual task) between healthy individuals and patients who suffer from chronic ankle instability.

the measurements will be collected using the OPTOGait system installed on a treadmill.

Eligibility Criteria:
Inclusion Criteria:

* history of at least one significant ankle sprain which occurred at least 12 months prior to enrolment in the study and was diagnosed by a physician or a physical therapist using clinical examination classifications described by Malliaropoulos et al
* history of at least two episodes of 'giving way', and feelings of ankle joint instability in the previously injured ankle joint of 1 year post-initial sprain
* the most recent injury occurred more than 6 weeks prior to the study enrolment
* the ability to apply full weight bearing on the injured lower extremity with no more than mild discomfort

Exclusion Criteria:

* evidence of a concomitant injury (such as a bony injury or significant muscular/tendon injury)
* previous ankle surgery
* other pathological conditions or surgical procedures in lower extremity
* neurological/vestibular or any other balance disorder.

The control group included healthy participants with no current or previous conditions that could affect proprioception.
Use of Hair to Diagnose the Presence of Breast Cancer

Using synchrotron X-ray diffraction, it has been reported that a hair from an individual with breast cancer exhibits a difference in its molecular structure compared to that of an individual without breast cancer. This difference is visible in the X-ray diffraction pattern as a ring superimposed on the pattern for normal hair.

The hypothesis of this study is that synchrotron x-ray diffraction can be used to differentiate hairs from women with medically diagnosed breast cancer from women not known to have the disease.

To test this hypothesis, hair from 2000 women attending radiology clinics for mammography will be collected, analysed by x-ray diffraction and then analysed using Fermiscan proprietary image analysis software. The mammogram status of the subjects will be blinded from the diffraction analysts. Results will then be compared with mammography results to allow a direct comparison between the Fermiscan test and mammography in terms of specificity and sensitivity.


Eligibility Criteria:
Inclusion Criteria:

* Adult women (aged \>20) who are undergoing mammography, and
* Who are willing and able to provide informed consent; and
* Who have usable scalp and/or pubic hair

Exclusion Criteria:

* Women who have dyed or permed their scalp hair within the previous 6 weeks and whose pubic hair is unavailable;
* Women with a history of breast cancer ever or other cancers (excluding non-melanoma skin cancer and CIN \[cervical intra-epithelial neoplasia\]) within 5 years.