cyrilzakka/clinical-trials huggingface dataset:
Smoking Tobacco and Drinking Study

This trial will test the efficacy of a 3-month intervention on Facebook targeting tobacco use and heavy episodic drinking against a 3-month Facebook intervention targeting tobacco use. Both groups will be offered a nicotine patch starter kit. The primary outcome is verified 7-day point prevalence abstinence from smoking at 3, 6, and 12 months.

Participants will be randomized to one of two conditions: (1) a Facebook-delivered intervention addressing tobacco use and heavy episodic drinking, tailored to readiness to quit smoking; or (2) a 3-month Facebook intervention targeting tobacco use. Both interventions will include 12 weeks of Facebook-based messages and activities tailored to participants' readiness to quit smoking.

Assessments will occur at baseline, 3, 6, and 12 months follow-up. Assessments will include measures on smoking and drinking patterns and thoughts about abstinence. All participants who report no past 7-day smoking will be asked to give biochemical verification of smoking status with saliva cotinine test kits that will be mailed to participants.

Eligibility Criteria:
Inclusion Criteria:

* read English
* between 18 and 25 years of age
* indicate they use Facebook "most" (≥ 4) days per week
* have smoked ≥100 cigarettes in their lives and currently smoke at least 1 cigarette per day on 4 or more days of the week
* have had at least one heavy drinking episode (5+ for men, 4+ for women) in the past month.

Exclusion Criteria:

* do not read English
* are not between 18 and 25 years of age
* indicate they do not use Facebook "most" (≥ 4) days per week
* have not smoked ≥100 cigarettes in their lives and currently smoke at least 1 cigarette per day on 4 or more days of the week
* have not had at least one heavy drinking episode (5+ for men, 4+ for women) in the past month.
Adolescent Depression Screening and Treatment in Mozambican Primary Care

This is a cluster-randomized pilot trial of depression screening and treatment implementation at four Youth-friendly Health Services (YFHS) in primary care clinics, two in Maputo City and two in Maputo Province. YFHS will be stratified by urbanicity, such that one YFHS in Maputo City and one YFHS in Maputo Province will be randomized to interpersonal psychotherapy (IPT)-A and the other YFHS in each location with be randomized to treatment as usual (TAU).

Mental disorders are the leading cause of disability among adolescents worldwide, but only a very small minority, mostly in high-resource settings, have access to mental health care. The investigators' work is focused on understanding how to increase access to mental health care for adolescents in low-resource settings. In Mozambique, where this work is based, there are just 15 psychiatrists and 180 psychologists to serve its population of 29 million. In collaboration with local stakeholders, including governmental policymakers and primary care providers, the investigators developed a plan to implement care for adolescent depression in primary care settings. The investigators now aim to examine changes in adolescent depression and acceptability of primary care-based mental health services compared to treatment as usual.

Eligibility Criteria:
Inclusion Criteria:

1. Providers:

   1. IPT-AG Arm: YFHS staff will be included in the study if they (a) conduct screening for depression and/or group IPT-AG and (b) provide consent to participate in the study.
   2. TAU Arm: YFHS staff will be included in the study if they (a) provide referrals for adolescents suspected of having mental illness or seeking mental health services and (b) provide consent to participate in the study. Treatment providers (Psychiatric Technicians and psychologists) will be included in the study if they (a) treat adolescents referred from participating YFHS for depression and (b) provide consent to participate in the study.
2. Patients: In both study arms, adolescents attending one of the four study YFHS will be included in the study if they:

   1. are between the ages of 12-19 years;
   2. screen positive for depression;
   3. provide informed consent (ages 16 -19) or if their guardian provides informed consent and they provide assent (if ages 12-15).
3. Study centers: must be clinics that have YFHS.

Exclusion Criteria:

In both study arms, adolescents will be excluded if they:

1. are unable to participate in treatment due to acute illness; and/or
2. are unable to communicate sufficiently in Portuguese to answer inclusion questions.
Exploring the Impact of VR-based Acupuncture Treatment on Patient Experience and Doctor-patient Interaction.

Develop and establish a virtual reality acupuncture system, and introduce the technology acceptance model to systematically explore the impact of acupuncture treatment effectiveness and its related medical experience and doctor-patient interaction

Whether it\&#39;s Western medicine\&#39;s surgical treatment or traditional Chinese medicine\&#39;s acupuncture and acupotomy treatment, for patients preparing to undergo invasive treatment, pre-treatment explanations can improve patient compliance and reduce patient anxiety about disease treatment. The application of virtual reality systems in the medical field is mostly in preoperative training and medical education, while in the field of traditional Chinese medicine, it focuses on acupuncture teaching, with less evaluation of explanations before acupuncture treatment. Therefore, this study will develop and establish a virtual reality acupuncture system, and introduce the technology acceptance model to systematically explore the impact of acupuncture treatment effectiveness and its related medical experience and doctor-patient interaction

Eligibility Criteria:
Inclusion Criteria:

* general public and people see a doctor in the department of acupuncture

Exclusion Criteria:

* participant refusing the intervention of the virtual reality
Assessment of Usability and Satisfaction With a Take-home Device Presenting Sound and Body Stimulation for Back Pain

Pain symptoms can have a variety of ways to be treated, from medications to physical therapy, with several options being available to patients. However, no one treatment may work for all people who experience pain, especially cLBP. The purpose of this study is to measure the compliance, usability, and satisfaction of an at-home, multi-modal stimulation device in a diverse population of people with chronic lower back pain (cLBP). The multi-modal device will include a combination of electrical stimulation, auditory stimulation, and integrative-health techniques, including mindfulness breathing, health coaching, and reflective journaling. The multi-modal device creation is based on prior knowledge in lower back pain treatment, which includes electrical stimulation of the back (Transcutaneous Electrical Nerve Stimulator or TENS) and integrative health modalities. In isolation, these treatments are only somewhat effective in reducing symptoms.

This pilot study will involve participants who experience cLBP as we investigate a novel at-home, multi-modal device design. The main objective of the pilot usability study is to examine compliance to the intended use of the multi-modal device and approach, as well as protocol feasibility, and satisfaction with the settings and design.


Eligibility Criteria:
Inclusion Criteria:

* Must be 18 years of age or older
* Must be within commuting distance to the University of Minnesota
* Able to provide consent and follow study instructions
* Must be able to understand English
* Must have chronic LBP, which is defined as lower back pain for more than 3 months
* A score of 4 or higher on the PEG
* Must be willing to commit to full duration of the study
* Not currently taking any benzodiazepines or sedative hypnotics

Exclusion Criteria:

* Back Pain associated with:
* Spondylolisthesis or spinal stenosis
* Sciatica or radiculopathy
* Rhematologic or inflammatory disease
* Trauma, fracture, dislocation, or previous back surgery
* A score of 10 on the PEG
* Pregnant
* Have an electrically implanted device, such as a pacemaker.
* Heart Disease
* Epilepsy
* Cancer
* Psychiatric conditions including psychosis, suicidal ideation, or substance abuse disorder
* A pure tone average of more than 40 dB HL at 500 dB, 1000 dB, or 2000 dB HL.
* Individuals currently using other lower back pain treatments during the study in which they are unable to maintain a steady state while participating in our study for one month before beginning the multi-modal regimen.
Does Complement Factor H Gene Polymorphism Play a Role in the Regulation of Vascular Tone in the Choroid?

Age related macular degeneration (AMD) is a multifactorial disease with a strong genetic component. Most importantly a genetic polymorphism in the gene encoding for the complement factor H (CFH) has been recently identified which is highly associated with an increased risk of developing AMD. This Tyr402His polymorphism located on chromosome 1q31 has been implicated to play a role in the development of the disease.

Given that it is known that impaired regulation of choroidal vascular tone is present in patients with AMD, the current study seeks to investigate whether the Tyr402His polymorphism is associated with altered choroidal autoregulation in healthy subjects. For this purpose a total of 100 healthy volunteers will be included in order to test the hypothesis that an impaired regulation of choroidal blood flow is present in subjects with homozygous Tyr402His variant.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged between 18 and 35 years
* Nonsmokers
* Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
* Normal ophthalmic findings, ametropy less than 3 diopters

Exclusion Criteria:

* Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
* Treatment in the previous 3 weeks with any drug
* Symptoms of a clinically relevant illness in the 3 weeks before the first study day
* Blood donation during the previous 3 weeks
INvestigational Study Into Transplantation of the Uterus

Observational study on cohort of 10 women undergoing uterine transplantation using deceased donors


Eligibility Criteria:
Inclusion Criteria:

1. Female
2. Age - 24-38 (or 40 if eggs frozen \<38)
3. AUFI

   1. Normal length vagina
   2. No renal pathology
4. BMI \<30kg/m2
5. ASA grade I
6. Meet psychological criteria
7. Meet HFEA criteria for IVF
8. Eligible for NHS treatment
9. Speak fluent English

Exclusion Criteria:

1. Unsuccessful oocyte retrieval (\<10 good quality embryos)
2. Previous multiple/significant surgeries
3. Severe endometriosis
4. Cancer patients \<5 years in remission
5. Previous living childbirth, adopted child or child born through surrogacy
6. HIV or Hepatitis B / C positive
7. Skin or intestinal neovagina
Remifentanil in Ventilated Preterm Infants

The purpose of this study is to evaluate efficacy of remifentanil in preterm infants during ventilator care with remifentanil and to analyze pharmacokinetics in preterm infants


Eligibility Criteria:
Inclusion Criteria:

* preterm infants (\<37weeks of gestational age)
* requiring ventilator care
* informed consent

Exclusion Criteria:

* major anomaly
* 48hrs after birth
* requiring operation during drug infusion
* cord blood pH \< 7.0
* intraventricular hemorrhage grade III or more
* investigators decision
Flax Mucilage and Apparent Nutrient Digestibility

The aim is to study the effects of flaxseed mucilage, rich in dietary fiber on apparent fat and energy digestibility in young adults.

A 3 times 1-wk randomised crossover dietary intervention study, where the full diet is provided to 17 young subjects along with different flaxseed mucilage preparations. During the last five days, fecal samples are collected. Fasting blood samples are collected on day 1 and 8 in each period and appetite sensation is registered three times daily before the main meals.

Eligibility Criteria:
Inclusion Criteria:

* 18-40y
* BMI 22-28
* healthy

Exclusion Criteria:

* smoking
* medication
* excess PA
Treatment of Bardet-Biedl-Syndrome With Metformin for Evaluation of a Possible Visual Improvement

In this prospective pilot study without control group children and young adults (10-25 years old) diagnosed with Bardet-Biedl syndrome and treated with Metformin for their adipositas will be evaluated for a possible additional effect of Metformin on visual acuity.

Within experiments with animals a positive effect of Metformin concerning the photo receptors was shown. Several patients of the university hospital Tübingen with Bardet-Biedl-Syndrome and Metformin therapy due to their adipositas reported a subjective improvement of the visual acuity which was confirmed by opthalmologic tests.

This will be checked in a prospective pilot study without control group including children and young adults (10-25 years old) diagnosed with Bardet-Biedl syndrome and treated with Metformin for their adipositas. Therefore a possible additional effect of Metformin on visual acuity will be evaluated under controlled conditions.

Eligibility Criteria:
Inclusion Criteria:

* clinically confirmed Bardet-Biedl-syndrome
* Visual acuity between 0.05 and 0.8
* Age \>=10 year to \<25 years
* Visual field III4e or V4e with diameter \>=5°, if II4e not seen
* informed consent of patient and/or legal representative

Exclusion Criteria:

* Hypoglycaemia (\<50mg/dl)
* Therapy with Metformin within the last three months
* Participation in another clinical trial
* pregnancy, lactation
* any contra indication concerning Metformin therapy
* Renal failure (creatinine clearance \< 60ml/min)
* any acute disorder accompanied by clouding of consciousness
* acute or chronic disorders possible accompanied by tissue hypoxia
* Liver insufficiency, alcohol abuse
* not fluent in German language
The Effectiveness of Virtual Reality on Anxiety Reduction in Women Undergoing Elective Egg Cryopreservation.

A randomized trial assessing the effectiveness of virtual reality exposure prior to an oocyte retrieval procedure in terms of anxiety level .

Eligible women, undergoing elective egg freezing, will be offered to participate in the study, and sign a consent form.

The patients will be randomized into 2 groups:

1. No intervention (routine management).
2. Exposure to scenery video, as a VR (virtual reality) session.

All women will be addressed prior to the procedure, while they are waiting, and upon consent will be asked to state their VAS (visual analogue scale) anxiety score and to fill the STAI (The State-Trait Anxiety Inventory questionnaire.) Vital signs (Heart rate, Blood pressure) will be recorded upon arrival.

Patients who were allocated to the VR arm will watch a 20-minute scenery video and following the session before entering the procedure will be asked to rate their VAS score and answer the STAI questionnaire once again. vital signs will be recorded again.

After recovery all women will fill the STAI questionnaire, VAS score and vital signs before they will be discharged.

Eligibility Criteria:
Inclusion Criteria:

* Patients before egg retrieval for social reasons (elective egg freezing)

Exclusion Criteria:

* Use of any medications for pain relief/ anti -anxiety /anti -depressants medication generally or prior to the intervention
* If suffers from any condition that Use of VR is not recommended:

  1. Risk for seizures
  2. Sensitivity to ﬂashing light/motion
  3. Predisposing to nausea/dizziness (vertigo, etc.) Any injury to the eyes/face/neck that would limit the use of the hardware, including blindness.
Nephrogenic Diabetes Insipidus During Prolonged Sevoflurane Sedation in the ICU: a Retrospective Analysis

The investigators aim to retrospectively explore the electronic medical records of all patients who were admitted to the Intensive Care Unit (ICU) of the UZ Brussels in the last 10 years (March 1st 2011- March 1st 2021) and who received prolonged sedation (\>24h) with sevoflurane.


Eligibility Criteria:
Inclusion Criteria:

* Sevoflurane administration \>24h
* 18 years and older

Exclusion Criteria:

* \< 18 years old
* Pre-existing diabetes insipidus
* Use of drugs at risk for diabetes insipidus (including lithium, cisplatin)
* Hypercalcemia (persistently \>2.75 mmol/L)
* Pituitary or acute brain surgery
* Patients requiring continuous renal replacement therapy
* Pregnancy
Developing Cognitive Training for Tourette Syndrome

Many researchers suspect that individuals with Tourette Syndrome (TS) may have a poor cognitive ability (i.e., response inhibition; RI) that is essential to inhibit inappropriate response such as vocal or motor tics. The investigators aim to test whether a well-established behavior therapy for TS can be improved by increasing the individual's RI capabilities. To this end, 20 children will be randomly assigned to behavior therapy with computer-based RI training or behavior therapy with placebo computer-based cognitive training. The investigators will test the hypothesis that computer-based RI training can be a useful addition to the well-established behavior therapy to enhance its therapeutic effect.

The current research seeks to examine the feasibility of using a computer-based RI training program as an adjunctive intervention for the Comprehensive Behavioral Intervention for Tics (CBIT). Our central hypothesis is that cognitive training designed to enhance RI will potentiate treatment outcomes of CBIT. To this end, the investigators will conduct a two-arm placebo-controlled double-blind trial, in which 20 children with TS will be randomly assigned to CBIT with computerized RI training (CBIT+RIT; n=10) or CBIT with placebo computer training (CBIT +PLT; n=10). CBIT consists of eight weekly sessions that present awareness training, competing response training, relaxation training and functional contingency management in a manualized format. The adjunctive computer training (RIT or PLT) will be delivered during the first 4 weeks of CBIT/HRT (i.e. 8 twice-weekly 40-min sessions). Tic symptoms and RI capabilities will be assessed at baseline, mid-treatment, post-treatment, and 1 month follow-up. This project is expected to increase our understanding about the nature of response inhibition deficits in TS and generate knowledge that will guide the development of effective cognitive interventions for TS.

Eligibility Criteria:
Inclusion Criteria:

* age between 9 and 17
* a diagnosis of TS or chronic tic disorder on the structured diagnostic interview
* moderate to severe levels of tic symptoms (YGTSS total score \> 13 for TS, or \> 9 for CTD), and (d) IQ \> 80.

Exclusion Criteria:

* current substance abuse or dependence
* current or past psychotic disorder, bipolar disorder, or schizophrenia
* 4 or more previous sessions of behavioral treatments for tic
* significant suicidal ideation and/or attempts within the past 3 months
* any recent (in the previous month) or planned change in medication for tic symptoms.
Anemia and Inflammation

During inflammation hepcidin concentrations are increased, leading to a decrease in iron absorption. In iron deficiency anemia hepcidin is suppressed due to the activation of erythropoiesis. Whether inflammation or anemia has the stronger effect on hepcidin is uncertain.


Eligibility Criteria:
Inclusion Criteria:

* BMI \<27.5kg/m2
* body weight \<70kg
* either non-anemic (Hb\>12.5g/dl) or anemic (Hb between 8-12 g/dl and ferritin \<15ng/ml)

Exclusion Criteria:

* pregnant or lactating
* chronic disease
* smoking
* inflammation defined as CRP\<5mg/L; AGP\<1g/L
Diagnostic Study to Identify Sentinel Lymph Nodes in Women With Stage I or Stage II Breast Cancer

RATIONALE: Diagnostic procedures, such as blue dye or imaging to identify sentinel lymph nodes, may improve the ability to detect the extent of disease and help plan effective surgery for removing breast tumors.

PURPOSE: Diagnostic trial to study the effectiveness of blue dye and an imaging procedure to identify the sentinel lymph node under the arm in women with stage I or stage II breast cancer.

OBJECTIVES: I. Determine whether the concept of a sentinel lymph node within the axillary nodal basin is valid in staging breast cancer. II. Determine the sensitivity of combined methods of identification of sentinel lymph nodes by patent blue V dye and gamma probe detection in these women.

OUTLINE: Patients receive patent blue V dye injection peritumorally prior to surgery. Preoperative lymphoscintigraphy is performed using technetium Tc 99 sulfur rhenium colloid injected around the tumor associated with intraoperative gamma probe detection. Nonpalpable tumors receive a localized injection using stereotactic injection techniques. Patients then undergo standard axillary (level I and II) lymph node dissection.

PROJECTED ACCRUAL: A total of 200 patients will be accrued for this study within 1 year.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically or cytologically proven stage I or IIA invasive breast cancer T0, T1, or T2 (no greater than 3 cm), N0 Noninflammatory Nonmetastatic No ductal carcinoma in situ Eligible for breast-conserving surgery Hormone receptor status: Positive or negative

PATIENT CHARACTERISTICS: Age: Any age Sex: Female Menopausal status: Pre- and postmenopausal Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Not pregnant No allergy or sensitivity to radiopharmaceuticals or patent blue V dye

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy Chemotherapy: No prior neoadjuvant chemotherapy Endocrine therapy: No prior endocrine therapy Radiotherapy: No prior neoadjuvant radiotherapy Surgery: No prior breast surgical biopsy or axillary surgery
CorRELation Between PatIent PErception and Findings on Clinical Examination

This is a multi-center, prospective, non-interventional study that aims to evaluate in daily clinical practice, the possible corelation between patIent perception of the ability to perform morning activities and physician evaluation; patients with COPD, grade C and D.

CorRELation between PatIent PErception of the Ability to Perform Morning Activities and Findings on Clinical Examination in COPD Patients

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of COPD, grade C and D according to GOLD Guidelines Revised 2011
* Current or past smokers, of at least 10 pack years
* Receive any inhaled combination therapy for COPD (inhaled corticosteroid / long acting β2-agonist bronchodilator) initiated for at least one month before entering in the study

Exclusion Criteria:

* History of exacerbation of COPD symptoms within the last month before visit 1, inclusive; history of asthma or allergic rhinitis; history of lung carcinoma or any other respiratory condition that may limit the airflow circulation
* Inability to understand study procedures and inability/refuse to complete CDLM questionnaires and/or record the values showed on the pedometer screen