cyrilzakka/clinical-trials huggingface dataset:
Effects of Body Contouring Surgery in Obese Patients

The aim of this study is twofold; 1) to assess the psychometric properties of the Finnish version of the BODY-Q questionnaire, 2) to assess the effects of body contouring surgery using patient-reported outcome measures.

The BODY-Q is translated into Finnish through forward and backward translation and a committee review. The preliminary version is pilot tested with 20 participants undergoing body contouring surgery.

The study is of longitudinal design gathering data from participants undergoing body contouring surgery due to obesity. Data collection takes place in the Department of Plastic Surgery, Helsinki University Central Hospital, Helsinki, Finland. The participants fill in three patient-reported outcome measures.

The outcomes of the three patient-reported outcome measures are compared with each other and internal validity assessed. Test-retest reliability is assessed after two weeks from the first completion of the questionnaires. With validated questionnaires the effects of body contouring surgery is assessed.

Eligibility Criteria:
Inclusion Criteria:

* Body contouring surgery due to:

A) massive weight loss B) Postbariatric weight loss

* Patient age over 18 years

Exclusion Criteria:

* Patient age under 18 years
* No body contouring surgery
* Surgical intervention performed in another hospital than Helsinki and Uusimaa Hospital District
* No obesity
The Poweroff Sleep Study

The primary objective is to explore the relationship between experimental condition (placebo or PowerOff) and sleep quality between pre-study and post-study. In addition, volunteers will wear actigraphy watches that collect objective measures of sleep, such as total sleep time, and these data points will be compared pre- and post-study.


Eligibility Criteria:
Inclusion Criteria:

* Sleep/Wake History. Participants must currently maintain a regular sleep/wake schedule (±2 hr average bedtime) and express willingness to continue to follow a regular sleep-wake schedule.
* Drug/Alcohol Use. Participants must be drug-free (including nicotine). No medications (prescription or over the counter) that significantly affect circadian rhythms or sleep are allowed. Subjects must report no history of drug or alcohol dependency to be included in the study.
* Evaluation of Medical Suitability. Only healthy men and women are to be selected for this study. Subjects will be free from any acute, chronic, or debilitating medical conditions. Normality will be established on the basis of self-report clinical history and diagnoses/. Any subject with symptoms of active illness, such as fever, infection, or hypertension, will be excluded.
* Evaluation of Psychiatric/Psychological Suitability. Individuals with a history of psychiatric illnesses or psychiatric disorders will be excluded. Individuals who are unaware of specific psychiatric diagnoses but had a history of treatment with antidepressant, neuroleptic medications, or major tranquilizers will be excluded from the study. Subjects will also be questioned to demonstrate their full understanding of the requirements, demands, and risks of the study and informed of the option to withdraw at any time.

Exclusion Criteria:

* Older adults are known to experience decreased depth of non-rapid eye movement sleep (NREM), as well as lesser amounts of deep sleep (NREM3), They therefore spend greater amounts of their sleep time in less protected lighter sleep stages. For these reasons, older adults (above age 65) will be excluded from the study.
* Individuals whom have had a negative or paradoxical response to an OTC sleep supplement or OTC sleep medication (Nyquil zzz's, Benadryl, melatonin, valerian, etc.).
* Individuals who are or are planning to become pregnant in the next 60 days.
The Effects of NSAIDs on Bone Metabolism Following Exercise

The purpose of this study is to determine the effects of a single dose of non-steroidal anti-inflammatory drugs on post-exercise markers of bone and muscle metabolism.

This protocol intends to determine how consuming a single dose of a non-steroidal anti-inflammatory drug (NSAID) affects circulating bone metabolism biomarkers and markers of damage skeletal muscle in response to a bout of plyometric exercise. This will be accomplished using a four trial, placebo-controlled crossover design with trials examining ibuprofen, celecoxib, flurbiprofen and placebo. These particular NSAIDs were chosen because of their widespread use in military populations and differing molecular mechanisms, which could cause differing effects on bone and muscle. Two hours after of consuming a single dose of an NSAID, participants will perform 10 sets of 10 plyometric jumps to induce a mechanical loading stimulus the bone and muscle tissues. Blood, urine, and muscle biopsy samples will be collected before and up to four hours after exercise. Biomarkers representing bone and muscle metabolism will determine the magnitude of adaptive responses to plyometric exercise while using NSAIDs.

Eligibility Criteria:
Inclusion Criteria:

* Must currently exercise at least 2 times per week
* Must be willing to discontinue the use of nutritional supplements, alcohol and nicotine during each study period (4 trials of 5 consecutive days each), unless approved by PI
* Must be willing to refrain from taking NSAIDs and similar medications during the course of the study (other than those given by the study team)
* Weigh at least 110 lbs and have a hemoglobin of 12.5 g/dL or higher

Exclusion Criteria:

* Known allergic reaction to any NSAID type medication
* History of gastrointestinal disorders/discomfort associated with or which may be aggravated with NSAID use
* History or known gastric ulcer
* History of endocrine disorders (e.g., diabetes, uncontrolled thyroid dysfunction, hypoparathyroidism, or hyperparathyroidism)
* History of bone-modifying disorder (e.g., osteogenesis imperfecta, osteoporosis, or rickets)
* Diagnosed bone fracture within last 6 months
* History of cardiovascular or renal diseases
* Pregnant or lactation in the last 6 months
* Currently taking or history of routine use of medications known to affect bone or calcium metabolism (e.g., thiazide diuretics, bisphosphonates, oral steroids)
* History of back or shoulder injury which may be aggravated by exercise
* Blood donation within 8 weeks of the study
* Current physical illness or injury limiting physical activity
* Known allergy to lidocaine
Gastric Electrical Stimulation for Abdominal Pain in Gastroparesis

To conduct a pilot study to evaluate the effects of new GES programming settings on abdominal pain in patients with gastroparesis and existing GES devices, whose abdominal pain has so far been refractory to drugs and/or devices.

Eligible patients will undergo detailed pain assessments as well as non-invasive physiologic assessment. Patients existing GES devices will be reprogrammed to new setting for 4 week and their GI symptoms including pain will be evaluated by a daily diary. At the end of 4 weeks detailed pain assessments and noninvasive physiologic assessments will be repeated.

Eligibility Criteria:
Inclusion Criteria:

* Should be able to give informed consent for the study
* Has Enterra GES device in place for at least 2 months
* Continue to have moderate to severe abdominal pain on at least one pain questionnaire or \>5 score (on a scale of 0-10 for pain) on the VAS questionnaire for at least 2 months.
* Abdominal pain should be either persistent; for example, daily for at least \>1 hour, be chronic for \>2 months, and refractory to original Enterra GES settings

Exclusion Criteria:

* Unable to provide informed consent
* Pregnancy
* Any other active health problems that would render patient unable to complete the study
Molecular Endotypes of Chronic Idiopathic Urticaria

This study plans to learn more about why some people with Chronic Idiopathic Urticaria (CIU) respond to treatment with omalizumab (Xolair). It will test people before they receive treatment with omalizumab as part of standard of care, to see if there are differences in their blood and skin that can predict who responds to treatment.


Eligibility Criteria:
Inclusion Criteria:

* CIU as defined as frequent urticarial lesions for ≥ 6 weeks
* Symptoms not controlled with standard dose antihistamines (loratadine 10mg daily, desloratadine 5mg daily, fexofenadine 180mg daily, cetirizine 10mg daily, or levocetirizine 5mg daily)
* Planned initiation of treatment with omalizumab (Xolair) as part of standard of care for antihistamine-refractory urticaria

Exclusion Criteria:

* Use of immunomodulatory drugs in the past 1 month prior to beginning the study
* Use of systemic steroids in the past 1 month prior to beginning the study
* Use of omalizumab in the past 3 months prior to beginning the study
* Use of any investigational agent in the past 30 days
* Untreated intercurrent illness
* Severe Asthma
* Primary diagnosis of flushing
Effect of Early Pain Management at Triage on Opioid Consumption

introduction: Pain remains one of the most common reasons of emergency department admission. Opioids are overprescribed in emergency departments to treat severe pain.

objective: assessing the impact of ealy pain pain management on the use of intravenous morphine and on patient satisfaction.


Eligibility Criteria:
Inclusion Criteria:

* over 18 years of age
* a visual analog scale (VAS) equal to or higher than 30/100 ,
* having given consent to participation
* No contraindications to products used in the course of the study.

Exclusion Criteria:

* having a vital distress that does not allow an adequate assessment of the intensity of the pain
* an inability to assess pain intensity according to the VAS,
* swallowing disorders or inability , or a contraindication or an allergy to the treatments used.
Evaluation of Sublingual Microcirculation in Burn During Resuscitation

The adequacy of fluid resuscitation will be monitored in burn patients using microcirculation.

Microcirculation camera will be placed on the base of the tongue and at different four quadrants. • Microcirculation parameters at baseline and after 8h , 16h and 24h of fluid resuscitation will be recorded. Fluid resuscitation with lactated ringer according to Parkland formula (4 ml/kg/%TBSA) 50% given during the first 8 hours, with the remainder given during the following 16 hours, will be initiated to maintain a urinary output of 0.5ml/kg/hr.Norepinephrine infusion will be started in case of circulatory failure at a rate of 0.02mic/kg/min to maintain MAP of 65-70mmHg.


Eligibility Criteria:
Inclusion Criteria:

* Age more than 18 years old
* Burn \>20% TBSA
* Patients with burn admitted within the 1st 6 hours

Exclusion Criteria:

* Age \< 18 years old.
* Pregnant patients.
* Patients with severe renal insufficiency.
* Patients shocked due to other causes as sepsis, hypovolaemia or cardiogenic shock
* Patients with airway edema that preclude the measurement of sublingual microcirculation
QUALITE Study - A Study of Fuzeon (Enfuvirtide) in Treatment-Experienced Patients With Human Immunodeficiency Virus-1 (HIV-1) Infection

This study will evaluate patient quality of life and tolerability of a HAART (highly active antiretroviral therapy) regimen containing twice-daily subcutaneous injections of Fuzeon in clinically stable, treatment-experienced patients with HIV-1 infection. All patients will use a 31-gauge thin-walled 8mm needle to administer Fuzeon. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adults or adolescents at least 16 years of age;
* HIV-1 infection;
* clinically stable, treatment-experienced;
* evidence of HIV-1 replication despite ongoing antiretroviral therapy;
* CD4 + count greater than 50 cells/mm3.

Exclusion Criteria:

* previous use of Fuzeon and/or T-1249;
* active, untreated opportunistic infection;
* inability to self-inject, unless a reliable caregiver is available to inject.
A Study to Compare the Pharmacokinetic Profiles of Etravil® Tablet 10mg and Etravil® Tablet 25mg

To evaluate the pharmacokinetics of single oral dose of Amitriptyline hydrochloride film-coated tablet 10mg \& 25mg

Randomized, Single dose, 2-way crossover, Open Study to compare the pharmacokinetics profile of Etravil®(Amitriptyline Hydrochloride) Tablet 10mg and Etravil®(Amitriptyline Hydrochloride) Tablet 25mg after a single oral administration in healthy male volunteers

Eligibility Criteria:
Inclusion Criteria:

* a healthy adult male within the range of 19 to 50 years old at the time of screening
* one with weight of more than 55kg, in the range of IBW 20%

  * Ideal Body Weight(IBW)(kg)={height(cm)-100}\*0.9
* one who understood completely about this study after the detailed explanation is given, decided to volunteer and gave written informed consent to participate in study in compliance with the requirement of the entire protocol.

Exclusion Criteria:

* one with clinically significant disease in liver, kidney, nerve system, respiratory system, endocrine system, blood, tumor, urinary system, cardiovascular system, mental disease or with medical history
* one with glaucoma
* one with disorders of micturition include benign prostatic hyperplasia
* one with gastrointestinal disease or with gastrointestinal surgical history which can affect the absorption of the investigational drug.
* one who is allergic or has clinically significant allergic history to the study drug, components or tricyclic antidepressants(TCA)
* one who shows the following result in vital sign: hypotension(systolic pressure ≤ 100mmHg or diastolic pressure ≤ 65mmHg) or hypertension(systolic pressure ≥ 150mmHg or diastolic pressure ≥ 95mmHg)
* one who has drug abuse history
* one who has taken any prescribed drugs, herbal agents or crude drugs within 2 weeks before study drug administration, or who has taken any over-the-counter (OTC) drugs or vitamins (Investigators will determine his eligibility by considering the effect of the drug on his safety or pharmacokinetic results in case other inclusion/exclusion criteria is satisfied.)
* one who has participated in other clinical study within 2 months before study drug administration
* one who donated whole blood within 2 months or component blood within 1 month or who are donated within 1 month before the treatment
* one who drank Over 21 units/week of alcohol(1 unit = 10g of pure alcohol) or subjects who would not be able to stop drinking alcohol during the hospitalization
* one who are heavy smoker more than 10 cigarettes/day within 3 months prior to screening or subjects who would not be able to stop smoking during the hospitalization
* one who had a beverage containing caffeine, drank alcohol, or smoked within 48hrs before the hospitalization or who had a beverage containing grapefruits during the hospitalization
* one with clinically significant observations considered as unsuitable based on medical judgment by investigators
Vitamin D Supplementation to Correct the Vitamin D Deficiency for Breast Cancer

An open clinical trial not randomized, multicentric. This study search to evaluate vitamin D supplementation efficacy at high dose (UVEDOSE, colecalciferol, oral solution at 100 000 UI) of vitamin D on day 1 of each cycles for breast cancer treated adjuvant chemotherapy.

A calcium supplementation will be prescribed in parallel.

An initial dosage of 25OH vitamin D rate will be done and a vitamin-calcic dosage will done on day 1 of every cycles of chemotherapy


Eligibility Criteria:
Inclusion Criteria:

* Breast adenocarcinoma should receive 6 cycles of adjuvant chemotherapy
* Women ≥ 18 years old (no age limit)
* Performance status :0 or 1
* Patients must be affiliated to a Social Security System
* Signed informed consent obtained before any study specific procedures.
* Vitamin D deficiency confirmed ( vitamin D result must be \< at 30 ng/ml)

Exclusion Criteria:

* Metastatic disease
* Patients with previous or concomitant other (not breast cancer) malignancy within the past 5 years EXCEPT adequately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix. Patients who have had a previous other malignancy must have been disease free for at least five years
* calcium or colecalciferol contraindications (vitamin D hypersensitivity - disease or an other condition result in hypercalcaemia or hypercalciuria -Calcic lithiasis- high vitamin D level)
* Presence of the following diseases in the last 3 years : endocrinal disease, A phosphor calcic disorder treated by vitamin D supplementation at 1000 UI/day or more (this patient who have received a dose \< 1000 UI/day, will be included after have to stop Vitamin D at least 48 hours ) - Osteopenia or osteoporosis confirmed treated
* Concomittant treatment with an other experimental product
* Pregnant or breastfeeding women
* Legal incapacity or physical, psychological or mental status interfering with the patient's ability to sign the informed consent or to terminate the study.
Nursing Follow up in Geriatric Oncology : Tracking Time of Caregiver Exhaustion Risk

In geriatric oncology, caregivers are submitted to a risk of exhaustion. To investigate the clinical risk factor of exhaustion, the researchers propose to conduct a prospective observational study during 6 months phone follow up of the caregivers. The recruitment will take place during the oncogeriatric assessment consultation.

The primary purpose aim to describe the caregiver of patient with 70 years old or more, suffered from cancer and for which a treatment is planned, along with their long term evolution.

The secondary purposes are to :

* Assess the exhaustion level felt by this caregiver
* Assess the medium delay of caregiver exhaustion apparition
* Relate factors associated to the medium delay of caregiver exhaustion apparition during patient chemotherapy and/or radiotherapy treatment

Eligibility Criteria:
Inclusion Criteria:

* Caregiver of :

  * patient with 70 years old or more, suffered from cancer and receiving specific cancer treatment (chemotherapy or radiotherapy )
  * Patient evaluated in a specific comprehensive oncogeriatric assessment
  * informed patient given a non-opposition form
  * Patient affiliated to a social protection scheme
* Informed consent given by the caregiver

Exclusion Criteria:

* Patient and caregiver under judicial protection
* Caregiver with understanding difficulties with French language
* Psychological, familial, social or geographic conditions that avoid a good clinical trial continuity
* Patient with ≤ 18 years old
* Caregiver and patient with significant cognitive troubles
* Caregiver and patient located in institution during inclusion period
The Efficacy and Safety of Landmark-guided Compared to Ultrasound-guided Erector Spinae Plane Block Techniques for Analgesia in Female Patients After Breast Surgery.

The erector spinae plane (ESP) block is a technique that helps alleviate acute pain. It involves injecting local anesthetic between the erector spinae muscle (ESM) and the vertebra's transverse process (TP). This technique can be guided by ultrasound or anatomical landmarks, and it can be performed while the patient is lying down, sitting or on their side.

Ultrasound guidance has established itself as the norm for regional anesthesia procedures, enabling live visualization of anatomical structures and enhancing the precision and safety of needle insertion. Conversely, the blind technique relies on anatomical landmarks and the ability to palpate to direct needle insertion. Although the blind technique might provide simplicity and efficiency, uncertainties persist concerning its precision and possible associated risks. As the popularity of the ESPB increases, a relevant query emerges: Should it be conducted with ultrasound guidance or through a non-guided technique? This study was designed to validate the efficacy and safety of a landmark-guided ESPB technique compared to an ultrasound-guided ESPB technique for analgesia in breast surgery. The hypothesis was that the ultrasound and anatomical landmark techniques for ESPB would provide equivalent analgesia. The study's primary objective was to compare the success rate of both techniques. The secondary objectives were to compare the dermatomal block spread, analgesic effectiveness, and technique-related complications.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years or older.
* Patients had an American Society of Anesthesiology (ASA) physical score of I-II.
* Patients undergoing unilateral elective breast surgery.

Exclusion Criteria:

* Patients had a contraindication to an ESPB (including coagulopathy, recent anticoagulant medication usage, or infection at the needle puncture site).
* Patients had a history of opioid addiction, preoperative opioid use, and allergies to study medications.
* Obesity (body mass index exceeding 35 kg/m²).
* If the placement of ESPB was not completed due to technique difficulties.
* Patients who expressed a lack of willingness to participate in the study were not considered eligible for participation.
CLL Therapy Approaches in Russia

This is going to be a non-interventional study (NIS). Assessment of variables will be carried out using data on patient's treatment in real-life clinical setting. Patients should be enrolled into study after evaluation of eligibility criteria by the investigator. No additional procedures besides those already used in the routine clinical practice will be applied to the patients. Treatment assignment will be done according to the current practice.

Evaluation of efficacy and safety of any approaches used for CLL/SLL treatment is not the primary objective of this study, though there is no treatment of interest. Study procedures will comply with all the local regulatory requirements regarding AE reporting (pharmacovigilance).

It is planned to enroll approximately 6000 patients (suggested number of patients on WW\~1000 pts, 1L\~2750 pts, RR\~2250 pts)

During the course of study's prospective part, it is planned to carry out at approximately 5 visits:

(if unscheduled visit performed - the information should be filled on nearest visit).

* Baseline visit: ICF signing, initial patient's data input will be done retrospectively, for patients who are already monitored by investigational site.
* Interim Visits (CRF will be filled every 6 months for therapy receiving patients and every 12 months for WW patients; if a patient transitions from WW to therapy, his/her CRF will be filled every 6 months; all patient's visits should be planned according routine practice and investigator's judgement on individual basis).
* Final visit (data collection on 24 months after enrollment): patient's data input will be done for previously enrolled patients (data update)


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Ability and willing to sign the ICF
* Diagnosed CLL/SLL (including watch and wait stage of disease) according to Russian clinical guides

Exclusion Criteria:

* Patients without CLL/SLL diagnosis
* Age \<18 years
* Patients who refused/did not sign the ICF