cyrilzakka/clinical-trials huggingface dataset:
Butterfly Pea Flower (Clitoria Ternatea) for Adjuvant TB Treatment

The goal of this clinical trial is to learn if butterfly pea flowers (Clitoria ternatea) decocta extract works to treat as adjuvant therapy for tuberculosis in adults. It will also learn about the safety of butterfly pea flowers decocta extract.

The main questions it aims to answer are:

* Does butterfly pea flower extract as an adjunct TB drug therapy drug affect the profiles of interferon gamma and interleukin-10 of people with tuberculosis?
* Does butterfly pea flower extract as an adjunct TB drug therapy drug affect the hematology profiles of people with tuberculosis?
* Does butterfly pea flower extract as an adjunct TB drug therapy drug affect the clinical symptoms and acid-fast bacilli microscopic analysis of people with tuberculosis?
* What medical problems do participants have when taking butterfly pea flower decocta extracts?

Researchers will compare butterfly pea flower extract as an adjunct TB drug therapy to monotherapy TB drugs to see if adjuvant butterfly pea flowers extract works to treat tuberculosis infection in 2-month initiation phase therapy.

Participants will:

* Take drug butterfly pea flower extract plus TB regimen drugs consisting of rifampicin, isoniazid, pyrazinamide, and ethambutol or monotherapy TB regimen drugs only every day for 2 months
* Willing to undergo treatment monitoring and visit the clinic once every 2 weeks for checkups and tests
* Keep a diary of their symptoms and the number of times they use a butterfly pea flower decocta extract


Eligibility Criteria:
Inclusion Criteria:

* Pulmonary TB patients were positive based on the results of the Rapid Molecular Test GeneXpert M. tuberculosis (MTB)/Rifampicin (RIF),
* Patients who were undergoing the initiation phase of anti-TB treatment for the first time,
* Non-Multi Drug Resistant (MDR)/Extensively-Drug Resistant (XDR) TB patients with first-line anti-TB treatment (rifampicin, isoniazid, pyrazinamide, and ethambutol),
* Patients \>18 years old,
* Patients who were willing to become research subjects and signed informed consent.

Exclusion Criteria:

* TB patients with Human Immunodeficiency Virus (HIV) positive,
* Patients who did not complete the study,
* Patients with non-compliance in taking medication,
* Patients with comorbidities (autoimmune and cancer),
* Smoking patients,
* Patients contraindicated in using butterfly pea flower extract.
Platelet Gel in Systemic Sclerosis

* Systemic sclerosis (scleroderma; SSc) is a connective tissue disease characterized by a progressive fibrosis of the skin and visceral organs.
* A diffuse cutaneous microvascular damage occurs in 30-50% of patients, often leading to digital ulcers development, responsible for pain, functional disability, disfiguring scars, digital bony reabsorption, infection and osteomyelitis.
* Although the availability of drugs as i.v. prostacyclin analogs, oral vasodilating agents, oral phosphodiesterase-5 inhibitors, oral endothelin receptor blockers has improved the prognosis, digital ulcers are frequently refractory to the medical treatment.
* Preliminary data seems to demonstrate a pivotal role played by some growth factors (PDGF, TGF beta 1-2, IGF) in the process of ulcers healing: tissue regeneration and re-epithelization. Alpha-granules in the platelets store these factors in significant amount.
* Recently, the application of a gel rich in platelets, prepared from donors' plasma taken by apheresis, seems to be beneficial to enhance pressure and vascular ulcers healing.
* On the basis of these considerations we expect that application of a platelet gel, combined with advanced dressing and conventional medical therapy, makes a more rapid healing of digital ulcers in patients with systemic sclerosis. We decided to conduct a double blind RCT to test this hypothesis


Eligibility Criteria:
Inclusion Criteria:

* Digital ulcers (NPUAP stage≥2) in patients with SSc (ACR criteria)
* Current medical treatment with intravenous prostanoids
* Availability to come to our centre for weekly ulcer assessment and medication
* Capacity to give informed consent

Exclusion Criteria:

* Clinical evidence of skin infection
* Current treatment with Bosentan or Sildenafil
* Presence of necrotic material occluding the wound bed.
Efficacy of Oxytocin vs. Carbetocin in Prevention of Postpartum Hemorrhage After Cesarean Section

Postpartum hemorrhage (PPH) is a common complication of childbirth and a leading cause of maternal morbidity and mortality. The prompt and effective treatment of subjects with PPH would reduce operation risks. Hence in this study, the efficacy of Oxytocin and Carbetocin was compared in prevention of postpartum hemorrhage after cesarean sections.


Eligibility Criteria:
Inclusion Criteria:

* At least one risk for postpartum hemorrhage and lack of hypersensitivity to oxytocin and carbetocin

Exclusion Criteria:

* Patients' refusal to cooperate, major therapeutic side effects, history of cardiac and renal disease or preeclampsia
Effects of Remote Intercessory Prayer

Intercessory prayer can improve the outcome of pregnancies?


Eligibility Criteria:
Inclusion Criteria:

* be pregnant, belong to the public health system

Exclusion Criteria:

* no consent to participate in the research
Pelvic Floor Muscle Contraction Among Physiotherapy Students Before and After "Women Health" Course

The study aim is to evaluate the ability to correctly contract pelvic floor muscle among physiotherapy students before and after "women health" course. Pelvic floor muscle contraction will be evaluated via transabdominal ultrasound.

Physiotherapy students during their studying in the physiotherapy Bachelor degree program will be examined. Students will be divided into 2 groups according to their year of studying (if they already studied "women health course or not implying 4th year students compared with 1-3 year level students). Each participant will be asked to contract the pelvic floor muscles.

The assessment of pelvic floor contraction will be measured by measuring bladder displacement via abdominal ultrasound. A curved linear array transducer will be placed in the transverse plane immediately suprapubically over the lower abdomen angled at 15-30 degrees from the vertical. Upward movement of the bladder during contraction will be marked as correct contraction. An on screen caliper and measurement tool will be used to measure bladder amount of bladder displacement.

Eligibility Criteria:
Inclusion Criteria:

* healthy students
* willing to participate in the study

Exclusion Criteria:

* has been treated before for pelvic floor rehabilitation
* active urinary tract infection
* pregnancy
* previous abdominal surgeries
Feasibility and Efficacy of a Digital Mental Health Intervention for Teen Wildfire Survivors

In October, 2017, Northern California experienced devastating and historic wildfires. Sonoma Rises is an app designed for anyone who was impacted by this event and is intended to help survivors of disaster find their new normal. This study will assess the feasibility and efficacy of a self-help post-disaster mental health intervention delivered via a mobile app with a sample of teens who are experiencing post-disaster mental health symptoms.


Eligibility Criteria:
Inclusion Criteria:

1. Males \& females aged 13-17 years directly impacted by the 2017 wildfires having lost their home or been temporarily displaced
2. Screen positive for PTSD (Child Trauma Screening Questionnaire = 5 or higher)
3. Have regular access to a smart phone and a computer
4. Have a personal email address
5. Speak and read English fluently
6. Have parental consent

Exclusion Criteria:

1. A positive self-reported history of psychosis, bipolar, or schizophrenia
2. Serious self-reported physical health concerns necessitating surgery or with prognosis \<6 months
3. A positive screen for a current Substance User Disorder (CRAFFT = 2 or higher)
4. Current self-reported suicidal ideation
5. Self-reported pregnancy
6. Self-reported less than four weeks of stable prescription medication for anxiety, anti-depressant, and sleep promoting medications prior to the screening assessment
Behavioral Determinants That May Influence People's Hand-hygiene and Environment Disinfecting

An anonymous online survey will be conducted to measure the barriers and facilitators parents and teachers experience to positively influencing children's hand-hygiene. A sub-section of the survey will also examine the barriers and facilitators they experience to surface cleaning. The final survey will be conducted with participants from Australia, China, India, Indonesia, Saudi Arabia, South Africa, and the United Kingdom. The data collected will be completely anonymous and there are no sensitive questions. The primary and secondary analyses will focus on the hand-hygiene items to examine the survey's internal and external validity. The results will inform a future school-based intervention.


Eligibility Criteria:
Inclusion Criteria:

* be 18 years or older;
* identify as a female or male; and
* be either a teacher or parent of children between 5 and 10 years old.

Exclusion Criteria:

* be 17 years or younger;
* not identify as a female or male; and
* not be a teacher or parent of children between 5 and 10 years old.
Mid-point Transverse Process to Pleura Block for Breast Cancer Surgery: A Randomized Controlled Trial

This study will compare the analgesic effects of midpoint transverse process to pleura (MTP) block to control as well as thoracic paravertebral block.

Paravertebral blocks (PVBs) are frequently used for regional anesthesia for breast surgery. Ultrasound-guided paravertebral block is an advanced skill. The needle tip can be difficult to visualize with ultrasound, and the proximity to neurovascular structures as well as the pleura presents a risk of neurovascular injection and pneumothorax respectively. The midpoint transverse-process to pleura (MTP) block incorporates a novel needle endpoint that is technically easier to achieve and more distant from neurovascular structures and the pleura compared to traditional PVB. This study will compare the analgesic effects of MTP block to control and PVB.

Eligibility Criteria:
Inclusion Criteria:

* English or French Speaking
* Scheduled for major breast surgery
* ASA physical status classification I-III
* BMI \<30kg/m2

Exclusion Criteria:

* Prior ipsilateral breast surgery
* Pre-existing neurological deficit or peripheral neuropathy involving the ipsilateral chest
* Contraindications to regional anesthesia
* Patient refusal of regional technique
* Chronic pain disorder
* Chronic opioid use
* Inability to provide informed consent
Ledderhose Disease: Radiotherapy or Not?

The aim of the LedRad trial is to determine the efficacy and durability of radiotherapy as treatment for patients with Ledderhose disease and to compare this to the natural course of Ledderhose disease.


Eligibility Criteria:
Inclusion Criteria:

* Patients with painful Ledderhose disease. The pain score measured with the VAS score and is at least 2 on the 11-point scale (0 = no pain to 10 = worst imaginable pain).
* Age ≥ 18 years
* WHO performance status 0, 1 or 2 (Appendix, section 18)
* Before patient randomisation, written informed consent must be given according to ICH/GCP, and WMO requirements.
* Controlling the Dutch language (speaking and reading).
* Able and willing to complete quality of life questionnaires in Dutch
* Must be accessible for treatment follow-up

Exclusion Criteria:

* Surgical intervention before for Ledderhose disease
* Previous radiation treatment for Ledderhose disease
* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
* Not able to lay prone for at least fifteen minutes
* Females who are pregnant at entry or who want to become pregnant within six months.
Transcranial Magnetic Stimulation for Depression in Autism Spectrum Conditions

In this research study the investigators aim to learn more about the therapeutic effects of a newer form of non-invasive transcranial magnetic stimulation (TMS), called theta burst simulation (TBS), on refractory depression in Autism Spectrum Conditions.

The overarching goal of this study is to examine treatment effects and elucidate the physiological biomarkers of a newer form of non-invasive brain stimulation therapy on refractory depression in a sample of participants with ASC (autism spectrum condition).

Aim 1: To compare the efficacy of 30-sessions of bilateral (BL) versus unilateral (UL) Theta Burst Stimulation to the dorsolateral prefrontal cortex (DLPFC) on depression severity in youth/young adults with ASC and co-occurring refractory major depressive disorder (MDD).

Aim 2: To identify physiological markers of target engagement of successful response to either UL or BL on depression severity in youth with ASC and co-occurring refractory MDD. These physiological markers include high-resolution electroencephalography (EEG) markers, social eye-tracking, and handgrip strength (collected via NIH toolbox's motor toolbox domain).

Aim 3: To identify feasibility of BL and UL in participants with ASC including systematic measures of safety and tolerability. This includes clinical measures such as rate of hospitalization and medication use.

Eligibility Criteria:
Inclusion Criteria:

* Have been diagnosed on the autism spectrum
* Have been diagnosed with depression and have failed one or more evidence-based antidepressant treatments (e.g. a Selective Serotonin Reuptake Inhibitor, talk therapy like Cognitive Behavioral Therapy)
* Do not have an intellectual disability

Exclusion Criteria:

* Substance use disorder
* Presence of metallic foreign bodies or implanted medical devices
* History of epilepsy
* Prior rTMS treatment
* For female subjects of child bearing potential, current pregnancy
Pharmacokinetics and Safety/Tolerability After Oral Administration of CKD-387 and D635 in Healthy Adults

The purpose of the clinical trail is to evaluate the pharmacokinetics and safety/tolerability after oral administration of CKD-387 and D635 in healthy adults.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy adults aged 19 to 55 years
2. Females must be menopause or surgical infertility
3. Signed informed consent form
4. Other inclusion criteria, as defined in the protocol

Exclusion Criteria:

1. History of clinically significant hepatic, renal, nervous, immune, respiratory, endocrine, hemato-oncology, cardiovascular systemic disease or psychosis disorder
2. Clinical laboratory test values are outside the accepted normal range at Screening

   * aspartate aminotransferase(AST), alanine aminotransferase(ALT) \> 1.25 times the upper limit of the normal range
   * Total Bilirubin \> 1.5 times the upper limit of the normal range
   * creatine phosphokinase(CPK) \> 1.5 times the upper limit of the normal range
   * estimated Glomerular Filtration Rate(eGFR, MDRD\* formula) \< 60 mL/min/1.73m2 (\*MDRD: Modification of Diet in Renal Disease)
   * Positive reaction on following tests: Hepatitis B, Hepatitis C, human immunodeficiency virus(HIV) and syphilis
   * systolic blood pressure(SBP) ≥ 150 mmHg or \< 90 mmHg, diastolic blood pressure(DBP) \> 100 mmHg or \< 50 mmHg
3. Subject who smoke heavily or drink caffeine or alcohol continuously and who cannot discontinue smoking, caffeine or alcohol intake during hospitalization
4. Participated in a clinical trial within 90 days prior to 1st IP dosing
5. Not eligible to participate for the study at the discretion of Investigator
6. Other exclusive inclusion criteria, as defined in the protocol
Gut Hormone Secretion and Macronutrients

The role of gut hormone (GLP-1, GIP, PYY...) in glucose homeostasis has been widely demonstrated. Furthermore modifications in their pattern of secretion seem to be involved in the improvement of glucose control in obese patients after bariatric surgery.

The purpose of this study is to assess the respective role of carbohydrate, fat and protein from a complete meal in gut hormones secretion.

The study is designed to asses the role of each individual macronutrient of a compete meal in gut hormones secretion in healthy volunteers.

8 healthy young male subjects will be studied on 5 different occasions. To asses the role of each macronutient the subjects will recieve one of the following test meal: a complete sandwich, the proteic part of this complete meal, the glucidic part and the lipidic part. The fifth test will be a fasting test.

To assess the entero-insular axis, a 5.5 hours hyperglycaemic clamp will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Male
* 18-35 years old
* 19 kg/m2 ≤ BMI ≤ 25 kg/m2
* Healthy
* Low to moderate physical activity
* Non smokers

Exclusion Criteria:

* Family history of diabetes mellitus
* Any medication
* Participation to blood spending or other clinical study in the 3 months before the beginning of this study
* Consumption of drugs
* Consumption of more than 50g of alcool in a week
* Vegetarian or particular diet
* Anamnèse d'intolérance alimentaire
* Family history of food intolerance
Pregnancy and Neonatal Outcomes Following Antenatal Exposure to Raltegravir: a Pooled Analysis From the European Pregnancy and Paediatric Infections Cohort Collaboration (EPPICC)

Raltegravir is the preferred INSTI for for treatment of antiretroviral-naïve pregnant women in the US Perinatal Guidelines, alongside Dolutegravir, and for late pregnancy. There are relatively limited information available on its use during early pregnancy, particularly the peri-conception period. The aim of the study is to assess "real-world" maternal, fetal and newborn outcomes following RAL use during pregnancy through pooled analysis of individual patient data from observational studies participating in the European Pregnancy and Paediatric Infections Cohort Collaboration.


Eligibility Criteria:
Inclusion Criteria:

* pregnant women living with HIV, exposed to Raltegravir at any time during the pregnancy participating in EPPICC and their infants.

Exclusion Criteria:

* see inclusion
A Trial to Compare the Efficacy of Rotigotine Transdermal Patch to That of Ropinirole on Early Morning Motor Impairment and Sleep Disorders in Subjects With Early-Stage, Idiopathic Parkinson's Disease

The objective of this trial is to compare the effect of rotigotine (SPM 962) and ropinirole on the control of early morning motor impairment and sleep disorders in subjects with early-stage PD.

Subjects who meet eligibility criteria will be randomly assigned either to rotigotine transdermal patch or ropinirole tablets. Trial medication will be titrated for rotigotine and ropinirole until an individual optimal dose is achieved. Following a Titration period of up to 4 weeks in the rotigotine arm and 6 weeks in the ropinirole arm, subjects will be maintained on the optimal or maximal dose for 4 weeks. At the end of the Maintenance period, subjects will be given the opportunity to enter a 2-year rotigotine patch extension trial.

The first subject was enrolled in December 2004. The last subject was enrolled in June 2005. Last subject out is expected for October 2005. The trial is still ongoing.


Eligibility Criteria:
Inclusion Criteria:

* Early-stage, idiopathic Parkinson's disease
Child Snack Variety Study

The purpose of this study is to determine how consumption of a snack food at a first course affects the hedonic ratings of that snack food compared to other foods, and how it affects intake of a second course. The results will have implications for guidance about the provision of snacks for preschool children and may help in identifying strategies for the prevention of obesity in children.


Eligibility Criteria:
Inclusion Criteria:

* Children who are enrolled in a participating childcare center
* Children who are between the ages of 6 and 14 years old at the time of enrollment

Exclusion Criteria:

* Children who are allergic to any of the foods served
* Children whose diets exclude any of the foods served
* Children who are absent from the childcare center on study days
* Children who are not able to complete study measures (e.g. refuse to eat study foods, only use the anchors or have low variability for their liking ratings, etc.)
HE4 as a Relapse Biomarker in Ovarian Cancers

HE4 is a more sensitive marker than CA-125 in patients with ovarian cancers. The interest of serum HE4 before surgery has been demonstrated to predict overall survival and its interest has also been shown in combination with CA-125 (ROMA algorithm) to identify high risk patients. To date, no study shows clearly the predictive potential of serum HE4 as an early relapse biomarker in ovarian cancers.


Eligibility Criteria:
Inclusion Criteria:

* Ovarian adenocarcinoma stage IIIa, IIIb or IV pleural, cytologically or histologically proven
* Patient scheduled to undergo neoadjuvant chemotherapy based on platinum followed by surgery and adjuvant chemotherapy
* Age ≥ 18 years .
* Performance status ECOG \> or = 2
* Adequate haemoglobin rate ≥ 10 g/dL
* Ability to provide written informed consent
* Patient's legal capacity to consent to study participation

Exclusion Criteria:

* Any previous treatment with platinum for ovarian carcinoma
* Patient with visceral metastases
* Contraindication for blood test
* Contraindication for surgery
* Contraindication for bevacizumab treatment
Evaluation of Serratus Plane Block on the Respiratory Pattern in Patients With Multiple Rib Fractures

In patients admitted following a trauma, the incidence of multiple rib fractures is reported to be 9,7%, and this can be even higher in high energy trauma like motor vehicle accidents (1). Pain deriving from rib fractures cause the patient to breath shallow in order to limit discomfort and this bring about negative consequences: shallow breathing and inability to clear secretions may cause pulmonary atelectasis eventually evolving to pneumonia. Given the aforementioned concerns, it is easy to understand why, in a context like this, control of chest pain become crucial. The best way to achieve adequate pain control have not yet been established: the aim of this study is to investigate on this clinical dilemma. In this study, 72 people with at least two monolateral rib fractures are going to be randomized into three groups: 1) standard treatment alone (intravenous analgesia: acetaminophen + morphine PCA); 2) continuous serratus plane block + standard treatment; 3) single-shot serratus plane block + standard treatment. The variables that are going to be recorded are the following: pain through the NRS scale, FEV1 and FVC through spirometry and finally an arterious gas analysis. Recording are going to be repeated at 72h after admission. The primary endpoint is to evaluate if the continuous serratus plane block is able to improve the FEV1/FVC compared to single shot or standard treatment alone. Secondary endpoints will be: the effect of continuous block on 1) resting and incident pain; 2) opioid consumption; 3) blood gas analysis parameters; 4) pulmonary complications at 1 month; 5) length of stay


Eligibility Criteria:
Inclusion Criteria:

1. Chest trauma with at least 2 monolateral rib fractures (monofocal or multifocal) with no flail chest
2. Age\>18 years
3. Hospital admission
4. Ability to provide written informed consensus
5. Awake patient, spontaneous ventilation
MK0431 (Sitagliptin) Pioglitazone Add-on Study for Patients With Type 2 Diabetes Mellitus (0431-055)(COMPLETED)

The clinical study determines the safety and efficacy of MK0431 in patients with type 2 diabetes mellitus who have inadequate glycemic control on pioglitazone as monotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients Have Type 2 Diabetes Mellitus
* On Diet/Exercise Therapy And Pioglitazone As Monotherapy

Exclusion Criteria:

* Patients Have Type 1 Diabetes Mellitus