cyrilzakka/clinical-trials huggingface dataset:
Study of Acid Peel and Laser for the Treatment of Melasma

The objective of this study is to evaluate laser treatment and acid peel for the treatment of melasma.

The purpose of this study is to evaluate the safety and efficacy of laser treatment and acid peel for the treatment of melasma.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of melasma lesion measuring at least 4 square centimeters.
* Age 18-75 years.
* Good health.
* Willingness and ability to understand and provide informed consent for participation in the study.
* Ability to communicate with the investigator.
* Must be willing to forgo other treatment options for melasma during the course of the study.

Exclusion Criteria:

* Inability to understand the protocol or to give informed consent.
* Mental illness.
* Under 18 years of age and over 75 years of age.
* Laser treatment in the last 6 months before enrollment.
* Isotretinoin within the past year.
* Lidocaine allergy.
* History of herpes simplex viral infection.
* Concurrent active disease to facial area (i.e acne).
* Bleeding disorder.
* History of abnormal wound healing.
* History of abnormal scarring.
Testing Pulse Stimulation to Improve Motor Function in People With ALS: A Pilot Study

The goal of this clinical trial is to assess the efficacy of TPS of the motor cortex on biomarkers and clinical endpoints in patients with ALS. The main questions it aims to answer are:

* Stage 1: Is there a change in the short intracortical inhibition (SICI) of the motor cortex from baseline to week 8?
* Stage 2: Is there a change from baseline to month 6 in the ALS functional rating scale-revised (ALSFRS-R) total score?

In stage 2, researchers will compare the group receiving the stimulation vs the group receiving a sham stimulation to see if there is a difference in motor cortex activity and in the ALSFRS-R score

Participants will receive either:

* the TPS treatment
* a sham TPS treatment


Eligibility Criteria:
Inclusion Criteria:

* Patients with diagnosis of sporadic ALS (definite or clinically probable) as defined by the World Federation of Neurology revised El Escorial criteria
* SVC of 50% or greater of estimated measure and presence of measurable motor evoked potential
* 21 to 80 years old and male or female

Exclusion Criteria:

* patients with fALS (based on medical history) that are unable to tolerate TMS and MRI studies or have a contraindication as described below
Endometriosis and Risk of Obstetric Complications

The aim of this study is to compare the rate of obstetric complications at first spontaneous pregnancy among women with endometriosis, with the rate of obstetric complications at first spontaneous pregnancy among women without endometriosis

All women followed up for a surgical or clinical/sonographic diagnosis of endometriosis in 11 italian referral Centres for the treatment of endometriosis, completed a questionnaire regarding their previous pregnancies. The same questionnaire was completed by women, attending a routine gynecologic visit, in whom surgery or clinical/sonographic evaluation excluded endometriosis.

Eligibility Criteria:
Inclusion Criteria:

* 30 to 50 years old women with at least one previous spontaneous pregnancy \> 12 weeks with surgical or clinical/sonographic diagnosis of endometriosis or in whom surgical or clinical/sonographic evaluation ruled out endometriosis

Exclusion Criteria:

* Pregnancy achieved by assisted reproductive techniques
* Pregnancy terminated before 12 gestational weeks
* Twin pregnancy
* Preexisting hypertension
* Lupus like anti-coagulant
* Non corrected uterine malformation
* Recurrent abortion
Rates of Gastric Ulcer by Endoscopy in Knee Osteoarthritis Patients Receiving LT-NS001 Versus Naprosyn®

LT-NS001 is a prodrug of Naproxen, which is inactive as a cox inhibitor while intact and is rapidly metabolized to Naproxen once absorbed. This trial will compare the rate of gastric ulcer by endoscopy over three months in patients with knee osteoarthritis, with patients receiving either LT-NS001 at a dose which provides comparable dose levels of Naproxen, or Naprosyn® 500mg (an approved treatment for OA).

This is a double-blind, double-dummy, active-comparator study of LT-NS001 versus Naprosyn® for 12 weeks in patients aged 45-80 with osteoarthritis of the knee who are candidates for ongoing NSAID therapy. The percentage of patients with a gastric ulcer by endoscopy (EGD) at week 12 will be compared. EGD is performed at screening and months 1, 2, and 3. Secondary objectives include assessment of pain in the affected knee by WOMAC questionnaire to demonstrate non-inferior pain control using LT-NS001 as compared to Naprosyn®. Information about gastrointestinal pain and tolerability will be collected.

The length of the study is up to 19 weeks with a 2-3 week screening period, a 12 week treatment period and a 4 week post treatment monitoring period.

Eligibility Criteria:
Inclusion Criteria:

* Osteoarthritis of knee
* Appropriate candidate for chronic NSAID therapy due to moderate or severe pain on most days in the 28 days before screening for study.

Exclusion Criteria:

* Pregnant/Nursing women
* History of GI bleeding, perforation or obstruction
* A documented symptomatic GI ulcer during past 5 years
* Presence of GI ulcer or more than 2 erosions on screening endoscopy
* Allergy to naproxen (or naproxen intolerance), acetylsalicylic acid, or other NSAID drug
Compliance of Parents of Children With Cerebral Palsy to Home Program Questionnaire

This study aims to evaluate the psychometric properties of the Compliance of Parents of Children with Cerebral Palsy to Home Program Assesment Questionnaire (CPHP-Q), a caregiver-report for adherence and frequency of home program implementation of parents of children with Cerebral Palsy.


Eligibility Criteria:
Inclusion Criteria:

1. having a child with CP 2 to 18 years,
2. being a primary caregiver,
3. understanding of Turkish without an interpreter, and Turkish literacy,

Exclusion Criteria:

1. having any chronic illness or disability to prevent the home program,
2. haven't applied home program before.
Effects of Muscle Energy Technique Versus Aerobic Exercises on Pain and Disability in Patients With Chronic Pelvic Pain

The aim of study is to find out the effects of muscle energy technique versus aerobic exercises on pain and disability in patients with chronic pelvic pain.


Eligibility Criteria:
Inclusion Criteria:

* women with chronic pelvic pain of \>6 months' duration and the cause of their pain is unknown
* CPP was located within the true pelvis (between and below the anterior iliac crests)
* Average score of at least 4 out of 10 (0-10) on a numeric rating scale
* moderate to severe pain on pelvic pain impact questionnaire

Exclusion Criteria:

* History of cancer
* Pregnancy at the time of inclusion
* Known pelvic pathology (eg, endometriosis, ovarian cyst, fibroid \>3cm)
* Intraabdominal and pelvic surgery within the last six months
* chronic or recurrent gastro-intestinal disease including irritable bowel syndrome
* Received any physiotherapy treatment within the previous month
A Study to Compare DB-1303/BNT323 Versus T-DM1 in Breast Cancer

This study is designed to compare efficacy and safety of DB-1303/BNT323 versus T-DM1 in HER2-positive, unresectable and/or metastatic breast cancer patients previously treated with trastuzumab and taxane.

This is a randomized controlled, 2-arm, open-label, multicenter phase III study to assess the efficacy and safety of DB-1303/BNT323 versus Trastuzumab Emtansine (T-DM1) in patients with human epidermal growth factor receptor 2 (HER2) -positive unresectable/metastatic breast cancer who have been treated with trastuzumab and taxanes. Approximately 224 patients with unresectable or metastatic HER2-positive breast cancer will be randomized 1:1 to receive DB-1303/BNT323 or T-DM1, respectively.

Eligibility Criteria:
Inclusion Criteria:

* Male or female adults ≥ 18 years at the time of voluntary signing of informed consent.
* Pathologically confirmed unresectable or metastatic HER2 positive breast cancer previously treated with trastuzumab and taxane
* Eastern Cooperative Oncology Group (ECOG) performance status score is 0 or 1.
* Presence of at least one measurable lesion according to RECIST v1.1
* Expected survival time ≥ 12 weeks.
* Patients must give informed consent to this study and voluntarily sign written informed consent form prior to the study.

Exclusion Criteria:

* Prior anti-HER2 ADC therapy.
* Previous history of interstitial lung disease/noninfectious pneumonitis/radiation pneumonitis requiring steroid therapy.
* Known serious hypersensitivity to the active ingredients of the study drug, inactive ingredients in the formulation, or other antibody drugs.
* Multiple primary malignancies within 3 years, except for adequately resected non-melanoma skin cancer, curatively treated in situ tumor, or contralateral breast cancer
* Uncontrolled infection requiring intravenous antibiotics, antiviral or antifungal agents, autoimmune disease requiring treatment, uncontrolled diabetes, hypertension, or other systemic disease that makes compliance with study procedures difficult
* Unrecovered toxicity from prior anticancer therapy, defined as toxicity (except for alopecia) not recovered to ≤Grade 1 (NCI-CTCAE v5.0) or baseline.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Trauma-focused CBT Versus EMDR in the Treatment of Posttraumatic Stress Disorder

This study will evaluate the effectiveness of trauma-focused cognitive behaviour therapy (TF-CBT) versus eye movement desensitization and reprocessing (EMDR) in the treatment of trauma survivors with post-traumatic stress disorder (PTSD). Patients will be randomly assigned to TF-CBT or EMDR. Follow-up assessments will be conducted at 3 and 12 months post-treatment. In addition to comparing the efficacy of the two protocols, an additional focus will lie on identifying predictors for treatment outcome.


Eligibility Criteria:
Inclusion Criteria:

* A full diagnosis of PTSD according to the DSM-IV or subthreshold PTSD (criteria for intrusive re-experiencing are fulfilled and either three avoidance/numbing symptoms or two hyperarousal symptoms are present)
* PTSD is related to one or more single-event traumas and participants have a clear memory of this event/these events (sufficient for constructing scenes to be used in exposure)
* Age between 18 and 70
* Sufficient fluency in Dutch to complete treatment and research protocol
* If participants are using anti-depressants, they need to be on a stable dose for at least 2 weeks before the beginning of treatment and remain on this dose throughout the treatment.

Exclusion Criteria:

* Dementia or other severe cognitive impairment
* Psychosis
* Depression with suicidal ideation
* Bipolar disorder
* Borderline Personality Disorder
* Anti-social personality disorder
* Substance dependence
* Current use of tranquilizers
* Exposure to prolonged and/or chronic trauma ("type-II-trauma")
Dry Needling Versus Graston Technique in Active Myofascial Trigger Points on Upper Trapezius

This study will compare the effects dry needling and Graston technique in active myofascial trigger points on upper trapezius. Half of the study participants will receive dry needling whereas other half will receive Graston technique.

This is a single blinded randomized controlled trial, will be conducted at Rawal General \& Dental Hospital, Islamabad. Both dry needling and Graston Techniques are used to release active Myofascial Trigger points with different mechanism.

Dry needling is technique in which without any medication or injection, dry needles are inserted into hyper irritable points in muscle. Graston technique is done with specially designed tools to locate knots within muscle by running the tools over the skin.

This study is planned with objectives to compare both treatment techniques on active myofascial trigger points in patients with neck pain. Effects of these will be measured on Neck Pain, Range of Motion, functional status and trigger points.

Eligibility Criteria:
Inclusion Criteria:

* Patient with non-specific pain in neck (acute and sub-acute)
* Age: 20-40 years
* Patient agrees to use the dry needling or Graston exclusively

Exclusion Criteria:

* Patients that were using any medication to reduce the pain and/or have any effect in the skeleton muscle.
* Patient taking other treatment in the same period of research.
* Patients having malignancy, tuberculosis, spinal cord injury, neurodegenerative diseases radiculopathies and hematoma.
* Patients on anticoagulants.
* Patient with chronic neck pain.
Rosuvastatin Versus Atorvastatin in the Treatment of Hypercholesterolaemia in African American Subjects(ARIES)

The purpose of this study is to compare the effect of 6 weeks of treatment with Rosuvastatin with 6 weeks of treatment with Atorvastatin in African American subjects with hypercholesterolemia.


Eligibility Criteria:
Inclusion Criteria:

* Fasting low density lipoprotein level as defined by the protocol.
* Self described African American race
* Fasting triglyceride level as defined by the protocol.

Exclusion Criteria:

* The use of lipid lowering drugs or dietary supplements after Visit 1.
* Active arterial disease eg Unstable angina, or recent arterial surgery
* Blood lipid levels above the limits defined in the protocol.
* Uncontrolled hypertension, hypothyroidism, alcohol or drug abuse.
Tenofovir in Early Pregnancy to Prevent Mother-to-child Transmission of Hepatitis B Virus

Mother-to-child transmission (MTCT) of hepatitis B virus (HBV) remains the major mode of transmission in most high and intermediate HBV endemic areas, despite existing WHO immunoprophylaxis recommendations. This immunoprophylaxis regimen, if given optimally, can prevent 75-80% of HBV MTCT, but optimal implementation is difficult because it requires administering monovalent HBV vaccine and hepatitis B immunoglobulin (HBIg) within 24 hours of birth. Due to the barriers of giving HBIg, the World Health Organization (WHO) states, "...owing to concerns related to supply, safety and cost, the use of HBIg is not feasible in most settings." Clearly, global control of HBV transmission will require improved MTCT prevention. Therefore, the investigators hypothesize that treating HBV early in pregnancy will lead to undetectable HBV DNA levels at delivery and prevention of MTCT of HBV without HBIg; a concept that has already been proven with HIV. Tenofovir disoproxil fumarate (TDF), an approved anti-HBV drug, is promising to prevent MTCT of HBV due to its high potency against hepatitis B and its safety record in pregnant women. A randomized, controlled clinical trial (RCT) will be necessary to determine if TDF given to HBV-infected pregnant women early in pregnancy plus vaccine to the newborn can decrease MTCT of HBV without HBIg. However, before embarking on a RCT, several critical knowledge gaps need to be addressed including the ideal timing for TDF initiation. The purpose of this proposal is to address these knowledge gaps.

The investigators hypothesize that anti-HBV therapy given in the late first or early second trimester achieves undetectable HBV DNA at delivery in \>=95% of pregnant women with chronic hepatitis B. The one-arm, open-label, interventional study aims: 1, To estimate the time to complete HBV DNA suppression (\<100 IU/ml) in 170 HBV DNA positive women who start TDF in the late first or early second trimester; and to estimate the proportion of women with HBV DNA \<100 IU/ml at delivery. 2, To address potential barriers to and the efficacy of implementing TDF in early pregnancy to prevent mother-to-child transmission of hepatitis B. The investigators will measure potential barriers to acceptability and effectiveness of this intervention: adherence, potential hepatitis B flares in mothers (safety), and the proportion of hepatitis B infections in the offspring at 1 year of age (efficacy).

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women aged 18 and over
* HBsAg positive
* In the 12th-20th week of pregnancy
* Willing to take TDF daily during pregnancy
* Providing written informed consent
* Plans to deliver at Shoklo Malaria Research Unit (SMRU)
* Able and willing to comply with study requirements

Exclusion Criteria:

* Anti-HIV positive
* Negative qualitative HBV DNA if HBeAg negative
* On immunosuppressive therapy
* Elevated creatinine
* History of kidney disease
* Short cervix
* History of pregnancy complications or prior pre-term labor
Optimizing Daily Mindfulness Interventions Using Peer Support to Increase Well-Being in First-Year Students

This project aims to examine the effect of a self-guided, evidence-based, online mindfulness intervention on well-being among first-year undergraduates at the 5 Claremont Colleges (5C's) and graduate students in the community. Additionally, it explores the feasibility and efficacy of peer support (pairs) as an adjunctive treatment component to enhance engagement and treatment effects, including social-connectedness, well- being, academic outcomes, and anxiety. Findings will provide insight into effective ways to (1) support students at The Claremont Colleges, and (2) leverage technology and peer support to implement mental health initiatives that are cost-effective, easily transportable, and scalable in low-resource settings.


Eligibility Criteria:
Inclusion Criteria:

* all participants must be either a first-year undergraduate student or a graduate student. Participants must be 18 years or older.

Exclusion Criteria:

* all participants must be either a first-year undergraduate student or a graduate student. Participants must be 18 years or older.
Biomarkers for Invasive Mucormycosis

Mucormycosis (MM) is one of the main invasive fungal infection (IFI), and is determined by filamentous fungi belonging to the order of Mucorales, with a mortality rate ranging from 20 to 60% according to localization. Prompt initiation of adequate antifungal therapy is critical for treating mucormycosis. Early diagnostic is therefore essential. The presence in the Mucorales' cell wall of uncommon monosaccharides open interesting perspectives for the development of specific diagnostic biomarkers.

This study evaluate a diagnostic test for mucormycosis in a cohort of patients with MM and in control groups (high-risk patients without MM and patients with another IFI).


Eligibility Criteria:
Inclusion Criteria:

* Men and women
* Age : Children and adults from 3 to 64 years old (18 to 64 for controls)
* In patients whose consent has been collected after information. In the case of children, information on the study will be given to the holders of parental authority and then to the child to obtain their consent.
* Patient social insured
* Specific medical conditions :

  1. For the case group :

     Any patient hospitalized in one of the departments of the University Hospital of Lille, in which the diagnosis of mucormycosis was conducted on the following criteria:
     * Conventional mycology data and / or
     * Positivity of q-PRC and / or
     * Anatomopathologic diagnosis Associated with a compatible clinical situation
  2. For the control group 1 Patient assessed for hematopoietic stem cell transplantation, considered at risk for IFI but for whom the pre-transplantation review will have excluded an ongoing infection
  3. For control group 2 Any patient hospitalized in a department of Lille University Hospital, in which the diagnosis of disseminated candidiasis or invasive pulmonary aspergillosis has been made according to specific classifications (EORTC/MSG criteria, AspICU criteria)

Exclusion Criteria:

* Patients for whom the inclusion criteria are not met
* Co-infection mucormycosis/other IFI
To Evaluate the Safety of Treating Autoimmune Diseases With Molecular Hydrogen Supplement

The supplementation of hydrogen molecules as an aid, adjuvant, may speed up recovering the course of the disease. The purpose of this study is to determine the safety and possible efficacy of hydrogen supplements in different formula and dose exposures for a clinical study in rheumatologic patients. Patients will receive a different dosage of either hydrogen capsules, hydrogen gas or hydrogen-rich water with their conventional treatment for a month. Investigators will test for any changes in haematologic, urine analysis and health status during and following the exposure period.

Hydrogen supplement has been shown to have significant removing effects on free radicals. International clinical trials have shown promise that hydrogen molecules may reduce chronic inflammatory and then speed up recovering the course of the disease.

The purpose of this study is to determine the safety and possible efficacy of hydrogen supplements in different formula and dose exposures for a clinical study in rheumatologic patients.

Study design: 27 rheumatologic patients will be recruited from the Tri-Service General Hospital for this study. Participants will be screened by doctors for their eligibility and undergo a series of tests (questionnaires and examinations). Consenting participants will then be allocated into 3 groups by different dosage forms (Gas, n=9; Water, n=9; Capsules, n=9). Participants in the gas group will then undergo exposure to 2% H2 in medical air via a high flow nasal cannula for either 1 (n=3), 2 (n=3) or 4 (n=3) hours every day for one month. Participants in capsule group will receive 1 (n=3), 3 (n=3) or 6 (n=3) capsules every day for one month. Participants in the water group will be suggested to drink 1 L hydrogen-rich water every day for one month. Participants will be examined their regular haematology, urine and health status before and after the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Age 20 to 80
* Able to compliant with the protocol
* Able to return to the hospital regularly

Exclusion Criteria:

* Pregnancy
* Expected pregnancy
Role of Cardiac Computed Tomography in Optimising Response to Cardiac Resynchronisation Therapy

The purpose of this study is to determine if detailed scanning of the heart before biventricular device insertion will improve outcomes for heart failure patients.


Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18, \<90
2. Patients with moderate or severe heart failure ( NYHA functional class II-IV) due to ischaemic or non-ischaemic cardiomyopathy.
3. QRS duration \>120ms on 12 lead ECG
4. LVEF \< 35%
5. LVEDD \>55 mm
6. Patients on optimum medical treatment for heart failure. The doses of these medications have been stable for 3 months.

Exclusion Criteria:

1. Patients with a cardiac or cerebral ischemic event within the previous three months prior to recruitment
2. Patients who had had an atrial arrhythmia within one month prior to recruitment
3. Patients with a systolic blood pressure of more than 170 or less than 80 mm Hg
4. Patients with a heart rate of more than 140 beats per minute
5. Patients with severe renal failure (eGFR \< 30)
6. Patients with a history of allergy to iodine based contrast agents
7. Predicted life expectancy \< 1 year
8. Pregnancy