cyrilzakka/clinical-trials huggingface dataset:
Bioclinical Study of Scalp Photoaging of a Population Male Over 65 Years Old.

The aging of skin, especially that of the scalp, is a combination of intrinsic and extrinsic aging factors secondary to the chronic sun exposure. For men with an alopecia genetic (= bald men), the solar part, in skin aging process, is major.

The helio-dermal scalp is frequently the site of cancers mainly after 65 years. Objectives are to identify specific biomarkers involved in the photo-aging of the alopecic scalp

Investigators can also hope to understand and to explain the inter-individual inequality of the aging of skin. They can hope to a better understanding of the biological mechanisms between photo-induced skin aging and photo-induced carcinogenesis.

Investigators propose to study 40 male patients aged 65 and over in order to compare the state of aging of their scalp skin in the alopecic zone :

not hairy photo-exposed (= ZH sun damage zone) versus occipital hair zone protected photo (= ZT control zone).

Patients will be recruited in the dermatology department of the St-Etienne University Hospital who will benefit from the removal of a scalp tumour in the alopecic zone.

This study aims to identify biological markers, by transcriptomic analysis, associated with aging of the scalp, by comparing for each patient the skin of the scalp exposed to the light ("ZH") to an unexposed witness skin ("ZT").

The study will include :

* examinations to characterize components of the scalp: transcriptomic, proteomic and immunohistochemical analysis of skin biopsies, and a swab sampling will identify the cutaneous microflora of the scalp
* noninvasive examinations, in vivo

Eligibility Criteria:
Inclusion Criteria:

* Requiring excision of an alopecic scalp lesion
* from consent signed
* Patient affiliated or entitled to a social security.

Exclusion Criteria:

* scalp infection
* inflammatory disease of the scalp
* genetic disease with even partial expression of the scalp
* medical treatment of scalp less than 3 weeks old
* antecedent radiotherapy of the cephalic extremity
* prior surgery of the scalp with regard to the area sampled
* Application of hair implants, or any other surgical or medical procedures of the scalp
* Washing of the scalp or application of a cosmetic product for less than 48 hours
* Artificial hair coloring.
* any contraindication to surgical excision
AMG 757 and AMG 404 in Subjects With Small Cell Lung Cancer (SCLC)

The main purpose of this study is to evaluate the safety, tolerability, and recommended phase 2 target dose of tarlatamab in combination with AMG 404.


Eligibility Criteria:
Inclusion Criteria:

* Participant has provided informed consent/assent prior to initiation of any study specific activities/procedures
* Age greater than or equal to 18 years old at the same time of signing the informed consent
* Participants with histologically or cytologically confirmed Small Cell Lung Cancer (SCLC) who progressed or recurred following at least 1 platinum-based regimen
* Eastern Cooperative Oncology Group (ECOG) 0 to 1
* Participants with treated brain metastases are eligible provided they meet defined criteria
* Adequate organ function as defined in protocol

Exclusion Criteria:

* History of other malignancy within the past 2 years with exceptions
* Major surgery within 28 days of first dose of tarlatamab
* Untreated or symptomatic brain metastases and leptomeningeal disease
* Prior anti-cancer therapy, including anti-PD1 or anti-PDL1 antibody therapy: at least 28 days must have elapsed between any prior anti-cancer therapy and the first planned dose of tarlatamab

Exceptions:

* Participants who received prior chemotherapy must have completed at least 14 days before the first dose of tarlatamab and all treatment-related toxicity resolved to grade ≤ 1.
* Participants who received prior palliative radiotherapy must have completed at least 7 days before the first dose of tarlatamab

  * Participants who received prior tarlatamab therapy or prior delta-like ligand 3 (DLL3) x cluster of differentiation 3 (CD3) bispecific therapy are not eligible
  * Participants who experienced recurrent grade 2 pneumonitis or severe or life-threatening immune-mediated adverse events or infusion-related reactions including those that lead to permanent discontinuation while on treatment with immuno-oncology agents
  * History of any immune-related colitis. Infectious colitis is allowed if evidence of adequate treatment and clinical recovery exists and at least 3 months interval observed since diagnosis of colitis
  * Participants with evidence of interstitial lung disease or active, non-infectious pneumonitis
  * Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of tarlatamab
  * History of solid organ transplantation
  * History of hypophysitis or pituitary dysfunction
  * Active autoimmune disease that has required systemic treatment (except replacement therapy) within the past 2 years or any other diseases requiring immunosuppressive therapy while on study. Participants with Type I diabetes, vitiligo, psoriasis, hypo- or hyper-thyroid disease not requiring immunosuppressive treatment are permitted
Robot-Assisted Rehabilitation After HIV-Associated Stroke: Botswana

Today, nearly 37 million people are living with HIV (PLHIV) worldwide and 30 to 40% of them will have neurologic complications leading to disability. Our long-term working hypothesis is that an effective solution for increasing rehabilitation access in Botswana and improving functional outcomes of PLHIV having experienced a stroke with or without HIV uses an affordable robot and mobile health technologies to create a cost-effective intervention strategy. For this project, we test the feasibility of affordable robot therapy.

We will test the feasibility of affordable robot therapy in three Aims. In Aim 1, we will optimize for the Botswana context, an affordable technology-based robot system with four exercise stations. We will optimize a prototype of our provisionally patented robot gym system, REHAB CARES, for therapy. Optimization will include increasing cost-effectiveness, utilizing more local resources and manufacturing, and using mobile health android platforms for games and data acquisition. In Aim 2, the efficiency of the newly modified robot system compared to standard of care will be assessed using 30 patients who have experienced a stroke, with or without HIV, will be recruited from those who are being treated by Princess Marina Hospital (PMH) and living in the surrounding community. They will receive therapy using the robot gym system and receive standard of care. We will assess functional outcomes including motor impairment, function, and quality of life. The study outcomes would then inform rehabilitation practices for PLHIV with stroke, with or without HIV, and suggest that affordable technology-mediated rehabilitation can reduce their motor dysfunction and resulting long-term disability.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of Stroke (at least 3 months post incident) with or without HIV, age over 18;
* medically stable (Able to tolerate therapy and given the determination as able to go through protocol by physician);
* have neurological function between 5 and 24 as defined by the NIH Stroke Scale (NIHSS);
* have no less than moderate cognitive function as defined by the International HIV-Dementia Scale
* Able to give consent.

Exclusion Criteria:

* unable to give consent;
* severely depressed (Becks Depression Inventory-Fast Screener);
* experiencing excessive pain (Visual Analog Scale (VAS) score greater than 4);
* have severe spasticity ( than 3) in muscle tone in elbow/shoulder/wrist hip/knee/ankle using the Ashworth Scale;
* have total paralysis or muscular contractures of upper or lower extremity;
* have a history of psychiatric disorder or cardiac problems;
* have a history of prior brain injury including lesions to the cerebella or brain stem;
* have open lesions on the upper or lower limbs;
* It is up to the physician to decide if a subject should be excluded due to severe drug and/or alcohol abuse or taking of medication that would impair cognitive ability.
Acute Effects of Alcohol Use on Chronic Orofacial Pain

Self-medication of pain with alcohol is a common, yet risky, behavior among individuals with chronic orofacial pain. Chronic pain status may affect the degree to which alcohol use relieves pain, but the independent contributions of pain chronification and alcohol-related expectations and conditioning have not been previously studied. This project addresses this gap in knowledge and will inform further research and clinical/translational efforts for reducing risk associated with these behaviors.


Eligibility Criteria:
Inclusion Criteria:

* Positive diagnosis of jaw pain, including temporomandibular joint and muscle disorder (TMD) (jaw pain group only)
* Consume at least 1 drink/month over the past 6 months

Exclusion Criteria:

* History of chronic pain other than jaw pain or TMD
* Current use of opioids
* Current major depression
* History of any psychotic disorder
* Undercontrolled hypertension or diabetes
* History of neurologic disease
* History of serious medical illness
* History of drug or alcohol dependence, including nicotine, or a pattern of hazardous alcohol use
Effect of Lidocaine Block in Traumatic Brain Injury

The goal of this or clinical trial is to explore efficacy of stellate ganglion block on dysphagia and activities of daily living in Traumatic Brain Injury Patients. The main question it aims to answer are:

Can stellate ganglion block improve the dysphagia and activities of daily living in Traumatic Brain Injury Patients.

Traumatic Brain Injury Patients will be divided into the the control group and observation group evenly. All the patients were provided with routine therapy, while the patients in the observation group were given stellate ganglion block. The swallowing function, and activities of daily living of the two groups of patients before and after treatment were evaluated.

Dysphagia, or swallowing difficulty, is a common symptom in Traumatic Brain Injury Patients. The goal of this or clinical trial is to explore efficacy of stellate ganglion block on dysphagia and activities of daily living in Traumatic Brain Injury Patients. The main question it aims to answer are:

Can stellate ganglion block improve the dysphagia and activities of daily living in Traumatic Brain Injury Patients.

Traumatic Brain Injury Patients will be divided into the the control group and observation group evenly. All the patients were provided with routine therapy, while the patients in the observation group were given stellate ganglion block. The swallowing function, and activities of daily living of the two groups of patients before and after treatment were evaluated.

Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years, meeting the diagnosis of Traumatic Brain Injury;
* presence of no contraindication for Stellate Ganglion Block;
* with stable vital signs and no severe liver or kidney dysfunction, metabolic disorders.
* informed consent form was obtained from the patient's family members, indicating their full - understanding of the study and agreement to participate.

Exclusion Criteria:

* unable to cooperate in completing treatment and assessment due to personal reasons or other disorders;
* complicated with other intracranial lesions, such as stroke;
* with severe consciousness disorders caused by other diseases.
Novel Pharmacotherapy for Dual Dependence

The purpose of this study is to evaluate the effects of Topiramate and Cognitive Behavioral Therapy for the treatment of alcohol and cocaine dependence.

Our objective is to understand the basic mechanisms that underpin substance dependence, and to develop efficacious treatments for individuals with comorbid cocaine and alcohol dependence.

Participants in this study will be randomly assigned to receive either 300 mg per day of topiramate or placebo. In addition, participants will receive weekly cognitive behavioral therapy for 12 weeks.Follow-up visits will occur at 2 weeks and 1,2,, and 3 months following completion of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Subjects will be men and women between the ages of 18 years and older.
* Must meet at least three of the seven DSM IV diagnostic criteria for alcohol and cocaine dependence.
* Express a desire for treatment.
* Literacy in English and ability to read, understand, and complete the ratings scales and questionnaires accurately, follow instructions, and make use of the behavioral treatments are required.
* Prospective subjects must report cocaine use of at least once per month and alcohol consumption of ≥21 drinks/week and ≥14 drinks/week for men and women respectively, during the past 30 days
* At least one positive urine drug screen for cocaine at screen or baseline prior to randomization.

Exclusion Criteria:

Please contact site for additional information
Safety Study of PLX-PAD Cells to Treat Pulmonary Arterial Hypertension (PAH)

The purpose of this clinical study is to assess the safety of PLX-PAD to treat pulmonary arterial hypertension (PAH). PLX-PAD is a cell-based product made of allogeneic Mesenchymal-like Adherent Stromal Cells (ASCs), derived from human full-term placentas following an elective caesarean section. This year-long study will evaluate the safety of three different dose levels of PLX-PAD, each given as a single intravenous infusion. This study will also evaluate effects that PLX-PAD may have on PAH, such as changes in the ability to exercise and on other tests used to measure the disease severity.


Eligibility Criteria:
Summary of inclusion and exclusion criteria.

Eligible subjects:

* Are between 18 and 75 years of age
* Have a minimum weight of 45 kg
* Have a diagnosis of idiopathic or heritable PAH, PAH associated with connective tissue disease (CTD), PAH associated with repaired congenital systemic-to-pulmonary cardiac shunt (at least one year since repair), or PAH associated with appetite suppressant/drug or toxin use confirmed by RHC
* Have a current WHO functional class II or III designation
* Have been stabilized, without dose changes for at least 30 days prior to the Screening visit on at least two approved PAH medications (e.g., PDE-5 inhibitor, ERA, prostanoid \[as inhalation or infusion\]); or IV prostanoid monotherapy. Subjects on an IV prostanoid must have been receiving therapy for at least three months prior to the Screening visit.
* Have a 6MWD equal to or greater than 200 meters (m) at the Screening and Baseline Visits.

Subjects must not:

* Have any evidence of pulmonary thrombus, significant coronary artery disease (CAD), left ventricular dysfunction, or a restrictive or congestive cardiomyopathy
* Have a history of malignancies within the past 5 years,with the exception of individuals with localized, non-metastatic basal cell carcinoma of the skin, in situ carcinoma of the cervix, or prostate cancer who are not currently or expected to undergo radiation therapy, chemotherapy and/or surgical intervention, or to initiate hormonal treatment during the study
* Be listed for transplantation
* Be pregnant or nursing
Dalbavancin Outpatient Pilot

The purpose of this research is to determine if a new antibiotic called dalbavancin will work to treat and cure certain infections while reducing the need for daily antibiotics by vein.

A phase 4, single-center, pilot open-label trial assessing the safety and efficacy of dalbavancin in the outpatient therapy of susceptible gram-positive infections requiring prolonged intravenous therapy.

Eligibility Criteria:
Inclusion

* \>=18 years of age
* Provide informed consent
* Agreement to attend required follow-up visits with reasonable transportation plan
* Afebrile for at least 24 hours prior to enrollment
* Expected survival ≥3 months
* If female, non-pregnant and non-lactating; all females of child-bearing potential must have a negative pregnancy test prior to study entry and must agree to use a highly effective method of birth control during the study and for one month thereafter.
* Anticipated hospital discharge within 8 days
* Joint and bone infection:
* Sterile site culture positive for susceptible organism
* Participants with bacteremia and right-sided infective endocarditis (IE):

  * 2 or more blood cultures positive for S. aureus (MSSA or MRSA or Streptococci)
  * Blood cultures negative for 72 hours within 7 days on standard of care antibiotic therapy
  * Definite diagnosis of right sided infective endocarditis by Duke Criteria
  * Echocardiographic assessment (TTE or TEE)
* For patients with opioid use disorder and history of injection opioid use,

  * Injection of opioid substances (IOS) in the last 6 months
  * Fulfill criteria for opioid use disorder

Exclusion

* Polymicrobial infection
* Baseline QTc \>500 msec
* Creatinine clearance \<30 mL per min
* Immunocompromised from neutropenia, AIDS, malignancy, chemotherapy, or receiving immunosuppressant medication including systemic corticosteroids (intranasal or inhaled corticosteroids acceptable)
* Patients with documented allergies to lipoglycopeptides, vancomycin, or teicoplanin
* Concurrent diseases that, in the Investigator's medical judgment, would interfere with the conduct of the study, confound the interpretation of the study results, or endanger the patient's well-being
* For participants with right-sided IE:
* No mitral or aortic valve involvement on echocardiogram
* Large, mobile vegetations (\>10mm)
* Perivalvular abscess
* Presence of an intracardiac device (defibrillator or pacer) or prosthetic valve
Phase 1 Clinical Study of QLS5132 Monotherapy in Advanced Solid Tumors

The Phase 1 trial includes Phase 1a (dose-escalation) and Phase 1b (dose-expansion):

* Phase 1a: Assesses safety, tolerability, PK, and preliminary efficacy of QLS5132 in advanced solid tumors using ATD + BOIN, given IV every 3 weeks. Up to 12 subjects may be enrolled in promising dose levels.
* Phase 1b: Evaluates QLS5132's anti-tumor efficacy in specific CLDN6-positive solid tumors, including ovarian cancer, NSCLC, gastric cancer, and others. Expansion studies at 1\~3 selected dose levels follow successful Phase 1a results.


Eligibility Criteria:
Inclusion Criteria:

* Advanced solid tumors;
* Measurable disease, per RECIST v1.1;
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
* Adequate organ function;
* Recover from all reversible AEs from previous anti-tumor treatment (i.e., Grade ≤ 1, according to NCI-CTCAE v5.0), excluding alopecia (any grade) and Grade ≤ 2 neuropathy peripheral;

Exclusion Criteria:

* Previous treatment with drugs targeting CLDN6 (including ADCs), or any drug containing topoisomerase I inhibitors (including ADCs);
* Received prior chemotherapeutic, investigational, or other therapies for the treatment of cancer within 2 weeks with small molecule and within 4 weeks with biologic before the first dose of QLS5132;
* Progressive or symptomatic brain metastases;
* Serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection;
* History of significant cardiac disease, or poorly controlled diabetes mellitus;
* History of recurrent autoimmune diseases;
* History of myelodysplastic syndrome (MDS) or AML;
* History of other active malignant tumors within 3 years before signing the informed consent form;
* If female, is pregnant or breastfeeding;
* Be allergic to any component of QLS5132 or its excipients.
Fosamax for Childhood Cancer Survivors

Survivors of childhood cancers face a variety of long-term problems. The investigators' recent study found that osteoporosis and osteopenia were common among these patients. The factors leading to, as well as the best treatment option for, this morbidity are unclear. Bisphosphonates are currently the standard therapy for osteoporosis in the elderly. However, the efficacy and safety of bisphosphonates for treating osteoporosis in long-term cancer survivors have not been tested. The investigators hypothesize that alendronate, an orally active bisphosphonate, is efficacious and safe in the treatment of osteoporosis in these patients.

The modern treatment for childhood malignancy includes surgery and chemoradiotherapy either individually or in combination. Despite the great achievement in improving patient survival, these treatments also greatly enhance the adverse effects on the unfortunate children. Our research group has recently conducted a pioneer study on the bone mineralization and bone mineral density (BMD) study in longterm childhood cancer survivors in local patients who have completed anti-cancer treatment for at least five years. This landmark study showed that persistent treatment-related adverse effects on skeletal development are common (up to 50%) in local long-term survivors of childhood cancers. Thus, it is important during this critical period of rapid somatic growth in adolescents and young adults that these cancer survivors achieve their peak potential for bone mineralization and strengthening. In this proposed study, we investigate with a randomized and controlled study design on the efficacy of a second-generation oral bisphosphonate, alendronate, to improve BMD over a 36-week period in long-term survivors of childhood cancers in Hong Kong. In addition to alendronate, all subjects in the active and control groups will receive alfacalcidol (vitamin D) and calcium carbonate throughout the whole study period. The study results will help paediatric oncologists to decide on the optimal remedial treatments against osteoporosis in long-term cancer survivors.

Eligibility Criteria:
Inclusion Criteria:

* Chinese patients who completed treatments for childhood cancers for at least 5 years
* Currently followed up in the Department of Paediatrics of Prince of Wales Hospital
* Younger than 18 years old at the time of diagnosis of underlying cancers
* Evidence of osteoporosis (i.e. BMD T- or Z-score \< -2.5 at lumbar spine)
* Older than 15 years of age at the time of recruitment

Exclusion Criteria:

* Current treatment (i.e. within 6 months) with maintenance systemic or high-dose inhaled corticosteroids
* Subjects who cannot cooperate for BMD measurements
* Pregnant female patients
* Subjects with prior history of allergy to alendronate or in whom alendronate treatment is contraindicated
Acthar Gel for Active Systemic Lupus Erythematosus (SLE)

This trial is to study Acthar Gel in participants with active systemic lupus erythematosus (SLE).

The doctor will assign eligible patients to one of two groups (like flipping a coin).

Participants will receive the treatment assigned to their group for 24 weeks:

* Acthar Gel
* Placebo Gel, which looks like Acthar Gel, but has no medicine in it.

The doctor or his staff will take measurements and ask questions to:

* see how well the gel is working
* see how safe it is for patients with SLE

This trial was initiated (started recruiting) in October 2016, but first patient was not enrolled (randomized) until December, 2016.

Eligibility Criteria:
Inclusion Criteria:

To be eligible to participate in this trial, a patient must:

* Have a diagnosis of SLE according to 4 of the American College of Rheumatology revised criteria
* Have active SLE
* Have moderate to severe rash and/or arthritis as demonstrated by BILAG-2004 score A or B in the mucocutaneous and/or musculoskeletal body systems at both Screening and Randomization Visits
* Have a documented history or screening result of

  1. positive antinuclear antibody (ANA), OR
  2. elevated anti-dsDNA or extractable nuclear antigen (ENA) antibodies
* Have been on prednisone (or prednisone equivalent) before the screening visit:

  1. at least 8 weeks, and
  2. at a stable dose of 7.5 mg to 30 mg for at least 4 weeks

Exclusion criteria:

A patient is not eligible to participate if he/she:

* Has a history of sensitivity to adrenocorticotropic hormone (ACTH) preparations or porcine products
* Has active lupus nephritis
* Has active central nervous system (CNS) manifestations of SLE