cyrilzakka/clinical-trials huggingface dataset:
Outcomes of Anti-HIV Therapy During Early HIV Infection

The purpose of this study is to find out if it is effective to give aggressive anti-HIV therapy to patients who have been infected recently with HIV.

Many doctors recommend that patients who have recently been infected with HIV begin anti-HIV treatment as soon as possible. However, early HIV infection is not yet completely understood, so it is not known if this is the best approach. This study will look at the effects of beginning anti-HIV treatment during early HIV infection.

Although many researchers have recommended initiation of aggressive antiretroviral therapy as soon as possible after HIV infection occurs, the tolerability and efficacy of this approach has not been systemically evaluated. Many features of primary HIV pathogenesis are incompletely understood. A more complete understanding of immune dynamics and viral pathogenesis during primary HIV infection is critical to determine optimal treatment intervention strategies. This study will evaluate the outcomes of potent antiretroviral therapy initiated at different stages of primary HIV infection.

Thirty-six of the study patients are coenrolled to ACTG 371 or another treatment protocol. All study drug treatment and toxicity management is performed according to guidelines in these treatment protocols. An untreated cohort of 12 patients is also followed on this study. Patients are stratified at enrollment according to their stage of acute or early HIV infection. Patients are evaluated for virologic, immunologic, and clinical parameters for 96 weeks. In addition, novel studies of source partner identification are proposed. An effort is made to determine the most likely source partner(s) for each study patient on the basis of patient recall of possible exposures. A separate study protocol will evaluate the source partner.

Eligibility Criteria:
Inclusion Criteria

Patients may be eligible for this study if they:

* Are at least 13 years old.
* Have acute or early HIV infection. The stage of HIV infection will depend on the results from certain lab tests.

Exclusion Criteria

Patients will not be eligible for this study if they:

* Are pregnant or breast-feeding.
Comparison of Tazarotene and Minocycline Therapies for Maintenance of Facial Acne Vulgaris

The purpose of the study is to compare the efficacy of three maintenance regimens (topical tazarotene, oral minocycline, or both) in sustaining improvement in acne.

For many years antibiotic therapy has been the backbone of therapy for inflammatory acne. However, topical retinoids also offer efficacy against inflammatory acne and the combination of a topical retinoid and an antibiotic can result in faster and more complete clearing of inflammatory lesions than either drug alone.

The reduced sensitivity of Propionibacterium acnes to antibiotics is a growing problem. Resistance is a major issue not only because it can result in treatment failure but also because of concerns that it may potentially be transferred to other bacteria that anti-acne antibiotics are used used against. One of the most important factors predisposing to the development of resistant strains of propionibacterium acnes is the prolonged use of antibiotics. Therefore, in order to help minimize the development for such resistance, it is evident that maintenance strategies for acne should aim to minimize the long-term use of antibiotics.

Topical retinoids are a rational choice for maintenance therapy due to their activity on microcomedones (the precursor for all acne lesions). Nevertheless, there is a paucity of data evaluating this use in a maintenance setting. The aim of this study was to determine whether patients with moderate to severe inflammatory acne who have achieved a good level of clearance (eg\>/= 75%) can maintain the improvement in their acne using maintenance therapy. THe study compared the efficacy of three maintenance therapies (topical tazarotene, oral minocycline, and topical tazarotene plus oral minocycline) in sustaining the clinical improvement attained after initial topical tazarotene plus oral minocycline therapy.

Eligibility Criteria:
Inclusion Criteria:

Moderate facial acne vulgaris 25-60 facial inflammatory acne lesions 10-100 facial comedos No more than 2 facial nodular cystic lesions (no more than 5 mm in diameter) For females of child bearing potential, a regular menstrual cycle Negative urine pregnancy test

Exclusion Criteria:

Uncontrolled systemic disease Acne vulgaris known to be resistant to antibiotics For females: pregnancy, breastfeeding, or planning pregnancy Use of estrogens or birth control pills for 12 weeks or less Any skin disease that may interfere with diagnosis or evaluation of acne vulgaris Known hypersensivity to any components in Tazarac gel or to any tetracyclines Use of any systemic retinoids in past 2 years Use of any systemic antibiotics, or participation in another drug or investigational study, in past 30 days Use of topical anti-acne medication in past 14 days
An Innovative Rehabilitating Meals-on-wheels Service for Frail Old People

The aim of the project is to assess the beneficial effect of offering frail old people a targeted meals-on-wheels service in 8 weeks in a randomized controlled trial

The aim of the project is to assess the beneficial effect of offering frail old people a targeted meals-on-wheels service in 8 weeks in a randomized controlled trial. The target group is, respectively old people discharged from an hospital stay, old people referred for exercise rehabilitation in the municipality and old people already receiving meals-on-wheels

Eligibility Criteria:
Inclusion Criteria:

* 65+ year,
* able to speak and understand Danish.
* has accepted to participate
* Is discharged from hospital, or
* is referred to exercise rehabilitation in the municipality or
* is receiving meals-on-wheels

Exclusion Criteria:

* terminal disease,
* living in a nursing home,
* receives a specific diet (e.g. diabetes, dysphagia, vegetarian or vegan)
Carvedilol Versus Endoscopic Band Ligation for Primary Prophylaxis of Oesophageal Variceal Bleeding

Carvedilol versus endoscopic band ligation for primary prophylaxis of oesophageal variceal bleeding in cirrhotic patients with arterial hypertension

A Randomized controlled trial of carvedilol versus endoscopic band ligation for primary prophylaxis of oesophageal variceal bleeding in cirrhotic patients with arterial hypertension

Eligibility Criteria:
Inclusion Criteria:

* • Aged \>18 years

  * Cirrhotic patients with arterial hypertension
  * Endoscopic evidence of medium/large-sized esophageal varices

Exclusion Criteria:

* • History of variceal bleeding or previous primary prevention of varices.

  * Portal vein thrombosis or previous porto-systemic shunts as TIPS.
  * Patients on drugs affecting portal pressure (beta blockers, nitrates).
  * Advanced cardiovascular disease including acute myocardial infarction, atrio-ventricular block, congestive heart failure, chronic peripheral ischemia, severe bradycardia.
  * Patients with severe respiratory diseases (COPD, bronchial asthma).
  * Uncontrolled diabetes mellitus
  * Renal impairment
  * Hepatocellular carcinoma
  * Allergy to carvedilol
  * Pregnancy or lactation
Prospective Interventional Study Exploring the Microbiota Recolonization in SR-GvHD Patients Receiving MaaT013

The objective of the ORION study is to explore the changes of gut microbiota composition following MaaT013 administration and its impact on the immune system in GVHD patients.

The french regulatory authority ANSM approved in July 2019 the use of MaaT013, a pooled microbiome-based enema formulation, under a formalized named-patient use program in France called "Autorisation Temporaire d'Utilisation - ATU nominative protocolisée - ATUn" or Early Access.

The ATUn is indicated to provide a benefit in the treatment of patients with grade III-IV aGVHD:

* In case of initial resistance to CS alone or in association or in case of failure to other treaments
* In first-line therapy in association with CS in case of steroid-dependance (inability to taper CS dose \<0.5 mg/kg/d)
* In case of digestive aGvHD with overlap syndrome The objective of the ORION study is to explore the changes of gut microbiota composition following MaaT013 administration and its impact on the immune system in GVHD patients.

Blood and stool samples will be collected at each visit which explained why the study is thus categorized as research involving the human person with low risks and constraints clinical trial (RIPH2).

Eligibility Criteria:
Inclusion Criteria:

* Patient ≥18 years old with Grade III-IV aGVHD with gut involvement undergoing treatment with MaaT013 through named-patient use program ATUn / Early Access
* Signature of informed and written consent by the subject or by the subject's legally acceptable representative for patients under guardianship or trusteeship.
* Affiliated or recipient from a social security scheme

Exclusion Criteria:

* Pregnancy and breastfeeding
* Vulnerable patients such as: minors, persons deprived of liberty, persons in Intensive Care Unit unable to provide informed consent prior to the intervention.
Low Level Laser Treatment and Breast Cancer Related Lymphedema

Manual Lymphatic Drainage (massage therapy) with compression (wearing a tight sleeve on the arm) is the current standard of treatment for breast cancer related lymphedema (arm swelling). Low-Level Laser Therapy (LLLT) was approved in 2006 by the FDA for professional and self/home treatment of lymphedema. LLLT is being offered as a treatment option in many lymphedema treatment settings, but there are few studies of the effectiveness of LLLT as a stand-alone lymphedema treatment or as a possible complementary lymphedema treatment modality to Manual Lymphatic Drainage. The objective of this proposed pilot study is to examine the impact of Advance Practice Nurse (ANP) administered LLLT, as both a stand-alone and complementary treatment, on arm volume, symptoms, and quality of life (QOL) in breast cancer survivors with lymphedema. Findings from this pilot study will be used to determine if LLLT has possible value in the treatment of lymphedema and warrants subsequent evaluation in a larger study.

The purpose of this proposed pilot study is to examine the impact of Advance Practice Nurse (ANP) administered LLLT, as both a stand-alone and complementary treatment, on arm volume, symptoms, and quality of life (QOL) in breast cancer survivors with related LE. Findings from this pilot randomized study will be used to determine if LLLT has possible value in the treatment of LE and warrants subsequent evaluation in a larger study.

Eligibility Criteria:
Inclusion Criteria:

Breast cancer survivors will be included if they:

1. are age 21 or older;
2. require professional treatment for Stage I or II lymphedema as defined by the International Society of Lymphology;
3. have an order for lymphedema treatment; and
4. are willing and able to drive to the study sites.

Exclusion Criteria:

Individuals will not be included if they:

1. are actively undergoing intravenous chemotherapy or radiation therapy;
2. have a history of bilateral lymphedema that prohibits extracellular fluid comparison to an unaffected limb;
3. are unable to stand upright for measurement of height and weight;
4. have active/metastatic cancer;
5. are pregnant,:
6. have artificial joints in areas where electrode placement is critical, or have a pacemaker/internal defibrillator; or
7. have congestive heart failure (CHF), chronic/acute renal or hepatic disease, pulmonary edema, thrombophlebitis, deep vein thrombosis (DVT), acute infection of any kind, and inflammation in the trunk or arms.
Enhanced Motivational Interviewing With Alcohol Positive Trauma Patients

The primary goal of this study is to test the efficacy of a brief intervention that includes the patient and a significant other, relative to an intervention including the patient only, for reducing alcohol use and alcohol-related problems among trauma patients.

Alcohol-positive trauma patients are more likely to be readmitted to a trauma center or subsequently die from an injury than are alcohol-negative patients. Empirically supported treatments to reduce alcohol use and alcohol-related problems (e.g., injuries, drinking and driving) in this high-risk population are needed, but few exist. This randomized controlled clinical trial assesses the efficacy of a brief intervention that includes the patient and a significant other, relative to an intervention including the patient only, for reducing alcohol use and alcohol-related problems among trauma patients.

Motivational Interviewing (MI), a brief, directive, non-confrontational intervention, has demonstrated some promise in this setting. Further, inclusion of a significant other (SO) in prolonged, intensive alcohol treatment appears to improve treatment retention and efficacy. Although inclusion of an SO in MI has been suggested, there are few data to support this endorsement.

Accordingly, this study will address whether motivational interviewing including both the trauma patient and an SO can more effectively decrease and maintain reductions in alcohol use and alcohol-related problems 6 and 12 months following discharge from the trauma unit than MI with the individual patient or an assessment-only condition.

The 2 MI groups will each receive 2 intervention sessions timed to occur in the hospital, and 1 booster session, occurring 1 month following discharge.

In the assessment-only condition, patients will receive only assessment of their drinking at baseline. This proposal will allow us to address the next phase of our program of research designed to develop easily disseminable treatments for these high-risk populations in medical settings. This study will also address potential mediators (motivation to change alcohol use, self-efficacy, alcohol treatment attendance, and social support for abstinence) and moderators of MI effects. The cost-effectiveness of the intervention will also be addressed.

Thus, this study will address both a significant public health problem and provide important information about MI mechanisms that may be relevant to the broader addiction treatment community.

Eligibility Criteria:
Inclusion Criteria:

* admitted to trauma unit
* greater than 18 years old
* had a blood alcohol concentration (BAC) greater than .01% according to a biochemical test OR self-reported drinking alcohol in the 6 hours prior to the event that caused their hospital visit OR scored 8 or higher on the Alcohol Use Disorders Identification Test (AUDIT)
* identify at least one eligible significant other

Exclusion Criteria:

* not English-speaking
* had a self-inflicted injury
* in police custody
* did not pass a mental status exam
Canadian Eye Injury Registry

The purpose of this study is to establish an eye injury registry to assess the mechanisms and outcomes of significant eye injuries occurring in Canada. The epidemiologic data will determine where public health strategies should be directed to prevent future eye injuries.

Currently there is no established database or recording system of eye injuries occurring in Canada. Estimates place the figure at approximately 100000 significant eye injuries occurring in our country every year. This represents a large public health and long-term disability challenge. Lost productivity of working-age individuals with vision loss amounts to $4.4 billion annually in Canada, part of which is due to eye injury. By recording the types, locations, and outcomes of significant eye injuries, it is hoped improved public health strategies may be established to prevent further ones. The need for such a database has been recognized by the Ivey Eye Institute, the Canadian National Institute for the Blind (CNIB) and the Canadian Ophthalmological Society (COS).

The United States Eye Injury Registry (USEIR) has been in existence for greater than 20 years. Through their database they have recorded thousands of eye injuries which has led to public health interventions through their various ocular societies. They have also established a standardized reporting system and ocular trauma score which has improved diagnosis and prognosis of eye injuries. This system has been used in many countries as a standardized reporting scheme for eye injuries.

It is hoped that through a pilot recording system established in London a framework for a national reporting system will develop. The objective is to use the standardized reporting system of the USEIR to report Canadian eye injuries.

The time frame for outcome measures will be 6 months. The patients will be followed along for this amount of time to assess there visual outcomes. No further follow up after 6 months will be undertaken for the purpose of the registry.

The hypothesis is that by recording the type and outcome of eye injuries, a better understanding of mechanisms and location of these injuries in Canada will occur. Subsequent public health interventions can then be made in conjunction with the CNIB and COS to improve eye health in Canada.

Eligibility Criteria:
Inclusion Criteria:

* Any patient who experiences an acute eye injury that has or has the potential to compromise the integrity of the eye. These are serious eye injuries resulting in permanent and significant (i.e. measurable or observable on routine eye examination) structural or functional change to the eye. Separate reports are to be filed for each eye involved in bilateral injuries.

Exclusion Criteria:

* Based on the standard of the United States Eye Injury Registry
* Mild ocular contusions
* Subconjunctival hemorrhage
* Superficial abrasions by themselves usually would not meet the criterion of serious and/or reportable injuries.
* The exclusion of these injuries will depend on the clinical judgement of the reporting physician.
Phase II Study Evaluating Busulfan and Fludarabine as Preparative Therapy in Adults With Hematopoietic Disorders Undergoing MUD SCT

The primary objective of this study is to assess the safety and efficacy of performing unrelated stem cell transplants using intravenous busulfan and fludarabine as preparative therapy and tacrolimus plus methotrexate as the GVHD prophylaxis regimen. The goal is to demonstrate safety, aiming for a transplant related mortality rate (TRM) of \< or equal to 40% at 100 days. A TRM of \> or equal to 60% will be considered unacceptable. Another goal is to demonstrate efficacy by showing and overall survival of \>40% at 1-year following transplant.


Eligibility Criteria:
Inclusion Criteria:

* No fully or single-antigen mismatched sibling donor is available to donate stem cells.
* Age \>15 and \<61
* ECOG PS \< or equal to 2
* Adequate renal function with serum creatinine \<2.0 mg/dl
* Pulmonary diffusing capacity \>40% of predicted
* Cardiac ejection fraction \>40% as measured by radionuclide wall motion study or echocardiography
* No active liver disease. Total bilirubin must be \< or equal to 2.0 mg/dl. Alkaline phosphatase and AST must be less than three times the upper limit of normal. Patients with hepatitis C and active hepatitis B are eligible only if a liver biopsy is performed and there is \< or equal to grade 2 inflammation. Patients wtih a history of HBV infection should be tested for HBeAg, antiHBe and HBV DNA (quantitative). Patients with active HBV viral replication should receive anti-viral therapy.
* Negative serology for the human immunodeficiency virus (HIV)
* Available HLA-matched donor (see HLA compatibility requirements below)
* Signed informed consent from the recipient

Exclusion Criteria:

* Ongoing active infection
* Pregnancy and/or nursing
* Active, uncontrolled CNS leukemia
* Opinion of BMT Committee that autologous or mini-allogeneic transplant would be the preferable form of treatment
* Receipt of any chemotherapy within 3 weeks of study entry except for hydroxyurea or imatinib mesylate. Use of interferon within 3 months of starting therapy.
Study of BBP-418 in Patients With LGMD2I

BBP-418 is being developed for the treatment of patients with Limb-Girdle Muscular Dystrophy Type 2I (LGMD2I). This is an open label study to determine the safety and tolerability of ascending dose levels of BBP-418 in the treatment of ambulatory and non-ambulatory patients with LGMD2I for which no approved therapy currently exists.

This is an open label study in ambulatory and non-ambulatory subjects with LGMD2I (also known as LGMD R9) previously enrolled in the natural history Study MLB-01-001. This is a study to determine the safety and tolerability of ascending dose levels of BBP-418 in those subjects.

Eligibility Criteria:
Inclusion Criteria:

* Have a body weight \>30 kg
* Have a genetically confirmed diagnosis of LGMD2I and be clinically affected (defined as demonstrating clinical weakness on bedside evaluation in either a limb-girdle pattern, or in a distal extremity)
* Able to complete the 10-meter walk test in ≤ 12 seconds unaided ("moderate disease") or are with "severe disease"/non-ambulatory as defined by being unable to complete the 10-meter walk unaided in \>12 seconds
* Willing to use an adequate method of contraception from time of consent through 12 weeks after last dose
* Previous enrolment in the Natural History study MLB-01-001

Exclusion Criteria:

* Evidence of clinically significant concomitant disease, including:

  * Any history of a gastrointestinal condition, including surgeries, which may affect absorption after oral administration
  * Any significant concomitant medical condition, including cardiac, pulmonary, renal, hepatic or endocrine disease other than that associated with LGMD2I
  * Any condition other than LGMD2I requiring therapy with prescription medicine (medication for common and mild concomitant conditions may be permitted after consultation with the PI)
  * Any other laboratory, vital sign, ECG abnormality, or clinical history or finding that, in the investigator's opinion, is likely to unfavorably alter the risk-benefit of study participation, confound study results, or interfere with study conduct or compliance
* If pregnant and/or breastfeeding or planning to conceive children within the projected duration of the study through 12 weeks after the last dose of study treatment.
* History of drug abuse including alcoholism within 2 years prior to consenting
* Use of ribose or other sugar alcohol-containing supplement within 60 days of Day 1
* Use of a corticosteroid within 60 days of Day 1
* Presence of a platelet disorder, bleeding disorder or other contraindication to muscle biopsy
* Actively on an experimental therapy or device or was on an experimental therapy or device within 60 days prior to Day 1.