cyrilzakka/clinical-trials huggingface dataset:
A Phase I Study of [177Lu]Lu-EVS459 in Patients With Ovarian and Lung Cancers

The purpose of this study is to evaluate the safety, tolerability, dosimetry and preliminary efficacy of \[177Lu\]Lu-EVS459 and the safety and imaging properties of \[68Ga\]Ga-EVS459 in patients aged ≥ 18 years with advanced high-grade serous ovarian cancer (OC) or locally advanced unresectable or metastatic non-squamous non-small cell lung carcinoma (non-sq. NSCLC).

The study will be done in two parts. The first part is called "escalation" and the second part is called "expansion". In both parts of the study, patients will initially be imaged with a \[68Ga\]Ga EVS459 positron emission tomography (PET)/computed tomography (CT) or PET/magnetic resonance imaging (MRI) scan. In the escalation part, different doses of \[177Lu\]Lu-EVS459 will then be tested to identify recommended dose(s) (RD(s)) for further evaluation. The expansion part of the study will examine the safety and preliminary efficacy of \[177Lu\]Lu-EVS459 at the RD(s) determined during the escalation part. The end of study will occur when at least 80% of the patients in the expansion part have completed the follow-up for disease progression or discontinued from the study for any reason, and all patients have completed treatment and the 36-month long-term follow-up period.

Eligibility Criteria:
Key Inclusion Criteria:

* Age \>= 18 years old
* Patients with advanced high-grade serous ovarian cancer (OC) or locally advanced unresectable or metastatic non-squamous non-small cell lung cancer (non sq. NSCLC) with disease progression following, or intolerance to, at least 1 line of therapy

Key Exclusion Criteria:

* Absolute neutrophil count (ANC) \< 1.5 x 10\^9/L, hemoglobin \< 10 g/dL, or platelet count \< 100 x 10\^9/L
* QT interval corrected by Fridericia's formula (QTcF) ≥ 470 msec
* Creatinine clearance \< 60 mL/min
* Unmanageable urinary tract obstruction or urinary incontinence
* Radiation therapy within 4 weeks prior to the first dose of \[177Lu\]Lu-EVS459

Other protocol-defined inclusion/exclusion criteria may apply.
Efficacy of Surgical Treatment of Osteomyelitis in Diabetic Foot Ulcers

Hypothesis:Surgical treatment of osteomyelitis in diabetic foot is more effective that medical treatment through antibiotherapy and leads wound healing in ulcers complicated with bone infection.Material and Methods: Randomized clinical trials which include two groups of patients (n=88), one receives medical treatment through antibiotherapy during 90 days and the other group receive conservative surgical treatment and antibiotics during 7 days after surgery. It will be studied differences between both groups in healing time, recidives, present and relationship of adverse events and outflow of quality of life related health .


Eligibility Criteria:
Inclusion Criteria:

* Patients with Diabetes Mellitus Type 1 or 2.
* Patients with diabetic foot ulcers.
* Patients with clinical suspects of osteomyelitis.
* Patients with positive probe to bone test.
* Patients with signs of osteolysis in the bone located adjacent to the ulcer in X-Ray
* Patients with transcutaneous oxygen oxygenation above 30 mmHg.
* Acceptance to participate in the study through prior informed consent.

Exclusion Criteria:

* Patients with osteomyelitis associated with necrotizing soft tissue infections.
* Presence of necrotic tissue in the wound bed, edges or margins of the lesion.
* HbAc1 \> 10.
* Presence of systemic toxicity such as fever, tachycardia, confusion, disorientation, vomiting or other signs usually related to systemic infection.
* Patients with bone exposure through the ulcer.
* Patients with absent pulses, ankle/brachial index (ABI) \<0.8 and TcPO2 \<30 mmHg.
* Pregnancy.
* Allergies to antibiotics.
* Any degree of renal impairment that contraindicated the administration of antibiotics proposed.
* Hepatic insufficiency.
* Mental Illnesses that prevent the understanding by the patient's proposed treatment, or for any other reason associated with your mental health, to recommend their inclusion.
Youth-Nominated Support Team Intervention for Suicidal Adolescents

This study will attempt to improve treatment adherence and reduce suicide risk among adolescents who are at risk for attempting suicide.

Despite substantial knowledge about adolescent suicide risk factors, few studies have been conducted to identify effective interventions for suicidal adolescents.

Youth-Nominated Support Team (YST) is an intervention designed to help suicidal adolescents after hospitalization. It is a psychoeducational social network intervention that targets poor treatment adherence and difficulties with social support. YST is designed to be a supplement to traditional or usual treatments.

Participants are randomly assigned to receive either treatment as usual (TAU) or TAU plus YST for 3 months. Adolescents who receive TAU plus YST nominate three or four adults from their family, school, and community settings to function as support persons. The support persons participate in a psychoeducation session that focuses on the adolescent's psychiatric disorder(s), individualized treatment plan, importance of treatment adherence, and suicide risk factors. They also maintain regular contact with the adolescent to support treatment adherence and progress toward treatment goals. Adolescents have assessments at 6 weeks, 3 months, 6 months, and 12 months. Internalizing behavior problems, perceived social support, treatment adherence, adaptive functioning, severity of depression and anxiety, severity and frequency of suicidal thoughts, and suicide attempts are assessed.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalization in a participating psychiatric facility
* Suicidal ideation, intent, or attempt

Exclusion Criteria:

* Severe physical or cognitive impairment that makes informed consent, nominations, or participation in assessments impossible
Adaptation and Implementation of a Cherokee-based Participatory Research Project to Reduce CVD Risk

This is a two phase project. Phase I is an online convenience sample to collect health and preference data for the intervention phase, as well as a partnership with community to co-create an intervention; Phase II. Phase II is an intervention to improve community connection and historical knowledge within Cherokee communities within the Cherokee Nation reservation involving consultation with Cherokee cultural and historical experts.

1. Identify necessary program enhancements to maximize reach and acceptability of the intervention for primary prevention of CVD in Cherokee Nation adults. The new intervention will have a broad reach, and thus, potentially greater public health impact. By building on the well-established and popular intervention, RTR, the goal is to maximize the likelihood that this intervention will be culturally acceptable, logistically feasible, and financially sustainable.
2. Conduct a pilot study (n = 40) to demonstrate acceptability and feasibility of the adapted intervention and research methods. The expectation is that the intervention will be culturally acceptable to participants, and retention and data collection protocols will support feasibility of a larger randomized controlled trial.

Eligibility Criteria:
Inclusion Criteria:

* Citizen of Cherokee tribe

Exclusion Criteria:

* Under the age of 18
Effect of Mulberry Leaf Extract on Glucose Response of a Test Meal

The aim of this study is to test the effects of Mulberry leaf extract on glucose response of a standardized complete meal when taken just before or when mixed with the meal.


Eligibility Criteria:
Inclusion Criteria:

* Male and female participants
* Healthy status (based on anamnesis)
* Age between 18 and 45 years
* BMI between 20 and 29.9 kg/m2
* Ability to understand and sign an informed consent form

Exclusion Criteria:

* Pregnant or lactating women
* Major medical/surgical event in the last 3 months potentially interfering with study procedures and assessments
* Known food allergy and intolerance to test product
* Medically known cutaneous hypersensitivity to adhesives and plasters
* Alcohol intake higher than 2 servings per day. A serving is 0.4 dl of strong alcohols, 1 dl of red or white wine, or 3 dl of beer.

Smokers

Volunteer who cannot be expected to comply with the protocol

Subject having a hierarchical link with the research team members.
Impact of a Diabetes Risk Score on Lifestyle Education and Patient Adherence

The purpose of this randomized, controlled study is to evaluate whether the knowledge of a personalized diabetes risk score affects adherence to a 12-week diet and exercise lifestyle change program in prediabetic patients. The intervention group will receive diabetes risk score results at the beginning of the twelve weeks, and the control group will not receive these results. Both groups will review their baseline and 12-week diabetes risk score results at the conclusion of the program and will be followed for an additional twelve weeks. Attendance rates and changes in weight, BMI, abdominal circumference, blood pressure, HgA1c, fasting blood glucose, cholesterol, and diabetes risk score will be compared between the groups.


Eligibility Criteria:
Inclusion Criteria:

* Men and women of all ethnic groups
* ≥30 -75 years of age
* Pre-diabetic defined as follows: fasting plasma glucose (FPG) 100-125mg/dL, HbA1c 5.7% to 6.4%.
* Body Mass Index ≥ 25 kg/m2
* Tricare beneficiary

Exclusion Criteria:

Diagnosis of type 1 or type 2 diabetes mellitus (defined as FPG ≥126 mg/dl on two different occasions or random blood sugar ≥200) If fasting glucose \>= 126 only once, a second lab does not need to be arranged in an attempt to diagnose diabetes. It is acceptable for the patient to proceed in the trial. Also, Tethys lab results (e.g., fasting glucose and A1C) should not be used to make decisions about including or excluding patients in the trial. Only Air Force lab results should be used to make this determination.

* Active duty military members
* Patients with untreated hypothyroidism or previously diagnosed Cushing's syndrome
* Subjects previously treated with metformin or thiazolidinediones in the previous 12 months
* Psychological or physical disabilities deemed likely to interfere with participation in the study
* Patients currently using weight-loss medications or medications known to affect body weight (i.e. chronic corticosteroid use)
* Major medical conditions that prevent participation in the Group Lifestyle Balance Prevention Program (i.e. severe cardiovascular or cerebrovascular disease, severe renal or liver dysfunction, etc.)
* Concurrent participation in a different weight loss program
* Previous bariatric surgery
* Unwilling to agree with the study assignments or provide informed consent
* Participation in any other research project that would interfere with this protocol
* Unable to read and write English
* Pregnant or nursing patients
* Female patients unwilling to undergo a pregnancy test or report possible pregnancy promptly and unwilling to take precautions to avoid pregnancy if potentially fertile during the study course

Discontinuation Criteria:

* Consent is withdrawn
* Death occurs
* A woman becomes pregnant
* Severe impairment of manual dexterity, vision, or intellectual function
* They become lost to follow-up because of a move or transfer outside of the geographic area
Observational Study of Persistence on Bafiertam Treatment in Routine Clinical Practice

This is an open-label, multicenter, observational study of the adherence of patients with relapsing-remitting multiple sclerosis (RRMS) prescribed Bafiertam (monomethyl fumarate) as their treatment.

Monomethyl fumarate (MMF) is the active metabolite of the fumarate class of drugs used for the treatment of RRMS. Bafiertam is a formulation of MMF and does not require enzymatic conversion after oral administration. Adult participants with a diagnosis of RRMS who have been receiving continuous treatment with Bafiertam monotherapy per the approved product label for no more than 3 months (90 days) are eligible to enroll in the study. Their satisfaction with Bafiertam treatment will be assessed using a 9-Item Treatment Satisfaction Questionnaire for Medication (TSQM-9). To be included in the study, patients.

Eligibility Criteria:
Inclusion Criteria:

1. Male or non-pregnant female aged 18 years and older.
2. Participants diagnosed with Relapsing forms of multiple sclerosis R(RMS) and satisfy the approved therapeutic indication for Bafiertam per the approved product labeling.
3. Participants may enroll if they are within 90 days of initiating therapy with Bafiertam.
4. Female participants of childbearing potential must practice effective contraception from Day -1 and be willing and able to continue contraception for the duration of the study.
5. Willing and able to sign the informed consent form (ICF) approved by the Institutional Review Board (IRB).
6. Willing and able to complete all the study procedures and communicate meaningfully with study personnel.

Exclusion Criteria:

1. Known hypersensitivity to fumarates including dimethyl fumarate, Tecfidera, and/or diroximel fumarate (Vumerity) or Bafiertam.
2. Participated in another clinical trial within 30 days, suffered or still recovering from a medically significant event of surgery within 30 days, or previously participated in a clinical study with a similar investigational product.
To Evaluate the Safety and the Pharmacokinetics of NVP-2203

The purpose of this study is to evaluate the safety and pharmacokinetics after administration of NVP-2203.

Phase 1 to evaluate the safety and pharmacokinetics after administration of NVP-2203.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult subjects who signed informed consent
* BMI of \>18.0 kg/m2 and \<30.0 kg/m2 subject, weight more than 50kg(45 kg or more for woman)

Exclusion Criteria:

* Subjects participated in another clinical trial within 6 months prior to administration of the study drug
* Inadequate subject for the clinical trial by the investigator's decision
A SAD/MAD Study of Safety, Tolerability and Pharmacologic Activity of BT200 in Normal Volunteers

Study BT200-01 is a first in human (FIH) study in male and female normal human volunteers (NHVs) that uses an Integrated Protocol Design. This Phase 1 study will comprise 4 sub-parts: Part A, a single ascending dose (SAD) study; Part B, a multiple ascending dose (MAD) study; Part C, a desmopressin challenge study to explore (i) whether desmopressin could be used as an antidote, and/or (ii) whether desmopressin stimulated vonWillebrand Factor (VWF) release is overcome with increasing BT200 doses; and Part D, a relative bioavailability (BA) study.

The primary objective of this study is to assess the safety and tolerability profile of BT200 in NHVs.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy male or female volunteers, age ≥ 18 years old at screening
2. If female, must be post-menopausal or status post hysterectomy
3. Able to comprehend and to give informed consent
4. Able to cooperate with the Investigator, to comply with the requirements of the study, and to complete the full sequence of protocol-related procedures

Exclusion Criteria:

1. Clinically significant medical history (including von Willebrand Disease, thrombocytopathy, or any type of bleeding diathesis) or ongoing chronic illness that would jeopardize the safety of the subject or compromise the quality of the data derived from his/her participation in this study
2. Clinically relevant abnormal findings on physical examination or clinically relevant laboratory abnormalities
3. History of infusion hypersensitivity reactions, significant drug allergy, or anaphylactic reactions
4. Substance abuse, mental illness, or any reason that makes it unlikely in the judgment of the Investigator for the subject to be able to comply fully with study procedures
5. Use of medication during 2 weeks before the start of the study, which in the judgment of the Investigator may adversely affect the subject's welfare or the integrity of the study's results
6. Concurrent treatment with other experimental drugs or participation in another clinical trial with any investigational drug within 30 days or 5 elimination half-lives (whichever is longer) prior to treatment start
Impact of the Use of FeelWell™ Compression Garment on Individuals With a BMI ≥35

To assess the effect of wearing a custom-fitted, FDA-registered, Class I device, compression garment (Obesinov, S.A.R.L.) by an individual with a BMI ≥ 35 on his/her day-to-day quality of life over a period of one year. Various measures of quality of life will be taken, including assessing an individual's level of pain, mood, self-stigma and comfort with the use of a compression garment. Additionally, to assess the impact of the compression garment on activity, strength, posture and movement of an individual with a BMI ≥35 over the period of one year.

Individuals suffering with obesity often experience daily pain and discomfort which limits movement, a critical factor in managing weight, cardio-metabolic health, mood, sleep, self-esteem and ultimately overall quality of life. Many individuals who experience weight gain have an abdominal or central distribution of weight which affects body mechanics leading to back pain, poor posture, difficulty walking with altered gait, knee, foot, ankle and leg pain (IT band, meralgia paresthetica) and other non-specific chronic pain. Chronic pain impedes mobility often incorporating depression and low motivation in an endless cycle. Furthermore, as individuals are losing weight, they often suffer from excess skin which also aggravates by chafing (arms, inner thighs), hanging down and interfering with gait.

The Investigators will examine the effect of wearing a custom-fitted, FDA-registered, Class I device, compression garment (Obesinov, S.A.R.L.) by participants with a BMI ≥ 35 on day-to-day quality of life over a period of one year. Various measures of quality of life will be taken, including assessing the participant's level of pain, mood, self-stigma and comfort with the use of a compression garment. Additional assessments include impact of the compression garment on activity, strength, posture and movement as well as potential impact of the use of this garment on weight loss and change in laboratory measures of metabolic health.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, over 18 years old.
* Subjects with a BMI of ≥ 35.
* Subjects in any stage of weight loss or maintenance.

Exclusion Criteria:

* Inability to put on or have help in putting on garment.
* Inability to participate in movement and exercise intervention.
* Panniculus grade \>3 at baseline or other body habitus that limits mobility.
* Duke Activity Status Index (DASI) score \< 3.62
* Medical condition limiting participation in trial or basic mobility.
* Current participation in a physical therapy program.
* Unwillingness to participate fully in trial.
* Participation in another trial at the same time.
* Patient Health Questionnaire (PHQ)-9≥15.
* Current or expected pregnancy
* Investigator's discretion
The Effects of Protein Supplementation and Resistance Exercise in Hemodialysis Patients

The objective of this study is to determine how protein supplementation, with or without exercise, affects functional capacity, strength, body composition, and physical activity in hemodialysis patients.


Eligibility Criteria:
Inclusion Criteria:

* On hemodialysis for more than 3 months, on a thrice weekly hemodialysis program;
* Adequately dialyzed (Kt/V \> 1.4).
* Age \> 18 years old.
* Properly functioning AV Graft

Exclusion Criteria:

* Patients unable to perform exercise due to cardiovascular disease, osteoarthritis, etc.
* Pregnant women.
* Severe unstable underlying disease besides commonly associated with ESRD. Cardiac patients that are stable will be included.
* Patients hospitalized within the last month prior to the study.
* Patients will not perform the MRI if contraindication as determined using the VUMC MRI Procedure Screening Form (attached) or prior claustrophobic reaction in an MRI scanner.
Allogeneic Stem Cell Transplantation (SCT) With Treosulfan, VP-16 and Cyclophosphamid for Patients With Acute Lymphoblastic Leukemia (ALL)

The present study is a multicenter, prospective phase II-study investigating the combination of treosulfan, etoposide, and cyclophosphamide as conditioning regimen for patients with acute lymphoblastic leukemia who are not eligible for a TBI-containing regimen.


Eligibility Criteria:
Inclusion Criteria:

* Acute lymphoblastic leukemia in first or subsequent complete remission
* Indication for allogeneic stem cell transplantation according to the actual protocol of the German Acute Lymphoblastic Leukemia Study Group
* Patient's age: 18-65 years
* HLA-identical or compatible related or unrelated donor (HLA-A, HLA-B, HLA-C, HLA-DRB1 and HLA-DQB1) (one antigen-mismatch allowed)
* Not eligible for total-body irradiation due to one of the following reasons:

  * prior radiation of the spine \> 30 Gy
  * prior radiation of the mediastinum \> 30 Gy
  * severe pulmonary infection during induction chemotherapy
  * DLCO \> 50%
* Patient's wishing to avoid total-body irradiation as conditioning regimen
* Patient's written informed consent
* Women and men capable of reproduction must agree to use highly effective methods of contraception until six months after treatment termination. For men: vasectomy, sexual abstinence, or partner is using hormonal IUD, implants, injectables, oral hormonal contraceptives or is surgically sterilized. For women: hormonal IUD, implants, injectables, sexual abstinence, surgical sterilization, vasectomised partner

Exclusion Criteria:

* No complete remission at time of registration
* Severe irreversible renal, hepatic, pulmonary or cardiac disease, such as

  * total bilirubin, SGPT or SGOT \> 3 times upper the normal level
  * Left ventricular ejection fraction \< 30%
  * Creatinine clearance \< 30 ml/min
  * DLCO \< 35% and/ or receiving supplementary continuous oxygen
* Positive serology HIV
* Pregnant or lactating women
* Severe florid infection
* Experienced hypersensitivity against cyclophosphamid, etoposide, or treosulfan
* Cystitis
* Obstructive renal function
* Participation in any other clinical drug trial
* Serious psychiatric or psychological disorders
* Progressive invasive fungal infection at time of registration