cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate High Protein Supplementation in HIV-Positive Patients With Stable Weight Loss

The purpose of this study is to determine whether a high-quality protein food supplement will help HIV-positive patients maintain, and possibly gain, muscle mass.

Many HIV-positive patients lose weight that they are then unable to regain. This may be because patients are not eating enough protein or are not eating the right kinds of protein. The protein eaten in foods (such as meat, eggs, or beans) may not be able to make up for the amount of protein lost due to HIV infection. This study gives patients high-quality protein food supplements to help them maintain and/or gain weight.

In many HIV-infected individuals with prior weight loss, the failure to regain weight and lean tissue is at least in part the consequence of inadequate protein intake or ingestion of a poor-quality protein rather than total caloric intake. Dietary sources of protein are presumably inadequate to meet the high metabolic needs caused by HIV infection. To achieve a target protein intake in the range (1.5 to 2.0 g/kg/day) demonstrated in other catabolic diseases necessary to achieve positive nitrogen balance and to generate substantial anabolic effects, this study will administer a supplement containing high-quality protein.

Two groups of 28 patients each are randomly chosen to receive either an oral nutritional supplement (Optimune) containing increased amounts of high-quality protein (whey), which is rich in cysteine and glutamine, or an isocaloric, identical-tasting supplement without added whey protein or amino acid supplementation. Weight, body composition, anthropometry, dietary intake, and general physical health are assessed at baseline and at Weeks 6 and 12. Plasma cysteine, glutathione, C-reactive protein, and prealbumin, along with urine IL-6, sTNFrII, and IL-1ra, are assessed at baseline and at Week 12.

Eligibility Criteria:
Inclusion Criteria

You may be eligible for this study if you:

* Are HIV-positive.
* Are at least 18 years old.
* Have an HIV level less than 5,000 copies/ml within 30 days of study entry.
* Have lost weight in the past year, but your weight has remained fairly stable in the 2 months prior to enrollment.
* Are expected to live for at least 6 months.
* Are usually able to eat enough to maintain your present weight.
* Are able to complete a 3-day food diary.

Exclusion Criteria

You will not be eligible for this study if you:

* Have gained a significant amount of weight in the past 2 months.
* Have any opportunistic (HIV-associated) infections.
* Are unable to eat enough food for any reason, or are on tube feeding.
* Have nausea, diarrhea, or vomiting in the 14 days prior to study entry.
* Are being treated for diabetes.
* Are receiving chemotherapy or radiation therapy to treat cancer.
* Are pregnant or breast-feeding.
* Are allergic to milk or mangoes.
* Have an implanted defibrillator.
SB208 for the Treatment of Tinea Pedis

This is a phase 2, multi-center, double-blind, randomized, vehicle-controlled study to be conducted in non immunocompromised adult subjects with interdigital tinea pedis.

A phase 2, multi-center, double-blind, randomized, vehicle-controlled study to be conducted in approximately 170 non immunocompromised adult subjects with interdigital tinea pedis. Subjects will apply the investigational product (IP) (SB208 or Vehicle Gel) to the interdigital areas and all affected and immediate surrounding areas of one or both feet once daily for 2 weeks, followed by a 4-week post-treatment observation period.

Eligibility Criteria:
Inclusion Criteria:

* Otherwise healthy male and female subjects with clinical diagnosis of interdigital t. pedis
* T.pedis provisionally confirmed at baseline by a positive KOH wet mount for segmented fungal hyphae on skin scraping from the target site

Exclusion Criteria:

* Women who are pregnant or nursing or planning on becoming pregnant
* Subjects with onychomycosis or moccasin-type t. pedis
* Subjects using topical or systemic anti-fungal agents
Pharmacokinetics and Safety of ALKS 5461 in Subjects With Renal Impairment and Normal Renal Function

This study will evaluate the effect of various degrees of renal function on the pharmacokinetics and safety of ALKS 5461.


Eligibility Criteria:
Inclusion Criteria:

For all subjects:

* Has a body mass index (BMI) of 18.0-40.0 kg/m\^2 and a total body weight \>50kg
* Agrees to use an approved method of contraception for the duration of the study
* Additional criteria may apply

For subjects with renal impairment:

* Has severe or end stage renal disease, and does not require dialysis
* Has stable renal function for at least 60 days preceding screening
* Additional criteria may apply

Exclusion Criteria:

For all subjects:

* Has any past history or current finding of a clinically significant observed abnormality, psychiatric or medical condition other than renal impairment
* Has a history of gastrointestinal surgery affecting drug absorption or biliary elimination, excluding appendectomy or cholecystectomy
* Is pregnant, planning to become pregnant, or lactating
* Has a history of clinically significant allergy or a hypersensitivity to opioids
* Additional criteria my apply

For subjects with renal impairment:

* Has evidence of compromised respiratory function, seizure disorder, or myasthenia gravis
* Has received a kidney transplant
* Additional criteria may apply
A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Lyme Disease

This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records regarding Lyme Disease

The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to the information provided in surveys and in medical records regarding Lyme Disease

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study
2. Male or female patients of any age (interest is given to children to compare with mothers)
3. Diagnosis of Lyme Disease

Exclusion Criteria:

1. Refusal to sign informed consent form
2. History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy.
3. Postoperative stoma, ostomy, or ileoanal pouch
4. Participation in any experimental drug protocol within the past 12 weeks
5. Treatment with total parenteral nutrition
6. Any clinically significant evidence of disease that could interfere with the subject's ability to enter the trial
7. Inability to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire study
Sargramostim in Reducing Graft-Versus-Host Disease in Patients Who Are Undergoing Donor Stem Cell Transplantation for Hematologic Cancer or Aplastic Anemia

RATIONALE: Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy or radiation therapy. Giving sargramostim to the stem cell donor and the patient may reduce the chance of developing graft-versus-host disease following stem cell transplantation.

PURPOSE: Clinical trial to study the effectiveness of sargramostim in decreasing graft-versus-host disease in patients who are undergoing donor stem cell transplantation for hematologic cancer or aplastic anemia.

OBJECTIVES:

* Determine the efficacy of sargramostim (GM-CSF) to mobilize CD34+ hematopoietic stem cells in donors and to reduce graft-vs-host disease in patients after allogeneic stem cell transplantation (SCT) for hematologic malignancy or aplastic anemia.
* Determine the safety of GM-CSF after allogeneic SCT transplantation in these patients.

OUTLINE: This is a pilot study.

* Donors: Donors receive sargramostim (GM-CSF) subcutaneously (SC) once daily on days 1-6. Donors undergo stem cell harvest on day 7.

Donors may undergo up to 3 apheresis procedures to reach the target stem cell dose and may receive additional GM-CSF prior to each collection.

* Patients: Patients receive conditioning therapy as per transplantation protocol RP98-15. Patients undergo allogeneic stem cell transplantation on day 0. Patients then receive GM-CSF SC once daily beginning on day 7 and continuing until blood counts recover.

Patients are followed weekly until day 100 and then at days 180 and 360.

PROJECTED ACCRUAL: A total of 10 patients and 10 donors will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of a malignant hematologic disease, including:

  * Acute or chronic leukemia
  * Myelodysplastic syndromes
  * Myeloproliferative disorder
  * Hodgkin's lymphoma
  * Non-Hodgkin's lymphoma OR
* Aplastic anemia
* Planned transplantation on an RPCI IRB-approved allogeneic stem cell transplantation protocol
* HLA-matched (6/6) related donor available

PATIENT CHARACTERISTICS:

Age

* 5 to 60

Performance status

* Not specified

Life expectancy

* Not specified

Hematopoietic

* Not specified

Hepatic

* Not specified

Renal

* Not specified

Other

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients and donors must use effective contraception
* No known allergy to GM-CSF
* No prior of adverse reaction to any yeast recombinant molecule

PRIOR CONCURRENT THERAPY:

Biologic therapy

* See Disease Characteristics
* No prior allogeneic stem cell transplantation

Chemotherapy

* Not specified

Endocrine therapy

* Not specified

Radiotherapy

* Not specified

Surgery

* Not specified
Post-Operative Thoracolumosacral Orthosis for PJK

Proximal junctional kyphosis (PJK) is a common post-operative radiographic finding after surgery for adult spinal deformity (ASD) patients. Although the clinical relevance of isolated PJK is unclear, PJK can progress to symptomatic proximal junctional failures which requires a large revision surgery. Currently, post-operative bracing with a thoracolumbosacral orthosis (TLSO) is common practice after spinal deformity surgery, however the efficacy of this in preventing PJK is unknown. This multi-center randomized control trial identified 84 patients undergoing thoracolumbosacral fusion for ASD and plans to study the efficacy of a novel post-operative TLSO in preventing the development of PJK as defined by the proximal junctional angle on 6-month post-operative X-rays.


Eligibility Criteria:
Inclusion Criteria:

* 30-75-years-old
* Undergoing primary thoracolumbosacral fusion for ASD with an upper instrumented vertebrae (UIV) between T8-L2 and lower instrumented vertebrae (LIV) of S1 or the ilium.

Exclusion Criteria:

* Osteoporosis (defined as a T-score \<-2.5 at the time of surgery)
* Body mass index (BMI) \>35 kg/m2
* Revision fusions
* Fusions for trauma
* Those with a neuromuscular etiology for their deformity (i.e. Parkinson's disease, cerebral palsy, post-stroke, etc.)
* An underlying inflammatory arthropathy
Emergency Department Vestibular Rehabilitation Therapy for Dizziness and Vertigo

ED-VeRT will enroll up to 125 adult emergency department (ED) patients presenting with a chief complaint of dizziness or vertigo to collect longitudinal outcomes over 3 months of follow-up. This will include 50 patients who were evaluated by an ED physical therapist (ie, vestibular rehabilitation) during their ED visit and 50 patients who received usual care. The aims of this trial are to: (1) obtain initial estimates of participant recruitment and retention, intra-cluster correlation, and between-group outcome differences that will inform sample size calculation for a future randomized clinical trial, and (2) assess feasibility and fidelity of a clinical classification protocol for undifferentiated dizziness among patients receiving ED vestibular rehabilitation.


Eligibility Criteria:
Inclusion Criteria:

* Chief complaint relating to dizziness or vertigo
* Ability to complete follow-up data collection electronically or by telephone
* English-speaking

Exclusion Criteria:

* Severe neurologic deficit concerning for ischemic or hemorrhagic stroke
* Known pregnancy, under police custody, unable to consent
Secondhand Smoke Exposure Reduction Study

The high prevalence of smoking in adults in many developing countries (e.g. in China, 61% among men and 7% among women) results in many children being exposed to secondhand smoke (SHS). Although in 2001 the American Academy of Pediatrics recommended the promotion of proper smoking hygiene, (i.e. smoking away from the immediate environment of infants and children), similar recommendations in many developing countries are either scarce or non-existent. We hypothesize that implementation of a package of smoking hygiene intervention measures delivered by community health workers (CHWs) will reduce Chinese children's exposure to SHS and improve their respiratory health.


Eligibility Criteria:
Inclusion Criteria:

1. household member has smoked one or more cigarettes daily for the past 30 days as self reported;
2. household smoker smokes a total of at least 10 cigarettes per week at home in the presence of the child, as self reported;
3. smoker household member and the child are living together in the same household and will live together during the entire period of the study;
4. residents of the study community;
5. able to communicate in Mandarin Chinese or local Shanghai dialect;
6. has signed an informed consent form or given verbal consent (for those who cannot read and write).

Exclusion Criteria:

1. reported residential coal burning and confirmed by the interviewer;
2. households with breast-feeding child;
3. household members do not smoke at home;
4. smoker member does not live in the same household as the under 5 child;
5. non-local community resident; and
6. not able to communicate in Mandarin Chinese or Shanghai dialect.
The Comparison of Wet Suction and Dry Suction Technique in EUS-FNA for the Outcomes in Pancreatic Solid Lesions

The objective of this randomized controlled trial is to evaluate whether wet suction technique (WST), compared with dry suction technique (DST), shall present a better outcome with regard to the diagnostic yield and specimen quality of patients with solid lesions in the pancreatics.

Endoscopic ultrasound guided fine-needle aspiration (EUS-FNA) has become an inevitable indispensable method for acquiring a pathological diagnosis in a variety of clinical conditions. It has been widely used due to the high sensitivity, specificity and safety. In order to improve the puncture efficiency of FNA, many domestic and oversea scholars have conducted several clinical trials. Among them, there are many studies on the type of needle, needle pattern, slow pull or vacuum suction, and there are only two related reports on wet suction (saline) and dry suction technique. There still have many controversies in the researchers about which technique is more dominant in the wet or dry suction. The wet suction technique is relying on pre-flushing the needle with saline to replace the column of air with fluid followed by aspiration at the proximal end, using a prefilled suction syringe with saline. It has been suggested that the presence of a saline-solution column might keep the needle from getting clogged while avoiding the inherent inconvenience of a metal stylet, so that it can improve the quality of specimens, diminish the contamination of blood, and increase the diagnostic yield and accuracy. Wet suction may become the development trend of EUS-FNA in the future because the application of wet suction is expected to improve the diagnostic efficiency and the quality of samples in FNA.

Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18 years, \< 80 years
2. female or male
3. Patients are required to undergo EUS-FNA after undergoing imaging examination (MRI, CT, or ultrasonography) which identify that the pancreatic lesions are existing and solid.
4. Agree to attend this study and signed informed consent letter

Exclusion Criteria:

1. bad physical condition, including hemoglobin ≤ 8.0 g/dl, severe cardiorespiratory dysfunction, and so on
2. Coagulopathy (platelet count \< 50,000/mm3, international normalized ratio \> 1.5) or having taken oral anticoagulation agents such as aspirin or warfarin in the previous week
3. Be rejected by anesthesia
4. Acute pancreatitis in the previous 2 weeks
5. Pregnant or lactation period
6. Psychiatric disease, drug addiction, or other reason for unreliable follow-up or questionnaires
7. Don't agree to attend this study and absence of informed consent
Effects of Ozone Therapy on Clinical Parameters and Inflammatory Cytokines in Chronic Periodontitis Patients

The objective of this study is to evaluate of ozone therapy on both clinical and biochemical effects in periodontally patients.

This study is evaluated clinical and biochemical effect of ozone therapy at 8 weeks in periodontitis patients.

Eligibility Criteria:
Inclusion Criteria:

* systemically healthy
* non-smokers
* chronic periodontitis participants

Exclusion Criteria:

* smokers
* pregnancy or lactation
* individiuals with any systemic disease
The Effects of Apomorphine on Experimental and Clinical Pain in Patients With Chronic Radicular Pain

The study aimed to explore the effect of the dopamine agonist apomorphine on spontaneous pain intensity and evoked cold clinical and experimental pain in patients with lumbar radicular neuropathic pain (NP). Patients received either apomorphine or placebo in a randomized double-blinded manner.

Although evidence suggests that dopaminergic systems are involved in pain processing, the efficacy of dopaminergic interventions in reducing pain remains questionable. This randomized, double blinded, placebo-controlled, cross-over study was aimed to explore the effect of the dopamine agonist apomorphine on spontaneous pain intensity and evoked cold clinical and experimental pain in patients with lumbar radicular neuropathic pain (NP).

Data was collected from 35 patients (18 men, mean age 56.2±13.1 years). The following five pain measures were tested before (baseline) and 30, 75 and 120 min subsequent to subcutaneous injection of 1.5 mg apomorphine or placebo in two separate sessions: spontaneous pain intensity, threshold and tolerance to cold pain in the most painful site in the affected leg and in a remote healthy site in the dominant hand.

Eligibility Criteria:
Inclusion Criteria:

1. Presence of radicular pain for at least 3 months;
2. Average pain level during the last week prior to enrollment \> 40 (0-100);
3. No use of a new analgesic drug within 30 days prior to entry to the study and
4. Adults who were capable of understanding the purpose and instructions of the study and signing an informed consent.

Exclusion Criteria:

1. Pregnancy or breastfeeding;
2. Presence of Parkinson's disease or any other extra-pyramidal diseases;
3. History of allergy to the investigational drugs: Apomorphine or Domperidone;
4. History of polyneuropathy and
5. Respiratory depression, dementia, psychotic diseases or hepatic insufficiency
Guided Online Self-help for Loneliness

The study seeks to investigate the efficacy of two internet-based self-help programmes administered with support from a therapist. The two active conditions consist of an internet cognitive behavioral therapy (ICBT) programme and a intervention of internet-based interpersonal psychotherapy (IIPT), both of which have been developed for the present study. The active conditions will be compared to a wait-list control group.

Participants will be recruited in Sweden with a nationwide recruitment.


Eligibility Criteria:
Inclusion Criteria:

* Frequent and distressing experiences of loneliness
* Can speak, write, and read the primary language of the country in which they reside (Sweden or the United Kingdom).
* Have access to an internet connection and a computer/smart phone/tablet
* Are prepared to participate in the study, regardless of the type of treatment they are randomly assigned to.

Exclusion Criteria:

* Changes in dosage of psychopharmaceutic medication in the last three months prior to the start of the study or a planned change during the initial treatment period.
* Other ongoing psychotherapeutic treatment
* Suicidal plans
* A previously diagnosed personality syndrome
* Ongoing substance abuse
* Other acute treatment need related to a psychiatric disorder requiring attention from a mental health professional (e.g. eating disorders such as anorexia nervosa).
Evaluation of Amphotericin B in the Treatment of Biopsy Proven Candida Esophagitis in Immunocompromised Patients

To determine the appropriate duration of amphotericin B therapy for Candida esophagitis. To compare the effectiveness of two different amphotericin B doses in the treatment of biopsy-proven Candida esophagitis. To determine if low-dose amphotericin B is less toxic than standard dose therapy during a limited treatment period. To evaluate pharmacokinetic and pharmacodynamic parameters of the two different dosing regimens.


Eligibility Criteria:
Exclusion Criteria

Co-existing Condition:

Patients with histological or clinical (skin rash, cotton wool exudates, Candida endophthalmitis, etc.) evidence of disseminated candidiasis are excluded.

Concurrent Medication:

Excluded:

* Systemic administration of amphotericin B for a proven or suspected systemic fungal infection.

Patients with the following are excluded:

* Documented Candida fungemia.
* Histological or clinical (skin rash, cotton wool exudates, Candida endophthalmitis, etc.) evidence of disseminated candidiasis.
* Systemic administration of amphotericin B for a proven or suspected systemic fungal infection.
* Patient refusal to enter study.

Patient must be an immunosuppressed host, with biopsy-proven Candida esophagitis.

* Patients with polymicrobial esophagitis will be included as long as Candida esophagitis is documented by esophageal biopsy.
* Informed consent must be signed and obtained.
Normative Reference Values of Equilibrium Coordination Test Among Children

A cross-sectional study will be conducted recruiting children of age group 8-15 years. Pilot study has been conducted for the determination of the sample size. The calculated sample size has come out to be, n=378 which can be taken for males and females separately. Stratified random sampling will be done according to age. Child will be asked to perform all tests one by one and the time taken (in seconds) will be noted required to perform the tests. The mean of three readings will be obtained using a mobile-based stop watch.

756 children will be recruited of age group 8-15 years. Five equilibrium coordination tests i.e. Sideways walking, tandem walking, cross-stepping, heel walking and toe walking will be performed by each child and three readings will be recorded. Mean of three readings will be considered as normative reference value of each test respectively.

Eligibility Criteria:
Inclusion Criteria:

* Typically developing school-going children with age group between 8 and 15 years
* Both male and female
* Able to walk independently
* Able to follow verbal commands

Exclusion Criteria:

* Any fracture of lower limb in last 6 months
* Any congenital anomaly affecting lower limb
* Any developmental disorder
* Any open wounds
* Those who are using any kind of assistive devices
* Any condition that affect the health status of the participants during the study
Study Evaluating the Effect of Sirolimus on Non-Melanoma Skin Cancer in Kidney Transplant Recipients

The purpose of this study is to determine the effect of sirolimus on the prevention of new non-melanoma skin cancer (NMSC) in kidney transplant recipients.


Eligibility Criteria:
Inclusion Criteria:

* Kidney transplant at least 1 year prior
* Subjects with a functioning renal allograft with calculated glomerular filtration rate (GFR) ≥40mL/min (Nankivell method) and proteinuria ≤500mg/day.
* Stable on cyclosporine or tacrolimus-based multi-drug immunosuppressive regimen
* History of NMSC within last 3 years

Exclusion Criteria:

* History of other cancer within last 3 years
* NMSC with metastatic disease or more than 20 NMSC lesions in last 12 months
* Multiple organ transplant