cyrilzakka/clinical-trials huggingface dataset:
Therapists to Administer Contingency Management-Therapist Phase - 1

The purpose of this study is to train therapists to administer contingency management (CM). This project will train up to 42 community-based treatment providers about the rationale for and the specifics of administering CM. Initial training will occur in 2-day workshops, followed by weekly supervision in delivery of CM with test cases. We expect that the majority of therapists will achieve high levels of competence and adherence in administering CM treatment within 3-5 test cases, as measured by ratings of audiotapes. To examine the efficacy of CM, each therapist who achieves adherence and competence in delivering CM will administer standard treatment alone or standard treatment plus CM to substance-abusing outpatients. In the CM condition, patients will have the opportunity to win prizes for submission of negative samples, and the treatment will be in effect for 12 weeks. In total, up to 200 patients will be randomly assigned to one of the two conditions. A research evaluator will conduct follow-up assessments, scheduled for 3, 6 and 9 months after treatment initiation.


Eligibility Criteria:
Inclusion Criteria:

Therapists who volunteer must have:

* at least one-year experience treating substance abusers, and at least 6 months employment at that center
* must commit to being available for both the workshop and individual training
* must be willing to allow random assignment of their patients to CM and non-CM treatments
The Effects of Anesthesia Type on the Prognosis of Hip Fracture Surgery on Elderly Patients

The aim of this study is to figure out whether anesthesia type have an influence on the prognosis of hip fracture surgery.30-day mortality and morbidity after the surgery are our main observational index,and according to literature and our experience,regional anesthesia may have a better prognosis after hip fracture surgery compared with general anesthesia.

Hip fracture is a common disease among elderly people,and has a high mortality and morbidity.But,seldom practice can be done to improve this condition.For a long time,whether anesthesia type could influence the prognosis after surgery is controversial.Several studies have confirmed regional anesthesia may be better for patients for its fewer complications.But most studies are retrospective,and information may be less convincing .Besides,as a matter of fact,patients of different anesthesia type may have different status,so,a scoring system may be need for comparing the status of patients of different groups.

Our study is a prospective observational trial.Patients needing hip fracture surgery are divided into two groups according to the anesthesia type during surgery:Regional Anesthesia group(RA),General Anesthesia group(GA).To evaluate the status of patients before surgery,we use Orthopedic POSSUM scoring system.It consists of 12 physiological factors and 6 operative severity factors.Then,we will observe outcome of the two groups and record every complication after surgery.Finally,the initial and adjusted morbidity and mortality according to Orthopedic POSSUM scoring system of the two groups are compared.

Eligibility Criteria:
Inclusion Criteria:

* Patients with hip fracture;
* Need surgery;
* Anesthesia type is regional anesthesia or general anesthesia;
* Age≥60 years.

Exclusion Criteria:

* Choosing conservative treatment;
* Other types of anesthesia or without anesthesia.
Stereotactic Body Radiation Therapy Versus Radiofrequency Ablation for Small Renal Masses

The execution of this study is pertinent to evaluating SBRT's short- and long-term efficacy and safety in the treatment of SRMs. This study will be the first to compare RFA and SBRT in the treatment of SRMs.


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥18 years of age and capable of providing informed consent
* Patients scheduled for treatment of their SRM using SBRT or RFA
* Patients who received a biopsy of their SRM prior to their scheduled SBRT or RFA treatment
* Patients who are willing to have a biopsy 12 months post-procedure
* Patients with renal tumor(s) ≤ 4.0 cm

Exclusion Criteria:

* Patients with large renal tumor(s)\>4.0 cm
* Patients who are unable to have a general anesthetic
* Patients who did not receive a biopsy of their SRM prior to their scheduled SBRT or RFA treatment
* Patients who are unable to comply with post-operative and/or follow-up protocol/phase of study
* Evidence of metastatic disease
* Uncorrectable bleeding diathesis
Pharmacokinetics and Safety of Rifabutin 150 mg Once Daily Versus Rifabutin 300 mg Thrice Weekly

To describe the pharmacokinetics of rifabutin 150 mg once daily versus rifabutin 300 mg thrice weekly in combination with LPV/r 400/100mg based HAART in HIV/TB infected patients

The overall aim of the project is to evaluate rifabutin as a replacement for rifampicin, for the combined treatment of tuberculosis and HIV infection. Rifabutin represents an alternative to rifampicin for HIV infected patients as its half-life is longer and the enzymatic induction effect appears to be less important on the associated ART drugs. This phase II trial is to determine precisely the pharmacokinetics parameters of rifabutin in combination with LPV/r regimens in Thai HIV/TB infected patients, in order to define optimal doses that will be further tested in a larger phase III trial comparing safety, tolerability and efficacy of rifabutin and rifampicin regimens.

Eligibility Criteria:
Inclusion Criteria:

1. Confirmed HIV positive after voluntary counseling and testing
2. Aged \>18-60years of age
3. PI-naïve (NNRTI intolerance/failure) or PI experience ( TB developed during on salvage regimen) without prior PI mutation
4. Any CD4 cell count
5. ALT \<5 times ULN
6. Serum creatinine \<1.4 mg/dl
7. Hemaglobin \>7 mg/L
8. TB is diagnosed and planned to receive stable doses of rifabutin containing anti-TB therapy for at least another 4 week period after initiation of ART
9. No other active OI (CDC class C event), except oral candidiasis or disseminated MAC
10. Body weight \>40kg
11. Able to provide written informed consent

Exclusion Criteria:

1. Current use of steroid (except short course steroid for IRIS) and other immunosuppressive agents.
2. Current use of any prohibited medications related to drug pharmacokinetics.
3. Patients with current alcohol or illicit substance use that in the opinion of the site Principal Investigator would conflict with any aspect of the conduct of the trial.
4. Unlikely to be able to remain in follow-up for the protocol defined period.
5. Patients with proven or suspected acute hepatitis. Patients with chronic viral hepatitis are eligible provided ALT, AST \< 5 x ULN.
6. Karnofsky performance score \<30%
7. TB meningitis and bone/joints ( due to longer period of anti TB drug)
8. Pregnancy
9. Patient choose to use efavirenz, not LPV/r. However, in ART naïve, EFV is allowed after intensive PK of LPV/r and rifabutin at week 2-4.
Vascular Function and Uterine Fibroids

The purpose of this study is to learn how uterine fibroids may be connected to heart disease and high blood pressure. It is not known what causes fibroids, but they frequently occur in women who also have high blood pressure, heart disease, and stroke. The investigators of this study want to learn if certain changes in the blood vessels or nerve activity can put women at risk for these diseases and for fibroids.

The investigators are inviting women, 25-50 years old, who have not gone through menopause to participate in this study. The investigators are looking for some women with uterine fibroids and some without uterine fibroids based on ultrasound or MRI. If the patients have not had a recent ultrasound or MRI of the uterus, a physician can provide one.

Individuals cannot participate if they have high blood pressure, diabetes, or disease in the kidneys, lungs, or blood vessels. Also, individuals who smoke, have high cholesterol, or are obese (BMI is higher than 30) cannot participate. Certain medications, including high blood pressure medications, beta-blockers and anti-depressants, will also limit potential patient participation. The investigators would be happy to review medications for potential participants.

Screen Day:

One of the members of the research team will review the study and the informed consent document with the patient. The patient will have their height, weight, blood pressure, pulse and respirations measured. The patient will also complete three questionnaires. If the patient has not had an ultrasound of the uterus in the last 12 months, a physician will complete one for her.

Study Day:

The patient will need to fast overnight (no eating or drinking). The investigators will draw a blood sample and then do a series of tests on the participant's blood vessels. For some of the tests, medication will be given through an IV. The investigators will also test nerve activity in the nerve on the outer aspect of the leg.

Eligibility Criteria:
Inclusion Criteria:

* Women 25-50 years old
* Premenopausal

Exclusion Criteria:

* Postmenopausal
* Pregnant or currently breastfeeding
* Using blood pressure medications or anti-depression medications
* High blood pressure
* Diabetes
* Disease in the kidneys, lungs, or blood vessels
* Chronic diseases (for example: Crohn's disease, rheumatoid arthritis, bipolar mood disorder, etc.)
* Smoker
* High cholesterol
* BMI higher than 30
Use of Virtual Reality Technology as a Sedation Replacement During Colonoscopy

A pilot non-randomized controlled study examined whether the use of VR technology can serve as an appropriate substitute for sedation in a colonoscopy examination.

VR is an attention-distracting technology via visual and auditory signals by a computer-generated virtual engulfing environment. This technology has already been used in a variety of medical conditions and previous studies have demonstrated the benefit of using it as an additional tool for pain relief and as a substitute to sedation in invasive procedure. In this study we examined the use of VR as a substitute for sedation in colonoscopy. In this randomized control study, 60 patients were sequentially enrolled in a 1:1 ratio to either standard sedated colonoscopy or VR-unsedated procedure. The primary outcome was the overall satisfaction of patients who underwent unsedated colonoscopy with VR headset compared with patients who underwent standard sedation colonoscopy. Pain during the procedure, PDR, colonoscopy duration, post colonoscopy adverse events, post colonoscopy recovery and time-to-return to daily functions and turnaround time at the endoscopy unit were secondary outcomes.

Eligibility Criteria:
Inclusion Criteria:

* adult patients (≥18) with any elective indication for colonoscopy.

Exclusion Criteria:

* known seizures' disorders, cognitive, visual or auditory impairment.
* patients who were unable or unwilling to sign an informed consent.
* Pregnant women.
Neurocognitive Features of Patients With Treatment-Resistant Depression

There is an urgent need for novel and effective interventions for treatment-resistant depression (TRD). In previous studies, ketamine has been shown to rapidly reduce depressive symptoms; however, the exact mechanisms of action of ketamine remain unknown. There are some preliminary findings to suggest that ketamine may exert its antidepressant effects through promotion of neurogenesis in the dentate gyrus. The aim of this study is to help delineate the neurocognitive effects of ketamine exposure using a behavioral task (specifically, a pattern separation task) and a battery of other well-established cognitive measures.

This is an assessment-only study, as we will be recruiting subjects to complete an assessment battery at two time points, before and after receiving ongoing ketamine administrations for at least four weeks.


Eligibility Criteria:
Inclusion Criteria:

1. be 18-80 years old
2. be able to read, understand, and provide written informed consent in English,
3. meet criteria for a current moderate/severe (\> 14 on QIDS-SR) depressive episode (unipolar or bipolar mood disorder),
4. have a history of \> 3 failed antidepressant trials, and be
5. be seeking ketamine ongoing treatment through the ketamine clinic at Massachusetts General Hospital and be deemed appropriate for the clinic.

Exclusion Criteria:

1. Subjects who will not provide consent to neuropsychological testing
2. Subjects who are not deemed appropriate for the ketamine clinic will not be enrolled
A Study of Concurrent Stereotactic Body Radiotherapy With Opdualag in Metastatic Uveal Melanoma

This is a phase 2 trial of concurrent stereotactic radiation therapy (SBRT) with immunotherapy with relatlimab and nivolumab for up to two years. SBRT will be given in three doses of 15Gy each to 1-5 separate metastases. Opdualag (nivolumab 480mg and relatlimab 160mg) will be given every 4 weeks for two years

Metastatic uveal melanoma has no standard therapy, but there is evidence that both radiation therapy and immunotherapy may be helpful and may be synergistic. This is a phase 2 trial of concurrent stereotactic radiation therapy (SBRT) with immunotherapy with Opdualag (nivolumab 480mg and relatlimab 160mg) for up to two years. SBRT will be given in three doses of 15Gy each to 1-5 separate metastases, limiting the total dosage to 700cc's of normal liver to \<15Gy. Opdualag (nivolumab 480mg and relatlimab 160mg) will be given every 4 weeks for two years. Objectives are to determine the safety and tolerability, and iRECIST will be used to determine responses.We will treat up to 50 patients.

Eligibility Criteria:
Inclusion Criteria:

* measurable metastatic uveal melanoma.
* No concomitant therapy.
* Prior PD1 or tebendafesp allowed.
* Performance status 0-1.
* No active Hepatitis B.
* No known HIV infection.
* WBC\>2000, ANC\>1500, Hgb \>8.
* Creatinine \< 3 x ULN.
* AST \& ALT \< 2.5 x ULN Bilirubin \< 2 x ULN.
* Albumin \>2.9

Exclusion Criteria:

* Liver tumor volume \> 50%.
* Active CNS metastases.
* Pregnancy.
* Prior therapy with Opdualag or relatlimab
* Certain autoimmune diseases.
* Previous liver embolization or radiation.
* Use of systemic steroids
Study of the Inflammation and Airway Changes That Occur After Exposure to Allergen in Asthmatics

This protocol describes a single site mechanistic study to investigate microRNAs (miRNAs) that are differentially expressed in the airway epithelium of patients with asthma at baseline and in response to allergen challenge. We hypothesize that allergen exposure enhances airway smooth muscle contractility and epithelial cell mRNA/miRNA production as a consequence of locally increased T-cell derived cytokine production. The study will involve three visits over the course of approximately 14 days. At Visit 1, participants will be characterized in detail with lung function testing, methacholine challenge testing, and allergen skin prick testing. At Visit 2, participants will undergo bronchoscopy with segmental allergen administration of either cat or dust mite standardized allergen extract. At Visit 3 (either 24 hours later or 7 days later), bronchoscopy will be performed to collect airway samples including bronchoalveolar lavage (BAL), epithelial brushings and endobronchial biopsies. Sample analysis will include measurement of miRNA and mRNA expression in epithelial brushings (RNAseq and qPCR); analysis of cell surface markers on BAL cells and blood cells; and collection of endobronchial biopsies for immunostaining of immune cells localization, immunoblotting of smooth cell protein phosphorylation, analysis of mucin content and smooth muscle cell subculture. A total of 38 subjects (26 asthmatics with stable or well-controlled asthma, 6 allergic non-asthmatics and 6 non-allergic non-asthmatics) will complete the study.


Eligibility Criteria:
Allergic/Non-Asthmatic subjects and Allergic/Asthmatic subjects

Inclusion Criteria:

* Positive skin test to dust mite or cat allergen

Non-Allergic/Non-Asthmatic subjects

Inclusion Criteria:

* Negative skin test to panel of 12 allergens, including dust mite and cat allergen

All groups

Exclusion Criteria:

* History of intubation for asthma exacerbation
* Use of Xolair (omalizumab) within the last 6 months
* Immunotherapy with cat or dust mite extract now or in the past 5 years
* ≥ 10 pack-years smoking or any smoking in the past year
* Other lung diseases, such as sarcoidosis, bronchiectasis or active lung infection
* History of dermatographia
* History of anaphylaxis to cat allergen
* Participation in another research study involving a drug or biologic during the past 30 days
* Presence of past or current medical problems/other factors that may pose additional risks from participation or influence study results, as determined per study investigator
Molecular Associations With Reproductive Failure

The overall hypothesis to be tested is: women with the molecular phenotype of highly skewed X chromosome inactivation are at increased risk of spontaneous abortion.

The overall hypothesis to be tested is: women with the molecular phenotype of highly skewed X chromosome inactivation are at increased risk of spontaneous abortion.

We will investigate this hypothesis through two complimentary aims. In the Background and Significance section, we first present data on a 53-member pedigree segregating an X-linked recessive lethal defect that results in skewed X inactivation in the carrier females via secondary selection against those cells with the defective X chromosome active. We have characterized this deletion to be a 500 kb (approximate) deletion in distal Xq28. Moreover, the carrier females show a statistically significant increase in the frequency of spontaneous abortion as compared to non-deletion carrying relatives. Secondly, in the Preliminary Studies section, we present data from a population based case-control study wherein highly skewed X chromosome inactivation is significantly correlated with idiopathic recurrent spontaneous abortion. This protocol attempts to elucidate the mechanism underlying this association.

The first specific aim is to determine if women with highly skewed X chromosome inactivation are at risk of pregnancy loss. This will be accomplished through a prospective protocol, analyzing X chromosome inactivation patterns in pregnant women and investigating a possible association between X chromosome inactivation and pregnancy outcome. The second aim will study the nature of pregnancy loss in women with skewed X chromosome inactivation. This aim will correlate maternal X inactivation patterns with abortus karyotype.

Eligibility Criteria:
Inclusion Criteria:

* Patients are prospectively ascertained women with either a new pregnancy (specific aim 1), or a spontaneous abortion (specific aim 2).
* Given our enrollment strategy, we anticipate enrolling women between the ages of 18 and 45.

Exclusion Criteria:

* The study is limited only to females.
* Children are not eligible to participate in this study. Because the patient populations studied are (aim 1) women with primary infertility undergoing fertility treatment and (aim 2) women who have recently had a spontaneous abortion, the research topic is irrelevant to children.
The Impact of VCT and Condom Distribution as HIV Prevention Strategies Among Youth in Kenya

The vast majority of new HIV infections occur in sub-Saharan Africa, where nearly 2 million people become infected with HIV/AIDS every year. Forty-five percent of these new HIV infections occur among people under 25 years old, and nearly all of them are due to unprotected sex. Ensuring the adoption of safer sexual behavior among youth is critical to keeping the new generations free of HIV.

This research study aims to examine, through a large randomized controlled trial, the impact of two HIV prevention strategies among a youth population in Kenya: Voluntary Counseling and Testing for HIV (VCT), and condom distribution.


Eligibility Criteria:
Inclusion Criteria:

Youth previously participated in an earlier study by Duflo, Dupas and Kremer in 328 primary schools in the same study site in Western Province, Kenya who consent to participate.

Exclusion Criteria:

Youth sampled for the study who do not consent to participate.
Evaluation of Hydrogen Peroxide and Hyaluronic Acid (BMG0703) in the Healing of Post-extraction Sites

A clinical study to evaluate the efficacy and safety of a mouthwash containing Hydrogen Peroxide, Sodium Hyaluronate and Glycine in the healing of post-extraction sites of wisdom teeth by film forming action.

57 subjects, with an indication for a third molar extraction, will be enrolled in the study. Participants selection will take place at the IRCCS "Ca" Granda Ospedale Maggiore Policlinico of Milan - UOC Surgery Maxillo Facial and Dentistry where the internship activity of the Degree Course in Dentistry and Dental Prosthetics, Dental Hygiene and the School of Specialization in Orthodontics of the University of Milan is held.

Subsequently, subjects will be equally divided and randomly assigned into the test or control groups. Assessment of outcomes will be carried out at a distance of 7 days.

Eligibility Criteria:
Inclusion Criteria:

* Acceptance of informed consent
* Need to carry out extraction of a third molar in total or partial impaction

Exclusion Criteria:

* subjects suffering from HIV
* subjects suffering from hepatitis
* serious systemic diseases preventing the use of specific dental therapies
* acute and/or chronic infectious diseases
* inability to provide consent
Taste Properties of Atazanavir and Cobicistat

The primary objective is to assess the taste properties of atazanavir (ATV) and cobicistat (COBI) alone and in combination as well as oral test formulations containing both ATV and COBI.


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Men and women, ages ≥18 years
* Subjects who are qualified professional sensory panelists
* Healthy subjects as determined by no clinically significant deviation from normal in medical history and physical assessment

Exclusion Criteria:

* Any acute or chronic condition that may alter taste or smell sensory perception
* Any significant acute or chronic medical illness or any surgery within 4 weeks of the study drug administration
* Positive HIV test using an oral swab kit (such as OraQuick®) to detect HIV-1 or -2 antibody
The Effects of the Combined Therapy of Acupuncture and Yoga Exercise on Weight Loss

The aim of this study is to examine the effects of combination of acupuncture and ayuveda yoga exercise on weight loss for the overweight.

Obesity is a common health problem in developed countries. At present,the medical staff have already been alerted that the obesity is a kind of disease actually and one of the epidemic diseases which erode the human health in the world. It is not only about the person's health but also a main public health problem. It has been caught to our attention that some diseases, such as cardiovascular diseases,diabetes, and high blood pressure are coming along with overweight and obesity. Recent studies had demonstrated a positive correlation between chronic diseases and obesity. There are many treatments for the obesity, in general, acupuncture may be an effective one. Acupuncture may suppress the people's appetite, slow down the stomach's creeping motion, and increase the stomach's evacuation time. Simultaneously, acupuncture controls the body through the absorption and storage of the calorie via the adjustment of the endocrine system. But we still need a more efficiency way to accelerate the body fat metabolism and decrease the storage of the fat in vivo. Therefore, the purpose of this study is to examine the effects of combination of acupuncture and ayuveda yoga exercise on weight loss among the overweight.

Eligibility Criteria:
Inclusion Criteria:

* BMI \> 24

Exclusion Criteria:

* Diagnosis of cancer.