cyrilzakka/clinical-trials huggingface dataset:
The Effect of Community Building Through Virtual, Team-Based Exercise on Burnout

This study is a randomized controlled trial that will look at whether virtual, team-based exercise improves burnout, sense of community, and mentorship connections among medical students, residents, fellows, and physicians.

Participants will be randomized to either a control group or an intervention group. The intervention group will be further randomized onto teams that will exercise for 3 months. All exercise (including walking, biking, lifting, yoga, and 40+ exercises) will be tracked via user's smartwatches (ie Apple, Garmin), smartphone fitness apps (ie MapMyRun), or manual upload, converted into Metabolic Equivalent of a Task (MET) minutes, and displayed on online leaderboards. Group activities will be encouraged by awarding raffle tickets for prizes to those who submit pictures with their teammates. Primary outcomes will be burnout, sense of community, and mentorship connections, with the hypothesis that getting everyone together for this team-based exercise will improve these metrics. After 3 months, both the control and intervention group will be enrolled in 3 months of the intervention to assess secondary outcomes: long-term burnout, sense of community, and mentorship connections, as well as adherence.

Eligibility Criteria:
Inclusion Criteria:

* Harvard Medical Students (HMS)
* Massachusetts General Hospital (MGH) Residents, Fellows, or Attendings

Exclusion Criteria:

* Non HMS Students or MGH Residents, Fellows, or Attendings
The Vision System for Mandibular Trajectory Assessment in Women With Mild Temporomandibular Joint Disorder

Recording mandibular movements plays an important role in stomatognathic system diagnosis and has been the subject of numerous research projects. This study presents theoretical assumptions and a practical solution in the form of a novel method of mandibular motion assessment.

In the presented method, mandibular movements are recorded by a mono vision system where a digital camera is fixed on a special extension arm attached to patient's head. During movement the camera records changing positions of two markers placed on two selected two points on a patient's face. With such data, it possible to assess the absolute range of mandibular abduction as well as displacements from optimal trajectory occurring during movement, which indicative of stomatognathic dysfunctions.

Eligibility Criteria:
Inclusion Criteria:

* temporomandibular joint disorder
* qualitative and quantitative impairments of mandibular movements

Exclusion Criteria:

* no impairments of mandibular movements
Trial Assessing the Effect of Preoperative Furosemide on Intraoperative Blood Pressure

The purpose of this study is to determine whether continuing or discontinuing furosemide (a diuretic) on the day of elective noncardiac surgery for those who take furosemide on a chronic basis, causes more intraoperative hypotension (low blood pressure) during surgery. Our hypothesis is that the usual practice of continuing furosemide on the day of surgery would contribute to more hypotension during surgery than discontinuing furosemide.

A significant proportion of patients who undergo surgery take medications on a chronic basis. Little is known about the effects of these medications on the successful conduct of anesthesia and surgery. Diuretics like furosemide may contribute to low blood pressure during surgery, an outcome associated with cardiovascular complications. However, many patients are recommended to take their diuretics on the day of surgery. We wished to determine if preoperative administration of furosemide contributes to intraoperative hypotension compared to placebo.

Comparison: We conducted a randomized, double blind placebo controlled trial to compare the effect of furosemide with that of placebo on intraoperative hypotension using intraoperative blood pressure recordings in patients who take furosemide chronically and were undergoing noncardiac surgery.

Eligibility Criteria:
Inclusion Criteria:

* All adults referred to preoperative assessment clinics by surgeons for elective non-cardiac surgery who routinely take furosemide.
* Participants must also be able to give informed consent

Exclusion Criteria:

* Less than 18 years of age
* Have comorbid conditions with which brief periods of hypotension may be particularly harmful such as: 1) pregnancy; 2) baseline hypotension (systolic \<100 mmHg at the preoperative assessment clinic); 3) autonomic dysfunction; 4) severe aortic stenosis.
* Patients who take furosemide only on an 'as needed basis' rather than 'regularly'.
* Those patients who take less than 10 mg of furosemide daily
* Those patients who are undergoing local anesthetic only surgical procedures
* Patients who are unwilling or unable to give informed consent.
Cesarean Wound Closure in Women With BMI 40 or Greater

The purpose of this randomized controlled prospective trial is to guide physicians on the most effective evidenced based skin closure during a cesarean section for the obese gravida, defined as a BMI of 40 or greater. The study will compare two closure methods: subcuticular sutures and surgical staples.

The study will screen and attempt to enroll pregnant women admitted to labor and delivery who have a BMI of 40 or greater. The participants will be randomized to receiving skin closure with subcuticular sutures or surgical staples if they undergo cesarean section. Either technique is currently standard of care. Participants who end up undergoing cesarean section will be included in the final data analysis. The participants will be followed for wound complication in the first 6 weeks post operatively. Wound complication will be defined as wound disruption or infection within 6 weeks post operatively.

Design and Project Type This study is a randomized controlled trial. At the study facility, in 2012 and 2013, over 300 cesarean sections were performed each year in women with BMI of 40 or greater. Based on this, the investigators expect the duration of the study to be 2 years. Randomization and data collection will be completed on 420 women.

Description of Intervention Two interventions will be used in this project: subcuticular suture and surgical staples. The subcuticular suture will be the size and type of suture chosen by the surgeon at the time of cesarean. The surgical staples will be the standard staples used on the labor and delivery unit.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant woman
* Time to approach and consent the patient prior to undergoing cesarean delivery
* Able to give informed consent, include age 18 or greater and ability to read and understand English
* BMI of 40 or greater on most recent hospital documentation
* Willingness to participate in the study and ability to read, understand and sign the informed consent document

Exclusion Criteria:

* Inability to give informed consent, including inability to read and understand English and age under 18 years
* Evidence of current skin infection or breakdown at or near the site of surgical incision
* Any immune compromised status, including AIDS
* Negative pressure wound therapy applied at time of surgery
Development of New Prenatal Diagnostic Tests From Maternal Blood

After extraction of the cell-free DNA circulating in maternal plasma, we aim at developing new techniques for fetal DNA enrichment to perform fetal gender determination, and indirect diagnosis of inherited diseases like Cystic Fibrosis, Huntington Disease, Myotonic Dystrophy, B-Thalassaemia...


Eligibility Criteria:
Inclusion Criteria:

* Mother and father-to-be both older than 18 years old
* Mother and father-to-be affiliated to social security
* Mother and father-to-be have good understanding of the protocol
* Pregnancy of the mother-to-be attested

Exclusion Criteria:

* Mother and father-to-be are younger than 18 years old
* Mother and/or father-to be refusing to participate
A Prospective, Multicenter, Observational Cohort Study to Evaluate the Efficacy and Safety of a Novel Anti-tumor Drug As a Radiosensitizer in Patients with Advanced Breast Cancer Brain Metastasis.

A prospective, multicenter, observational cohort study to evaluate the efficacy and safety of a novel anti-tumor drug as a radiosensitizer in patients with advanced breast cancer brain metastasis.


Eligibility Criteria:
Inclusion Criteria:

1. Males or females who are at least 18 years of age on the day of signing the informed consent form.
2. Patients with advanced breast cancer that is inoperable and has metastasized to the brain, confirmed by histology or cytology.
3. Patients who are planned to receive, currently receiving, or have completed intracranial radiotherapy after discussion by a multidisciplinary team (MDT) at the stage of brain metastasis.
4. Patients who are planned or currently receiving a systemic treatment regimen with a novel anti-tumor drug selected by the physician, within 3 weeks before radiotherapy, during radiotherapy, or within 3 weeks after completion of radiotherapy. These drugs include:

   ADC drugs (such as T-DXd, T-DM1, etc.), CDK4/6 inhibitors, TKI drugs (such as Pyrotinib, Tucatinib, etc.), Novel chemotherapy drugs (such as Utidelone, Irinotecan liposomes, etc.), Bevacizumab, PD-1/PD-L1 inhibitors, etc.
5. Patients with a traceable medical history during the treatment period.
6. Patients who are able to sign the informed consent form to participate in the study.

Exclusion Criteria:

1. The subject has leptomeningeal metastasis.
2. If the patient has concurrent brain metastasis, the neurological symptoms are too severe to cooperate with radiotherapy.
3. The subject has not signed the informed consent form.
4. Pregnant or breastfeeding women.
5. Other situations deemed by the investigator as unsuitable for inclusion in the study.
US Clinical Study of the Apnex Medical Hypoglossal Nerve Stimulation (HGNS) System to Treat Obstructive Sleep Apnea

The overall goal of the study is to evaluate the safety, efficacy and therapy settings of the Hypoglossal Nerve Stimulation (HGNS) System for stimulating the hypoglossal nerve to help maintain airway opening in subjects with Obstructive Sleep Apnea (OSA).


Eligibility Criteria:
Eligibility Criteria

1. Previously diagnosed with moderate-to-severe obstructive sleep apnea.
2. Subject has failed or does not tolerate CPAP treatment.
3. Age between 21 and 70 years.
4. Body mass index (BMI) less than or equal to 37.
Improving Smoking Cessation Quitlines: Pilot Study of Acceptance Therapy

The purpose of this study is to demonstrate that Acceptance Therapy (ACT's) implementation outcomes are at least as good as those of traditional cognitive behavioral therapy (CBT).

Implementation outcomes:

* end of treatment and 6-month follow-up data retention rates;
* intervention implementation quality;
* number \& length of calls completed.

Comparison of each arm's implementation


Eligibility Criteria:
Inclusion Criteria:

1. aged 18 and older;
2. smokes at least 10 cigarettes daily and has done so for at least the past 12 months;
3. wants to quit smoking in the next 30 days;
4. willing to be randomly assigned to either group;
5. willing and able to speak and read in English;
6. willing and medically eligible to use nicotine replacement therapy (NRT),
7. currently resides in the U.S., and expects to continue for at least 12 months;
8. not participating in other smoking cessation interventions;
9. has regular access to a telephone.
10. has regular access to an email address.

Exclusion Criteria:

* The Exclusion criteria are the opposite of the Inclusion criteria listed above. In addition, the following exclusion criteria also apply:

  1. another member of household enrolled in the study;
  2. currently using medication or nicotine replacement products to help with quitting smoking;
  3. currently using any non-cigarette tobacco products;
  4. pregnant or breastfeeding;
  5. had a heart attack in last 30 days;
  6. within the last 6 months, diagnosed with angina, heart pain, or irregular heartbeat;
  7. serious adverse reactions to nicotine patches including anaphylaxis and related symptoms such as hives, respiratory difficulty, and/or angioedema.
An Investigator-initiated Clinical Study of LM303 Injection for the Treatment of Advanced Solid Tumours

This is a single-arm, open-label, exploratory study to evaluate safety and efficacy of LM303 Injection in patients with advanced solid tumors. The purpose of this study is to evaluate the safety and tolerability, antitumor activity and immunoreactivity.


Eligibility Criteria:
Inclusion Criteria:

1. AJCC (V8) stage III or IV melanoma, non-small cell lung cancer, cervical cancer and other solid tumors (confirmed by histology) for which existing treatment is ineffective or without standard treatment;
2. The patient has residual lesions that can be used for surgical resection (\>1.5cm3) or biopsy (\>1.5cm3) and measurable after resection for TIL collection and efficacy evaluation;
3. Laboratory inspection index requirements:

   * Blood routine: lymphocyte ratio \> 20%; neutrophil count \> 1.0 × 10\^9/L; white blood cells \> 3.0 × 10\^9/L; platelets \> 100 × 10\^9/L; hemoglobin \> 80 g/ L;
   * Liver function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ upper limit of normal x 2.5, if there is liver metastasis ≤ upper limit of normal x 5; alkaline phosphatase (ALP) ≤ upper limit of normal x 2.5; total gallbladder Red pigment (TBIL)≤normal upper limit×1.5;
   * Renal function: urea ≤ upper limit of normal × 1.5; creatinine (Cr) ≤ upper limit of normal × 1.5;
4. Left ventricular ejection fraction (LVEF) ≥ 50%;
5. ECOG physical condition is 0 or 1;
6. The expected survival time is more than 3 months;

Exclusion Criteria:

1. Suffering from active or previous autoimmune diseases ;
2. Severe liver and kidney dysfunction, severe heart disease, coagulation dysfunction, and hematopoietic dysfunction;
3. Combined with severe infection or persistent infection and cannot be effectively controlled;
4. Central nervous system metastasis and/or cancerous meningitis;
5. With uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage;
6. Requires systemic steroid therapy;
7. Positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HbcAb); positive for hepatitis C virus (HCV) antibody; positive for human immunodeficiency virus (HIV) antibody; positive for syphilis;
REvascularization CHoices Among Under-Represented Groups Evaluation: The RECHARGE Trial - Minorities

This is a research study in minorities to compare the outcomes of two procedures that restore blood flow to the arteries of the heart. In one procedure the blockages are ballooned and then stented with a small wire mesh tube through a small incision in the wrist or the groin. The other procedure is an open-heart operation in which healthy blood vessels from inside the chest, leg, and/or forearm are used to "bypass" the blockages (like a detour). Outcomes will be measured by comparing survival and improvement in quality-of-life.

The RECHARGE: Minorities Trial is a multicenter, 1:1 randomized, open-label superiority trial.

Patients meeting the eligibility criteria for whom there is equipoise for revascularization with CABG and PCI, as determined by the local Heart Team, will be included. Participants will be followed for 5-10 years. Telephone follow-up will be conducted by the a central follow-up coordinating center at 30 days, 3 months, 6 months, and thereafter every 6 months through 36 months post-randomization. After 36 months, follow-up will be performed every year (48, 60, 72, 84, 96, 108, 120 months). A repeat transthoracic echocardiogram and blood draw for serum creatinine, hemoglobin and lipids should be performed at 1 year, as per standard of care, at either an out-patient facility or in a hospital.

Eligibility Criteria:
Inclusion Criteria:

1. Patient must identify as a minority
2. Patient is at least 18 years old.
3. Multivessel or left main CAD is present for which revascularization is intended and for which there is equipoise between CABG and PCI according to local Heart Team assessment.
4. Ability to provide written informed consent and comply with all follow-up procedures, including QOL questionnaires.

Exclusion Criteria:

1. ST-segment elevation MI within 3 days
2. Cardiogenic shock
3. Prior PCI within 1 year or any prior CABG anytime
4. Planned hybrid revascularization (PCI after CABG or CABG after PCI)
5. Planned single vessel revascularization (other than isolated left main disease)
6. Need for any cardiac surgical or interventional procedure other than coronary revascularization at the present time or anticipated within 3 years
7. Pregnancy (women of child-bearing potential must have a negative pregnancy test within 1 week before randomization) or intent to become pregnant within 1 year after randomization Unable to tolerate, obtain or comply with dual antiplatelet therapy for at least 3 months if presentation with stable CAD or 6 months if presentation with a troponin-positive acute coronary syndrome Current participation in another investigational drug or device study that has not reached its primary endpoint Life-expectancy less than 3 years due to concomitant non-cardiac conditions Any condition(s) are present that are likely to interfere with the study protocol procedures including medication adherence and follow-up through 10 years (e.g. mental disability, substance abuse, anticipated international relocation, etc.)
A Phase I Trial of Gemcitabine and Radiation in Locally Advanced Unresectable Cancer of the Pancreas

Radiotherapy plus Single-Agent Chemotherapy/Radiosensitization. Involved-field irradiation using 4-15 MV photons; plus Gemcitabine, NSC-613327.

This is a Phase I trial of gemcitabine given weekly as a 30 minute infusion administered concurrently with radiation in patients with locally advanced or locally recurrent pancreatic carcinoma. Patients will be treated with external beam radiation therapy in a standard manner. Gemcitabine will be administered as a 30 minute infusion beginning on the first day of irradiation and weekly afterwards for a total of 5 doses. Patients will be assessed clinically for acute toxicity which will be graded per RTOG and DCT toxicity grading system.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

Histologically or cytologically proven unresectable adenocarcinoma of the pancreas or ampulla of Vater. Surgical consult at NCI confirming unresectability fulfills requirement.

Unresectable disease defined as tumor with: Gross involvement of regional nodes or direct extension to any of the following sites: Duodenum, Spleen, Bile duct , Colon, Peripancreatic tissue, Adjacent large vessels, Stomach.

Metastatic disease requiring local radiotherapy allowed. No CNS metastasis.

No lymphomas or neuroendocrine tumors.

No peritoneal carcinomatosis.

PRIOR/CONCURRENT THERAPY:

Biologic Therapy: More than 4 weeks since immunotherapy.

Chemotherapy:

No prior chemotherapy for newly diagnosed disease.

More than 4 weeks since chemotherapy for recurrent disease (6 weeks since nitrosoureas, mitomycin, or suramin).

Endocrine Therapy: More than 4 weeks since hormonal therapy.

Radiotherapy:

No prior radiotherapy for newly diagnosed disease.

No prior abdominal or pelvic radiotherapy.

More than 4 weeks since radiotherapy for recurrent disease. No prior radiotherapy for locally advanced disease after resection allowed.

Surgery:

Prior resection allowed.

Biliary decompression or gastric bypass allowed.

PATIENT CHARACTERISTICS:

Age: 18 and over.

Performance status: ECOG 0-2.

Hematopoietic:

ANC greater than 2,000/mm(3).

Platelets greater than 100,000/mm(3).

Hepatic: AST/ALT no greater than 2.5 times normal.

Renal:

Creatinine less than 1.5 mg/dL.

Creatinine clearance at least 60 mL/min,

Cardiovascular:

No myocardial infarction within 6 months.

No unstable angina.

No congestive heart failure (NYHA class III/IV).

OTHER:

HIV seronegative.

No medical or psychiatric contraindication to protocol therapy.

No concurrent malignancy other than: Skin cancer, Cervical carcinoma in situ.

No pregnant or nursing women.

Adequate contraception required of fertile patients.
Open-label, Randomized, Active-controlled Study of LEV Used as Monotherapy in Patients With Partial-Onset Seizures

To demonstrate the non-inferiority of Levetiracetam (1000 mg/day) versus Carbamazepine Immediate-Release (400 mg/day) used as monotherapy for at least 6 months in a Chinese population with newly or recently diagnosed Epilepsy who are experiencing Partial-Onset Seizures (POS).


Eligibility Criteria:
Inclusion Criteria:

* Subject is of Chinese origin and ≥ 16 years of age
* Subject is newly or recently diagnosed with Epilepsy, having experienced unprovoked Partial-Onset Seizures (POS)
* Subject has experienced at least 2 unprovoked seizures in the year preceding randomization, of which at least 1 unprovoked seizure occurred in the 3 months preceding randomization
* Subject has had an Electroencephalogram (EEG) and a brain Computed Tomography (CT) scan or brain Magnetic Resonance Imaging (MRI) scan consistent with a diagnosis of Epilepsy with POS

Exclusion Criteria:

* Subject tests positive for human leukocyte antigen major histocompatibility complex, class I,B (HLA-B)\* 1502 allele
* Subject has a history or presence of seizures of other types than Partial-Onset Seizures (POS)
* Subject has only experienced type IA nonmotor seizures
* Subject has a history or presence of seizures occurring only in clustered patterns
* Subject has a history of clinical or Electroencephalogram (EEG) findings suggestive of Idiopathic Generalized Epilepsy prior to randomization
* Subject has current or previous diagnosis of pseudoseizures, conversion disorders, or other nonepileptic ictal events that could be confused with seizures
* Subject has a history of Status Epilepticus
A Randomized Study of SPK-10001 Gene Therapy in Participants with Huntington's Disease

The main goal of this study is to evaluate the safety, tolerability, and preliminary efficacy of SPK-10001 in participants with Huntington's Disease.


Eligibility Criteria:
Key Inclusion Criteria:

* Have confirmed huntingtin (HTT) cytosine-adenine-guanine (CAG) repeat length ≥40 on genetic testing and confirmation diagnostic test by the central laboratory (CL) at screening.
* Have striatal atrophy demonstrated by caudate/intracranial volume less than the age-adjusted cutoff values associated with HDISS Stage 1.
* Have UHDRS Total Motor Score (TMS) equal to or greater than the age-adjusted cutoff value associated with HDISS Stage 2.
* Have UHDRS Total Functional Capacity (TFC) greater than or equal to 11.
* Use of cholinesterase inhibitors, memantine, amantadine, or riluzole must have been at stable dosing for at least 12 weeks before screening and baseline and anticipated to remain stable during the first 12 months after SPK-10001 administration.
* Antidepressant or benzodiazepine use must have been at stable dosing for at least 12 weeks before screening and baseline and anticipated to remain stable during the first 12 months after SPK-10001 administration.
* Antipsychotics for motor symptoms or mood stabilization (i.e., irritability or aggressive behavior) and/or tetrabenazine, valbenazine, or deutetrabenazine must have been at a stable dose for at least 12 weeks before screening and baseline and are anticipated to remain stable during the first 12 months after SPK-10001 administration.

Key Exclusion Criteria:

* A safe trajectory is not able to be identified for targeting placement of the cannula into the caudate or putamen on both sides of the brain due to extent of atrophy or other anatomical features.
* Have received an antisense oligonucleotide therapy during the past year.
* History of deep brain stimulation.
* History of or intention to undergo gene therapy, cell transplantation, or brain surgery during the course of the study.
* Have participated in an investigational drug study with a systemic administration within 6 weeks or 5 half-lives of screening, whichever is longer.

Additional protocol-defined inclusion/exclusion criteria apply.