cyrilzakka/clinical-trials huggingface dataset:
Does Cold Provocation Increase Brown Adipose Tissue Volume?

About 28 healthy subjects are randomized to 1 hour/day of coldprovocation or to the best of ability to avoid feeling cold, for 6 weeks. Basal metabolic rate and magnetic resonance (for determination of brown adipose tissue volume) imaging are performed before and after the study.


Eligibility Criteria:
Inclusion Criteria: healthy subjects -

Exclusion Criteria: any significant disease, ot other conditions that interferes with magnetic resonance imaging

-
Cryobiopsy Vs. Forceps Biopsy for Peripheral Pulmonary Lesions

This multicenter clinical trial evaluates the diagnostic yields of cryobiopsy and forceps biopsy for peripheral lung nodules. In the cryobiopsy group, cryobiopsy is the primary method, supplemented by forceps biopsy. Conversely, in the forceps biopsy group, forceps biopsy is the primary method, supplemented by cryobiopsy. The study also explores the complementary relationship between the two methods and examines differences in diagnostic rates based on the order in which the procedures are performed.

This is a multi center, clinical trial evaluating the diagnostic yields of cryobiopsy and forceps biopsy methods used for the biopsy of peripheral lung nodules. In the cryobiopsy group, cryobiopsy is the primary method, with forceps biopsy used as an auxiliary technique, while in the forceps biopsy group, forceps biopsy is the primary method, with cryobiopsy as the auxiliary technique. The study also investigates the complementary relationship between these biopsy methods and evaluates differences in diagnostic rates based on the sequence of the procedures.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Obtained written informed consent
* Subjects having \<30mm nodule on computed tomography
* Subjects without contraindication to brochoscopy

Exclusion Criteria:

* Patients with central lesions that can be visually confirmed by bronchoscopy or those with suspicious findings of cancer metastasis in the mediastinal lymph nodes, who do not require radial bronchial endoscopic ultrasound (RP-EBUS).
* Patients who cannot discontinue medications that increase bleeding risk, such as antiplatelet agents or anticoagulants.
* Patients with bleeding disorders (e.g., platelet count \< 100,000/mm³).
* Patients with severe comorbidities (e.g., serious respiratory or cardiovascular diseases) that make bronchoscopy unsafe.
* Patients with hypersensitivity or allergies to drugs commonly used in endoscopic procedures, including lidocaine, midazolam, fentanyl, or flumazenil.
* Pregnant or breastfeeding patients.
* Patients with confirmed lung cancer undergoing rebiopsy for genetic testing or other purposes.
A Study To Determine If Coadministration Of Tamoxifen Alters The Extent Or Rate Of Palbociclib (PD-0332991) Absorption Or Elimination In Healthy Male Volunteers

A single 125 mg oral dose of the investigational compound PD-0332991 will be administered alone and after steady-state dosing of tamoxifen to determine if coadministration of tamoxifen alters the plasma pharmacokinetics of PD-0332991 in healthy male volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male between the ages of 18 and 55 years of age inclusive
* Body mass index (BMI) between 17.5 and 30.5 kg/m2
* Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures

Exclusion Criteria:

* a positive urine drug screen
* a supine systolic blood pressure \>140 mm Hg, or diastolic blood pressure \>90 mm H.
* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
AK104 for Recurrent or Metastatic Vulvar Cancer

This is a multicenter, open-label, phase II clinical study, aiming to the evaluate the efficacy and safety of AK104 (an anti- PD-1 and CTLA-4 bispecific antibody), alone or combined with chemotherapy, in subjects with recurrent or metastatic vulvar cancer not amenable to curative surgery or radiotherapy.


Eligibility Criteria:
Inclusion Criteria:

Age \>=18 and \<=80. ECOG of 0 or 2. Life expectancy ≥ 3 months. Histologically confirmed vulvar cancer (squamous cell carcinoma or adenosquamous carcinoma), not amenable to curative surgery or radical radiotherapy.

For Cohort A, subjects should have experienced failure on at least one previous systemic therapy, or intolerance to standard therapy.

At least one measurable tumor lesion per RECIST v1.1. Adequate organ function as assessed in the laboratory tests. Female subjects of childbearing potential must have a negative serum pregnancy test prior to the the first administration and agree to use effective methods of contraception

Exclusion Criteria:

Subjects with other histopathological types of vulvar cancer, such as melanoma, sarcoma, etc.

Systemic or curative (surgery or radiotherapy) anti-tumor therapy within 4 weeks prior to the first administration.

Previous treatment with immune checkpoint inhibitors (e.g., anti-PD-1 antibody, anti-PD-L1 antibody, anti-CTLA-4 antibody, etc.).

Active or potentially recurrent autoimmune disease.
The Efficacy and Safety of Thunderbeat in Thyroid Surgery

The aim of this study is to compare the results of total thyroidectomy using the Thunderbeat device to that with the harmonic scalpel.

Thunderbeat instrument combines an advanced bipolar clamp to the existing ultrasonic cutter. In the animal study with pig, the result of Thunderbeat shows fast abalation rate and same thermal conductivity. There has been reported a significant reduction in operative time and same complications with Thunderbeat in gynecology patient who underwent laparoscopic hysterectomy with lymph node dissection. Comparison of the utilization of this new device, however, with the Harmonic scalpel in thyroidectomy has not been performed in any study. The objective of this study is to compare the results of thyroidectomy using the Thunderbeat to that with the Harmonic scalpel device in respect to hemostasis, operative time and perioperative complications. All patients undergoing a thyroidectomy in our endocrine surgery department are randomized into those operated with Thunderbeat (Group A) and those with Harmonic scalpel (Group B).

Eligibility Criteria:
Inclusion Criteria:

* thyroidectomy
* normal vocal cord

Exclusion Criteria:

* additional surgical procedures together with the total thyroidectomy (i.e., parathyroidectomy or cervical lymph node dissection)
* Thyroid cancer patients with lymph node metastasis
* pregnant women
* uncontrolled hypertension, DM, chronic kidney failure, coagulation disorders
* aspirin or anti-platelet agent in 7 days
* Graves' disease or Hashimoto thyroiditis
* history of radiation treatment in head and neck area
Effects of Anticholinergic or Long-Acting Beta 2 Agonist on FeNO and Pulmonary Function in SCI

To determine the acute and chronic effects of a short course of treatment on spinal cord injured (SCI) individuals with either an anticholinergic agent (tiotropium) or with a β₂ agonist (Salmeterol) on:

* Fraction of expired NO (FeNO)
* Selected Biomarkers of inflammation in exhaled breath condensates (EBC)
* Pulmonary function, as measured by pulmonary function tests and body plethysmography


Eligibility Criteria:
Inclusion Criteria:

1. Chronic Spinal Cord Injury (\>1 year post-injury)
2. All American Spinal Injury Association (ASIA) classifications
3. Stable tetraplegia (level of injury C3-C8, non-ventilator dependent)
4. Age 18-65 years

Exclusion Criteria:

1. Smoking, active or history of smoking within last 6 months;
2. Active respiratory disease;
3. Known history of asthma during lifetime or recent (within 3 months) respiratory infections;
4. Use of medications known to affect the respiratory system;
5. Use of medications known to alter airway caliber;
6. Coronary heart and/or artery disease;
7. Hypertension;
8. Adrenal insufficiency;
9. Pregnancy;
10. Severe Milk Protein Allergy;
11. Lack of mental capacity to give informed consent;
12. Previous allergic reaction or hypersensitivity to salmeterol or tiotropium;
13. Individuals taking medication(s) with known /potential drug interactions or suggested therapy modification for concomitant use with salmeterol or tiotropium such as:

(1) selective alpha-/beta- blockers: carvedilol, labetalol; (2) non-selective beta-blockers: Carteolol; Levobunolol; Metipranolol; Nadolol; Penbutolol; Pindolol; Propranolol; Sotalol; Timolol); (3) CYP3A4 Inhibitors: (e.g, Atazanavir; Clarithromycin; Conivaptan; Darunavir; Delavirdine; Fosamprenavir; Imatinib; Indinavir; Isoniazid; Itraconazole; Ketoconazole; Lopinavir; Nefazodone; Nelfinavir; NiCARdipine; Posaconazole; QuiNIDine; Ritonavir; Saquinavir; Telithromycin; Voriconazole; (4) Iobenguane I 123 / Sympathomimetics: Albuterol; Aminophylline; Arformoterol; Armodafinil; Benzphetamine; Caffeine; Dexmethylphenidate; Dextroamphetamine; Diethylpropion; Dipivefrin; DOBUTamine; DOPamine; Doxapram; Dyphylline; EPHEDrine; EPINEPHrine; Fenoterol; Formoterol; Isometheptene; Levalbuterol; Levonordefrin; Lisdexamfetamine; Metaproterenol; Methamphetamine; Methylphenidate; Midodrine; Modafinil; Naphazoline; Norepinephrine; Oxymetazoline; Phendimetrazine; Phentermine; Phenylephrine; Pirbuterol; Propylhexedrine; Pseudoephedrine; Sibutramine; Terbutaline; Theophylline; Xylometazoline.
A Study to Evaluate the Effectiveness and Patient-Reported Outcome of Adalimumab in Patients With Moderate to Severe Plaque Psoriasis in China

The objective of this non-interventional, observational study is to assess the effectiveness and patient reported outcome of adalimumab in patients with moderate to severe psoriasis in real world clinical practice in China.


Eligibility Criteria:
Inclusion Criteria:

* Participant who is in compliance with eligibility for adalimumab based on the local label;
* Moderate to severe plaque psoriasis patients eligible to use adalimumab according to the local label without any contraindication
* Patients have signed the authorization (or informed consent where applicable) to disclose and use personal health information after been prescribed with adalimumab.

Exclusion Criteria:

* Patients who are pregnant or breast feeding at enrolment or wish to become pregnant during the following adalimumab treatment and within 150 days since adalimumab discontinuation;
* Patients in any psoriasis related clinical trial at the time of enrolment, at baseline or at any point during the study follow-up;
* Patients with active tuberculosis or other severe infections (e.g. sepsis and opportunistic infections) as well as moderate to severe cardiac insufficiency.
* Patients with difficulties for adequately reading, understanding and completing patient questionnaires.
Prevention of Linear Growth Failure in Infants and Young Children With Lipid-based Nutrient Supplements (iLiNS-DOSE)

The use of lipid-based nutrients (LNS), such as Nutributter or fortified spread (FS), have been associated with improved growth and development outcomes among infants in Ghana and Malawi. Modified versions of such supplements have been developed to improve their nutrient density and quality and to lower their costs. Such modified products have proven acceptable to infants and their guardians in Malawi and Ghana. In the present trial, the investigator aim to identify the lowest growth-promoting daily dose of modified LNS. Additionally, the investigators will test a hypothesis that LNS that does not contain milk promotes growth as well as milk-containing LNS when given for 12 months at a 10-40 g daily dose to 6-18 month old infants in rural Malawi.

Six-month old healthy infants are identified through community surveys in the study area. 1920 infants meeting set criteria are randomised into receiving the following intervention between 6 and 18 months of age: 1) standard treatment from 6-18 months (i.e.no supplements, with delayed intervention between 18-30 months of age (ST-DI), 2) 10 g / day milk-containing LNS (LNS-10gM), 3) 20 g / day milk-containing LNS (LNS-20gM), 4) 20 g / day milk-free LNS (LNS-20gNoM), 5) 40 g / day milk-containing LNS, (LNS-40gM) 6) 40 g / day milk-free LNS (LNS-40gNoM). The families receive the food supplements at 2-weekly intervals and the participants undergo a morbidity evaluation weekly, a limited development assessment at 4-weekly intervals and anthropometric evaluation at 26-week intervals and laboratory analyses at enrollment and at 18 months. Growth outcome analyses are done at 18 and at 42 months of age.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent from at least one guardian
* Age 5.50 months to 6.49 months
* Availability during the period of the study.
* Permanent resident of Mangochi District Hospital or Namwera Health Centre catchment area

Exclusion Criteria:

* Weight for length Z score (WLZ) \< -2.0
* Presence of oedema
* Severe anaemia (Hb\<50 g / l)
* Severe illness warranting hospital referral
* History of allergy towards peanut
* History of anaphylaxis or serious allergic reaction to any substance, requiring emergency medical care
* Concurrent participation in any other clinical trial
Continuous Versus Intermittent Enteral Feeding in Critically Ill Patients

1. Nutritional support during critical illness is important to improve the clinical outcome of patients. Recently, the apply of early enteral nutrition is recommend in critically ill patients on basis of data that enteral nutrition can be helpful to prevent the hospital-acquired infections.

   * However, in critically ill patients, the smooth progress of nutritional support is often hindered by gastrointestinal intolerance, underlying clinical condition, and temporal necessity of procedure or operation.
   * Continuous feeding method, compared with intermittent feeding, is expected to reduce the risk of gastrointestinal intolerance, and improve the nutritional support, but this hypothesis is not supported by appropriate evidences.
2. We will elucidate to compare the efficacy and safety of the continuous feeding method in critically ill patients, compared with the intermittent feeding method.

   * Prospective, randomized controlled study
   * Primary outcome: the achievement rate of target nutritional goal within 7 days after the start of enteral nutrition
   * Secondary outcome: gastrointestinal tolerance, In-ICU/hospital mortality, frequency of hospital-acquired infection, ICU/hospital length-of-stay, duration of mechanical ventilation


Eligibility Criteria:
Inclusion Criteria:

* adult patient admitted in the intensive care unit
* age 20 years old or more
* The enteral nutritional support is expected to be available within 48 hours after ICU admission

Exclusion Criteria:

* previous abdominal surgery within 1 month
* gastrointestinal bleeding, bowel obstruction, refractory vomiting/diarrhea
* hypersensitivity to prokinetics, history of seizure or phechromocytoma
* enteral feeding via enterostomy or gastrostomy
* difficulty to insert or maintain nasogastric tube
* need for specialized feeding (ex: hemodialysis diet, chronic renal failure diet, diabetes diet)
* pregnancy
GS-5885, GS-9451, Tegobuvir and Ribovirin in Treatment-Experienced Subjects With Chronic Genotype 1a Or 1b Hepatitis C Virus (HCV) Infection

This is a Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of GS-5885, GS-9451, Tegobuvir and Ribavirin (RBV) Compared with GS-5885, GS-9451 with Tegobuvir or RBV in Treatment-Experienced Subjects with Chronic Genotype 1a or 1b Hepatitis C Virus (HCV) Infection.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years with chronic HCV infection
* Liver biopsy results ≤ 3 years prior to screening indicating the absence of cirrhosis. Alternatively, a non-invasive procedure conducted within 6 months of screening is permitted in countries where allowed
* Monoinfection with HCV genotype (GT) 1a or 1b
* HCV RNA ≥ 104 IU/mL at screening
* Prior treatment and adherence with one course of pegylated interferon alfa and RBV
* The subject's medical records must include sufficient detail of prior treatment with pegylated interferon alfa and RBV (start/stop dates and viral response) to allow for categorization of prior response as either null, partial, breakthrough or relapse.
* Body mass index (BMI) 18-40 kg/m2 inclusive
* Screening ECG without clinically significant abnormalities and with QTcF interval (QT corrected using Fridericia's formula)

  ≤ 450 msec for males and ≤ 470 msec for females.
* Agree to use two forms of highly effective contraception for the duration of the study and for 7 months after the last dose of study medication. Females of childbearing potential must have a negative pregnancy test at screening and baseline.

Exclusion Criteria:

* Discontinuation of prior treatment with pegylated interferon alfa and RBV due to an adverse event, toxicity reasons or were lost to follow-up
* History of significant cardiac disease
* Exceed criteria delineated in Section 4.2 for laboratory measure thresholds related to leukopenia, neutropenia, anemia, thrombocytopenia, and thyroid stimulating hormone (TSH).
* Diagnosis of autoimmune disease, decompensated liver disease, poorly controlled diabetes mellitus, significant psychiatric illness, severe chronic obstructive pulmonary disease (COPD), HIV, hepatitis B virus (HBV), hepatocellular carcinoma or other malignancy (with exception of certain resolved skin cancers), hemoglobinopathy, retinal disease, or are immunosuppressed.
* Current abuse of amphetamines, cocaine, opiates, or alcohol. Methadone use is not allowed, however stable buprenorphine maintenance treatment for ≥ 6 months is permitted.
Effectiveness of Self-care Rests on Knowledge, Self-care and Cardiometabolic Control of Adult Men With Diabetes Mellitus

This research project has the main objective to analyze the benefits of self-care supported for adult men with Diabetes Mellitus. Treat yourself will randomized-controlled clinical study, randomized cluster to be developed with men aged between 40 and 70 years who have type 2 diabetes and are registered with the Health Strategy teams of the Municipality of Family Maringa. The recruited subjects will be randomly allocated into two groups: intervention group and control group. In the first, individuals will participate in a self-care intervention supported by a nurse, based on supported self-care and behavior change protocol; and second, individuals participate in conversation circles and will have the assistance normally provided by health services. The follow-up will take place for six months and will be collected information: socioeconomic, demographic, behavioral health, complications, laboratory and anthropometric. It is intended, through this study, demonstrate the effectiveness of this type of intervention, user-centric, on the health of men with DM, reinforcing this option of choice for professionals and users within the Primary Health Care (PHC).


Eligibility Criteria:
Inclusion Criteria:

* Having medical diagnosis of DM2;
* Being male;
* Age between 20 and 59 years;
* Is domiciled in the city of Maringa in the FHS coverage area; Being part of the ESF families register.
* Being able to answer the questions of data collection instruments;
* Relate visual ability , hearing and locomotor to perform self-care;
* Have telephone contact (mobile or fixed) for monitoring the program.

Exclusion Criteria:

* Present lesions in target organs (brain, heart, kidneys, eyes) or comorbidities/complications resulting from diabetes, recorded in medical records, such as chronic renal failure;
* Have psychological or other disorders , registered in the medical records, and that compromise the understanding of the study, who do not agree or do not have availability to participate in the intervention;
* Moving to another location that does not have coverage of the ESF, or even to another city.
Transvaginal Pelvic Ultrasound in the ED

Pelvic ultrasound is frequently performed in the ED in non-pregnant women to assess for ovarian pathology, though its use has not been described in the medical literature. This observational study aims to describe its use in clinical ED practice.

Pelvic ultrasound is frequently performed in the ED in non-pregnant women to assess for ovarian pathology. During the pelvic examination a transvaginal ultrasound probe is used to visualize ovarian size, determine echotexture, assess whether ovarian tenderness is present, and sometimes measure ovarian blood flow. Though pelvic ultrasound is used in the Hennepin County Medical Center ED routinely, there is a paucity of literature assessing it's utility.

This observational study will help determine the usefulness of this imaging modality, and how often it changes management in clinical practice.

Specifically, this study will attempt to determine how often transvaginal ultrasound identifies the structures of interest, and then will correlate these findings with the final ED diagnosis. If a formal ultrasound is obtained, the findings of the ED ultrasound will also be compared to the findings of the formal ultrasound.

The treating physicians will be queried the diagnosis and management plans before and after the pelvic US to ascertain changes in management.

Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18 years old female
* ED bedside transvaginal ultrasound to be performed in a non-pregnant woman with at least one ovary
* Willing to discuss how they are doing at 7-10 days via phone
* Valid phone number

Exclusion Criteria:

* If a diagnosis of ovarian torsion, mass, TOA or other ovarian pathology is known before ED ultrasound
* Previously enrolled in this study