cyrilzakka/clinical-trials huggingface dataset:
The Effect of Spontaneous Respiration on Pulse-oximetry Measurements

This is a study designed to measure, characterize and describe changes on pulse-oxymetry values produced as a result of deep breaths in patients with stable chronic hypoxemic respiratory failure.

There is no standard way of measuring rest pulse-oxymetry in terms of depth of respiration. Rest pulse-oxymetry values are used in the clinical setting to make therapeutic decisions regarding the need of supplemental oxygen. The primary goal of this study is to measure the change of pulse-oxymetry values during an experimental protocol of 10 deep breaths during one minute in patients with chronic hypoxemia. 45 patients will be studied in this first phase. In a second phase, secondary goals will be to measure Vd/Vt vent, noninvasive cardiac output and CT densitometry during the same deep breaths protocol in a subset of 13 patients with the grater increase observed in the first phase of study.

Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic lung disease causing rest hypoxemia, with rest SpO2 values equal or lower than 94% on room air
* Ambulatory patients capable of performing 6 min walking test
* Patients older than 18 years old.

Exclusion Criteria:

* Patients with significant collagen disease causing Raynaud phenomenon.
* Patients with hypothermia lower than 35 degrees Celsius
* Patients with rest SpO2 values equal or lower than 80% on room air
* Patients unable to perform PFTs
* Patients unable to complete 6 min walking test without supp O2.
* Patients unable to perform experimental deep breaths on CT scan
Efficacy and Safety of NYX-2925 in Subjects With Fibromyalgia

To evaluate the efficacy of NYX-2925 versus placebo for the treatment of fibromyalgia.

This is a randomized, double-blind, placebo-controlled study to assess the efficacy and safety of NYX-2925 in subjects with fibromyalgia.

This 13- to 16-week study will include a 1- to 4-week Screening Period followed by a 12-week double-blind, randomized, placebo-controlled Treatment Period.

Eligibility Criteria:
Inclusion criteria:

* Informed consent
* Subject has a history of fibromyalgia that was diagnosed \>1 year prior to screening and reports at least moderate pain over the last week
* Stable protocol allowed medication and other therapies during the study
* Agrees to use highly effective birth control during the study
* Has not participated in an interventional study for at least 30 days and agrees not to participate in another interventional study during the study

Exclusion Criteria:

* Pain due to other conditions or diseases that would complicate participation in the study or pain reporting
* Current or historical serious medical conditions
* Prior participation in NYX-2925 clinical trial
A Study of the Absorption, Metabolism, and Excretion of GBT440 in Healthy Male Subjects

This study will provide information regarding the metabolic pathway of GBT440, the need for evaluation of potential drug-drug interactions, and the need for studies in special populations. The administration of radiolabeled drug is necessary to fully characterize the rates and routes of elimination of GBT440, providing further quantitative information on the disposition of GBT440. The results from this study will permit a comprehensive comparison between animal and human routes of elimination and metabolic profiles of GBT440.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy; non-smoking male; 18 to 55 years old, inclusive
2. Weighs at least 50 kg and not more than 110 kg
3. Agrees to use contraception
4. Willing and able to give written informed consent

Exclusion Criteria:

1. Evidence or history of clinically significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder
2. History of stomach or intestinal surgery that would potentially alter drug absorption
3. History of hypersensitivity or allergy to drugs, foods, or other substances
4. History or presence of abnormal electrocardiogram
5. Exposure to significant radiation or participated in more than 1 other radiolabeled study drug trial within 12 months of Screening
6. Participated in another clinical trial of an investigational drug within 30 days (or 5 half-lives of the investigational drug, whichever is longer) prior to Screening
A Study of SHR-A1811 as Neoadjuvant Treatment for Patients With HR-Positive, Low HER2 Expression Breast Cancer

HR-positive breast cancers accounts for about 50% to 60% of all breast cancer patients. Neoadjuvant Chemotherapy is the core treatment mode for this type of breast cancer, and endocrine therapy can be used in some low-risk patients. However, the pathological complete response (pCR) rate obtained is low. HER2 is an important prognostic indicator and therapeutic target for breast cancer. Nearly 60% of HR-positive breast cancers have low expression of HER2, and antibody-drug conjugates (ADC) targeting HER2 may achieve better efficacy in this subtype.

This prospective, single-arm study is being conducted to evaluate the efficacy and safety of SHR-A1811 for early-stage or locally advanced breast cancer patients with HR-Positive, Low HER2 Expression. Subjects will receive the neoadjuvant therapy of SHR-A1811 for eight cycles, and then undergo surgery within 4 weeks after neoadjuvant therapy. The follow-up visit will last for at least 5 years.

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 18 to 70 years old (inclusive);
2. Treatment-naive patients with clinically confirmed T2-T3, any nodal status and M0;
3. HR-positive, HER2 low expression, the expression of Ki-67 exceed 14% invasive breast cancer confirmed by histology or cytology;
4. ECOG performance status of 0-1;
5. Normal organ and bone marrow function;
6. Patients of childbearing age must consent to use highly effective contraception for 7 months from the start of study screening until the last study medication and agree not to breastfeeding;
7. Patients voluntarily joined the study and signed informed consent;

Exclusion Criteria:

1. Patients have evidence of metastatic breast cancer, or inflammatory breast cancer;
2. Patients previously received antineoplastic therapy or radiotherapy for any malignancy, excluding cured malignancies such as cervical carcinoma in situ, basal cell carcinoma, or squamous carcinoma;
3. Patients received any other anti-tumor therapy at the same time, including endocrine therapy, bisphosphonates or immunotherapy;
4. Patients have major surgical procedures unrelated to breast cancer within 4 weeks before the first medication, or not fully recovered from surgical procedures;
5. Clinically significant pulmonary or cardiovascular disease;
6. Failure to swallow, chronic diarrhea, intestinal obstruction, or presence of other factors affecting drug administration and absorption;
7. Known to be allergic to any study drug or any of its excipients;
8. History of immunodeficiency, including HIV-positive, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation;
9. Pregnant and lactating women;
10. Patients with serious concomitant diseases or other comorbidities that will interfere with the planned treatment, or any other condition that is not suitable for participation assessed by investigator.
Safety and Efficacy of Exenatide as Monotherapy

This Phase 3 trial is designed to compare the effects of twice-daily exenatide and twice-daily placebo with respect to glycemic control in drug-naive patients with type 2 diabetes treated with diet and exercise.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with type 2 diabetes
* Treating diabetes with diet and exercise
* HbA1c between 6.5% and 10.0%, inclusive
* Body Mass Index (BMI) between 25 kg/m\^2 and 45 kg/m\^2, inclusive

Exclusion Criteria:

* Have previously completed or withdrawn from this study
* Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
* Have been treated with any antidiabetic agent
* Have used drugs for weight loss (for example, Xenical, Meridia, Acutrim, or similar over-the counter medications) within 3 months of screening
* Are currently treated with any of the following excluded medications: \* drugs that directly affect gastrointestinal motility; \* systemic corticosteroids (excluding topical and inhaled preparations) by oral, intravenous, or intramuscular route used regularly (longer than 2 weeks) or used within 2 weeks immediately prior to screening for this study
Efficacy and Safety of Lenvatinib as a Conversion Therapy for HCC

Lenvatinib is the standard of care for patients with advanced hepatocellular carcinoma (HCC). The aim of the single-arm, open-label, phase II clinical trial is to assess efficacy and safety of lenvatinib as a preoperative conversion therapy in patients with potentially resectable HCC. Investigator hypothesized that lenvatinib may be an effective conversion treatment for HCC, and preoperative treatment with lenvatinib can improve resectability in patients with potential resectable HCC and improve the long term survival.

For patients with potentially resectable HCC (intermediate or advanced stage), upfront therapy with surgical resection is of high recurrence rate after surgery. The aim of the single-arm, open-label, prospective phase II clinical trial is to evaluate whether preoperative lenvatinib treatment could improve resectability and therefore improve the long term survival.

Participants who are recruited in this study in this study will be treated with lenvatinib and will be evaluated for the feasibility for surgical resection by a multidisciplinary team every 8 weeks. If the participants underwent curative resection, they will receive lenvatinib treatment for 48 weeks after surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female aged 18-75;
2. The participant must have confirmed diagnosis of HCC histologically or clinically;
3. The participant must have at least one untreated intrahepatic lesion that can be evaluated by contrast-enhanced CT or MRI;
4. The BCLC stage B/C patients, more than 3 tumor nodes or have portal vein tumor thrombus (Vp3-Vp4 according to LCSGJ PVTT classification) or extrahepatic metastases limited to one organ and the number of metastases nodules is no more than 3;
5. ECOG PS 0-1 and Child-Pugh A;
6. Surgical resection is not the first choice according to MDT evaluation;
7. Written informed consent;

Exclusion Criteria:

1. WBC\<4.0\*10\^9/L, HB\<80 g/L, PLT\<75\*10\^9/L and NEUT\<1.5×10\^9/L;
2. Coagulation function: (prothrombin time) international normalized ratio (INR) \>1.2;
3. Liver function: serum albumin (ALB)\<3.5 g/dl, total bilirubin (TBIL)\>1.5 times the upper limit of normal range, alanine aminotransferase and aspartate aminotransferase (ALT and AST)\>3 times the upper limit of normal range; renal function index: serum creatinine (CRE)\>1.5 times the upper limit of normal range; uncontrolled hypertension (\>150/90mm Hg);
4. Lymph node metastasis to hilar of lung or liver, or peripheral tissue adhesion;
5. Participated in other clinical trials 30 days before enrollment;
6. With ascites, hepatic encephalopathy, Gilbert syndrome, sclerosing cholangitis;
7. Suspected allergy to study drug;
8. With other organ dysfunction, it is not expected to be tolerated general anesthesia or hepatectomy;
9. Other conditions that the investigators considered not unsuitable for inclusion.
Effect of Postextubation High-Flow Nasal Cannula vs Noninvasive Ventilation in Patients With Hypercapnic COPD

To test if high-flow conditioned oxygen therapy is noninferior to NIV for preventing postextubation respiratory failure and reintubation in patients with hypercapnic COPD, investigators plan to conduct the participants level, 1:1 randomized trial at the respiratory ICU. Participants were randomized to undergo either high-flow conditioned oxygen therapy or noninvasive mechanical ventilation after extubation. Primary outcomes were reintubation and postextubation respiratory failure within 72 hours. Secondary outcomes included length of RICU stay after extubation and mortality; partial pressure of arterial carbon dioxide.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of AECOPD
* Extubation must be performed after 48 hours of invasive ventilation
* Must be treated sequentially with HFNC or NIV after extubation
* PaCO2≥50mmHg when extubation
* Positive End Expiratory Pressure (PEEP) ≤8cmH2O (1cmH2O=0.098 kPa) when extubation

Exclusion Criteria:

* Do-not-intubate
* Tracheostomies
* Accidental extubation
* Self-extubation
A Phase 2 Study of ABBV-3067 Alone and in Combination With ABBV-2222

This study will evaluate the safety, tolerability, and efficacy of ABBV-3067 given alone and in combination with various doses of ABBV-2222 in adults with Cystic Fibrosis who are homozygous for the F508del mutation.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed clinical diagnosis of Cystic Fibrosis (CF) who are homozygous for the F508del CF transmembrane conductance regulator (CFTR) mutation
* Stable pulmonary status
* Lung function \>= 40 and \<= 90% of predicted normal for age, gender and height at Screening

Exclusion Criteria:

* History of solid organ or hematopoietic transplant
* Cirrhosis with portal hypertension
* Use of CFTR modulator therapy within 60 days prior to Screening
A Community-based Resilience Group Psychotherapy for Only-child Loss Parents in China

Two communities in Changsha was selected, where principle investigators' institution located, to recruit 80 participants into intervention group and control group. Resilience therapy group was intervened by a psychotherapy developed by the researchers, which lasts 8 weeks. The themes of each week are start-up, mutual help, trust in yourself, thanksgiving feedback, care for yourself, emotional management, end-up. Measurement was conducted before the intervention, immediately after intervention, 3-month after intervention, and 12-month after intervention. A questionnaire was used during each measurement, including several scales in it, including resilience and depression.The saliva test of Dehydroepiandrosterone was also done in each measurement.


Eligibility Criteria:
Inclusion Criteria:

1. had only one child but now passed away;
2. failed to have another children;
3. volunteered to participate;
4. the score of resilience was under 72 points indicating a lower or middle level

Exclusion Criteria:

1. in the acute bereavement period (\<6 months);
2. unable to participate in activities due to severe physical illness;
3. receiving drug treatment for mental illness;
4. receiving other psychological therapy
Determinants of Metabolic Control in Children With Type 1 Diabetes Mellitus

A good metabolic control of type 1 diabetes mellitus (T1DM) is crucial to avoid long-term complications associated with the disease. Although recent evidences suggest that a good metabolic control of T1DM is partly independent of management intensity and could be anticipated since onset, factors that influence glycated haemoglobin (HbA1c) patterns remain poorly understood and are likely to be genetic.

While significant progress has been made in understanding of the genetic contribution to T1DM onset, very few studies have evaluated the role of genetic factors on T1DM metabolic control.

This study aims to create a comprehensive database of genetic and phenotypic data in a cohort of children and young adults with T1DM and to evaluate genetic and environmental factors that might predict trajectories in glycemic control


Eligibility Criteria:
Inclusion Criteria

Cases:

* age between 6 and 21 years;
* patients suffering from type 1 diabetes

Controls:

* age between 6 and 21 years;
* patients for whom a venous sampling is planned

Exclusion criteria

Cases:

* patients for whom it is not possible to collect information on the clinical history, starting from the onset of diabetes
* patients with other types of diabetes mellitus (type 2, monogenic diabetes, diabetes related to cystic fibrosis...)
* patients incapable of expressing valid informed consent or whose parents are incapable of expressing valid informed consent.

Controls:

* subjects with type 1 and 2 diabetes
* obese subjects and those with a family history of diabetes and obesity or other metabolic disorders
* subjects with HbA1c \>6%
* patients incapable of expressing valid informed consent or whose parents are incapable of expressing valid informed consent.
Multi-Family Group Therapy for Reducing Behavioral Difficulties in Youth

This study will examine the effectiveness of a multiple family group mental health service delivery strategy in improving mental health service use and outcome for urban, low income children of color, ages 7-11 years old with disruptive behaviors and their families.

Oppositional defiant disorder (ODD) and conduct disorder (CD) are two common childhood psychiatric disorders. Children with ODD frequently have temper tantrums, argue excessively with adults, deliberately attempt to annoy or upset people, and blame others for their mistakes or behavior. Children with CD may exhibit aggression toward people and animals, destruction of property, deceitfulness, and rule breaking. The symptoms of these disorders can negatively affect children's social, family, and academic lives. Research has shown that early, comprehensive treatment leads to better treatment outcomes. Both disorders are commonly treated using parent training techniques. A multiple family group therapy setting may prove to be more engaging and beneficial than standard care for both parents and children. This study will examine the effectiveness of a multiple family group (MFG) mental health service delivery strategy in improving mental health service use and treatment outcome for urban, low income children of color with ODD or CD.

Participants in this 18-month, open-label study will be randomly assigned to either receive standard of care or participate in an MFG in addition to receiving standard of care. Participants assigned to standard of care will receive treatment that is traditionally offered to outpatients. Participants in an MFG will meet in their groups once a week for 16 weeks. Sessions will include adult caregivers and all children over age 6. Each session will follow the same procedures, and will proceed through the following stages: creating social networks; information exchange; group discussions; individual family practice; and homework assignment. Assessments of youth functioning will be held at Weeks 8 and 16 and Months 6 and 18 post-treatment.

Eligibility Criteria:
Inclusion Criteria:

* Youth participants are between the ages of 7 and 11
* Adult caregivers are available to participate in the research and intervention activities
* Both youth and adult caregiver are English- or Spanish-speaking
* Youth meets criteria for a primary diagnosis of oppositional defiant disorder or conduct disorder, as measured by the Disruptive Behavior Disorder Rating Scale (DBD)

Exclusion Criteria:

* Youth has significant cognitive impairment that might interfere with understanding of program content or informed consent process
* Youth or adult has emergency psychiatric needs that require services beyond those provided within an outpatient setting (e.g., hospitalization or specialized placement outside the home)
* Youth who are wards of the state
Cross-over Pilot Study of Blood Cholesterol Response to Dietary Saturated Fat in Patients With Autosomal Dominant Hypercholesterolemia

We are performing a pilot cross-over diet study involving 5 patients with heterozygous FH and 5 patients with unexplained ADH. The patients will be randomized to a low versus high saturated fat diet for 4 weeks each. We hypothesize that patients with unexplained ADH may have an exaggerated cholesterol response to saturated fat intake. The specific aim of this study is to quantify the increase in LDL-C in unexplained ADH patients compared to FH patients. The pilot study proposed here will develop preliminary data to be used for future funding proposals of larger, randomized studies.


Eligibility Criteria:
Inclusion Criteria:

1. Adults, age \> 18 years or \< 80 years
2. Pre-treatment LDL-C greater than the 95th percentile for age and sex (corresponding to 190 mg/dL for most adults), with one of the 2 following criteria: (1) tendon xanthoma (proband or first-degree relative) or (2) either first-degree relative with premature CHD (age less than 55 years in men or 65 years in women) or pretreatment LDL-C greater than the 95th percentile for age and sex.
3. Willing to come off medical therapy 4 weeks before and during study.
4. Willing to follow high/low saturated fat diet
5. Willing to attend dietary counseling sessions
6. Willing to attend frequent clinic visits
7. Subjects willing to participate under the conditions described in the informed consent form (ICF) and able to sign the ICF and applicable HIPAA forms.

Exclusion Criteria:

1. Presence of any clinically significant uncontrolled endocrine disease known to influence serum lipids or lipoproteins. Note: patients on thyroid replacement therapy can be included if the dosage of thyroxine has been stable for 6 weeks prior to the first study visit and thyroid-stimulating hormone (TSH) level is within the normal range.
2. Conditions of severe acute vascular stress (e.g. acute coronary syndrome, ischemic stroke, or major vascular surgery) within 3 months prior to the first study visit.
3. Patients unable to maintain their current activity level or planning to increase their activity level (e.g. new exercise regimen).
4. Pregnant or breast-feeding women.
5. Major illness
6. Secondary cause of dyslipidemia (e.g. obstructive liver disease, hypothyroidism, or nephrotic syndrome)
7. Hospitalization within 3 months
8. Substance abuse (illegal drug use, chronic alcoholism or problematic use of alcohol or total daily alcohol intake \>2 drinks per day in men and \> 1 drink per day in women).
9. Immunodeficiency or HIV-positive status
10. Illiteracy
11. Severe medical condition that may impair the ability of the person to participate in a nutrition intervention study (e.g. digestive disease with fat intolerance, advanced malignancy, or major neurological, psychiatric or endocrine disease)
12. Any other medical condition thought to limit survival to less than 1 year
13. Difficulties or major inconvenience to change dietary habits
14. History of food allergy with hypersensitivity to any of the components of olive oil or nuts
Treatment of Transsphicteric Fistula-in-ano by Method of Laser Thermoobliteration(FiLaC™).

This is a randomized, controlled, parallel study to compare the results of treatment for patients with transsphincteric fistulas-in-ano.

We are planning to eroll 120 patients in this study,the duration of the stady be 3 years. Each of two groups will include 60 people. Pationts in the first group will be assigned to get treatment of the fistula-in-ano by laser thermo-obliteration (FiLAC™), patietns of the second group will forego monopolar coagulation of the fistulas tract with suturing the internal fistulas opening.

Eligibility Criteria:
Inclusion Criteria:

1. Informed consent to the study;
2. Patients with high transsphincteric fistula (\>1/3), suprasphincteric fistula whithout abscesses;
3. The presence of a formed fistulous tract \> 2 cm in length.

Exclusion Criteria:

1. Suprasphincteric fistula with abscesses or infiltrates;
2. Extrasphincteric fistula;
3. Length of fistula tract \< 2 cm;
4. The presence of sever scars in the region of internal fistula opening, wide fistula opening \> 5 mm;
5. Crohn's fistulae