cyrilzakka/clinical-trials huggingface dataset:
Effects of Medications in Patients With Hypogonadism

The aim of the present study was to demonstrate the influences of three different treatment strategies on biochemical parameters and testicular volume (TV) in patients with idiopathic hypogonadotropic hypogonadism (IHH).


Eligibility Criteria:
Inclusion Criteria: hypogonadotropic hypogonadism

* decreased serum testosterone concentration below the normal range (serum T \< 300ng/dL),
* FSH and LH levels within or below the normal range,
* absence of a pituitary or hypothalamic mass lesions on MRI, presence of gonadotropin response to repetitive doses of GnRH,
* normal smell test and normal karyotypes

Exclusion Criteria:

* previous androgen treatment,
* history of smoking,
* presence of bilateral anorchia,
* intellectual deficiency,
* diabetes mellitus,
* arterial hypertension or dyslipoproteinemia,
* medication of any kind and drug abuse. Because of possible confounding effects, patients with other hormone deficiencies were excluded.

Participants with iron, vitamin B12 or folate deficiency were also excluded.
Evaluating the Effectiveness of Incentive Spirometry

Post-operative pulmonary complications (PPCs) have a major impact on patients and healthcare expenses. The goal of perioperative respiratory therapy is to improve airway clearance, increase lung volume, and mitigate atelectasis. Incentive spirometers (IS) are ubiquitously used to prevent atelectasis and PPCs-implementation of which requires substantial provider time and healthcare expenses. However, meta-analyses have demonstrated that the effectiveness of ISs is unclear due to poor patient compliance in past studies.

The goal of this investigation is evaluate the effectiveness of IS on post-operative clinical outcomes. The aims of this investigation are to evaluate 1) if IS use compliance can be improved by adding a use-recording patient reminder alarm, and 2) the clinical outcomes of the more compliant IS users vs. the less-compliant IS users.


Eligibility Criteria:
Inclusion Criteria:

* Undergoes any cardiothoracic surgery
* Is transferred to the cardiothoracic surgery intermediate (step-down) unit at Rhode Island Hospital
* Already prescribed an incentive spirometer as standard-of-care
* Followed by any healthcare provider
* Ability to sign informed consent and comply with all study procedures including follow-up for up to 1 year

Exclusion Criteria:

* \<18 years of age
* Vulnerable population who in the judgment of the investigator is unable to give Informed Consent for reasons of incapacity, immaturity, adverse personal circumstances or lack of autonomy.
Managing Breast Cancer Treatment: Dyad's Perspectives on Treatment Decision, Financial and Family Burden.

The purpose of this study is to understand the financial burden and treatment decisions, based on both of patient's and family's perspectives in breast cancer patients who receive systemic chemotherapy, targeted therapy or immuno-therapy and their family caregivers .

This study utilizes a cross-sectional survey and qualitative research design. Data collection includes questionnaire surveys and recorded qualitative interviews. A total of 224 patients or family members who meet the criteria will be invited to participate in the study at oncology units and outpatient clinics. Among them, 30 subjects, either patients or family caregivers will be invited to explore their experience on and concerns about financial burden and treatment decision making as facing breast cancer.

Eligibility Criteria:
Inclusion Criteria:

* breast cancer

  1. Patients with newly diagnosed or recurrent breast cancer who require chemotherapy or targeted immunotherapy as recommended by their physicians
  2. Age 20 to 70
  3. Within 0.5 to 3 years of newly diagnosed or recurrent breast cancer
  4. Ability to perform housework or wage employment before cancer
  5. Those whose cognitive function is sufficient to read newspaper news and answer questionnaires
* breast cancer family

  1. Patient has been 0.5 to 3 years since the first diagnosis or recurrence of breast cancer and the doctor recommends chemotherapy or targeted immunotherapy
  2. Patient's self-reported family members who are involved in the patient's physical, social, or medical caregivers with cancer
  3. Age 20 to 65
  4. Able to perform housework or wage workers
  5. Those whose cognitive function is sufficient to read newspaper news and answer questionnaires

Exclusion Criteria:

* breast cancer

  1. Patients who were disabled before suffering from cancer
  2. only undergoing surgery or hormone therapy
* breast cancer family

  1. Persons with physical, mental and social disabilities
  2. Family members who are not involved in the patient's physical, social, or medical care for cancer
Headache After Diagnostic Lumbar Puncture

The objectives of this study are to investigate the effects of needle design, needle size and stylet reinsertion on the risk for headache after diagnostic LP (lumbar puncture, Post-LP headache). The following needles are used in the study:

1. Sprotte 25 Gauge (G) (0.5 mm) atraumatic needle with introducer
2. Sprotte 22 G (0.7 mm) atraumatic needle with introducer
3. Spinocan 25 G (0.5 mm) cutting needle


Eligibility Criteria:
Inclusion Criteria:

* Subjects undergoing diagnostic LP during their neurological work-up at Umeå University Hospital, Sweden, from 28 May 2013 until the study is fully recruited and;
* Willing to participate and
* Providing informed consent

Exclusion Criteria:

-Subjects unable to participate in the study follow-up
A Multicenter, Open-Label Trial to Evaluate the Safety and Efficacy of the Sufentanil Sublingual Tablet 30 mcg in Patients With Post-Operative Pain

This is a multicenter, open-label study in patients 40 years and older who are undergoing a surgical procedure.

Patients may receive one dose of ST 30 mcg as needed for pain management, but no more frequently than every 60 minutes, for up to 12 hours.

This is a multicenter, open-label study in patients 40 years and older who are undergoing a surgical procedure.

Upon meeting all entrance criteria, patients will be administered the first dose of ST 30 mcg and will remain in the study for up to 12 hours for safety and efficacy measurements. Patients may receive additional doses of ST 30 mcg as needed for pain management, but no more frequently than every 60 minutes.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients who are 40 years of age or older.
2. Patients who have undergone a surgical procedure with general anesthesia or spinal anesthesia that does not include intrathecal opioids during the operation.
3. Patients classified as American Society of Anesthesiologists (ASA) class IIII (Appendix I).

Exclusion Criteria:

1. Patients who have taken an opioid for more than 30 consecutive days, at a daily dose of more than 15 mg of morphine (or equivalent), within the past 3 months prior to surgery (e.g. more than 3 doses per day of Vicodin®, Norco®, Lortab® with 5 mg hydrocodone per tablet).
2. Patients with a positive drug of abuse screen unless the positive test result is consistent with a prescribed medication.
3. Patients with a history of opioid dependence within 2 years before the start of the study, defined as meeting the DSM-IV-TR™ Criteria for Substance Dependence specified in Appendix II.
4. Patients who have used any illicit drugs of abuse within five years before the start of the study.
5. Patients who have abused any prescription medication or alcohol within one year before the start of the study.
6. Patients with an allergy or hypersensitivity to opioids.
7. Patients who are currently taking monoamine oxidase inhibitors (MAOIs) or have taken MAOIs within 14 days of the first dose of study drug.
8. Patients with current sleep apnea that has been documented by a sleep laboratory study or are on home continuous positive airway pressure (CPAP).
A Randomized Trial of Induction Methods in Premature Rupture of Membranes

This study evaluates the addition of transcervical Foley catheter balloon and vaginal prostaglandin E2 induction in premature rupture of membranes. Half of participants will be used combine transcervical Foley catheter balloon and vaginal prostaglandin E2, while the other half will be used alone vaginal prostaglandin E2.


Eligibility Criteria:
Inclusion Criteria:

1. singleton pregnancy,
2. gestational age ≥34 weeks,
3. rupture of membranes,
4. cephalic presentation,
5. bishop score ≤5,
6. had less than three uterine contractions in every 10 minutes.

Exclusion Criteria:

1. Patients who had contraindications for vaginal delivery,
2. previous uterine surgery,
3. fetal malpresentation,
4. multifetal pregnancy,
5. more than three contractions in 10 minutes,
6. contraindications to prostaglandins,
7. a category II or III fetal heart rate pattern,
8. anomalous fetus,
9. fetal demise
10. women with immediate delivery indications -
The Effects of Two Endometrium Preparation Protocols in Frozen-thawed Embryo Transfer in Women With Irregular Cycles

There are two main cycle regimens used for endometrial preparation for frozen embryo transfer （FET) in women with irregular cycles: hormone replacement therapy cycles (HRT) in which the endometrium is artificially prepared by estrogen and progesterone hormones with/without a gonadotrophin releasing hormone agonist (GnRH-a) down regulation, and ovulation induced cycles (OI) in which follicular development is supported with increasing doses of gonadotrophin hormones and ovulation is induced. At present, there is still no sufficient evidence that which kind of frozen embryo transfer cycle regimen to plan more advantage. The purpose of this study was to compare the pregnancy outcome of hormone replacement therapy cycles (HRT) and ovulation induced cycles (OI) in women with irregular cycles.

This study is a prospective randomized controlled trial. Patients with irregular cycles undergoing FET in reproductive medicine renter of Sun Yat-sen Memorial Hospital will be recruited who should not be elder than 40 and had more than 3 frozen embryos. They will be randomized to receive either the OI-FET cycle (group OI-A) or the HRT-FET cycle (group HRT-B). In group OI-A, the follicular development is supported by Letrozole(LE) 2.5mg,once daily,is introduced on cycle day 3 .And on cycle day 10 , a Vagina ultrasound is introduced to monitor the development of the follicular ,following by intramuscular gonadotrophin 37.5\~75 IU/d until there is a Luteinizing Hormone(LH) surge or ovulation .On the day appearing Luteinizing Hormone surge，patient is always introduced intramuscular human chorionic gonadotrophin(HCG) 10000 IU.If there is sill no Luteinizing Hormone surge when the follicle is 20-24mm ,the ovulation will be induced by HCG.Then the luteum is supported by HCG 2000-2500 IU/3d.Transfer of thawed embryos will be performed 3 days after ovulation is observed. In group HRT-B, oral estradiol, 2 mg, once daily, is introduced on cycle day 3 with an increasing doses protocol. If the endometrial thickness is greater than 7mm, progesterone 40-60 mg in oil will be administered via intramuscular injection. Transfer of thawed embryos will be performed 3 days later.

Eligibility Criteria:
Inclusion Criteria:

* Age forty years old or less
* Has irregular Menstruation (cycle more than 35 days or less than 24 days ) or has regulation Menstruation but previous data suggest that abnormal ovulation
* Frozen embryos number more than three

Exclusion Criteria:

* Has Chocolate cyst or adenomyosis of uterus
* Clear hydrosalpinx
* Uterine scar or intrauterine adhesion and endometrial thickness \<7mm before ovulation
* recur thick endometrium（\<7mm）
* repeated implantation failure（≥3 times）
* Cancel the cycle because of having no dominant follicle in the ovulation induction（OI)+FET before or the growth of endometrium not good in the HRT+FET before
Safety and Efficacy of Itacitinib in Participants With Bronchiolitis Obliterans Syndrome Following Lung Transplantation

The purpose of this study is to evaluate the safety, efficacy, pharmacokinetics, and pharmacodynamics of itacitinib in participants with post-lung transplant bronchiolitis obliterans syndrome (BOS).


Eligibility Criteria:
Inclusion Criteria:

* Double lung transplantation ≥ 1 year before informed consent. Confirmed BOS progression to Grade 1, 2, or 3 diagnosed within 1 year of screening

  \*Confirmed BOS progression to Grade 1, 2, or 3 diagnosed within 2 years of screening AND:
* A ≥ 200 mL decrease in FEV1 in the previous 12 months

OR

\*A ≥ 50 mL decrease in FEV1 in the last 2 measurements.

• Willingness to avoid pregnancy or fathering children.

Exclusion Criteria:

* History of a single lung transplant
* FEV1 decline attributable to cause(s) other than BOS.
* Participants who have had any significant change (eg, addition of new agents) in an immunosuppressive regimen in the 4 weeks before screening.
* Untreated and/or symptomatic gastroesophageal reflux disease.
* Significant infectious comorbidities including invasive fungal disease, B. Cepacia, non TB mycobacteria, or TB.
* Receipt of JAK inhibitor therapy after lung transplant for any indication. Treatment with a JAK inhibitor before lung transplant is permitted.
* Laboratory values at screening outside the protocol-defined ranges.
* Active HBV or HCV infection that requires treatment, or at risk for HBV reactivation (ie, positive HBsAg).
* Known HIV infection.
* History of active malignancy within 3 years of screening.
* Women who are pregnant or breastfeeding.
* Treatment with an investigational agent, procedure, or device within 30 days of enrollment, or within 5 half-lives of the investigational product, whichever is longer.
A Phase I Open-Label Study of the Effects of Tacrolimus and Cyclosporine on CP-690,555 in Healthy Volunteers

A new immunosuppressive drug, based on the inhibition of important enzymes in the immune system, called JAK, is being developed by Pfizer to prevent transplant rejection. Since many treatments for transplant rejection may be administered together, this research study will analyze the effects of common transplant rejection therapies, Tacrolimus and Cyclosporine, on the JAK inhibitor, CP-690,550.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males between 21 and 55 years, inclusive.
* Healthy females of non-childbearing potential between 21 and 55 years, inclusive.
* Total body weight greater than 132 pounds.

Exclusion Criteria:

* Evidence or history of clinically significant disease
* Females of childbearing potential
Coupons for Safe Water Project

Guaranteeing access to safe drinking water is still a challenge in rural households in developing countries, and unsafe water sources are responsible for millions of deaths each year around the world. Coupons for free dilute chlorine solution are a cost-effective and effective way of ameliorating child health and reducing diarrhea incidence. It is still an empirical challenge, however, to see if the positive health effects will be maintained when the program is implemented at scale. In this study, investigators conduct a randomized controlled trial (RCT) at scale to study the impacts of a chlorine coupon program implemented at health clinics on child health, including self-reported diarrhea, fever, and cough incidence in the previous two weeks. Investigators further investigate the pathway of the impact, such as self-reported and objectively measured use of chlorine and frequency of visits to health clinics.

Guaranteeing access to safe drinking water is still a challenge in rural households in developing countries, and unsafe water sources are responsible for millions of deaths each year around the world. Coupons for free dilute chlorine solution are (i) a cost-effective solution to targeting water treatment for households that need it and will use it and (ii) an effective way of ameliorating child health and reducing diarrhea incidence. It is still an empirical challenge, however, to see if the positive health effects will be maintained when the program is implemented at scale. In this study, investigators conduct a randomized controlled trial (RCT) at scale to study the impacts of a chlorine coupon program implemented at health clinics on child health, including self-reported diarrhea, fever, and cough incidence in the previous two weeks. Investigators further study the pathway of the impact, such as self-reported and objectively measured use of chlorine and frequency of visits to health clinics. Investigators monitor the program's impact at Health and Demographic Surveillance Systems (HDSS) sites in collaboration with the Kenya Medical Research Institute (KEMRI). Data collection includes child mortality, as well as verbal autopsies for deceased children. Data on mortality will be useful for future meta-analyses that pool data from multiple studies in order to estimate the mortality impact of free chlorine distribution schemes.

Eligibility Criteria:
Inclusion Criteria:

* Currently pregnant women
* Women living inside Health and Demographic Surveillance Systems (HDSS) catchment areas.

Exclusion Criteria:

- Women who do not consent.
Long COVID-19 and MAB Study

This study will be observational only. It will provide real-world evidence generated from a representative and large-scale COVID patient base. The adoption, pilot testing and use of NIH PROs among viral tested patients with research purpose on long COVID will be unique and innovative. With the existing and proven scientific rigor, NIH PRO system will be adopted, then modified and tailored to form the long hauler specific, comprehensive instrument, helping generalize future knowledge regarding COVID-infected patients.


Eligibility Criteria:
Inclusion Criteria:

* Have been tested for COVID at one of the MultiCare facilities,
* AND 18 years old or older at the viral test,
* AND have no problem understanding English or Spanish.

Exclusion Criteria:

* Pediatric patients younger than 18 years old at the time of testing,
* OR patients who are pregnant,
* OR patients who plan to get pregnant in 3 months,
* OR patients who are hospitalized at the time of recruitment,
* OR patients who have cognitive impairment(s) at the recruitment.
CLEAR Sepsis Clinical Study

To investigate the relationship between initial ClearSight™ derived hemodynamic parameters and outcomes (death, ongoing organ dysfunction or delayed ICU admission) in patients with acute infection and possible sepsis, with a focus on venous blood lactate (\< 2.0, 2.0-3.9, and ≥ 4.0 mmol/dL) and hemodynamic subgroups, using ED patients presenting with minor infections or asthma/COPD exacerbations as controls (henceforth referred to as Sepsis Mimic Group).


Eligibility Criteria:
Venous Blood Lactate Groups

Inclusion Criteria:

* ≥ 18 years of age at the time of enrollment
* Any combination of acute symptoms and signs that the treating ED physician, after initial history and physical examination, attributes to a systemic infection
* ED Physician confirms likely hospital admission (\> 50%) due to suspicion of infection
* ED Physician confirms intention to order both blood cultures and venous blood lactate levels
* Ability to enroll patient and begin ClearSight™ monitoring within three (3) hours of ED presentation

Exclusion Criteria:

* Initial venous blood lactate measured \> 3 hours after ED arrival
* Pre-existing infection for which patient is being treated with antibiotics as an outpatient
* Prisoners
* Pregnant women
* Any previous medical condition with life expectancy of \< 3 months (patients with ESRD and heart failure are not excluded)
* DNR or comfort care order preexisting to ED visit or established in the ED
* Palliative care or hospice consult in the ED
* Known severe aortic insufficiency
* Known history of Raynaud's disease
* Poor follow-up candidate in the opinion of the Investigator
* Current or planned enrollment in an investigational trial that in the opinion of the Investigator may significantly affect hemodynamic data collection.

Control Sepsis Mimic

Inclusion Criteria:

* ≥18 years of age at the time of enrollment
* Presents to the ED with a chief complaint consistent with a minor infection (upper respiratory infection, soft tissue infection, viral infection) or an asthma or COPD exacerbation on whom the treating physician is not ordering labs for blood cultures or lactate levels
* Ability to enroll patient and begin ClearSight™ monitoring within three (3) hours of ED presentation.

Exclusion Criteria:

* Pre-existing infection for which patient is being treated with antibiotics as an outpatient
* Prisoners
* Pregnant women
* Any previous medical condition with life expectancy of \< 3 months (patients with ESRD and heart failure are not excluded)
* DNR or comfort care order preexisting to ED visit or established in the ED
* Palliative care or hospice consult in the ED
* Known severe aortic insufficiency
* Known history of Raynaud's disease
* Poor follow-up candidate in the opinion of the Investigator
* Current or planned enrollment in an investigational trial that in the opinion of the Investigator may significantly affect hemodynamic data collection.
* Treating physician is planning on ordering either a lactate or blood cultures on the patient.
Efficacy Analysis of Minimally Invasive Carroll's Technique in Treatment of Congenital Idiopathic Clubfoot

Congenital clubfoot(CCF) is a kind of common congenital foot deformities in children. Though Ponseti method can cure most of the CCF patients, there are still part of patients can not get satisfactory recovery, especially those children classified as Dimeglio grade Ⅲ and Ⅳ. Carroll's technique is considered to be an ideal method of surgical treatment. But the postoperative scar is relatively large, and accordingly the postoperative complications is still common. Based on the clinical practice of the investigator's group, a modification of Carroll's technique, minimally invasive Carroll's technique, was applied. For the Dimeglio grade Ⅲ and Ⅳ CCF, the postoperative excellent and good rate was over 90%. Therefore, the investigator conducted a multicenter randomized controlled trial on treatment of congenital idiopathic clubfoot with minimally invasive Carroll's technique.


Eligibility Criteria:
Inclusion Criteria:

* First diagnosed congenital idiopathic clubfoot cases classified as Dimeglio grade Ⅲ and Ⅳ

Exclusion Criteria:

* Age≤28 days, and Age\>4 years.
* Accompanied by serious diseases of other organs.
* Children with inherited metabolic disease and connective tissue disease.
* Clubfoot caused by trauma, cerebral palsy, congenital multiple joint contracture, polio, spina bifida occulta, and clubfoot derived from spinal cord disease.
Comparison Between Interactive Internet-based Education and Counseling for the Management of Acne With That of Internet-based Education Alone

This study will develop and evaluate the efficacy of an Internet-based education program incorporating virtual coaching. For this study, the virtual coach will consist of online videos aimed at providing acne education and promoting behaviors that support healthy skin. The use of Web-based technologies and virtual coaching in acne-related patient education is novel, and may significantly improve clinical outcomes and quality of life in acne patients. We hypothesize that an interactive Internet-based education and counseling program will be more effective than Internet-based education alone in improving clinical outcomes and quality of life in acne patients.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of mild to moderate acne vulgaris
* 13 years of age or older at time of assent, may be men or women.
* Able read and understand English.
* Able to hear and see the educational videos.
* Access to computer with Internet access.
* Capable of giving informed consent.
* Not currently using any prescription acne treatment.

Exclusion Criteria:

* Non-English speaking individuals.
* Self-reported exposure to environmental or chemical comedogenic agents
* Women with self-reported hyperandrogenism (e.g., PCOS)
* Women self-reporting current use of any form of specific acne-directed hormonal therapy
* Men or women with self-reported history of Cushing syndrome or congenital adrenal hyperplasia