cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Mazdutide for Treating PCOS

The goal of this clinical trial is to learn the efficacy of Mazdutide in treating obese female adults diagnosed with polycystic ovary syndrome (PCOS). The main question it aims to answer is: Does Mazdutide lower the free androgen index (FAI) in obese female adults with PCOS? Participants will take Mazdutide once every week for 24 weeks and visit the clinic once every 4 weeks for checkups and tests.


Eligibility Criteria:
Inclusion Criteria:

* BMI≥28kg/M2
* No plan for pregnancy in the coming 8 months after enrollment
* Patients should meet at least two of the three criteria according to the 2023 international evidence-based guideline for PCOS :

  1. Irregular cycles and ovulatory dysfunction: \< 21 or \> 35 days or \< 8 cycles per year; \> 90 days for any one cycle
  2. Polycystic ovaries: ≥20 follicles in at least one of two ovaries (diameter\<10mm), confirmed by ultrasound
  3. Biochemical hyperandrogenism: total testosterone\>1.67 nmol/L or clinical hyperandrogenism: modified Ferriman Gallwey score (mFG)\>4

Exclusion Criteria:

* Previous history of acute or chronic pancreatitis or pancreatic injury
* Previous history or family history of medullary thyroid cancer, multiple endocrine neoplasia type 2a or 2b
* Severe hypertriglyceridemia (TG\>5mmol/L)
* Type 1 or type 2 diabetes mellitus
* Other endocrine diseases that can cause secondary PCOS, including but not limited to: 21 hydroxylase deficiency, prolactinoma, hypothyroidism, Cushing's syndrome, etc
* Pregnancy or breast-feeding
* Patients with other serious diseases affecting heart, liver, kidney, or other major organs
* Patients with any type of cancer
EMA-Defined Tinnitus Subgroups

The purpose of this research study is to test a new way of measuring the severity of tinnitus using a tool called Ecological Momentary Assessment (EMA) of Tinnitus. We will compare the relationship with this tool with another widely used questionnaire. Previous studies we have done suggest there are different patterns of tinnitus bother; we plan to explore how often these patterns occur, and how many patterns of tinnitus bother there are. And lastly we want to test how reliable this type of testing is for measuring the amount of bother people experience from their tinnitus.

Hypothesis 1: We will be able to identify 6 or more distinctive patterns of tinnitus.

Hypothesis 2: EMA will provide a reliable method for more accurately capturing the amount of bother individuals have from tinnitus.

You to need to complete this brief survey to determine if you meet the criteria for participation in the study. You are free to skip any questions that you prefer not to answer. We will only use the information you provide in this survey to determine if you qualify for the EMA-Defined Tinnitus Subgroups study.

To be in this study, you will be required to have a smart phone that can receive text messages, is connected to the internet, and will allow you to connect via the internet to a Washington University secure server. It is necessary to connect to the Washington University server in order to complete a short survey four times a day for two separate two-week periods.

The study involves us sending you text messages at 4 random times during the day, between the hours of 8: 00 am - 9: 00 pm. The texts prompt you to click on a link and respond to a short EMA survey regarding what you are doing, what your environment is, and how your tinnitus is at that moment. These text messages will be sent daily for two weeks. Then you will have two weeks off. Finally you will again receive the text messages asking for you to respond to the survey for two more weeks. You will receive a total of 112 text messages over four weeks. In addition we will send you four emails or texts asking you to complete a survey at the following times: before you complete your first set of EMA surveys, at the end of the first set EMA surveys, prior to starting the second set of EMA surveys, and a final time after you have completed the final EMA survey. This study requires no visits to Washington University.

In order to participate you must complete this short prescreening survey to see if you qualify.

Eligibility Criteria:
Inclusion Criteria:

* Age between the ages of 21 and 80.
* Have subjective, unilateral or bilateral, tinnitus of 6 months' duration or longer.
* Must be score of 1, 2, 3, or 4 on Global Bother Score. (Range is 0-4, with 0 being not bothered and 4 being extremely bothered)
* Must have access to a smart phone device compatible with the notification system.
* Must be able to read, write, and understand English.

Exclusion Criteria:

* Tinnitus related to Workman's Compensation Claim or other litigation-related situations.
A Cohort Study on the Pathogen Spectrum of Liver Transplant Recipients Complicated With Infection

The goal of this observational study is to map the pathogen profile of secondary infections in liver transplant recipients, to correlate the basic immune status with the characteristics of the secondary infection pathogen profile, and to establish an early warning system for monitoring secondary infections, so as to explore safe and effective therapeutic modalities to further reduce the morbidity and mortality of liver failure. The main questions it aims to answer are:

* Characterize the distribution of pathogenic bacteria infecting liver transplant recipients.
* Establish a monitoring and early warning system for secondary infections.

Liver transplantation is recognized as the most effective treatment for end-stage liver disease, and China's liver transplantation technology has reached the international level, with survival rates of 90%, 80%, and 70% at 1, 5, and 10 years after surgery, respectively. During the perioperative period of liver transplantation, transplant recipients with preoperative organ dysfunction, high surgical trauma, postoperative application of immunosuppressive drugs, and low anti-infective capacity are highly susceptible to associated infections, which are more likely to occur than in other transplant recipients, and have become an important factor affecting the prognosis of liver transplantation. Foreign studies reported that 18% of postoperative liver transplantation deaths were caused by infections, of which bacterial infections were the most common, followed by viral and fungal infections. In the first month after liver transplantation, the incidence of infection is the highest, and bacterial pneumonia is the most common infection, with a high case fatality rate, and the hospitalization time of the patient is significantly prolonged, and the economic expenditure is increased. Early clarification of the type and distribution of pathogenic bacteria infecting liver transplant recipients and prompt initiation of appropriate anti-infective therapy are essential to improve the survival of liver transplant recipients.

Eligibility Criteria:
Inclusion Criteria:

1. Agree to participate in this study and sign the informed consent form;
2. Be of any gender and aged 18-70 years old;
3. No life-threatening underlying diseases and complications during the perioperative period.
4. Undergo liver transplantation within 24 hours.

Exclusion Criteria:

1.Patients deemed unsuitable by the investigator to participate in the study.
Optimal PERioperative Antiplatelet Therapy Investigation ON Abdominal Surgery After Coronary Stent Implantation

The purpose of this study is to evaluate the impact of perioperative aspirin continuation on clinical outcomes in patients with a history of coronary stent implantation who are scheduled for abdominal surgery.

PCI with coronary stent implantation is performed for a huge number of patients with coronary artery disease. Approximately 20% of these patients undergo non-cardiac surgery within three years after PCI. However, there is a scarcity of clinical evidence regarding the efficacy of perioperative aspirin continuation on cardiovascular events.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a history of coronary stenting and scheduled for abdominal surgery
* Patients on a single antiplatelet agent

Exclusion Criteria:

* Patients on dual antiplatelet therapy (DAPT)
* Patients on anticoagulation therapy
* Patients with a history of stent thrombosis
* Patients with CHADS2 score \>= 5
* Patients at extremely high risk of bleeding and unable to continue preoperative aspirin
* Patients incapable of consent, including those under 20 years of age
* Other patients for whom either discontinuation or continuation of antiplatelet agents is deemed inappropriate by the attending physician
Clinical,Endoscopic and Radiological Assessment of Portal Hypertension in Children With Chronic Liver Diseases

Portal hypertension is a significant cause of morbidity and mortality in children with chronic liver disease and portal vein obstruction. It results in severe complications such as ascites, hepatic encephalopathy and gastrointestinal variceal bleeding. (Sutton et. al., 2018).

Esophageal varices is an important manifestation of portal hypertension that develops over time in children with chronic liver disease. The risk of esophageal varices hemorrhage increases depending on the underlying disease as well as the duration of the disease and the mortality rate as high as 5% - 20 % during patient follow up. Invasive procedures such as gastroscopy are performed repeatedly to detect the presence and progression of esophageal varices. Many non-invasive methods have been investigated to their efficacy in determining the presence of esophageal varices and the risk of complications in the presence of portal hypertension. (Taşkın et.al., 2023).

Early diagnosis of portal hypertension is often difficult as it can be asymptomatic. During this stage, the patient may feel nothing except for mild fatigue or abdominal discomfort and therefore, patients mostly go undiagnosed (Hartl et.al., 2021). (Selicean et.al., 2021). However, it is worth noting that some of the results from medical investigation may be abnormal during this stage. These include abnormal liver function, abnormal routine blood examination (thrombocytopenia), and changes in the stiffness of the liver which can be found during ultrasound despite the patient being asymptomatic. ( Mohanty et al., 2021).

Though the gold standard to diagnose portal hypertension is hepatic venous pressure gradient (HVPG) and a value more than 10 mmHg defines clinically significant portal hypertension (CSPH) ( Man Zhang et.al., 2022). Since HVPG measurement is scarcely available and invasive, several non-invasive tests are used as surrogate markers of CSPH. Amongst them, elastography techniques measuring liver stiffness (LS) and spleen stiffness (SS) are the extensively studied ones which can be done by elastography machines that can be attached to conventional ultrasound (USG) machines . Amongst them, 2D-shear wave elastography (2D-SWE) is the most recent one, and it assesses stiffness and related parameters by tracking shear waves propagated through a media. (Sattanathan et.al., 2023).


Eligibility Criteria:
Inclusion Criteria:

- 1- Age: \< 18 years 2- Manifestations of hepatic disease like jaundice, hepatic encephalopathy, organomegally.

3- Children previously diagnosed with chronic liver disease

Exclusion Criteria:

* 1- Age: \> 18 years. 2- Non compliant child during technique of elastography. 3- Patient with ascites. 4- Patient with portosystemic shunt surgery
Safety and Tolerability of SHR-1316 in Subjects With Advanced Tumors

The purpose of this study is to access the safety and tolerability of the study drug known as SHR-1316 in metastatic/advanced malignancies

This is an open-label, non-randomized, dose escalation/expansion phase I study, SHR-1316 is a humanized IgG4 monoclonal antibody that binds specifically to human PD-L1.The major aims of the study are to define the safety profile of this new drug, and to determine a recommended dose and schedule for potential additional trials.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female ≥18 years of age
2. Subjects with confirmed advanced malignancies (histologically or cytologically)
3. ECOG Performance status of 0 or 1
4. Adequate organ functions
5. Life expectancy ≥12 weeks;

Exclusion Criteria:

1. Subjects with active autoimmune disease.
2. Systemic cytotoxic chemotherapy, biological therapy, or major surgery within 4 weeks of the first dose of trial treatment
3. Previous received PD-1 or PD-L1 therapy
4. Known Active central nervous system (CNS) metastases
5. Known Clinically significant cardiovascular condition
6. Active infection or an unexplained fever \>38.5°C
7. History of immunodeficiency
Myo-inositol Therapy on the Dynamics of Embryo Development in Patients Suffering From PCOS Undergoing ICSI Treatment

The purpose of this study is to analyse the activity of myo-inositol on pregnancy rate, embryo development dynamics and oestradiol and progesterone concentration in blood serum and Superoxide Dismutase (SOD) and catalase concentration in follicular fluid of patients with Polycystic Ovary Syndrome (PCOS) undergoing Intracytoplasmic Sperm Injection (ICSI).


Eligibility Criteria:
Inclusion Criteria:

ICSI treatment due to infertility

PCOS patients enrolled according to the criteria established by representatives of the American Society of Reproductive Medicine (ASRM) and the European Society of Human Reproduction and Embryology (ESHRE)

Exclusion Criteria:

Severe endometriosis BMI \<17 and \>30 Metabolic diseases Lowered ovarian reserve
Study of Treatment Free Remission in Patients With Chronic Myeloid Leukemia in Chronic Phase

The principal aim of this study is to evaluate complete molecular remission in patients with chronic myeloid leukemia (CML) in deep molecular response after stopping tyrosine kinase inhibitor (TKI) treatment. The second aim is to characterize the immunological status of patients with CML at the time of TKI interruption and then at 3 months after the interruption.

ARGENTINA STOP TRIAL is a multicentre, open-label, uncontrolled trial to estimate the persistence of molecular remission in patients with chronic phase Chronic Myeloid Leukemia (CML) in Deep Molecular Response after stopping Tyrosine Kinase Inhibitor (TKI)

Primary Objective:

- To identify the proportion of patients who continue on Major Molecular Response after discontinuing treatment with TKI.

Secondary objectives:

* To characterize the immunological status of patients with CML at the time of interruption and then at 3 and 12 months after the interruption.

Tertiary objective: To evaluate the pharmacoeconomic impact of interrupting the treatment.

Eligibility Criteria:
Inclusion criteria:

1. Signed Informed consent.
2. Patients with a diagnosis of CML BCR-ABL positive in CP treated with approved TKI (Imatinib, Nilotinib or Dasatinib) in 1st line or in 2nd line due to intolerance to the 1st line or in 2nd line due to the lack of deep MR with 1st line TKI, which never presented criteria for treatment failure.
3. Age ≥ 18 years
4. ≥ 4 years of treatment with imatinib, nilotinib or dasatinib.
5. Achievement of MR 4.5 in a standardized laboratory (BCR-ABL1 IS ≤ 0.0032%).
6. Evidence of MR 4.5 sustained for ≥ 2 years, as documented in at least 4 tests performed at least 3 months apart.
7. Evidence of typical quantifiable BCR-ABL1 transcript (b3a2 \[e14a2\] and / or b2a2 \[e13a2\], typical isoforms of p210).

Exclusion criteria:

1. Patients who previously discontinued TKI and demonstrated recurrence of the disease.
2. Patients with failure to any TKI at any time.
3. Patients who presented accelerated phase or CML in blast crisis at any time.
4. Patients with atypical transcript not quantifiable by RT qPCR
5. BCR-ABL mutation detected at any time during the course of the resistant disease
Effect of Orally Delivered Phytochemicals on Aging and Inflammation in the Skin

The objective is to determine, in a small number of participants, the protective effects of UV-induced skin erythema (reddening or "sunburn") following oral administration of sulforaphane, curcumin, or a combination of the two plant (diet)-based supplements. The investigators will be using the over-the-counter nutritional supplements Crucera-SGS and Meriva-SF to deliver the biologically stable sulforaphane precursor and a highly bioavailable formulation of curcumin. Volunteers will be challenged with UV irradiation at 2-times the minimum erythematous dose (M.E.D.) on discrete 2 cm diameter circles on the upper buttocks. Skin redness will be monitored daily using a chromometer. Biomarkers will then be evaluated in blood, urine, and skin biopsies.

Oral sulforaphane (SF) delivery results in systemic protection of a wide variety of organ systems which The investigators hypothesize will also include the skin, based on animal studies and preliminary evidence in human volunteers. Since The investigators have only previously evaluated the ability of topical sulforaphane application to protect skin from UV-induced erythema, the next logical step is to evaluate the ability of oral delivery to affect the skin of healthy human volunteers. Curcumin is also a potent anti-inflammatory that acts upon different biochemical pathways from SF, and it is an antioxidant. It was discovered over a century ago, it has been the subject of well over a hundred clinical studies, and it has been an ingredient in common foods eaten by millions of people, for centuries. Before and after consumption of each of these common food ingredients, The investigators will: (a) measure the Phase 2 cytoprotective response in human skin, (b) determine whether it leads to reduced UV-induced erythema (reduced inflammation), (c) evaluate changes in age-related markers such as dermal elasticity, keratin and collagen levels, (d) measure advanced glycation end-products (AGEs) in the serum, as biomarkers of systemic (including the skin) reduction in AGE levels, and (e) measure the levels of these biomarkers in skin punch biopsies. The investigators will also evaluate the effects of combined oral SF and curcumin. The investigators anticipate that there may be a true synergistic response between SF and curcumin, and the experiments designed herein are designed to show that synergy, if it exists.

Eligibility Criteria:
Inclusion Criteria:

* 18-70 years old, healthy
* Willingness to avoid sun exposure to study site
* Willingness to adhere to cruciferous vegetable-free diet

Exclusion Criteria:

* Use of photosensitizing medications
* Use of medications that cause skin flushing
* Use of anticoagulants/antiplatelet therapies
* Allergies to anesthetic agents
* Use of systemic retinoids or steroids (excluding female contraceptives and levothyroxin)
* Topical retinoids or steroids at study sites
* Antibiotic use
* Current students of the Principal Investigator
* Procedures performed at the study sites
* Smokers/tobacco users
Effects of Trunk Exercise on Trunk Control and Balance in Persons With Stroke

This study examined the effects of trunk exercise on unstable surfaces on trunk control and balance for persons in the sub-acute stage of stroke. The hypothesis was that, compared to upper limb exercises in well supported sitting position, this exercise would lead to better trunk control and sitting and standing balance. The results supported the hypothesis.

Inpatients in the sub-acute stage of stroke were randomly assigned to receive upper limb range of motion exercises in well supported sitting position or trunk exercises on unstable surfaces in supine and sitting, 30 min per session, 2 sessions per week for 6 weeks, in addition to their daily conventional stroke rehabilitation. Sensorimotor functions, including hand grip strength, plantar sensitivity, stroke rehabilitation assessment of movement and Fugl-Meyer lower extremity motor scale, and clinical outcome assessments, including Trunk Impairment Scale and 6-meter walk test, were conducted by a blinded assessor. Biomechanical outcome measures included center of pressure area while maintaining static posture and peak displacement while leaning forward, and the average speed of the unaffected arm raising (to represent the ability to provide a stable foundation for focal movement). These measures were taken in sitting without foot support, sitting with foot support and standing to reflect trunk control, sitting balance and standing balance, respectively.

Eligibility Criteria:
Inclusion Criteria:

* age: between 20-80 years old
* first time stroke
* could sit without back support at least 20 seconds
* could understand and follow experimental instructions

Exclusion Criteria:

* medically unstable
* other neuromuscular/musculoskeletal problems that would affect balance
A Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Tolerability of Asenapine With Flexible Dosing From 5mg to 20mg in Adults With Developmental Stuttering

The purpose of this research study is to find out the potential benefits and safety of asenapine (Saphris®) in adults who suffer from the developmental form of stuttering.

It is hypothesized that individuals who are randomly assigned to asenapine will have an improvement in speech as compared to a placebo.


Eligibility Criteria:
Inclusion Criteria:

Subjects can be enrolled in the study only if they meet all of the following criteria:

1. Subjects must satisfy DSM-IV criteria for stuttering.
2. The nature of stuttering must be developmental in origin with the onset prior to ten years of age.
3. Subjects must have a score of moderate or higher on the SSI-IV. 4) Women of child-bearing potential are eligible to participate as long as they are practicing a medically accepted form of contraception (i.e. condom with spermicide or diaphragm, oral or depot contraception, or an intrauterine device).

5)Subjects will be male or female from the ages of 18-70. 6)Subjects will be of only English speaking.

Exclusion Criteria:

Subjects will be excluded from the study for any of the following reasons:

1. Stuttering related to a known neurologic cause (e.g. head trauma, stroke).
2. Unstable medical or psychiatric illness.
3. Active substance abuse within three months prior to study inclusion.
4. Any illness that would require the concomitant use of a CNS active medication during the course of the study.
5. Subjects with Parkinson's dementia or other degenerative neurologic illness.
6. Subjects who are pregnant or nursing an infant.
7. No minors (under the age of 18) will not be enrolled in this study as the research with this compound in children and adolescents has not been fully performed.
8. Subjects who suffer from seizures, irregular heartbeat or an elevated blood sugar level (glucose).