cyrilzakka/clinical-trials huggingface dataset:
Safety of Anti-Depressant for Chronic Obstructive Pulmonary Disease (SAD-COPD)

Objective: Determine whether treatment of perceived stress, anxiety, and depression with anti-depressant therapy improves dyspnea scores, 6-minute walk (6MW) distance and quality of life (QoL) in patients with Chronic Obstructive Pulmonary Disease (COPD) and ILD (Interstitial Lung Disease) undergoing pulmonary rehab.

The study is a prospective, randomized, double-blinded, placebo-controlled study to assess the effect of an SSRI on 6MW, dyspnea scores, and QoL in COPD and ILD patients undergoing pulmonary rehab. Thirty subjects that carry an ICD-9 code diagnosis of COPD and/or ILD and CES-D (Center for Epidemiologic Studies Depression) score of \> 16 will be recruited from Duke Pulmonary Rehab.

Multivariable regression models will be constructed to evaluate the relationship between perceived stress, anxiety, and depression with adjustments by race, gender, age, BMI and GOLD score. A multivariable regression model will be constructed to assess whether treatment of perceived stress, depression, and anxiety with antidepressant therapy (sertraline) is an effect modifier on 6MW distance and dyspnea scores in patients with COPD or ILD who are enrolled in pulmonary rehab.

Descriptive statistics will be used to examine the socio-demographic characteristic data. Student t-tests will be performed to assess group differences in continuous data. Categorical variables will be examined using the Pearson's Chi-Squared test.


Eligibility Criteria:
Inclusion Criteria:

* Male or female with an ICD-9 code diagnosis of COPD and/or ILD
* Mild, moderate, or severe major depression symptoms based on Center of Epidemiologic Studies Depression (CES-D) score \> 16.
* Able to complete informed consent†
* Read and write in English

Exclusion Criteria:

* Current treatment with antidepressants
* Current treatment with anti-psychotics
* Severe physical disability that would interfere with lung assessment
* History of major psychiatric illness, including bipolar disorder, psychoses, and/or severe personality disorder.
* Active suicidal ideations
* Serious cognitive problems (dementia syndrome) or cognitive impairment defined as MMSE \< 22
* Recent loss of spouse within 6 weeks of study enrollment.
* History of alcohol or drug dependence in the last 6 months.
* Pregnant women or nursing mothers
* Poorly controlled concomitant conditions that pose additional procedure risk as determined by the investigator.
A Case Control Study of Women With Multiple Sexual Partners

Both population based surveys and more focused research studies indicate that increased numbers of sexual partners and partner concurrency contribute to increased risk for acquisition of sexually transmitted infection (STI), including HIV infection. However, unlike for men, both national and sub-population-based studies consistently find that the great majority of women with or without STIs report only 1-2 sex partners in the preceding year and that a minority of women acknowledge \> 3 sex partners over the same period, suggesting that this relatively small proportion of women with higher numbers of sex partners play a disproportionate role in sustaining community STI rates. Despite these observations, surprisingly little is known about women with increased numbers of sexual partners, the factors which contribute to increased partner number, and the potential for those factors to be intervened upon to reduce risk for STI. The implications of these facts for STI/HIV prevention efforts are profound. For instance, interventions that include the implication that target audiences have multiple sex partners might be dismissed as irrelevant by those with single partners. Conversely, interventions targeting women with multiple sex partners may be based on assumptions derived from data which, while representative of the general target audience, may not reflect relevant circumstances for the subset of women with higher numbers of partners.

This study will begin to generate data that will provide critical information on this topic and help inform future development of STI/HIV interventions tailored to womens' individual circumstances and contexts. The investigators hypothesize that women with 4 or more sexual partners during the past year will report higher rates of depression and substance abuse (alcohol and drugs), higher rates of intimate partner violence, less social support, more non-vaginal sex, more same-sex contacts, and higher rates of STIs than women reporting only one sexual partner during the past year.

The objectives of this protocol are: (1) To delineate factors that are important modifiable predictors of sexually transmitted infection (STI) risk in the context of increased numbers of sexual partners, comparing those participants with one sexual partner to those with 4 or more sexual partners during the past year. (2) To define the prevalence of infection with Chlamydia, gonorrhea, trichomoniasis, syphilis, genital herpes, and HIV in women reporting one sexual partner in the past year compared to women reporting 4 or more sexual partners during the past year.

Eligibility Criteria:
Inclusion Criteria:

* female,
* age 16 years or older,
* report of either one sexual partner during the past year or 4 or more sexual partners in the past year,
* able to provide written informed consent

Exclusion Criteria:

* Drug and/or alcohol intoxication at the time of enrollment,
* exhibition of any type of disruptive or unsafe behavior that would not be conducive to participating in this study
FIBROmyalgia: Somatic Tracking and Exercise Program Study

The goal of this clinical trial is to learn if the combination of two interventions is more effective in treating fibromyalgia symptoms than one intervention alone. The participant group will be people with fibromyalgia in age group 18-65 years. The two interventions to be tested over sixteen weeks are:

* weekly exercise sessions in groups
* weekly consultations with a therapist

The main question it aims to answer is: Is the combination of group exercising and somatic tracking work more efficient than physical activity alone in terms of managing fibromyalgia?

Participants will wear Fitbit activity trackers, register pain intensity daily on a mobile app, and answer the Fibromyalgia Impact Questionnaire (FIQ). They will be divided into four groups:

* one group receiving the exercise intervention
* one group receiving the psychological intervention
* one group receiving both intervention
* one control group recieving general physical activity recommendations

Before the sixteen weeks intervention period, there will be a baseline period of eight weeks. Durng the baseline period, participants will wear activity trackers and maintain their usual lifestyle.

Researchers will compare the combination of the interventions against only one intervention and the control group.

Fibromyalgia is a chronic condition characterised by musculoskeletal pain, fatigue, poor sleep and an overall reduced quality of life. It is well known that physical activity improves symtpons of fibromyalgia, although not all people affected by the condition have positive experiences from exercising. People with fibromyalgia have also stated that physical activity alone is not enough for managing symptomes effectively. This is the background for the proposed randomized controlled trial with a 2\*2 factorial design, where two interventions are tested, alone and in combination.

There will be a baseline period of 8 weeks and an intervention period of 16 weeks.

Evaluations will occur at the end of the baseline period (8 weeks), half-way through the intervention period (16 weeks), and at the end of the intervention period (24 weeks).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with fibromyalgia according to the criteria specified in Wolfe et al (2016)
* Able to perform light physical activity
* Able to provide written informed consent
* Owning a smartphone
* Able to be followed for 24 weeks

Exclusion Criteria:

* Pregnant
* Severe co-morbid psychiatric or neurological disorders
* Current participation in another clinical trial
* Recent surgery or other physical constraints preventing exercise
A Phase 2 Study to Evaluate Safety of Long-term AL001 Dosing in Frontotemporal Dementia (FTD) Patients (INFRONT-2)

A Phase 2 open label study evaluating the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of AL001 in participants with a Granulin mutation or C9orf72 mutation causative of frontotemporal dementia.

This is a Phase 2, multicenter, open label study evaluating the safety, tolerability, PK and PD of AL001 administered intravenously in participants with a Granulin mutation or C9orf72 mutation causative of frontotemporal dementia.

Eligibility Criteria:
Inclusion Criteria:

* At screening, female participants must be nonpregnant and nonlactating
* In good physical health on the basis of no clinically significant findings from medical history, physical examinations (PEs), laboratory tests, ECGs, and vital signs.
* Participant is a carrier of a loss of function progranulin gene (GRN) mutation or carrier of a hexanucleotide repeat expansion C9orf72 mutation

Exclusion Criteria:

* Known history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric, human, or humanized antibodies or fusion proteins.
* History of alcohol abuse or substance abuse
* Participant resides in a skilled nursing facility, convalescent home, or long term care facility
Sleep Apnea in Look AHEAD Participants - Ancillary to Look AHEAD

To assess the effects of weight loss on sleep disordered breathing in obese, Type 2 diabetics with obstructive sleep apnea.

BACKGROUND:

Weight loss is a frequently recommended treatment for obese patients with obstructive sleep apnea (OSA). The empirical support for this recommendation is lacking. Based on descriptive studies, weight loss appears to improve but not abolish sleep disordered breathing. Moreover, the degree of improvement in OSA is quite variable and not directly proportional to weight loss. The lack of randomized trials, the study of predominantly male samples, and the absence of follow-up evaluations leave physicians and patients unsure about the utility of weight loss treatment in obese OSA patients.

The study is ancillary to the Look AHEAD clinical trial which is sponsored primarily by the National Institute of Diabetes and Digestive and Kidney Diseases and secondarily by the National Heart, Lung, and Blood Institute, the National Institute of Nursing Research, the Office of Research on Women's Health, the National Center on Minority Health and Health Disparities, and the Centers for Disease Control and Prevention. The Look AHEAD study is a multicenter, randomized clinical trial to examine the long-term effects of a lifestyle intervention designed to achieve and maintain weight loss in overweight diabetics.

DESIGN NARRATIVE:

The study will assess the effects of weight loss on sleep disordered breathing in 120 obese, Type 2 diabetics with obstructive sleep apnea (respiratory disturbance index \[RDI\] greater than or equal to 15) who are randomly assigned to either weight loss (n=60) or usual care (n=60) treatments within the context of the Look AHEAD study. Home polysomnography studies will be performed before treatment and at one and two years. Among the 60 weight loss subjects, the investigators will assess the relative importance of changes in neck and abdominal fat in explaining the variability of changes in sleep disordered breathing after weight loss. Finally, they will examine the relationship between changes in sleep-disordered breathing and changes in blood pressure after weight loss in the 60 weight loss participants. Specifically, this research will: 1) determine the efficacy of a weight loss program in reducing sleep disordered breathing in obese Type 2 diabetics; 2) identify sources of variability in sleep disordered breathing associated with weight loss; and 3) examine the role of sleep disordered breathing in mediating changes in blood pressure associated with weight loss. The results of this study will provide an empirical basis for making recommendations about the effectiveness of weight loss in Type 2 diabetics with OSA.

Eligibility Criteria:
An estimated 176 obese, diabetic subjects with obstructive sleep apnea, 50% women and 40% minorities.
Iron Metabolism in Dragon Boat Athletes

The purpose of the study is:

* To investigate the effect of sport-specific stress in the iron metabolism of dragon boat athletes
* To investigate the effects of sport-specific stress in the activity of pro-hepcidin and hepcidin

This investigation evaluates the effects of sport-specific stress in iron metabolism of dragon boat athletes. Recent studies showed a significant increase in hepcidin activity under exercise (Röcker L. et al.(2005): Iron regulatory protein hepcidin is increased in female athletes after a marathon. European Journal of Applied Physiology, S. 95, 569-571)which possibly influences the iron metabolism.

In particular in this investigation the activity of pro-hepcidin and hepcidin under sport-specific stress is analysed. Therefore elite dragonboat athletes will be included to this study. Every athlete is tested once. At one exercise day from every athlete the iron metabolism especially the change of hepcidin, prohepcidin and iron before and after a specific dragonboat intervention is analysed.

Eligibility Criteria:
Inclusion Criteria:

* athletes performing dragon boat sport

Exclusion Criteria:

* acute clinically significant intercurrent diseases
Popliteal SNB:Evaluation of Block Dynamics After Subparaneural Injection Below CPN & TN

This study aims to assess the effect of twin subparaneural injection into individual paraneural sheaths of Common Peroneal Nerve (CPN) and Tibial Nerve (TN) below their point of divergence from the sciatic nerve on the sensory motor blockade after Popliteal Sciatic Nerve Block (PSNB) at the popliteal fossa (back of the thigh) for patients requiring lower limb surgeries.

Ultrasound (US) guided Popliteal Sciatic Nerve Block (PSNB) has been routinely used to provide surgical anaesthesia for ankle and foot surgeries, and the introduction of ultrasound (US) guidance has improved the ease and accuracy of performing PSNB. However, the challenge of achieving the optimal 'readiness for surgery' time after the US guided PSNB continues to confront anaesthesiologists. Cumulative evidence indicates that a subparaneural PSNB improves sensory motor block outcome when compared to subepimyseal PSNB where the local anaesthetic is deposited outside the paraneural sheath.

While these are encouraging results, producing sensory motor blockade, i.e. surgical anaesthesia in the area innervated by the sciatic nerve within 30 minutes of local anaesthetic (LA) injection, after a subparaneural PSNB, remains a challenge with the success rate varying from 62-92%. Reasons for this shortcoming, despite LA being deposited in subparaneural space, close to the epineurium of the sciatic nerve, is probably multifactorial as the nerve size, surface area exposed to local anaesthetic, and internal architecture (the connective tissue component) of the sciatic nerve and its branches are all seems to influence block onset time and completeness. It was observed from our clinical practice that distal subparaneural injection (twin halo) into individual paraneural sheaths of common peroneal nerve (CPN) and tibial nerve (TN) below the point of divergence at the popliteal fossa demonstrated a faster sensory motor blockade after PSNB. Therefore, this study aims to assess the effect of twin subparaneural injection into individual paraneural sheaths of CPN and TN below their point of divergence from the sciatic nerve on the sensory motor blockade after PSNB at the popliteal fossa.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status I-III scheduled to undergo elective foot and/or ankle surgery under regional anesthesia.

Exclusion Criteria:

* Patient refusal, ASA physical status \> Ⅲ, pregnancy, neuromuscular disorder, prior surgery in the popliteal fossa, coagulopathy, allergy to local anaesthetic drugs, and skin infection at the site of needle insertion.
Study of PREMEdication Before Laryngoscopy in Neonates in France

This study is a national prospective survey on practices of premedication before laryngoscopy in neonates. The survey will evaluate adequation to the French best practice guidelines to improve their dissemination and to identify current practices of premedication before laryngoscopy in neonates in French units (agents, dosing, efficacy, safety)

Laryngoscopy for intubation or less invasive surfactant administration (LISA) in neonates is a stressful and painful procedure that necessitates a sedo-analgesia except in the case of an immediate life-threatening emergency. Nevertheless, there are discrepancies in premedication practices amongst neonatal units. In order to optimize analgesia before laryngoscopy in neonates, the French neonatal society issued best practice guidelines in January 2023 for premedication before laryngoscopy in neonates. These guidelines were published in an English peer-reviewed journal and presented in national conferences. However, the implementation of new premedication protocols in neonatal units can be made difficult due to local habits, poor dissemination of the guidelines and a limited level of evidence on some premedication agents. Thus, conducting a survey one year after issuing the best practice guidelines on premedication seems important to evaluate French premedication practices and to evaluate the impact and dissemination of the guidelines

Eligibility Criteria:
Inclusion Criteria:

* Every neonate (corrected gestational age \< 45 weeks of gestation) that undergoes a laryngoscopy (for intubation or LISA) or a laryngeal mask insertion, that received a premedication or not during the 28 days of the survey.

Exclusion Criteria:

* Laryngoscopy or laryngeal mask insertion in the operating room
* Opposition to data collection of a parent or holder of parental rights
Feasibility Study of the Vessel Restoration System (VRS) for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery (SFA) and/or Popliteal Artery (PA) After Sub-optimal Percutaneous Transluminal Angioplasty (PTA) or Atherectomy: REACTIVATE I

Feasibility Study of the Vessel Restoration System (VRS) for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery (SFA) and/or Popliteal Artery (PA) after Sub-optimal percutaneous transluminal angioplasty (PTA) or Atherectomy: REACTIVATE I


Eligibility Criteria:
Inclusion Criteria:

Subjects for this study must meet all of the following general eligibility criteria

AND the answer must be "YES" to all general inclusion criteria:

1. Subject (or Legal Guardian) is willing and able to provide consent before any study-specific tests or procedures are performed and agree to attend all required follow-up visits.
2. Male or female subject of at least 18 years of age.
3. Chronic symptomatic lower limb ischemia defined as Rutherford classification 2, 3, or 4.
4. Has screen failed from the ACTIVATE II study due to the presence of Grade C or D dissection(s).

Exclusion Criteria:

1. Life expectancy, documented in the Investigator's opinion, of less than 1 year.
2. Cerebrovascular accident (CVA) or transient ischemic attack (TIA) or cardiac event (e.g., PCI for STEMI/NSTEMI, unstable angina) within 6 months prior to the index procedure.
3. Chronic renal insufficiency with serum creatinine ≥ 2.5 mg/dL or eGFR \<45 ml/min within 30 days prior to the index procedure or treatment with peritoneal or hemodialysis.
4. Subject has a platelet count \< 100,000 cells/mm3 or \> 700,000 cells/mm3 within 30 days prior to the index procedure or has a history of bleeding diathesis.
5. Receiving oral or intravenous immunosuppressive therapy.
6. Subject has white blood cell (WBC) count \< 3.0 (3,000 cells/mm3) within 30 days prior to the index procedure.
7. History of major amputation in the target limb.
8. Any major intervention planned at the index procedure or within 30 days post-index procedure including treatment of contralateral limb.
9. Subject is pregnant, breastfeeding, or planning to become pregnant in the next 30 days. Subjects (male and female) of childbearing potential must agree to use effective birth control measures for 30 days after the index procedure.
Dietary Intervention With Únicla Dairy Products (DANTIAN)

Dietary intervention with Únicla dairy products, naturally enriched with selenium and omega-3 fatty acids, may improve thyroid-stimulating hormone (TSH) levels in women with subclinical hypothyroidism

To analyze in women diagnosed with subclinical hypothyroidism, the effects of consumption of dairy products rich in selenium and omega-3 on symptoms related to thyroid disease and blood lipid profile, inflammatory response, and fatty acid levels in the red blood cell membrane among others.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of subclinical hypothyroidism
* TSH levels between 3 and 10 mIU / L
* Normal levels of free triiodothyronine ( T3) and free thyroxine (T4)
* Without previous or current treatment with levothyroxine

Exclusion Criteria:

* Thyroid surgery or reception of radioactive iodine in a previous period of 12 months
* History of cardiovascular disease and / or thrombosis
* Established diagnosis or clinical suspicion of kidney or liver failure, chronic infections, blood diseases, type I diabetes and type II diabetes
* Drug treatments that affect thyroid function (corticosteroids, amiodarone, propranolol, lithium)
* Statin treatment and / or hormone replacement therapy
* Adjuvant treatment with trace elements, vitamins or antidepressant and antipsychotic drugs
* Hospitalization for serious illness or elective surgery in the past 4 weeks
* Diseases and / or treatments that affect intestinal absorption (proton pump inhibitors)
* Pregnant, planning to become pregnant or breastfeeding women
* Consumption of ω-3 PUFA type food supplements
* Intolerance and / or allergy to lactose and / or cow's milk proteins
* Any pathology that requires close control, advises against their participation or there is an inability to move independently
* Habitual residence outside the study's influence area
* Participation in another clinical trial with drugs, or in other experimental studies
* Refuse to sign the informed consent